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The LifeShirt Real-Time is intended for use during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, temperature, and body position data may be collected. The system is intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. The LifeShirt Real-Time is indicated for reuse by multiple adult patients in applications that may include pharmaceutical studies in which respiratory information is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.

The LifeShirt Real-Time consists of the following components: the LifeShirt garment, LifeShirt Recorder/Transmitter, a wireless flash card, a data Flash Card, VivoMonitor™ real-time software and VivoLogic® analysis and reporting software. A cleared pulse oximeter, blood pressure cuff, and a temperature sensor are optional accessories provided for use with the device.

This 510(k) summary focuses on modifications to an existing device, the LifeShirt, rather than a standalone study of a new medical device. As such, the information provided primarily addresses the equivalence of the modified device to its predicate, with limited detail on specific performance acceptance criteria and study data in the format requested for a new device's comprehensive performance evaluation.

Here's an analysis based on the provided text, highlighting the limitations due to the nature of this 510(k):

1. Table of acceptance criteria and the reported device performance

Explanation: The document describes a "Special 510(k)" submission, which is used for modifications to a legally marketed device that do not significantly alter its fundamental scientific technology or intended use. For such submissions, the FDA typically focuses on demonstrating that the changes do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to its predicate. Therefore, the "acceptance criteria" here are largely implied to be maintaining the performance of the predicate device, with specific verification of the new features (wireless communication and temperature probe).

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

The document does not specify a separate "test set" sample size in the context of clinical data for performance evaluation. The "performance testing" mentioned refers to engineering verification and validation activities for the new features (wireless data transmission, EMC). There is no mention of a pre-defined subject cohort used for clinical performance testing for the modified features.

Data Provenance: Not explicitly stated for specific clinical tests, as the focus is on engineering verification of new features and equivalence to an already cleared device.

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

Not applicable in this Special 510(k). The document describes engineering verification testing, not a clinical study requiring expert-established ground truth for a diagnostic outcome.

4. Adjudication method for the test set

Not applicable. There is no mention of a clinical test set requiring expert adjudication for 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

Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned. The device records physiological data for later analysis by a physician.

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

This Special 510(k) is about a hardware device with software components, not a standalone algorithm in the typical sense of a diagnostic AI. The "VivoLogic analysis and reporting software" is part of the system for "later analysis by a physician," implying a human-in-the-loop workflow. The performance testing focuses on the accuracy of data transmission and fundamental device capabilities.

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

The document does not detail the type of ground truth used as it relates to clinical diagnostic accuracy, as this was not a primary focus of this Special 510(k). The "ground truth" for the performance testing mentioned (e.g., accuracy of data transmission) would be engineering standards and successful transfer of data files.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning algorithm that requires a training set for its development. The "VivoLogic processing software" likely uses established algorithms for physiological data analysis, not a learning-based approach that requires a training set in the AI sense.

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

Not applicable, as there is no mention of a training set for a machine learning algorithm.

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The Reusable Multiple-Patient LifeShirt is intended for use during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, and body position data may be collected. The system is intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. The Reusable Multiple-Patient LifeShirt is indicated for reuse by multiple adult patients in applications that may include pharmaceutical studies in which respiratory information is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.

The Reusable Multiple-Patient LifeShirt consists of the following components:

1. LifeShirt data acquisition system including the vest with inductive plethysmograph sensors, ECG sensors, a data cable and a connected Handspring Visor® device with software for data collection and storage onto a flash memory card;
2. LifeShirt data transfer software to transmit the data from the user's personal computer to the VivoMetrics Data Center;
3. VivoMetrics Data Center, a database operated by VivoMetrics personnel which stores and provides an audit trail for collected data; and
4. VivoLogic data analysis software for viewing and analyzing patient data.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VivoMetric's Reusable Multiple-Patient LifeShirt:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state a specific sample size for a 'test set' in the context of evaluating diagnostic performance or clinical effectiveness. The validation focused on cleaning and functionality. No information on data provenance (country of origin, retrospective/prospective) related to a diagnostic test set is available, as the study was not primarily a diagnostic performance study.

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

This information is not mentioned in the provided 510(k) summary. The submission focuses on showing substantial equivalence concerning changes for multi-patient reuse and the associated cleaning/functional validation, not on evaluating diagnostic accuracy against a ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not mentioned as there was no diagnostic performance study involving interpreting a test set of data.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done based on the provided text. The submission focuses on substantial equivalence based on technical characteristics and validation of cleaning/functionality, not on evaluating human reader performance with or without AI assistance.

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

A standalone performance study of the VivoLogic Analysis Software in terms of its diagnostic accuracy (e.g., classifying apneas) was not explicitly detailed in the context of this 510(k) submission. The submission states the system is "intended to provide analysis of breathing patterns as an aid in classifying apneas," but it focuses on the hardware modification for multi-patient reuse, not the re-validation of the analytical software's standalone performance. The previous 510(k) for the single-patient device might have contained such data, but it is not included here.

7. Type of Ground Truth Used

For the cleaning validation, the "ground truth" would be the successful removal of biological contaminants to a specified level, verifiable through laboratory assays (e.g., microbial counts, protein detection). For functional validation, the "ground truth" would be that the device accurately continues to record physiological data within specified tolerances after multiple washings, which could be measured against a known signal input or by comparison to another validated device. Specific details of these ground truths (e.g., specific assays, tolerance levels) are not provided in this summary. There is no mention of ground truth in the context of diagnostic accuracy from expert consensus, pathology, or outcomes data, as this was not a diagnostic performance study.

8. Sample Size for the Training Set

This information is not applicable/not mentioned for this submission. The 510(k) specifically addresses a modification to allow multi-patient reuse, not the de novo development or re-training of an AI algorithm. The VivoLogic analysis software's training would have occurred prior to the original single-patient device's submission.

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

This information is not applicable/not mentioned for this submission. As above, the submission focuses on hardware modification, not AI algorithm training.

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The LifeShirt is a noninvasive ambulatory monitoring device that continuously monitors and stores respiration and ECG onto a CompactFlash™ memory card within a portable battery powered Handspring Visor® worn on a belt or within a pocket. The patient may be located at home or in an alternate care setting. The monitored subject can enter symptoms, activities, and medications into the Handspring Visor® that becomes part of the digital data stream. An optional NONIN pulse oximeter and Critikon noninvasive blood pressure monitor can be connected into the Visor for recordings during sleep or defined activities. The purpose of this system is to collect and store cardiac, respiratory, and blood pressure data as well as body position, various types of activities annotated with symptoms and a medication diary for subsequent analysis and archival at a data center utilizing the VivoLogic 1.0 software program. Data is transferred to the data center generally after the end of a patient data recording session.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the VivoMetrics LifeShirt System, detailing its components, intended use, and substantial equivalence to predicate devices. It includes a letter from the FDA confirming clearance and the indications for use. However, it does not present any performance data, acceptance criteria, or details of a validation study for the device's accuracy or effectiveness.

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