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The Actical is a compact, lightweight, waist-, wrist-, or ankle-worn activity monitor that may be used to assess human gross motor activity, caloric expenditure, and estimates of energy expenditure based on motor activity in any instance where quantifiable analysis of physical motion is desirable.

The subject device can be classified as physiological signal conditioner as described in 21 CFR 882.1845. Actical is a physiological data recorder consisting of a data recorder which can be worn on the waist (hip), wrist, or ankle of the subject and that detects, measures, and records physical Activity data. A Reader is used to transfer the recorded rata to a Personal Computer (PC) running the Actical Host software. The host software is used to configure the data recorder for data collection, to retrieve logged data from the recorder, to display data and trend graphs, and to provide a means to store the logged data in a PC for later use.

The provided text is a 510(k) summary for the Actical Physiological Signal Recorder. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, performance studies, or the methodologies used to establish ground truth.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily covers:

• Contact person and date
• Trade name, common name, classification, and product code
• Legally marketed substantially equivalent predicate devices
• Description of the device
• Intended Use
• Comparison of technical characteristics, stating that "Results of performance tests, risk analysis, and verification and validation testing demonstrate that the devices are substantially equivalent." However, it does not detail these tests, criteria, or results.
• FDA's letter of clearance, confirming substantial equivalence.

Without a detailed study report, specific acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies cannot be described.

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The VitalSense XHR can be used in any setting where physiological body core temperature, skin temperature, or heart rate are used to further the understanding of body function or where quantifiable analysis of temperature or heart rate data is desirable.

The subject device can be classified as physiological signal conditioner as described in 21 CFR 882.1845. VitalSense XHR is a physiological data recorder that is worn on the body. Up to ten sensor inputs may be used with a single VitalSense XHR recorder. The device senses and records physiological data and displays the data on its LCD screen. Recorded data may be transferred later to a PC for display and conversion for export to other programs.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Summary of Device Performance Study

The provided documentation for the Respironics VitalSense XHR (K061870) describes a submission for a modified device based on a predicate device (VitalSense K033534). The core of the study is a demonstration of substantial equivalence to this predicate device by showing that modifications (primarily to software for heart rate display) have no impact on safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria for specific physiological parameters (e.g., accuracy ranges for temperature or heart rate) alongside reported device performance. Instead, it states:

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

• Test Set Sample Size: Not specified. The document refers to "performance tests, risk analysis, and verification and validation testing" but does not give a sample size for human subjects or data points used in these tests.
• Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether the data was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described. This device is a physiological data recorder, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: The documentation implies that "performance tests, risk analysis, and verification and validation testing" were done on the device itself. Given that it's a physiological recorder, its performance fundamentally relates to its ability to accurately sense and record data in a standalone manner. However, specific details of these "performance tests" are not provided. The focus is on the substantial equivalence of the modified software within the existing hardware.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. The document implies that the device's measurements (body core temperature, skin temperature, heart rate) are considered the "truth" for the purpose of demonstrating substantial equivalence to the predicate device. It's likely that established measurement standards or comparison to other validated devices would serve as the ground truth during performance testing, though this is not detailed.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physiological recorder, not an AI/ML device that requires a training set in the typical sense. The software modification described (allowing heart rate display) would not involve a machine learning training set.

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

• Ground Truth for Training Set: Not applicable, as no training set for AI/ML is described.

In summary:

The submission for the VitalSense XHR focuses on demonstrating substantial equivalence to an existing predicate device after a software modification. The provided text outlines a regulatory submission process rather than a detailed scientific study with quantitative performance metrics, test set descriptions, or expert involvement in establishing ground truth for a diagnostic algorithm. The "acceptance criteria" are broad statements about meeting regulatory requirements and ensuring the modifications have no impact on safety and effectiveness, rather than specific numerical targets for physiological measurement accuracy.

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The Actiheart is an ambulatory Heart Rate and Activity Recorder. Actiheart may be used to quantifiably measure Heart Rate, Activity, and estimates of Caloric Expenditure. This device is not intended for use as an ECG monitor.

Actiheart is a compact, ambulatory, physiological Heart Rate and Activity data recorder. Actiheart may be attached to the chest surface through the use of standard ECG electrodes. Recorded data may be transferred later to a PC for display and conversion for export to other programs.

The document provides details of the Actiheart device, an ambulatory Heart Rate and Activity Recorder. It includes information on its substantial equivalence to a predicate device, indications for use, device description, and performance testing results against acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size of unique patients or recordings for the test sets. Instead, it refers to "libraries of ECG waveforms" such as the MIT-BIH Normal Sinus Rhythm waveform library, European ST-T waveform library, and AAMI Normal Sinus Rhythm waveform library. These are standardized, publicly available databases of ECG recordings, often used for testing algorithms and devices. The provenance of these publicly available libraries is generally known, but not detailed in this document. The testing described is a "bench test comparison report" and relies on "library recordings of known Heart Rate." This suggests a retrospective analysis using pre-recorded data.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Ground truth for these waveform libraries is typically established through a combination of expert cardiological review and often includes reference annotations that have been meticulously validated.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set. Given that it relies on established ECG waveform libraries, the ground truth (e.g., true heart rate, QRS complex locations) from these libraries would serve as the reference, precluding the need for real-time expert adjudication of the device's output.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The study focuses purely on the standalone performance of the Actiheart device against established benchmarks and in comparison to a predicate device in a bench test setting. It does not evaluate human readers' improvement with or without AI assistance.

6. Standalone Performance

Yes, a standalone performance study was conducted. The "Actiheart to Mini Logger Series 2000 bench test comparison report" directly assesses "the Heart Rate detection performance characteristics of both devices side-by-side against a set of library recordings of known Heart Rate." This is further supported by "Additional testing with the use of simulated recordings per ASTM EC13:2002," and the detailed "Assessment of non-clinical performance data" which lists various tests applied to the "submitted Recorder" (Actiheart) against specific performance requirements. These tests evaluate the device's ability to detect and measure heart rate independently.

7. Type of Ground Truth Used

The ground truth used for the performance testing cited in Table 10D is based on "known Heart Rate" from "libraries of ECG waveforms" such as MIT-BIH, European ST-T, and AAMI Normal Sinus Rhythm waveform libraries. These libraries contain reference annotations (e.g., R-peak locations, true heart rates) typically established through expert consensus and automated validation. The document also mentions testing with "simulated recordings per ASTM EC13:2002," implying a ground truth derived from controlled, simulated ECG signals.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for any algorithms within the Actiheart device. It mentions "proprietary code transforms digitized signal and detects location of features in ECG complex" and "proprietary algorithms to detect motion" and "proprietary algorithm" for caloric expenditure, but does not detail the development or training of these algorithms.

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

The document does not provide information on how the ground truth for the training set (if any was used for the proprietary algorithms) was established.

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The Mini-Logger® Series 2000 (hereafter referred to as Mini-Logger) is a compact, lightweight, physiological data logger for monitoring heart rate, interbeat-interval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, and obesity/weight loss studies. The device can be used for any assement of human heart rate or IBI, temperature, and activity that requires logging of data over time and an integrated analysis of the forementioned parameters. The Mini-Logger® may be used in any instance where quantifiable analysis of physiological data is desirable.

The Mini-Logger® Series 2000 is a compact physiological data logger whose physical size and appearance are similar to a small TV remote control. The Mini-Logger® is powered from two replaceable, non-rechargeable lithium cells. The Mini-Logger® is generally worn in the shirt pocket or on a belt using its optional soft pouch. Direct-wired probes used to sense the physiological data are plugged into one or more of the four available data input channels. The device acquires and logs digital data and resistances whose values represent the amplitudes of physiological signals. The physiological signals are temperature, heart inter-beat-interval (IBI), counts representing gross motor activity, and resistance representing ambient light intensity.

This 510(k) Premarket Notification document for the Mini-Logger® Series 2000 does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. The document focuses on demonstrating substantial equivalence to a predicate device (Vitalog HMS-5000) rather than presenting a performance study with defined acceptance metrics.

Therefore, many of the requested sections regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from the provided text.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• Weight: 125 grams
• Battery type: 3.6 volt lithium cells (2 each)
• Moisture susceptibility: Not water resistant
• Memory: 128 Kilobyte or 1 Megabyte
• Storage Temperature: -10 C to 50 C at 0-95% relative humidity
• Operating Temperature: 0 C to 40 C |
  | Compatibility: | Compatible with IBM-compatible computer for data download (Implied by substantial equivalence) | Communicates data with an IBM-compatible computer. |
  | Sensor Interface: | Ability to interface with specified sensor technologies | Accepts direct-wired probes for physiological data into four input channels; utilizes thermistor, Polar chest band with ECG skin electrode, motion-sensitive switch, and photoconductive sensor technologies. |

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

• Not provided. This document is a 510(k) submission focused on substantial equivalence, not a detailed clinical or performance study report. There is no mention of a specific "test set" in the context of device performance evaluation with a defined sample size or data provenance (e.g., country of origin, retrospective/prospective). The assessment appears to be based on a comparison of technical characteristics and intended use to the predicate device.

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

• Not applicable/Not provided. Since there's no described "test set" for performance evaluation, there's no mention of experts establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Without a defined test set requiring ground truth, there is no adjudication method 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. The Mini-Logger® is a physiological data logging device, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed or described.

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

• No, not in the context of an "algorithm" as typically conceived in AI/imaging. The device itself is a standalone data logger. Its performance is inherent in its ability to accurately acquire and record physiological signals according to its specifications and the principles of the sensors used. The 510(k) primarily assesses this standalone capability against a predicate.

7. The Type of Ground Truth Used

• Not explicitly stated in the context of a performance study. For a device like the Mini-Logger®, "ground truth" would typically refer to the actual physiological values (e.g., a reference thermometer for temperature, a gold-standard ECG for heart rate/IBI) used to calibrate and verify the accuracy of the device's sensors and logging. However, the document does not detail such calibration or verification studies with specified ground truth methods. The ground truth for this submission is implicitly the performance and established safety/effectiveness of the predicate device for the purpose of demonstrating substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device is not an algorithm that uses a "training set" in the sense of machine learning.

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

• Not applicable. As above, there is no "training set" for this device.

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