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510(k) Data Aggregation
(329 days)
Blood Pressure Monitor DSK-1031 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guideline, display of cuff condition, display of body movement detection and two memory accounts to save measurement results.
Blood Pressure Monitor DSK-1031 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at upper arm non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the nylon cuff that is applicable to arm circumference between 8.7 and 16.5 inches (between 220 and 420 mm) and is powered by four AA alkaline batteries or AC adaptor. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines appropriateness of cuff application. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO (World Health Organization) guideline also on the display. User can choose to activate clock function of the device to review measured readings with measurement date and time.
The provided 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1031 (K112620) focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It explicitly states that no clinical tests were submitted because "differences between the subject device and the predicate devices do not affect clinical performance" (Section 6, (2) Clinical tests).
Therefore, the document does not contain the acceptance criteria or a study proving the device meets performance criteria through clinical data. The information below is extracted from the provided text, primarily relating to its equivalence claims which are based on established standards rather than a de novo clinical performance study.
Here's an attempt to answer your request based on the available information:
Acceptance Criteria and Device Performance Study for Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1031 (K112620)
Based on the provided 510(k) summary, the device's "acceptance criteria" for performance are not explicitly stated in terms of specific clinical accuracy thresholds (e.g., mean difference and standard deviation against a reference standard in a clinical study). Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical tests and adherence to recognized standards.
The document states that the device was evaluated "in accordance with IEC and SP-10" to demonstrate substantial equivalence and establish better safety. ANSI/AAMI SP-10 is a key standard for blood pressure monitors. While the specific numerical acceptance criteria (e.g., AAMI accuracy standards for mean difference and standard deviation) are not explicitly listed in the summary, adherence to ANSI/AAMI SP-10 implies meeting those criteria for accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria derived from clinical studies are not presented in this 510(k) summary, and no clinical performance data is reported, this table cannot be fully completed as requested.
However, based on the implicit criteria of substantial equivalence and adherence to ANSI/AAMI SP-10, the "reported performance" is that the device is expected to meet the accuracy requirements of this standard through its design and non-clinical testing.
| Acceptance Criterion (Implied by adherence to ANSI/AAMI SP-10) | Reported Device Performance (Implied from non-clinical tests and substantial equivalence) |
|---|---|
| Blood Pressure Accuracy (Systolic) | Expected to meet ANSI/AAMI SP-10 requirements |
| Blood Pressure Accuracy (Diastolic) | Expected to meet ANSI/AAMI SP-10 requirements |
| Pulse Rate Accuracy | Expected to meet relevant standards |
| Electrical Safety | Conforms to IEC 60601-1:1998 + A1:1991 + A2:1995 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 (various revisions) and CISPR 11 |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable for a clinical test set, as no clinical tests were submitted.
- Data Provenance: Not applicable for a clinical test set. The submission focuses on non-clinical engineering and performance testing against standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable as no clinical test set with expert-established ground truth was submitted.
4. Adjudication Method for the Test Set
- Not applicable as no clinical test set was submitted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No MRMC comparative effectiveness study was done or reported. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool involving human readers.
6. If a Standalone Performance Study (algorithm only without human-in-the-loop performance) was done
- Yes, a form of standalone performance assessment was implicitly done through the non-clinical tests demonstrating compliance with recognized standards such as ANSI/AAMI SP-10. This standard sets forth requirements for the accuracy of automated sphygmomanometers, which constitutes a standalone performance assessment for the device's core function. However, the details of the specific tests and resulting numerical accuracy are not provided in this summary.
7. The Type of Ground Truth Used
- For the non-clinical performance (accuracy) relative to standards like ANSI/AAMI SP-10, the "ground truth" would typically be established by a reference method (e.g., auscultation by trained observers with a mercury sphygmomanometer) as specified in these standards. The specific ground truth used in the underlying tests is not detailed in the summary.
8. The Sample Size for the Training Set
- Not applicable as this is a traditional medical device submission, not an AI/ML-based device that typically involves training sets. The device uses an oscillometric method, which is a well-established algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable as this is not an AI/ML-based device using a "training set." The oscillometric algorithm's principles are based on established physiological measurements and engineering.
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(162 days)
Wrist Blood Pressure Monitor WSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines, display of body movement detection and two memory account to save measurement results.
Blood Pressure Monitor WSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at wrist non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the cuff that is applicable to wrist circumference between 4.9 and 8.9 inches (between 125 and 225 mm), singly mounted. The device is powered by two AAA alkaline batteries. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.
The provided text is a 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor WSK-1011. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, a standalone study for the device's performance against those criteria, or an MRMC comparative effectiveness study.
The summary states:
- "No clinical test report is submitted because differences between the subject device and the predicate devices do not affect clinical performance."
- "The subject device was evaluated in accordance with IEC and SP-10 not only to demonstrate the substantial equivalence but also to establish the better safety."
Therefore, based solely on the provided text, I cannot directly answer most of your detailed questions regarding acceptance criteria, study specifics, ground truth, and sample sizes for a clinical performance study. The document explicitly states no clinical test report was submitted due to assumed equivalence in clinical performance.
However, I can extract information related to the non-clinical tests that were performed.
Here's what can be inferred or directly stated from the provided text, with limitations:
1. Table of acceptance criteria and the reported device performance:
Since no clinical study report is provided, specific numerical acceptance criteria (e.g., mean difference, standard deviation) for blood pressure accuracy cannot be extracted from this document, nor can the device's performance against such criteria. The document states the device was evaluated according to IEC and SP-10 standards. These standards (such as ISO 81060-2 for non-invasive sphygmomanometers) would define the acceptance criteria for accuracy.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/Not provided. No clinical test set details are given.
- Data Provenance: Not applicable/Not provided for clinical data. The non-clinical tests follow IEC and SP-10 standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No clinical test set details are given.
4. Adjudication method for the test set:
- Not applicable/Not provided. No clinical test set details are given.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a blood pressure monitor, not an AI-powered diagnostic imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document implies that the device's performance was evaluated through non-clinical bench testing against established standards (IEC and SP-10) for substantial equivalence in safety and effectiveness. A standalone clinical performance study was explicitly stated as not submitted.
7. The type of ground truth used:
- For non-clinical tests, the "ground truth" would be measurements obtained using reference standards and calibrated equipment as specified by IEC and SP-10 standards for blood pressure monitor testing.
- For clinical performance, if a study were done, the ground truth for blood pressure measurement would typically be established by validated invasive or non-invasive reference methods (e.g., auscultatory method by trained observers using a mercury sphygmomanometer). However, as stated, no clinical tests were submitted.
8. The sample size for the training set:
- Not applicable/Not provided. This device is a hardware blood pressure monitor, not an AI/machine learning model that typically requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided, for the same reason as above.
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(162 days)
Blood Pressure Monitor DSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines display of body movement detection and two memory account to save measurement results.
Blood Pressure Monitor DSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at upper arm non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the nylon cuffs, regular size cuff for arm circumference between 8.7 and 12.6 inches (between 220 and 320 mm) and large size cuff for arm circumference between 8.7 and 16.5 inches (between 220 and 420 mm), and is powered by four AA alkaline batteries or AC adaptor. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.
The provided text describes a 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1011. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report that establishes clinical efficacy against specific acceptance criteria.
The acceptance criteria for blood pressure monitors are typically defined by recognized standards such as the ANSI/AAMI/ISO 81060-2 standard (or its predecessors, such as ANSI/AAMI SP10). However, the document states that no clinical test report was submitted because "differences between the subject device and the predicate devices do not affect clinical performance." Instead, non-clinical tests were performed.
Therefore, this response will outline the typical acceptance criteria for blood pressure monitors (as implied by the referenced standards) and explain that the provided document does not directly present the results of a study proving the device meets these criteria through clinical testing. It relies on non-clinical testing and substantial equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance
Since no direct clinical study results with specific performance metrics are provided in the document, I will outline the typical acceptance criteria for automated sphygmomanometers (based on standards like ISO 81060-2, which is what "IEC and SP-10" likely refer to for blood pressure monitors) and note that the document claims the device meets these standards through non-clinical testing and substantial equivalence.
| Acceptance Criteria (Typical for Automated Sphygmomanometers per e.g., ISO 81060-2) | Reported Device Performance (as implied by the document) |
|---|---|
| Accuracy (Mean Difference) | The device was evaluated in accordance with "IEC and SP-10" (referring to standards like ANSI/AAMI SP-10, which specifies accuracy requirements for automated sphygmomanometers). The conclusion from non-clinical tests states "the subject device is not only as safe and as effective as the predicate devices but is also safer and more effective than the predicate devices." This implies that the device meets the accuracy requirements specified in these standards for both systolic and diastolic blood pressure. |
| Accuracy (Standard Deviation) | (See above) Implied to meet the standard deviation requirements as per "IEC and SP-10". |
| Cuff Pressure Accuracy | Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.) |
| Pressure Indication Range | 3 to 300 mmHg. (This is a specification, not a performance criterion, but tested against the device's stated capabilities.) The document indicates this range was tested and found acceptable during non-clinical tests. |
| Pulse Rate Accuracy | Implied to meet accuracy requirements as per "IEC and SP-10" since it determines pulse rate. |
| Electromagnetic Compatibility (EMC) | Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.) |
| Electrical Safety | Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.) |
| Mechanical Safety | Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.) |
| Biocompatibility of Patient Contacting Materials | Passed. The patient contacting materials had been used with predicate devices and do not go through any different process, implying their biocompatibility has been previously established. |
| Software Verification and Validation | Passed. (Though not explicitly detailed, implicitly covered under "non-clinical tests" to ensure device functionality, including features like irregular pulse rhythm detection, body movement detection, and memory functions, perform as intended.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable (N/A) – No clinical test set data is provided in this document. The submission states, "No clinical test report is submitted."
- Data provenance: N/A
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A – No clinical test data is provided. For blood pressure monitor clinical studies (which were not submitted here), ground truth is typically established by trained technicians or clinicians using a reference standard device (e.g., a mercury sphygmomanometer) following a rigorous protocol (like the auscultatory method).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A – No clinical test data is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A – This document is for a standalone blood pressure monitor, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in effect, a standalone evaluation was performed, albeit via non-clinical testing and substantial equivalence arguments. The device itself is an automated, standalone blood pressure monitor. The submission concludes, based on non-clinical tests against recognized standards ("IEC and SP-10") and comparison to predicate devices, that the device is "as safe and as effective" as its predicates. This implies the device's algorithm and hardware were validated in a standalone capacity to meet the performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" refers to the established reference values and performance metrics defined by the "IEC and SP-10" standards (e.g., accuracy requirements against a precisely calibrated pressure source or a clinical reference standard). The device was tested to conform to these predefined standard requirements.
8. The sample size for the training set
- N/A – This document does not describe a machine learning algorithm that requires a separate training set. The device uses an oscillometric method, which is a well-established principle for blood pressure measurement, not typically "trained" in the manner of deep learning models.
9. How the ground truth for the training set was established
- N/A – Not applicable as there is no mention of a training set for a machine learning model.
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(245 days)
FB-270/DS-270 is a portable blood pressure monitor for non-invasive blood pressure measurement, monitoring intraday variance of blood pressure in daily life. They measure systolic and diastolic blood pressure and heart rate, at set interval within 24/48 hours or manually, and store the data to SD card (memory card). The collected data can ensure the change in the day of the blood pressure in the personal computer using CD-ROM for exclusive setup. Physicians at medical institutions will check the data on personal computer for analysis of hypertensive and hypotensive diseases.
Ambulatory Blood Pressure Monitor FB-270/DS-270 measures highest and lowest blood pressure and heart rate, automatically at interval within 24/48 hours or manually, by its measuring algorithm written in SD card (memory card) inserted into FB-270/DS270. The measuring algorithm is written into SD card by personal computer with specific software installed. Physicians at medical institutions will check stored data of intraday blood pressure variance in daily life on personal computer. This device consists of Cuff main unit employing both Riva-Rocci Korotkov method and oscillometric method, and cuff unit. The cuff can be applied to upper arm circumference in range of 9.06 in. to 12.6 in. (230 mm to 320 mm) for Cuff respectively. Microphone detecting Korotkov sound is incorporated into the device. The cuff consists of pressurizing blooder and nylon cover, and the device consists of microcomputer, event switch, pump, electronically controlled exhaust valve, microphone and indicator. Programming to the device, readout of data measured by the device, and analysis of measurement results are executed by personal computer with exclusive analysis software BH-270 installed. Programming to SD card and readout of measured data from SD card are executed by general use memory reader. Physicians can analyze various graphs such as trend graph, distribution map, histogram, correlation diagram displayed on PC.
The provided text describes the Ambulatory Blood Pressure Monitor FB-270/DS-270 and its substantial equivalence to predicate devices, focusing on technical characteristics and safety testing rather than a specific clinical study with detailed acceptance criteria and reported device performance.
Therefore, many of the requested items cannot be fully extracted based on the provided document. However, I can provide information on what is available:
1. A table of acceptance criteria and the reported device performance
The document states that the device was subjected to tests according to IEC60601-1 (electrical safety), IEC60601-1-2 (electromagnetic compatibility), and ANSI/AAMI SP10 (blood pressure measurement accuracy). It reports that the device "passed the tests of these standards and met the requirements."
- Acceptance Criteria (General): Meeting the requirements of IEC60601-1, IEC60601-1-2, and ANSI/AAMI SP10.
- Reported Device Performance: "passed the tests of these standards and met the requirements."
Specific numerical acceptance criteria and performance metrics (e.g., mean difference and standard deviation for blood pressure measurements as per ANSI/AAMI SP10) are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to a "clinical study made for DS-240 according to ANSI/AAMI SP10" and states its applicability to the subject device, suggesting that no new clinical study specifically for the FB-270/DS-270 was conducted or detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As implied above, a new clinical study with expert ground truth establishment for the FB-270/DS-270 is not explicitly detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is an Ambulatory Blood Pressure Monitor, which measures physiological parameters. It is not an AI-assisted diagnostic imaging device requiring a multi-reader multi-case study or assessing human reader improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently "standalone" in its measurement function (algorithm only). The measurement algorithm itself is described as performing measurements without human intervention during the monitoring period. Its performance is assessed against the ANSI/AAMI SP10 standard, which evaluates the accuracy of the blood pressure measurement algorithm directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood pressure monitors evaluated against standards like ANSI/AAMI SP10, the "ground truth" typically involves simultaneous measurements by trained observers using a reference standard (e.g., mercury sphygmomanometer) following a specific protocol. The document states "Because there is no technical difference of measuring algorithm and measuring accuracy, we consider clinical study made for DS-240 according to ANSI/AAMI SP10 is also applicable to the subject device." This implies the ground truth for the predicate device's study (DS-240) would have been established according to the ANSI/AAMI SP10 standard, which requires expert comparison measurements.
8. The sample size for the training set
This information is not provided. The document describes the device's measurement algorithm, but does not discuss training data for an AI/machine learning model.
9. How the ground truth for the training set was established
This information is not provided. The document does not describe the training of a machine learning model, and therefore no ground truth for a training set is discussed.
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(106 days)
WS-1100WS-1100PV system is intended for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adults in a homecare environment.
The device features include the display of irregular pulse rhythm detection, the classification display of measured blood pressure values against the guideline by World Health Organization or equivalent guidelines, the personal setting for individual blood pressure target values, the two memory banks to save the measurement results with date and time of measurement and the transferring the saved results to personal computers.
Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are measured in the wrist artery using the oscillometric method. WS-1100WS-1100PV is a single-mounted device of the main unit and the cuff unit. ABS and PMMA are used for the outer housing of the main unit and the Lenticular image is printed as the positioning guide to remind the user to take correct posture for blood pressure measurement. The preformed cuff unit, which is applicable to wrist circumference approximately between 4.9 and 8.5 inches (between 125 and 215 mm), includes the inflatable bladder and the nylon shell. The device consists of the microprocessor, the pressure-frequency converter, the operation keys, the pump, the electromagnetic deflation control valve (ECV) and the display. The device is powered by two AAA alkaline batteries. The cuff, wrapped over the user's wrist, is inflated and deflated during the course of a measurement. Circuits within the cuff sense the oscillations in pressure against the cuff produced by the expansion and contraction of the arteries in the wrist in response to each heart beat. The amplitude of each pressure waves is measured, converted to millimeters of mercury, and displayed on the LCD as a digital value.
Measured blood pressure values are classified against the guideline by World Health Organization or equivalent guidelines and the classified levels are displayed in the reading display. The device compares the measured blood pressure value to the individual target value set by the user and flashes the value when it exceeds the target value.
The device also compares the longest and the shortest time intervals of the detected pulse waves to the mean time interval and flashes heart mark to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25 %.
The user of WS-1100/WS-1100PV can choose to save the measurement results in either one of two memory banks, each of which has the capacity for sixty readings, or not to save the results at the end of a measurement. The results are saved along with the date and time of the measurement and the user can review the saved readings. The device also has feature to display the saved readings taken in the morning and the evening separately. The user can also review the saved readings on a personal computer by downloading saved readings using the designated USB cable included in the product package. The application software is downloaded over the internet.
The provided text describes a 510(k) premarket notification for a Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV. It outlines the device's technical characteristics, intended use, and its comparison to predicate devices, particularly Nissei Model WS-500 Digital Wrist Blood Pressure Monitor (K003444). The document does not provide a detailed report of a study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics. Instead, it refers to compliance with existing standards (IEC60601 and ANSI/AAMI SP-10) and notes a minor difference in the test protocol for wrist circumference compared to the predicate device.
Therefore, many of the requested specific details, such as a table of acceptance criteria with reported device performance, sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study results, standalone performance, and training set information, are not present in the provided text.
Based on the information available:
-
A table of acceptance criteria and the reported device performance:
The document states that the device was tested and "fulfilled the requirements from these standards" (IEC60601 and ANSI/AAMI SP-10). However, specific numerical acceptance criteria (e.g., accuracy ranges for systolic and diastolic pressure, clinical grading based on AAMI criteria) and the corresponding reported device performance values are not provided in the text. It only generally states compliance. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The text mentions "clinical studies performed with the subject device" but does not provide the sample size, country of origin, or whether the studies were retrospective or prospective. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference standard (e.g., mercury sphygmomanometer) following specific protocols, rather than "experts" in the context of image interpretation. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
MRMC studies are typically performed for AI-assisted diagnostic devices where human readers interpret medical images. This device is an automatic blood pressure monitor; therefore, an MRMC comparative effectiveness study in the context of human readers with AI assistance is not applicable and no such study is described. The device is standalone in its measurement function. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the device itself is a "standalone" automatic sphygmomanometer. The document states, "Blood pressure, systolic and diastolic, and pulse rate are measured in the wrist artery using the oscillometric method." The entire description of its operation indicates it functions without real-time human intervention in the measurement process. The compliance with IEC60601 and ANSI/AAMI SP-10 would involve testing this standalone performance against reference methods. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For blood pressure monitors, the ground truth for accuracy studies is typically established by simultaneously measuring blood pressure using a reference standard method (e.g., a mercury sphygmomanometer manned by a trained observer or another validated oscillometric device) in accordance with the protocols outlined in standards like ANSI/AAMI SP-10. The text does not explicitly state this, but it is the standard practice for such devices to meet the referenced standards. -
The sample size for the training set:
This device is not described as using machine learning in a way that requires a separate "training set" in the common AI sense. Its underlying algorithm for oscillometric measurement is based on established physiological principles and signal processing, not on a data-driven machine learning model that would need a large labeled training set. Therefore, this information is not applicable or not provided in the context of this device. -
How the ground truth for the training set was established:
As above, this is not applicable as the device's main function does not appear to rely on a trained machine learning model requiring a ground-truthed training set.
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(248 days)
The Portable Air Massager putifino AM-7 is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Portable Air Massager putifino AM-7 simulates kneading and stroking of tissues by using an inflatable garment (Cuff).
Portable Air Massager putifino AM-7 is a powered inflatable tube massager, which stimulates kneading and stroking of tissues with the hands by pressurizing and depressurizing the massaging garment (cuff) wrapped around the calf. The cotton and velour massaging cuff with inflatable bladder inside is assembled to the controller to facilitate the device's compactness and portability. The device is applicable to calves whose circumferences are between 8.7 to 17.7 inches (22 to 45 cm). With the included attachable extension hook, the applicable range extends to 19.7 inches (50 cm). The device owns three modes of massage pattern and three levels of massage intensity, which are controlled by the microprocessor. Operation of the mode button on the controller during massaging will switch the massage patterns. In MODE 1, massage is given by repetition of pressurization and depressurization of the cuff, where pressurization is set to one pressure level. In MODE 2, massage pattern of MODE 1 is repeated at two pressure levels. In MODE 3, which is intended to temporary increase blood circulation, approximately 10 minutes of massage at low pressure level and approximately 20 minutes of rest are repeated. In MODE 1 and 2, operation of the pressure button on the controller will switch the massage intensities: weak, moderate and hard. The user of the device can confirm both massage mode and level with the illuminated indicator on the controller.
The Portable Air Massager putifino AM-7 is a Class II device (21 CFR 890.5650 - Powered inflatable tube massager) indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. It simulates kneading and stroking of tissues using an inflatable garment (cuff).
This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study. Substantial equivalence is established by comparing the technological characteristics and indications for use of the new device to a legally marketed predicate device. Therefore, a traditional study proving the device meets specific acceptance criteria as you might see for a novel, high-risk device is not presented in this document. Instead, the "study" is the comparison itself, which aims to show that the new device is as safe and effective as the predicate.
Here's an analysis of the provided information in the context of substantial equivalence:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" for novel performance metrics in the way a clinical trial would define them. Instead, the acceptance criteria are implicit in demonstrating that the device's technological characteristics and intended use are similar enough to a predicate device that it raises no new questions of safety or effectiveness.
The table below summarizes the comparison between the subject device (Portable Air Massager putifino AM-7) and the predicate device (Salton, Inc., Relaxor Perfect Touch Air Massaging System K050697), highlighting the similarities that establish substantial equivalence.
| Feature / Acceptance Criteria (Implicit for Substantial Equivalence) | Subject Device: Portable Air Massager putifino AM-7 Performance | Predicate Device: Relaxor Perfect Touch Air Massaging System Performance | Outcome (Meets Acceptance Criteria) |
|---|---|---|---|
| Indication for Use | Temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. Simulates kneading and stroking of tissues using an inflatable garment (Cuff). | Temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. Simulates kneading and stroking of tissues using an inflatable garment. | Meets: Identical indications for use. |
| Operational Principle | Provides massage by inflating and deflating the bladder inside a massaging garment with an air pump and electric control valve. | Provides massage by inflating and deflating a massage garment. | Meets: Same fundamental mechanism of action. |
| Massage Mode/Pattern | 3 massage patterns (Mode 1, Mode 2, Mode 3 - Blood circulation improvement mode). | Not explicitly "patterns" but "Press Zone" and ability to specify massage areas through garments with separated chambers (which the subject device doesn't have). Allows "Intermittent" compression. | Meets: Both use intermittent compression. Differences in specific patterns are considered "product features" that do not affect substantial equivalence. |
| Massage Intensity/Level | 3 massage levels (Weak, Moderate, Strong). | 6 massage levels. | Meets: Both offer variable intensity; difference in number of levels not considered a fundamental safety/effectiveness difference. |
| Massage Pressure Range | Specified pressures for each mode/intensity (e.g., Mode 1: Weak 9.3kPa (70mmHg), Moderate 13.3kPa (100mmHg), Strong 17.3kPa (130mmHg); Mode 2: Weak 70/80mmHg, Moderate 100/110mmHg, Strong 130/140mmHg; Mode 3: 6.0kPa (45mmHg)). Overall pressure range: 0-200mmHg. | Intensity Settings 1-6 with corresponding pressures: 80, 104, 128, 152, 176, 200 mmHg. Overall pressure range: 0-250mmHg. | Meets: Both operate within a comparable and safe pressure range for massager devices, with overlapping pressure values. The maximum pressure of the subject device (200mmHg) is within the predicate's range (0-250mmHg). |
| Intermittent Compression | Yes | Yes | Meets: Both use intermittent compression. |
| Massage Time | Mode1: 10 minutes; Mode2: 10 minutes; Mode3: Approx. 10 mins massage / 20 mins rest (repeated). | 15 minutes. | Meets: Pre-set timer functionality is similar. Differences in specific durations are not considered to raise new safety/effectiveness questions. |
| Massage Part | Calves | Leg & Foot, Feet, Arm, Neck & Shoulders, Lower Back, Hands. | Meets: While the subject device is for calves only, this narrowing of application does not represent a new safety/effectiveness concern. Both are for limb/body massage. |
| Number of Chambers | 1 | 1 to 12, Varies with Garments. | Meets: The subject device's single chamber simplifies its design but does not introduce new risks compared to multi-chamber systems. |
| Material (Operation Unit) | ABS | ABS | Meets: Same material for operation unit. |
| Material (Massage Garment) | Surface: Cotton / Polyester / Nylon; Back: Velour (for the cuff). | TPU; Nylon with TPU Backing 190X70 with TPU Backing. | Meets: Different materials but both are common, biocompatible textiles/plastics used in medical devices and are not expected to cause new safety concerns. |
| Pressure Control | Microprocessor and Pressure Sensor. | Microprocessor. | Meets: Both use microprocessor control. The addition of a pressure sensor in the subject device enhances control rather than creating a new safety risk. |
| Inflation Mechanism | Pressurization pump. | Pressurization pump. | Meets: Same inflation mechanism. |
| Deflation Mechanism | Electronic control exhaust valve. | Exhaust valve. | Meets: Both use an exhaust valve; electronic control is an enhancement, not a new risk. |
| Power Source | 2 x 1.5-Volt "AA" Alkali battery, Consumption 2W. Designed for portability. | Main body: 120V 60Hz, Consumption 26W; AC Adapter: 120V 60Hz, Consumption 36W. | Meets: Different power sources (battery vs. AC) but both are standard and safe for consumer electronics. The portability via batteries is a design difference, not a new safety concern. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission is a 510(k) for substantial equivalence and does not involve a "test set" in the context of clinical performance data collection. Instead, it relies on a comparison of technical specifications and indications for use against a predicate device that is already legally marketed. There is no specified sample size, data provenance, or retrospective/prospective study design in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As explained above, there is no "test set" or "ground truth" derived from expert consensus in this type of 510(k) submission. Substantial equivalence is determined by regulatory review of documented technical specifications and comparison to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication method described in the document. The FDA's review process determines substantial equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a powered inflatable tube massager. It is a physical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to its purpose and regulatory pathway.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. Its performance is inherent in its electromechanical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a device seeking substantial equivalence, the "ground truth" is typically the established safety and effectiveness profile of the legally marketed predicate device. The new device is deemed safe and effective if it does not introduce new questions of safety or effectiveness compared to the predicate.
8. The sample size for the training set
Not applicable. This is a 510(k) for substantial equivalence, not an AI/machine learning device requiring training data.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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(145 days)
The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or known hypertension in a home care environment as an adjunct to medical management.
The device displays irregular pulse rhythm indication when it is detected during measurement.
The Model DS-1901 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of systolic and diastolic blood pressure and pulse rate in adult patients in a homecare environment. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes an air pump for automatic cuff inflation, an electric valve, pushbutton controls, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic blood pressure readings, pulse rate and irregular pulse rhythm a wide-ranged arm cuff and a carrying case. The memory circuit stores the thirty most recent readings plus the computed average of the stored readings, which will be retained after power turn-off or battery removal and can be intentionally deleted. The system is powered by four AA-size batteries or, optionally, by a 6V AC adapter.
The provided text is a 510(k) summary for the NIHON SEIMITSU SOKKI CO., LTD. Model DS-1901 Digital Blood Pressure Monitor. This document explicitly states that there is no difference in intended use and technology characteristics between the subject device and the predicate device (K050697). The reason for the 510(k) submission is to include detection and display of irregular pulse rhythm in the Indications for Use Statement, a feature already present in the predicate device.
Therefore, the study conducted for this specific 510(k) submission (K071384) primarily relies on the equivalency to the predicate device, K050697. The document does not describe a new, independent study with specific acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies for the DS-1901 device itself. Instead, it refers to the performance of the predicate device.
Based on the information provided, here's a best effort to address the prompt, acknowledging the limitations of the document for a direct answer to all questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate) | Reported Device Performance (from Predicate) |
|---|---|
| Pressure: +/- 3 mmHg | Pressure: +/- 3 mmHg |
| Pulse rate: +/- 5% or reading | Pulse rate: +/- 5% or reading |
2. Sample size used for the test set and the data provenance
The document for K071384 does not specify a distinct test set or its sample size. It states that the subject device (DS-1901) is equivalent to the predicate device (K050697). Therefore, the performance data is inferred from the predicate device. The provenance of the data for the predicate device is not detailed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving experts to establish ground truth for this submission, as it relies on equivalency to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study with an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a digital blood pressure monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone automatic blood pressure monitor. Its performance, as stated through equivalency to the predicate, is the "algorithm only" performance for blood pressure and pulse rate measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For blood pressure monitors, the "ground truth" (or reference standard) for accuracy is typically a manually performed auscultatory measurement using a mercury sphygmomanometer or another validated reference device, conducted by trained personnel. This information is not explicitly stated in the provided document but is the common standard for such devices.
8. The sample size for the training set
Not applicable. The document does not describe a training set for an algorithm development for this specific submission, as it relies on equivalency to a predicate device.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a training set or how its ground truth would be established.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is an equivalency study to a previously cleared predicate device, Model 1901 Digital Blood Pressure Monitor (K050697). The 510(k) submission for the DS-1901 explicitly states: "There is not a difference of intended use and technology characteristic between the subject device and any predicate device (K050697)." The reason for the submission was to formally add "detection and display of irregular pulse rhythm" to the Indications for Use, a feature already present in the predicate. The performance specifications (accuracy of pressure and pulse rate measurement) are therefore directly inherited from the predicate device, which would have undergone its own validation testing to demonstrate these accuracies against a reference standard.
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(114 days)
The DM-3000 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adolescents (age 12 to 21 years) adult patients, i.e., age 21 and above and is intended to be operated by physicians or under supervision of a physician.
The Model DM-3000 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement of systolic and diastolic blood pressures and pulse rate in adult patients under the supervision of a physician. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes air pumps for automatic cuff inflation, electric valves, button controls, circuitry to detect and process minute pressure oscillations, a bar LCD to display mercury-column-like pressure flow and a segment LCD to display blood pressure and pulse rate as a digital value and operation indications such as inflation, measurement error and battery error. Measurement can be made either automatically, where entire operation including inflation and deflation of the cuff and determination of blood pressures and pulse rate is automatically done, or manually, where only inflation and deflation of the cuff are automatically done but determination of the blood pressures is done by a physician using a stethoscope. The unit saves the last reading in its memory circuit. The system is powered by the AC adaptor or the rechargeable nickel battery.
Here's an analysis of the provided text regarding the Nissei Model DM-3000 Digital Blood Pressure Monitor with respect to acceptance criteria and supporting studies:
It's important to note that the provided text is a 510(k) Premarket Notification Summary for a blood pressure monitor. These summaries often focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a full, independent clinical study with detailed acceptance criteria for a novel device. As such, some of the requested information (especially regarding performance thresholds, detailed study design, and expert involvement for "AI" or "algorithm" focused criteria) is not explicitly present because the device is a medical measurement instrument, not an AI diagnostic tool.
1. Table of Acceptance Criteria and Reported Device Performance
For the Nissei Model DM-3000 Digital Blood Pressure Monitor, the primary performance criterion is accuracy, which is assessed against the ANSI/AAMI Standard SP10-1992. The document states that the new device has the same measurement accuracy for both blood pressure and pulse rate as its predicate device. This implies that the predicate device's performance already met the ANSI/AAMI standard, and the new device maintains that performance.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Blood Pressure Accuracy (per ANSI/AAMI SP10-1992) | "Same measurement accuracy for both blood pressure and pulse rate" as the predicate device (Nissei Model DM-3000, K993890), which was previously cleared under the same standard. |
| Pulse Rate Accuracy (per ANSI/AAMI SP10-1992) | "Same measurement accuracy for both blood pressure and pulse rate" as the predicate device (Nissei Model DM-3000, K993890), which was previously cleared under the same standard. |
| Electromagnetic Compatibility | Complies with IEC 60601-2, 2001 (with referenced amendments) and IEC 60601-1-2, 2001. |
Note: Specific numerical accuracy thresholds (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in this summary, but would be defined by the ANSI/AAMI SP10-1992 standard.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical evaluation" but does not specify the sample size for any test set. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given that this is a 510(k) for an update to an existing device, it's likely a relatively small clinical evaluation focused on confirming the equivalence of the updated features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth during the clinical evaluation. For blood pressure monitors, ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a auscultatory method with a mercury sphygmomanometer as the reference standard, following established protocols.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method. For blood pressure monitor accuracy studies, multiple reference readings are often taken and averaged, but a formal adjudication process (like 2+1 or 3+1 for discordant readings) is not a typical requirement for establishing ground truth for simple physiological measurements like blood pressure in the same way it would be for image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images with and without AI assistance, and it's not applicable to a non-invasive blood pressure monitor.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation of the device's automatic measurement capabilities was done. The description indicates:
- "Measurement can be made either automatically, where entire operation including inflation and deflation of the cuff and determination of blood pressures and pulse rate is automatically done..."
- The clinical performance and accuracy testing was conducted against the ANSI/AAMI SP10-1992 standard, which is designed to evaluate the standalone performance of automated sphygmomanometers.
7. The Type of Ground Truth Used
For blood pressure monitors, the ground truth is typically established by expert reference measurements, specifically auscultatory readings obtained by trained clinicians using a calibrated reference device (often a mercury sphygmomanometer) in parallel with the device under test. This is the standard method specified in the ANSI/AAMI SP10 standard.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is because the device is a conventional blood pressure monitor, not an AI/ML-based algorithm that requires a "training set" in the machine learning sense. The device uses established oscillometric principles for measurement, validated through engineering design and a clinical evaluation.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. For traditional medical devices like blood pressure monitors, the "ground truth" concept applies to the validation or test set (as discussed in point 7), not a separate training set.
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(7 days)
The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or know hypertension in a home care environment as an adjunct to medical management.
The Model DS-1901 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of systolic and diastolic blood pressure and pulse rate in adult patients in a homecare environment. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes an air pump for automatic cuff inflation, an electric valve, pushbutton controls, circuitry to detect and process minute pressure oscillations, an I.CD display of systolic and diastolic blood pressure readings and pulse rate, a wide-ranged arm cuff and a carrying case. The memory circuit stores the thirty most recent readings plus the computed average of the stored readings, which will be retained after power turn-off or battery removal and can be intentionally deleted. The system is powered by four AA-size batteries or, optionally, by a 6V AC adapter.
Here's a breakdown of the acceptance criteria and study information for the Nissei Model DS-1901 Digital Blood Pressure Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The primary standard referenced for performance and accuracy is the ANSI/AAMI Standard SP10-2002, Electronic or Automated Sphygmomanometers. While the document doesn't explicitly list specific numerical acceptance criteria values for this standard within the provided text, it states that the device meets the standard. The functional performance of the device is described as having the "same measurement accuracy for both blood pressure and pulse rate" as its predicate device (Nissei Model DS-181).
| Acceptance Criteria (from ANSI/AAMI SP10-2002) | Reported Device Performance (DS-1901) |
|---|---|
| Measurement Accuracy for Blood Pressure | Meets ANSI/AAMI SP10-2002; Same measurement accuracy as predicate device (DS-181) |
| Measurement Accuracy for Pulse Rate | Meets ANSI/AAMI SP10-2002; Same measurement accuracy as predicate device (DS-181) |
| Arm Circumference Range Functionality | Evaluated for circumference of 23 to 43 cm with compensating algorithm |
| EMC/EMI Compliance | Meets IEC 60601-1-2, IEC 61000-4-x series |
| Safety and Effectiveness | Well recognized as safe and effective for intended use; Same operating principles and intended uses as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document mentions "clinical evaluation" was performed, but the number of subjects is not provided.
- Data Provenance: Not explicitly stated. Given the manufacturer (Nihon Seimitsu Sokki., Co., Ltd. from Japan) and the submission to the FDA in the US, the clinical evaluation could have been conducted in Japan, the US, or another country. The document does not specify if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For a blood pressure monitor, ground truth is typically established by trained medical professionals (e.g., physicians, nurses) using validated manual methods (like auscultatory measurements using a stethoscope) concurrently with the device being tested. No details are provided about these individuals.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not applicable to a standalone blood pressure monitor. The device itself is designed to perform the measurement, not assist a human in interpreting diagnostic images or data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Standalone Performance: Yes, the entire clinical evaluation (e.g., against ANSI/AAMI SP10-2002) is a standalone performance assessment. The device is intended to provide blood pressure and pulse rate readings directly to the user (patient) or clinician without requiring real-time human interpretation of the measurement process itself. The accuracy metrics associated with the ANSI/AAMI standard directly reflect the standalone performance of the algorithm and hardware.
7. The Type of Ground Truth Used
- Type of Ground Truth: The document implies that the ground truth for blood pressure and pulse rate measurements would have been established using validated reference methods, typically auscultatory blood pressure measurements performed by trained observers, as is standard practice for clinical validation of automated sphygmomanometers per ANSI/AAMI SP10. The text does not explicitly state "auscultation" but refers to the accuracy against the standard, which relies on such methods.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. The DS-1901 is a device that includes an algorithm for measurement and compensation, but it's not a machine learning or AI model trained on a large dataset in the typical sense that would have a separate "training set" and "test set" for algorithm development. Its "algorithm" is likely fixed logic and calculation based on biomedical engineering principles, not a learnable model. While it has a "personal mode" that determines inflation value from past measurements, this is a user-specific adaptation, not a global training process.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the machine learning sense for this device. The "ground truth" for developing the underlying measurement algorithms would be based on fundamental physiological and engineering principles, validated against established reference methods during the device's design and engineering phases.
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(15 days)
For the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e. age 18 and above. The product is recommended for use by patients capable of understanding written and/or oral directions in a home care environment.
The Nissei Model DS-1862 is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of blood pressure and heart rate. The method of operation is the oscillometric method and the site of measurement is the brachial artery in the arm. The system is microprocessor controlled and includes an air pump for automatic inflation; fuzzy logic to regulate opening cuff pressure, circuitry to detect and process minute pressure oscillations; an electromagnetic deflation-rate control valve, an eleven-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the thirty most recent measurement results for two patients plus the computed average of the stored readings; error displays, a standard arm cuff, and an optional large arm cuff.
The provided documents describe the Nihon Seimitsu Sokki Co. Ltd. (Nissei) Model DS-1862 Digital Blood Pressure Monitor and its substantial equivalence to a predicate device, the Nissei DS-181.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the performance specifications of the predicate device, which the new device (DS-1862) aims to match or improve upon. The reported device performance for the DS-1862 is stated as "SAME" across several key metrics, implying it meets or exceeds the predicate's specifications.
| Acceptance Criteria (Predicate Device DS-181) | Reported Device Performance (DS-1862) |
|---|---|
| Operating Principle: Oscillometric method | SAME (Oscillometric method) |
| Indication for use: For noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e., age 18 and above. | SAME |
| Display: 7 Digit LCD | 11 Digit LCD |
| Measurement Range: Sys 50-250 mm Hg (cuff press.) Dia 40 to 180 mm Hg Pulse rate 40 to 160 pulse/min | SAME |
| Accuracy: ±3 mm Hg (cuff press.) ±5% of reading (pulse rate) | SAME |
| Cuff arm circumference: 230 to 320 mm | 170 to 350 mm |
| Power supply: Four AA size batteries | SAME |
| External dimensions: 160mm W x 100mm D x 52mm H | 163mm W x 180mm D x 83mm H |
| Memory: 7 Measurement results, Computation of the average of stored data. | 30 Measurement results x 2, Computation of the average of stored data. |
| Weight: 265 g. w/o batteries | 420 g. w/o batteries |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). They only mention "bench and user testing" and "clinical testing data."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable in this context. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting results with and without AI assistance. The study focuses on the device's accuracy compared to a validated predicate.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was effectively performed. The device itself is an automated system for measuring blood pressure. The "bench and user testing" and "clinical testing data" likely refer to the performance of the device's algorithm and hardware in isolation, as well as its use by individuals. The focus is on the device's intrinsic accuracy and functionality.
7. Type of Ground Truth Used
The ground truth for the accuracy assessment (±3 mm Hg for cuff pressure and ±5% for pulse rate) would typically be established by a validated reference measurement method. For blood pressure monitors, this usually involves:
- Auscultation by trained observers: Using a mercury sphygmomanometer and stethoscope, where multiple trained observers independently take readings, and their consensus or average is used as the reference.
- Invasive arterial pressure measurement: In a clinical research setting, direct intra-arterial pressure measurement can be used as the gold standard, though this is less common for routine validation of home-use devices.
The documents do not explicitly state which method was used, but the "Accuracy" specification (±3 mm Hg) is a standard requirement for blood pressure monitors and implies comparison against a highly accurate reference.
8. Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. While the device uses a "pressure measurement algorithm designed to detect, filter, process, and store pressure readings," the documents do not provide any information about a specific training set or its size. For older-generation oscillometric devices, the "algorithm" is often based on established mathematical models and signal processing techniques rather than a machine learning model that requires a distinct training phase with labeled data in the same way modern AI systems do.
9. How the Ground Truth for the Training Set Was Established
Given the lack of information on a specific "training set" in the context of modern machine learning, this information is not provided and likely not applicable in the typical sense for this type of device and its submission. The algorithms for oscillometric blood pressure measurement are generally developed and refined based on engineering principles and physiological understanding, and then validated with clinical testing against established reference methods.
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