(266 days)
The Portable ECG Monitor PM10 is intended to record and store Lead I ECG signals, and display heart rate for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Portable ECG Monitor PM10 has simple user interface without ECG trace viewing function.
The Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.
The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, measurement etc.
The provided text is a 510(k) Summary for the Contec Medical Systems Co., Ltd Portable ECG Monitor, model PM10. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a novel device. As such, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a tabular format as it would for a performance study. Instead, it compares the proposed device's specifications to those of a predicate device to establish substantial equivalence. The "acceptance" in this context is that the device's measured performance aligns with or is sufficiently similar to the predicate's, and meets relevant voluntary consensus standards.
Here's a table based on the "Substantially Equivalent (SE) Comparison" in the document (Table 1):
| Characteristic / Acceptance Criteria (Implied) | Predicate Device (K112622) Performance | Proposed Device (PM10) Performance |
|---|---|---|
| Product Code | DPS (Implied from "Same") | DPS |
| Regulation Number | 870.2340 (Implied from "Same") | 870.2340 |
| Intended Use | Record/store Lead I ECG, display HR | Record/store Lead I ECG, display HR |
| Lead | Lead I (Implied from "Same") | Lead I |
| Recording mode | Automatic (Implied from "Same") | Automatic |
| Measurement parameters | Heart rate | Heart rate |
| Display | LCD (Implied from "Same") | LCD |
| HR measurement range | (Not explicitly stated for predicate) | 30bpm~300bpm |
| HR measurement accuracy | (Not explicitly stated for predicate) | ±1bpm or 1% |
| Power supply | Battery (Implied from "Same") | Battery |
| Electrical safety conformance | (Implied to comply with IEC 60601-1) | Complies with IEC 60601-1 |
| EMC conformance | (Implied to comply with IEC 60601-1-2) | Complies with IEC 60601-1-2 |
| Patient Contact Material | Metal electrode (Implied from "Same") | Metal electrode |
Explanation of "Acceptance Criteria" for this submission: For a 510(k), the "acceptance criteria" largely involve demonstrating that the device meets recognized standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 60601-2-47, IEC 60601-1-11, ISO 10993-5, ISO 10993-10) and has performance characteristics that are "substantially equivalent" to a legally marketed predicate device. The document explicitly states "The test results demonstrated that the proposed device complies with the following standards" for non-clinical tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no sample size for a clinical test set, nor any information on data provenance (country, retrospective/prospective). The assessment relies on non-clinical engineering and bench testing, and comparison to a predicate device.
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 applicable, as no clinical study or test set with human data requiring expert ground truth was conducted or submitted (see point 2).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study or test set was conducted that would require adjudication.
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 a "Portable ECG Monitor" for recording and displaying heart rate, not an AI-driven diagnostic tool that assists human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's core functions (recording ECG signals and displaying heart rate) are standalone in nature, as it processes the ECG signal and derives heart rate without human intervention in that specific computation. However, this is not an "algorithm-only" performance study in the sense of a complex AI diagnostic algorithm. The non-clinical tests verifying its compliance with standards and its stated heart rate accuracy (±1bpm or 1%) serve as the standalone performance verification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Electrical safety and EMC: Ground truth is defined by the technical requirements and test procedures outlined in the specified IEC standards (IEC 60601-1, IEC 60601-1-2). Compliance with these standards is the "ground truth."
- Biocompatibility: Ground truth is established by the test procedures and acceptance criteria within ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization).
- Heart rate accuracy: The accuracy of ±1bpm or 1% would be verified against a known, precise input signal (e.g., using an ECG simulator or a reference standard). The known input signal acts as the "ground truth."
8. The sample size for the training set
Not applicable. This document describes a traditional medical device, not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).