Search Results
Found 3 results
510(k) Data Aggregation
(298 days)
The PhysioGlove ES Model I is a reusable 12-lead diagnostic ECG examination system. The system can be used with 12-lead cables or the PhysioGlove device. When used with the PhysioGlove, it is intended to conduct an electrocardiogram. The diagnostic and automatic measurement features are not available. When used with a 12-lead cable, it is intended for use in resting diagnostic electrocardiograph examination of adults. The PhysioGlove ES Model I is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device provides waveform parameters and ECG analysis for healthcare provider interpretation.
The PhysioGlove ES Model I ECG Analysis Program assists the physician in measuring and interpreting 12-lead EGGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.
The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system consists of an electronics data acquisition unit and software that runs on a medical grade PC. The system uses either a standard, FDA-cleared, 10electrode EGG cable, or the PhysioGlove to obtain ECG data from the patient. The electronics performs analog processing and analog to digital conversion of a 12 lead diagnostic ECG.
The digital packets from the front-end enter the PC via the USB port. The software for the PC performs a variety of functions, including patient registration, ECG display, and storage.
In addition the system provides ECG analysis. The ECG Analysis Program is a software algorithm only. When the system is used with the PhysioGlove, the ECG Analysis Program is not available.
The PhysioGlove ES Module I is intended to be marketed in two configurations.
- Configuration 1 standard ES Model I without ECG analysis. .
- . Configuration 2 - standard ES Model I with ECG analysis.
The provided 510(k) summary for the Commwell Ltd. PhysioGlove ES Model I with ECG Analysis (K103791) does not contain detailed information about specific acceptance criteria and the study that proves the device meets these criteria for its ECG Analysis Program. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to general performance standards, rather than presenting a performance study with quantitative acceptance criteria against reported device performance.
Therefore, for aspects like acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, the document explicitly states:
- "There are no recognized consensus standards applicable to the ECG Analysis System algorithm."
- "The modifications made to the PhysioGlove ES Model I with ECG analysis did not require clinical testing to support substantial equivalence."
This indicates that a specific performance study with detailed acceptance criteria and reported metrics, as you've requested, was not part of this particular submission for the ECG Analysis Program. The submission relies on the substantial equivalence to the GE 12SL ECG Analysis Program (K092369), which implies that the performance characteristics of the GE program are assumed to be met or are sufficient for the intended use.
However, I can extract the available information and highlight what is mentioned:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with software verification and validation | "Software Verification and Validation" was performed. |
| Performance testing of the system | "Performance testing" was performed. |
| Usability in the intended environment | "Usability testing was done to demonstrate the efficacy of the PhysioGlove in its intended environment." |
| Compliance with IEC 60601-1-4 (Programmable Medical Systems) | The device "compl[ies] with the Guidances and/or Special Controls" and lists this standard. |
| Compliance with IEC 62304 (Software Life Cycle for Medical Devices) | The device "compl[ies] with the Guidances and/or Special Controls" and lists this standard. |
| Compliance with IEC 60601-2-51 (Safety of Electrocardiographs) | The device "compl[ies] with the Guidances and/or Special Controls" and lists this standard. |
| Overall Functionality | "In all instances, the device functioned as intended." |
| Assistance to physician in interpreting 12-lead ECGs (Implied by Intended Use) | The analysis program "assists the physician in measuring and interpreting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation." |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated for the ECG Analysis Program's performance. The submission indicates that "clinical testing" was not required for substantial equivalence of the modifications for the ECG analysis. Instead, it refers to the predicate device (GE 12SL ECG Analysis Program, K092369) for this functionality.
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 explicitly stated. No specific performance study with expert-established ground truth is detailed for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated. No specific performance study is detailed.
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, an MRMC comparative effectiveness study was not done as part of this submission. The document states: "The modifications made to the PhysioGlove ES Model I with ECG analysis did not require clinical testing to support substantial equivalence." The role of the analysis program is described as providing "an initial automated interpretation" to be "confirmed, edited, or deleted by the physician," but no study on physician improvement with or without the AI is provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated in terms of a formal performance study. While the ECG Analysis Program is a "software algorithm only," and its output is an "initial automated interpretation," the submission does not provide data on its standalone performance (e.g., sensitivity, specificity for specific cardiac conditions) against a ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Since no specific performance study is detailed, the method for establishing ground truth for any potential internal testing is not provided.
8. The sample size for the training set:
- Not explicitly stated. There is no information about the training data for the ECG Analysis Program, as the device is incorporating the GE 12SL ECG Analysis Program.
9. How the ground truth for the training set was established:
- Not explicitly stated. This information would typically be part of the documentation for the GE 12SL ECG Analysis Program, which is a predicate device.
In summary:
This 510(k) submission for the Commwell PhysioGlove ES Model I with ECG Analysis primarily demonstrates substantial equivalence by leveraging the pre-established approval of the GE 12SL ECG Analysis Program (K092369) and the PhysioGlove ES Model I (K050674). It does not present new, detailed performance study data for the ECG analysis algorithm against specific quantitative acceptance criteria. Instead, it focuses on software verification, validation, and compliance with general safety and performance standards, concluding that "there are no new questions of safety and effectiveness issues."
Ask a specific question about this device
(89 days)
The 12 lead glove is designed to configure the ECG electrodes in a single unit for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms).
The PhysioGlove is a glove that incorporates a system of Ag/AgCI electrodes for use in recording ECGs. The glove terminates in a standard 15-pin mini D-type connector. The PhysioGlove is intended to be used with the cleared PhysioGlove ES-1 software, for recording diagnostic 12-lead ECGs.
The provided text describes the PhysioGlove, an ECG electrode glove, and its regulatory clearance. However, it does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond general statements of efficacy and compliance with broad standards.
Therefore, many of the requested sections cannot be filled with information directly from the provided text.
Here's an attempt to answer based on the available information:
Acceptance Criteria and Device Performance Study for PhysioGlove (K083677)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Clinical Efficacy: Ability to conduct an electrocardiogram comparable to a standard 12-lead ECG cable. | "Clinical testing was done to demonstrate the efficacy of the PhysioGlove compared to a standard 12-lead ECG cable. In all instances, the device functioned as intended." | This is a general statement and lacks specific performance metrics (e.g., sensitivity, specificity, accuracy, signal quality parameters, correlation coefficients). |
| Compliance with Performance Standards: Adherence to recognized medical device standards for ECG equipment. | "The device was tested according to the following performance standards: IEC 60601-2-25, EC53 and EC 11." | The document confirms testing against these standards, implying compliance, but does not provide results for specific tests within these standards. |
| Intended Use: Function as a 12-lead glove for configuring ECG electrodes. | "The 12 lead glove is designed to configure the ECG electrodes in a single unit for the purpose of conducting an electrocardiogram." | The device is described as functioning for its intended purpose. |
| Patient Chest Girth Range: Suitable for patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms). | "It is for use in patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms)." | This is an intended use specification, not a performance metric that was tested and confirmed in results provided here. |
| Safety and Effectiveness (Relative to Predicates): As safe and effective as identified predicate devices. | "The PhysioGlove is as safe and effective as the Tapuz ECG Electrodes Apron and the IneedMD 12-Lead Glove." | This is a conclusion of the equivalence assessment, not a specific performance metric. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The text only mentions "clinical testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- 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
- No, an MRMC comparative effectiveness study involving AI assistance is not mentioned. The device is an ECG electrode glove, not an AI-powered diagnostic system. The comparative study was between the PhysioGlove and a standard 12-lead ECG cable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The PhysioGlove is a hardware device (electrode glove), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The text implies that the ground truth for the clinical comparison was established by the standard 12-lead ECG cable. The PhysioGlove's efficacy was compared to this standard, suggesting the standard itself served as the reference for "normal" and "intended" ECG recordings. Specific details on how "efficacy" was measured or adjudicated are not provided.
8. The sample size for the training set
- Not applicable, as this is a hardware device for recording, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Limitations in Provided Text:
The 510(k) summary provides a high-level overview for regulatory clearance. It confirms that the device was tested against relevant standards (IEC 60601-2-25, EC53, and EC 11) and underwent "clinical testing" demonstrating efficacy compared to a standard ECG cable. However, it lacks specific details regarding:
- The design and methodology of the clinical study.
- Quantitative results of the clinical testing (e.g., specific metrics for signal quality, diagnostic agreement, or concordance).
- Sample sizes for any tests.
- Details about how "ground truth" was rigorously established or evaluated beyond comparison to a "standard 12-lead ECG cable."
Ask a specific question about this device
(406 days)
The PhysioGlove ES Model I is a reusable 12-Lead diagnostic ECG examination system. It is intended for use in resting diagnostic electrocardiograph examination of adults. It is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device only provides waveform parameters for healthcare provider interpretation and does not itself provide suggested interpretations.
The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system has been tested to a variety of performance standards. The PhysioGlove ES Model I consists of an electronics data acquisition unit and software that runs on a medical grade PC. The PhysioGlove ES Model I uses a standard, FDA-cleared, 10-electrode ECG cable to obtain ECG data from the patient. The electronics performs analog processing and analog to digital conversion of a 12 lead diagnostic ECG. The digital packets from the front-end enter the PC via the USB port. The software for the PC performs a variety of functions, including patient registration, ECG display, and storage. Users may also vary ECG acquisition parameters.
There is no information in the provided text about acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) summary and an FDA clearance letter for the PHYSIOGLOVE ES MODEL I. These documents primarily focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
The information provided only describes the device, its intended use, and states that "The system has been tested to a variety of performance standards." However, it does not detail what those standards are, the results of the tests, or any specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, or other study-related details based on the given text.
Ask a specific question about this device
Page 1 of 1