(74 days)
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:
- 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;
- LifeShirt data transfer software to transmit the data from the user's personal computer to the VivoMetrics Data Center;
- VivoMetrics Data Center, a database operated by VivoMetrics personnel which stores and provides an audit trail for collected data; and
- 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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device can be cleaned for multiple adult patient use. | Cleaning validation performed and demonstrated. The ability of the cleaning process recommended in the Reusable Multiple-Patient LifeShirt User Guide to clean the device was validated. |
| Device performs as intended following multiple washings. | Functional validation performed and demonstrated. The device performs as intended following multiple washings. |
| Maintains the same intended use as the predicate device. | The device has the "same intended use" as the predicate device (recording physiological data for later analysis by physician; analysis of breathing patterns as an aid in classifying apneas; displaying heart rate changes; indicated for reuse by multiple adult patients in pharmaceutical studies or general healthcare market). |
| Maintains the same principles of operation as the predicate device. | The device has "same principles of operation" as the predicate device. |
| Maintains the same technological characteristics as the predicate device such that the change in use does not affect diagnostic effect. | The device has "same technological characteristics" as the predicate device. The only difference is reuse by multiple vs. single patients, which "does not affect the device's diagnostic effect," which monitors the same physiological parameters (respiration, ECG, pulse oximetry, blood pressure, body position) as the predicate. |
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.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).