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Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.

Arm Blood Pressure Monitor, model: BPM-A7VL is a Noninvasive Blood Pressure Measurement System that is intended for measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. lt measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The BPM-A7VL is small, portable and used in home or medical facilities environment. The Arm Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-A7VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 23cm33cm and cuff of size 33cm47cm.

The provided text describes a 510(k) submission for an Arm Blood Pressure Monitor (model: BPM-A7VL). This is a non-invasive blood pressure measurement system. The acceptance criteria and the study proving the device meets these criteria are primarily focused on its clinical accuracy, electrical safety, electromagnetic compatibility (EMC), biocompatibility, and software performance.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for blood pressure monitors are typically defined by recognized standards such as ISO 81060-2 and IEC 80601-2-30. The text explicitly states that the device's performance complies with these standards.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: 85 subjects were used for the clinical accuracy test.
   • Data Provenance: The document does not explicitly state the country of origin. It indicates a "clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2," implying a formal clinical study. The submission is from Shenzhen IMDK Medical Technology Co., Ltd. (China), so it's highly probable the study was conducted retrospectively or prospectively in China, but this is not definitively stated. The study type is prospective clinical accuracy testing, as it involves a concurrent comparison with a reference standard.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The clinical accuracy testing for blood pressure monitors, as per ISO 81060-2, typically involves a comparison against a reference method (usually auscultatory measurements using a mercury or aneroid sphygmomanometer by trained observers). The document mentions "Aneroid sphygmomanometer" and "Measuring Method: Aneroid/auscultation method" as the reference equipment.
   • ISO 81060-2 requires at least two trained observers (experts) to simultaneously and independently measure blood pressure using the reference method, usually blinded to each other's readings and the device's readings. The document does not explicitly state the number or qualifications of these observers, but their involvement is a fundamental requirement for ISO 81060-2 compliance. They would be healthcare professionals (e.g., physicians, nurses, technicians) specially trained and certified for accurate auscultatory blood pressure measurement.

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

   • For ISO 81060-2, the standard adjudication method typically involves the simultaneous independent measurements by two trained observers. If their readings differ by a certain threshold (e.g., > 4 mmHg), a third observer or a consensus reading might be involved for specific cases, or those readings might be discarded. The document does not detail the exact adjudication criteria but implies adherence to the ISO standard.

4. 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, an MRMC comparative effectiveness study was not done. This document is for a non-invasive blood pressure monitor, which is a physical measurement device, not an AI-assisted diagnostic imaging tool where MRMC studies are typically performed. The "AI" component mentioned refers to the automated measurement algorithm within the device, not a separate AI for interpretation assistance to human readers.

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

   • Yes, in essence, standalone performance was evaluated. The clinical accuracy study evaluates the device's (algorithm's) ability to accurately measure blood pressure independently of direct human interpretation, comparing its output directly against a highly accurate reference standard. The device itself is "standalone" in its measurement function.

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

   • The ground truth for the clinical accuracy study was established using expert auscultatory measurements (performed by trained observers) from a validated reference device (Aneroid sphygmomanometer, Model: CM-BPM-D, K211084), following the methodology prescribed by ISO 81060-2.

7. The sample size for the training set:

   • Not applicable / Not specified. This submission is for a medical device that uses an oscillometric measurement principle and internal algorithms. It is not an AI/ML device that typically undergoes explicit "training" on a separate dataset in the same way as, for example, an image classification model. The software component mentioned underwent "verification and validation," which implies testing against requirements and design specifications, not training on a dataset. The algorithms are likely fixed based on established oscillometric principles.

8. How the ground truth for the training set was established:

   • Not applicable. As explained above, there isn't a "training set" in the context of an AI/ML model for this type of device. The ground truth for the performance verification (clinical accuracy testing) was established via expert auscultatory measurements against a reference device, as detailed above.

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TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for an EMS/TENS Massager Device, indicating it has been found substantially equivalent to a predicate device.

It details:

• The device name and regulatory information.
• The date of the review and clearance.
• General controls and additional regulations applicable to the device.
• Instructions on when a new 510(k) might be required for changes.
• Information about quality system regulations and reporting adverse events.
• The Indications for Use for the TENS (pain relief) and EMS (muscle performance) functions.
• Confirmation that it is for Over-The-Counter Use.

There is no mention of:

• Specific performance metrics or acceptance criteria for the device's functions (e.g., pain reduction levels, muscle strength improvement percentages).
• Any studies (clinical or performance) conducted to demonstrate the device meets any such criteria.
• Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot fulfill your request for the detailed table and study information based on the provided text.

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Fingertip Pulse Oximeter (Model:C101A2,C101B1,C101A3) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.

SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained. The pulse oximeter, model C101A2, C101B1, C101A3 is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.

The device is not for life-supporting or life-sustaining, not for implant.

The device is not provided sterile and is NOT a reprocessed single-use device.

The device is a spot-check pulse oximeter and does not include alarms.

The device does not support the measurement in the condition of low perfusion.

The device is not intended for life-supporting or life-sustaining.

The device is reusable and does not need sterilization.

Acceptance Criteria and Device Performance Study for Pulse Oximeter (Model C101A2, C101B1, C101A3)

The provided document, a 510(k) Summary for the Pulse Oximeter (Model C101A2, C101B1, C101A3), indicates that the device is substantially equivalent to a previously cleared predicate device (Pulse Oximeter, Model C101H1). This means that the acceptance criteria and performance data for the subject device are considered equivalent to those established for the predicate device.

Crucially, the document states: "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the predicate device, additional testing was not considered necessary to support the substantial equivalence."

Therefore, the information below refers to the performance that the predicate device (K173123) demonstrated, which the subject device (K221979) is claimed to meet by virtue of substantial equivalence. The summary does not include new testing data specifically for the subject device's performance against these criteria, except for biocompatibility due to a color change in patient-contacting materials.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the specifications of the predicate device, which the subject device is deemed to meet.

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

The document explicitly states that "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the predicate device, additional testing was not considered necessary to support the substantial equivalence."

Therefore, no new performance test data for SpO2 or PR accuracy is included for the subject device (K221979) in this submission. The assumption is that the previously cleared predicate device (K173123) met these criteria, and since the technology is the same, no new testing was deemed necessary for these aspects. Details regarding the sample size and data provenance for the predicate device's original performance testing are not provided in this summary.

For Biocompatibility testing (which was performed for the subject device due to a color change in patient-contacting materials):

• Sample Size: Not specified for each test (Cytotoxicity, Irritation, Sensitization), but standard procedures would involve multiple samples of the actual patient-contacting materials.
• Data Provenance: Not specified; assumed to be conducted in a laboratory setting as per international standards (ISO 10993).

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 in the 510(k) summary, as no new clinical or performance studies for SpO2/PR accuracy were conducted for the subject device. For the original predicate device, pulse oximeter accuracy studies typically involve comparing the device's readings to arterial blood gas analysis (co-oximetry) measurements, which serve as the ground truth. This process usually involves clinical personnel (e.g., nurses, physicians, respiratory therapists) performing the measurements and often statistical experts involved in data analysis, but not necessarily "experts establishing ground truth" in the sense of image interpretation.

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

This information is not applicable/not provided as no new clinical or performance studies involving adjudication were conducted for the subject device.

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 as the device is a Pulse Oximeter, not an AI-assisted diagnostic tool involving human readers.

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

The device is a standalone pulse oximeter that provides direct measurements of SpO2 and PR. Its performance evaluation would inherently be "standalone" in the sense that it directly measures physiological parameters without human interpretation in the loop (beyond reading the display). The performance criteria listed (SpO2/PR accuracy) are indicative of standalone performance against a clinical reference standard. The document states "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." This implies that the standalone performance requirements previously established for the predicate device were considered met.

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

For pulse oximetry, the ground truth for SpO2 accuracy is typically arterial blood gas analysis (co-oximetry), which provides a highly accurate measure of arterial oxygen saturation. For Pulse Rate (PR), the ground truth is often established by electrocardiography (ECG) or a manually measured pulse using a stopwatch. This information is not explicitly stated in this 510(k) summary for the predicate device's original testing, but these are the standard methods for validating pulse oximeter performance.

8. The sample size for the training set

This is not applicable/not provided. The device is a traditional medical device (pulse oximeter) that relies on physical principles (spectrophotometry and photoplethysmography) rather than machine learning or AI models that require training data.

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

This is not applicable/not provided for the same reason as above; there is no "training set" in the context of this traditional device.

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Fingertip Pulse Oximeter C101H1 is a non-invasive device intended for spot checking of function of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.

SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained.

The pulse oximeter, C101H1, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring. The device is not for life-supporting or life-sustaining, not for implant.

The device is not provided sterile and is NOT a reprocessed single-use device.

The device is a spot-check pulse oximeter and does not include alarms.

The device does not support the measurement in the condition of low perfusion.

The device is not intended for life-supporting or life-sustaining.

The device is reusable and does not need sterilization.

Here's an analysis of the provided information, describing the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for the C101H1 are largely established by demonstrating substantial equivalence to the predicate device (Fingertip Pulse Oximeter A310/ K153021) and adherence to relevant international standards. The performance metrics listed for the predicate device serve as the de facto acceptance criteria for the C101H1 in terms of comparable specifications.

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

• Sample Size for Clinical Test Set (SpO2 accuracy): 12 healthy adult volunteer subjects.
• Data Provenance: The study was conducted on a volunteer population, implying a prospective study. The location is not explicitly stated, but given the manufacturer's location in Shenzhen, China (as indicated in the 510(k) summary), it is highly likely that the study was conducted there, or at least with subjects geographically accessible to the company or its clinical partners.

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

• The document describes the ground truth for SpO2 accuracy as being established by arterial blood CO-Oximetry. This method itself is the "expert" or gold standard. There isn't information provided about individual experts, such as physicians or lab technicians, establishing the ground truth; rather, it relies on the accuracy of the CO-Oximetry device and its operation. It states "Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference CO-Oximetry providing functional SaO2 for the SpO2 accuracy comparison."

4. Adjudication Method for the Test Set

• Not applicable for this type of test. The ground truth (SaO2 from CO-Oximetry) is an objective measurement, not a subjective interpretation requiring adjudication among multiple experts. The device's reading is compared directly to this objective ground truth.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a Pulse Oximeter, which provides a direct physiological measurement (SpO2 and PR). It does not involve human readers interpreting images or data where AI assistance would be relevant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the performance study for SpO2 accuracy is a standalone performance evaluation of the device's algorithm. The "C101H1 Pulse Oximeter" itself, without human interpretation influencing the measurement output, was evaluated against the gold standard CO-Oximetry. While humans operate the device, the core "performance" reported (A_rms) directly reflects the device's measurement accuracy.

7. The Type of Ground Truth Used

• The ground truth used for the SpO2 accuracy test was objective measurement from a gold-standard device: arterial blood CO-Oximetry, which provides functional SaO2.

8. The Sample Size for the Training Set

• The document does not specify a separate training set for the clinical performance evaluation. The clinical trial described focused on validation of the device's accuracy against a reference standard using 12 healthy volunteers. Pulse oximeters typically use fixed algorithms based on known light absorption properties of oxygenated and deoxygenated hemoglobin, rather than machine learning algorithms requiring a distinct training phase on clinical data. Performance testing (e.g., pulse rate accuracy, cleaning/disinfection) does not typically involve "training data" in the AI sense.

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

• As no explicit training set is mentioned in the context of device performance in this document, this question is not applicable. The underlying physics and algorithms are generally developed based on a foundational understanding of spectroscopy and validated through engineering tests and subsequent clinical trials like the one described.

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The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.

The Ultrasonic Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing the principle of Doppler shift of an ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and organic light-emitting diode screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at a frequency of 2 MHz. The reflected continuous wave signal is received by one of the crystals and then any detected Doppler shift is presented to the user.

The main unit is powered by two 1.5V AA alkaline batteries.

The provided S510(k) summary for the Ultrasonic Doppler (Model YM-2T8) does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based diagnostic device.

The document describes a fetal ultrasonic monitor and accessories which uses continuous-wave Doppler technology to detect fetal heart rate. This is not an AI/algorithm-based diagnostic device in the sense of image interpretation or complex pattern recognition. Instead, it's a hardware device that measures a physiological parameter.

Therefore, the requested information, which is highly relevant for AI/algorithm-based medical devices (like those in radiology or pathology where performance metrics, ground truth establishment, and human reader studies are crucial), is not found in this submission.

This S510(k) focuses on:

• Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device (K153475 - SD5 Ultrasonic Tabletop Doppler).
• Performance Testing: Primarily non-clinical testing related to:
  • Biocompatibility (ISO 10993-1, 5, 10)
  • Electrical safety and electromagnetic compatibility (EMC) (IEC 60601-1, 1-2, 1-11)
  • Ultrasound and Acoustic Testing (IEC 60601-2-37, NEMA UD2)
  • Software Verification and Validation (adhering to FDA guidance for moderate software level of concern)

The document explicitly states "8. Clinical Performance Testing: Not Applicable" (page 6), further indicating that the type of study you're asking for, which involves human readers, AI assistance comparison, or complex ground truth establishment on a test set, was not performed or deemed necessary for this specific device.

If this were an AI medical device, the information would likely be found under "Clinical Performance Testing" or a similar section dedicated to the algorithm's diagnostic accuracy.

In summary, none of the requested information (acceptance criteria table, sample size, expert number/qualifications, adjudication, MRMC, standalone performance, ground truth type, training set details) is present because this is a hardware device for physiological measurement, not an AI diagnostic algorithm.

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