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The BGP-100 blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.

Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement.

BGP-100 Sein Blood Glucose & Pressure Monitor system BGP-100 combines the function of a blood glucose monitoring system and a blood pressure meter in one unit. Supplies with the meter are test strips, lancets, lancing device, storage case and control solution. The blood glucose monitoring system is turned on by strip insertion; Once the user confirms that the numerical code on the display, and strip bottle all match, a test strip is inserted into the meter and glucose testing can proceed. The user then supplies finger-tip blood or control solution to the strip and the meter starts the measurement, which is completed in 5 seconds. Sein Electronics Co., Ltd has provided instructions and illustrations explaining, that the blood drop will be pulled into the strip sample entry by capillary action until meter beeps and the result will be show on liquid crystal display ("LCD") after 5 seconds. Results are automatically stored in the meter's memory for tracking purposes. The capacity of memory is 150 blood glucose values and average value of past 14 days or 30days. Control Solution is sold separately from the kit. BGP-100 adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface panel has power switch, mode switch, memory switch, for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 60 most recent measurement results. User should wrap the pressure cuff around the wrist with the palm facing up and pushes the "Power" button. The cuff will be full with appropriate air pressure automatically. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically repressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The air of cuff is automatically deflated during blood pressure measurement. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.

The provided text is a 510(k) summary for the "Blood Glucose and Blood Pressure Monitor System, Model BGP-100." While it describes the device and its intended use, it does not include detailed information on acceptance criteria for device performance or a study demonstrating that these criteria have been met. It primarily focuses on demonstrating substantial equivalence to predicate devices, but the performance data itself is absent from this document.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance details.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This information would typically be found in a more detailed performance study report within the full 510(k) submission, not necessarily in the publicly available summary. The summary states "Performance" as a technological characteristic in a comparison table but leaves it blank, suggesting the details are in the main submission.

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This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using wrist cuff and oscillometric method of measurement.

Full Auto Wrist Digital Blood Pressure Monitor SE-311 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement.

There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents.

The user interface panel of SE-311 has power button, time button, time button, user button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure, pulse rate, time, date and user. SE-311 has memory capacity to store the 180 most recent measurement results for four users and the function to transmit the measured data to PC through RS232C cable.

The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate.

All system functions are preprogrammed. The user is cautioned in the instruction manual aqainst attempting any programming or other modification.

No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.

The provided text is a 510(k) summary for the Sein Electronics Co., Ltd. Full Auto Wrist Digital Blood Pressure Monitor SE-311. This summary focuses on demonstrating substantial equivalence to a predicate device (SE-312) rather than presenting a standalone study with detailed acceptance criteria and performance data from a new clinical trial.

Therefore, much of the requested information regarding a specific study to prove the device meets acceptance criteria, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, or detailed ground truth methodologies, cannot be extracted from the provided text. The submission's primary argument for safety and effectiveness is based on the device being "safe and effective as the predicate device cited above" due to "identical" or "similar" technological characteristics.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges for blood pressure measurements) for the SE-311 and then report the SE-311's performance against these criteria. Instead, it claims "Performance: Identical" to the predicate device (SE-312).

Here's a table based on the provided "Summary comparing technological characteristics with predicate device":

2. Sample size used for the test set and the data provenance

• Sample size for the test set: Not provided. The submission focuses on comparing technological characteristics to a predicate device, not on presenting a new clinical study with a test set of patients.
• Data provenance: Not provided, as there's no mention of a specific clinical study for the SE-311 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/Not provided. The submission does not describe a clinical study where experts established ground truth for a test set.

4. Adjudication method for the test set

• Not applicable/Not provided. No test set or adjudication method is described.

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

• No. This device is a digital blood pressure monitor, not an AI-assisted diagnostic tool. An MRMC study is not relevant here, and no such study is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The device performs measurements automatically using the oscillometric method. Its standalone performance is inherently what is being described as "identical" to the predicate. However, detailed results of such a standalone performance test are not provided in this summary. The user applies the cuff and initiates the measurement, but the measurement itself is automated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not explicitly stated for the SE-311. For blood pressure monitors, ground truth typically involves simultaneous or near-simultaneous measurements using a recognized reference standard (e.g., mercury sphygmomanometer with auscultation by trained observers) following established protocols (e.g., ISO, AAMI standards). Since the performance is claimed to be "Identical," it's implied that the predicate device (SE-312) adhered to such ground truth methods, and the SE-311 is expected to do the same.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device that would typically have a "training set" in the context of data-driven model development.

9. How the ground truth for the training set was established

• Not applicable/Not provided, as there is no training set described for an AI/machine learning model.

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This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement.

Digital Blood Pressure Monitors SE-9000, SE-9200 and SE-9400 are intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement. There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents. The user interface panels of SE-9200 and SE-9400 have power button, mode button, memory button and liquid crystal display ("LCD") except that SE-9000 has power button, mode/pressure button, memory button, start button. SE-9000, SE-9200 and SE-9400 have memory capacity to store the 140 most recent measurement results. The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate. All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.

The provided document does not contain any information regarding specific acceptance criteria for performance, nor does it detail a study proving the device meets said criteria.

The document is a 510(k) summary for a blood pressure monitor, focusing on establishing substantial equivalence to a predicate device. It briefly touches on device characteristics, intended use, and general safety and effectiveness.

Therefore, I cannot provide the requested information. The document explicitly states:

• "This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)"
• The table in Paragraph 14 only compares technological characteristics and states "Identical" or "Similar" for categories like "Performance," "Design," and "Human factors." It does not provide quantitative performance metrics or acceptance criteria.

To answer your questions, I would need a different type of document, such as a performance study report or a detailed test plan with acceptance criteria.

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This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement

SE-7070 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement.

There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents.

The user interface panel has a power switch, a mode switch, a memory switch and a liquid crystal display ("LCD") for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 58 most recent measurement results.

The device measures blood pressure through the use of a automatic inflating cuff. Pressurization is automatically governed. The device has fuzzy logic function that establishes automatically initial inflation pressure according to blood pressures of patients. The cuff automatically deflates during blood pressure measurement.

The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate.

All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification.

The provided text describes a 510(k) summary for the "Full Auto Arm Digital Blood Pressure Monitor, Model SE-7070." It doesn't contain a detailed study proving acceptance criteria. Instead, it claims substantial equivalence to a predicate device (Full Auto Blood Pressure Monitor, Model SE-7700H) based on similar technological characteristics and performance.

However, based on the general information provided for a blood pressure monitor submission, and general regulatory expectations for such devices, I can construct a hypothetical response that aligns with what would typically be required, highlighting the missing specific data points from this particular document.

It is crucial to note that the detailed "study that proves the device meets the acceptance criteria" is NOT present in the provided text. The text focuses on establishing substantial equivalence through a comparison of characteristics, not on presenting a full clinical validation study with specific performance metrics and statistical analyses.

Therefore, the following outlines what would typically be expected in such a submission, using the information available and noting where details are absent in this specific document.

This 510(k) submission for the Full Auto Arm Digital Blood Pressure Monitor, Model SE-7070, seeks to demonstrate substantial equivalence to a predicate device (Model SE-7700H) rather than presenting a standalone study with detailed acceptance criteria and performance reports. The document focuses on comparing technological characteristics and asserting similarity in performance.

However, to provide a comprehensive answer as requested for a device like this, we can infer common acceptance criteria for blood pressure monitors and identify what information is missing from this particular submission regarding a direct performance study.

1. Table of Acceptance Criteria and Reported Device Performance

For an automatic blood pressure monitor, the primary acceptance criteria typically relate to accuracy, often benchmarked against a recognized standard like ISO 81060-2 or AAMI/ANSI/ISO 81060-2. These standards define accuracy requirements for both systolic and diastolic blood pressure measurements.

Hypothetical Acceptance Criteria (Based on ISO 81060-2/AAMI standards):

• Mean difference in SBP (e.g., [X] mmHg)
• Standard deviation of differences in SBP (e.g., [Y] mmHg)
• Percentage of measurements within certain absolute differences (e.g., % within 5 mmHg) |
  | Accuracy - Diastolic Blood Pressure (DBP):
  Mean difference (device vs. reference) ≤ ±5 mmHg,
  Standard deviation ≤ 8 mmHg (AAMI/ISO 81060-2) | Not reported in the provided text. A typical submission would include a clinical validation study demonstrating:
• Mean difference in DBP (e.g., [A] mmHg)
• Standard deviation of differences in DBP (e.g., [B] mmHg)
• Percentage of measurements within certain absolute differences (e.g., % within 5 mmHg) |
  | Pulse Rate Accuracy:
  Typically ±5% or ±5 beats per minute (whichever is greater) (e.g., from IEC 60601-2-30) | Not reported in the provided text. A typical submission would include accuracy statistics for pulse rate. |
  | Clinical Validation Protocol Adherence:
  Compliance with a recognized standard (e.g., AAMI/ANSI/ISO 81060-2:2018) | Implied but not detailed. The submission states "Performance: Similar" to the predicate, which would imply similar adherence to standards, but no explicit details of a validation study are provided. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not provided in the document. Blood pressure monitor validation standards (e.g., ISO 81060-2) typically require a minimum of 85 participants (equally distributed across various blood pressure ranges, age groups, and arm circumferences) for a validation study.
• Data Provenance: Not provided in the document. A full submission would specify the country of origin of the study participants and whether the study was prospective (specifically designed for this device validation) or retrospective. Given the device manufacturer is from Korea, a prospective study might have been conducted there, but this is speculative without the actual study details.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable/Not explicitly stated in the context of this document. For blood pressure monitor validation studies, the "ground truth" is typically established by at least two, and often three, trained and certified observers (auscultators) using a mercury or calibrated aneroid sphygmomanometer, blind to the automated device readings. These observers are highly trained in the auscultatory method.
• Qualifications of Experts: Not provided in the document. Typically, these would be medical professionals or trained technicians with specific certification in blood pressure measurement following the auscultatory method, ideally with demonstrated inter-rater reliability. The document does not mention the role or qualifications of experts for establishing ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not explicitly stated. In a blood pressure validation study, the reference measurements from the multiple observers (e.g., two or three) are statistically compared. If there are discrepancies beyond a certain limit, a third observer might be used, or the average of the closest two might be taken. The document does not describe such a process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done (or at least not indicated in this document). This type of study (MRMC) is generally used for diagnostic imaging devices where human readers interpret images, and the AI's effect on their diagnostic accuracy is assessed. For a blood pressure monitor, the device directly outputs a measurement, and human interpretation of the device's output is not the primary focus of effectiveness.

6. Standalone (Algorithm Only) Performance Study

• Yes, implicitly. For an automatic blood pressure monitor, the clinical validation study (if conducted) assesses the performance of the "algorithm only" (i.e., the device's automated measurement) against the gold standard auscultatory method. The results described under point 1 (mean difference, standard deviation) would typically come from such a standalone performance study. However, the details of such a study are not provided in this document. The document primarily asserts "Performance: Similar" to a predicate device.

7. Type of Ground Truth Used

• Gold Standard Reference Measurements: For blood pressure monitors, the ground truth for validation is typically established through simultaneous manual auscultatory measurements performed by trained observers using a mercury sphygmomanometer or a validated, calibrated aneroid device. This is considered the clinical gold standard for non-invasive blood pressure measurement.

8. Sample Size for the Training Set

• Not applicable/Not provided. This device is an automatic blood pressure monitor that uses an oscillometric method with "fuzzy logic function." While "fuzzy logic" implies some form of algorithmic decision-making, the document does not suggest a machine learning model that requires a distinct "training set" in the modern AI sense with labeled images or data for pattern recognition. The "fuzzy logic" likely refers to predefined rules or heuristics for optimizing inflation/deflation and signal processing rather than a data-driven machine learning training process. Therefore, a separate "training set" in the context of AI development is not indicated or specified.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not provided. As stated above, a distinct "training set" as understood in AI/machine learning development is not indicated for this device's "fuzzy logic" function according to the provided text. If an earlier iteration of the algorithm or an initial calibration involved data, its collection and "ground truthing" methods are not described in this document.

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To measure of systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.

Full Auto Wrist Digital Blood Pressure Monitor, SE-312

Based on the provided text, the document is a 510(k) clearance letter for the "Full Auto Wrist Digital Blood Pressure Monitor, SE-312" (K012054). This type of document from the FDA primarily focuses on establishing "substantial equivalence" to a predicate device, rather than requiring a detailed study demonstrating device performance against specific acceptance criteria for this particular device.

Therefore, most of the requested information regarding acceptance criteria and performance studies is not present in these documents. The 510(k) process typically relies on comparisons to already-cleared devices to demonstrate safety and effectiveness.

However, I can extract the following:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail metrics for this specific device. The entire 510(k) process implies acceptance if substantial equivalence to a legally marketed predicate device is demonstrated for the stated indications for use.
• Reported Device Performance: Not explicitly enumerated in a performance table in these documents. The clearance is based on the comparison to a predicate device, assuming similar performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not describe a specific test set or clinical study for this device's performance.

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. No test set or ground truth establishment process is described for this device in these documents.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication method is described.

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

• No. This device is a blood pressure monitor, not an AI-assisted diagnostic tool. An MRMC study is not relevant here and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This device is a physical diagnostic monitor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable for this device. The concept of "ground truth" as used for AI/diagnostic algorithms doesn't apply directly to a blood pressure monitor submission in this context. Substantial equivalence relies on comparing the device's design and operating principle to a predicate, and potentially some basic performance data if presented, but not typically a complex ground truth dataset.

8. The sample size for the training set

• Not applicable. This isn't an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This isn't an AI/machine learning device that requires a training set or ground truth for it.

In summary: The provided 510(k) documents grant clearance based on substantial equivalence to a predicate device. They do not contain the details of a de novo clinical study with explicit acceptance criteria and performance data for the "Full Auto Wrist Digital Blood Pressure Monitor, SE-312." Such detailed performance studies are typically found in the 510(k) submission itself (which is not provided) and would compare the device's accuracy against a recognized standard (e.g., AAMI, BHS protocol for blood pressure devices).

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the SEIN SE-30 TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Proprietary Name : SE-30 TENS Common or Usual Name : Transcutaneous Electrical Nerve Stimulator Classification Name : Stimulator, Nerve, Transcutaneous (Pain Relief)
The SEIN SE-30 TENS device is equivalent to the Graham-Field, Inc. Micro TENS Plus transcutaneous electrical nerve stimulator.
Each product is used for the symptomatic relief of and management of long term intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
One output channel, Asymmetric bi-phasic & phasic rectangular shape with zero net direct current, Pulse Width 105-450 us programmed insert protected circuit, Pulse Rate 1-200 pulse/sec programmed, Power Source two alkaline AAA batteries 1.5 volt, Maximum Voltage Load 200 ohm 26 V, 500 ohm 40 V, 1 Kohm 52 V, open 90 V, Maximum Output charge/pulse (500 ohm load for safety) 58.5 uc/pulse, Maximum Output average current (500 ohm load for safety) 3.375 mA, Size 70(W) x 79(H) x 17(D) mm, Weight 80 grams, Recharge Battery Option N, Battery Check N, Water Use Option N, Discriminate Polality Automatically Change, Gel Pad Adhesive Type, Treatment 15 min. (no daily limit), MODES AVAILABLE Mode 1: [Modulation] 1. Pulse Rate : 1-100 pps 2. Pulse Width: 220-450 usec, Mode 2... [Burst] 1. Pulse Rate: 16 pulse/burst. 4b/sec 16 pulse/burst. 7b/sec 63-125 pps 2. Pulse Width : 105-450 usec, Mode 3... [Modulation] 1. Pulse Rate : 1-5 pps 2. Pulse Width : 220 usec, Mode 4... [Burst] 1. Pulse Rate: 220 pulse/burst, 1b/sec 90 pulse/burst. 1b/sec 2. Pulse Width: 220-450 usec

Here's an analysis of the provided text regarding the SEIN SE-30 TENS device, framed by the requested acceptance criteria and study information.

It's important to note that the provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. For such devices, "acceptance criteria" and "study" typically refer to demonstrating substantial equivalence to a predicate device, as well as adherence to recognized performance standards. This is different from the type of clinical performance study often associated with AI/software devices. The acceptance criteria here are about demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Acceptance Criteria and Study for SEIN SE-30 TENS Device

The SEIN SE-30 TENS device demonstrated substantial equivalence to a predicate device (Graham-Field, Inc. Micro TENS Plus) and compliance with the ANSI/AAMI NS4-1985 standard. The "acceptance criteria" are implied by these comparisons and the requirements of the 510(k) process for demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a TENS device seeking 510(k) clearance, the "acceptance criteria" are generally met by demonstrating that the device is as safe and effective as a legally marketed predicate device and complies with relevant performance standards. The reported device performance is primarily a comparison of technical specifications.

Comparison of General Specifications between SEIN SE-30 TENS and GRAHAM-FIELD Micro TENS Plus (Predicate Device)

2. Sample Size Used for the Test Set and Data Provenance

For TENS devices seeking 510(k) clearance, there isn't typically a "test set" in the sense of a dataset for an AI algorithm. Instead, the "test" involved comparing the new device against a predicate device's specifications and performance against a recognized standard (ANSI/AAMI NS4-1985).

• Sample Size for Test Set: Not applicable in the context of a dataset for an AI algorithm. The "test" involved a single physical SEIN SE-30 TENS device being evaluated against specifications and standards.
• Data Provenance: The data is primarily derived from engineering specifications, design documents, and testing results of the SEIN SE-30 TENS device, alongside the known specifications of the predicate device. The testing was conducted by SEIN Electronics Co., Ltd. in Korea. It's a "prospective" evaluation in the sense that the device was specifically tested to meet the standard and demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable in the context of establishing ground truth for image/data interpretation. This summary does not mention any expert review of clinical cases.
• Qualifications of Experts: Not applicable. The "ground truth" for this regulatory submission is the established performance characteristics of the predicate device and the requirements of the ANSI/AAMI NS4-1985 standard.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no "test set" in the context of clinical data requiring expert adjudication. The comparison was primarily based on objective technical specifications and standard compliance.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This type of study is not typically required or performed for TENS device 510(k) submissions, which focus on electromechanical similarity and performance standard compliance rather than diagnostic accuracy or human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. The SE-30 TENS is a physical medical device, not an AI algorithm. Its performance is inherent in its design and operation, not subject to standalone algorithmic testing.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is:
  • The established technical specifications and therapeutic claims of the legally marketed predicate device (Graham-Field, Inc. Micro TENS Plus).
  • The requirements of the recognized industry standard ANSI/AAMI NS4-1985.
  • The intended use for Transcutaneous Electrical Nerve Stimulators (pain relief).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The SEIN SE-30 TENS is a physical TENS device and does not involve machine learning or a "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, the K991397 submission for the SEIN SE-30 TENS device demonstrated its "acceptance criteria" were met by proving substantial equivalence to a predicate device through a comparison of technical specifications and by showing compliance with a relevant performance standard (ANSI/AAMI NS4-1985). The framework of AI/software device evaluation (test sets, ground truth by experts, MRMC studies) does not directly apply to this traditional medical device submission.

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For the measurement of systolic and diastolic blood pressure and pulse rate in adult patients.

The SEIN SE-330 Wrist Blood Pressure Meter is a semi-automatic electronic device designed to measure blood pressure and pulse, and in which a compact wrist cuff is used in place of the standard wrist cuff. Inflation and deflation are accomplished through the use of a manual inflation bulb and solenoid valve respectively. Blood pressure and pulse are measured using the oscillometric method. A liquid crystal display of up to six digits is employed to record blood pressure and pulse. Power is supplied by two lithium batteries (size CR2032). Built-in memory allows the display of the previously measured blood pressure and pulse values for comparison to current measurements. An automatic power cut-off feature after one minute of non-use is built into the device to permit saving of energy. The measuring range of the device is 20-280 mmHg (pressure) and 40-200 pulses per minute with an accuracy of +3mmHg or 2% of the reading, whichever is greater, for the pressure and t5% of the reading for pulse. The dimensions of the SE-330 Blood Pressure Meter are 58 mm (W) and 70 mm (D) x 23.8 mm (H). The weight of the meter is approximately 110 g including two batteries. The wrist cuff dimensions are 314.7 mm (1) x 70 mm (w). Battery life for the device is approximately 150 measurements.

The provided text describes a 510(k) summary for a Digital Wrist Blood Pressure Meter, Model SE-330. It outlines the device's technical specifications and a study conducted for its approval. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the device's measuring range is 20-280 mmHg (pressure) and 40-200 pulses per minute. While these are not explicitly termed "acceptance criteria" in the text, they define the operational limits of the device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 108 patients
• Data Provenance: The document states "A clinical trial... conducted on 108 patients," implying the data was collected prospectively for this study. The country of origin for the data is not specified in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document refers to the "cuff-stethoscope auscultatory method" as the comparator for determining blood pressure and pulse. This method typically involves trained medical professionals (e.g., doctors, nurses). However, the number of experts used to establish the ground truth for the test set and their specific qualifications (e.g., years of experience) are not specified in the provided text.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. It mentions the "cuff-stethoscope auscultatory method" as the basis for comparison, which usually relies on direct measurement by a human observer. There is no mention of multiple experts or any reconciliation process (like 2+1 or 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The study compares the device's performance against a standard manual method, not the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The study described is a standalone performance test of the device, comparing its measurements to the traditional cuff-stethoscope auscultatory method. The device itself is an "Automatic Digital Wrist Blood Pressure Meter," implying it operates without continuous human-in-the-loop adjustment for each reading, other than initial placement and activation. Therefore, this can be considered a standalone performance study for the device's measurement capabilities.

7. Type of Ground Truth Used

The type of ground truth used is the cuff-stethoscope auscultatory method for determining blood pressure and pulse. This is a clinically accepted, established method for blood pressure measurement, serving as the gold standard for comparison in this context.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The description pertains to a clinical trial for performance evaluation against a standard, not the development or training of an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not applicable or not provided in the document.

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