(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."
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.