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The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.

The Disposable Thermometer Covers and Sheaths, made of PE and EVA, are used for either oral or rectal measurements for digital or mercury thermometers. The products and packaging are non-sterile and are not made with natural rubber latex. The size may vary to accommodate differences in digital and mercury thermometers. The inner packing material is paper, while the outer packing material is carton. Each outer packing contains 100 pieces of covers and sheaths.

The provided text describes a medical device called "Disposable Thermometer Covers and Sheaths" and its 510(k) submission for market clearance. It does not contain information about a study proving the device meets acceptance criteria in the way typically associated with AI/ML-driven devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth dataset). Instead, the "acceptance criteria" and "study" refer to adherence to established standards and bench testing for device safety and effectiveness.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document refers to "bench testing" and "safety testing" against standards, which implies samples of the device were tested, but the specific number of units or tests is not provided.
• Data Provenance: The testing was conducted by KANG ZE INDUSTRIAL CO., LTD. or laboratories they commissioned. The raw data and specific locations are not detailed, but it's related to the manufacturing of the device in China. This is not a "clinical data provenance" in the sense of patient data. It's more about laboratory testing of the product itself.

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

This section is Not Applicable to this submission. The "ground truth" for this type of device (thermometer covers) is established by adherence to recognized international and national standards for material safety (biocompatibility, chemical content) and physical performance (e.g., maintaining barrier integrity). Expert consensus for diagnosing a medical condition is not relevant here.

4. Adjudication method for the test set

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations of clinical data. This device's evaluation relies on objective laboratory tests against pre-defined thresholds within the specified standards.

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

This section is Not Applicable. This is not an AI/ML-driven device. It's a physical medical device (thermometer covers). Therefore, no MRMC study or AI assistance evaluation was performed.

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

This section is Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for this device's acceptance is based on validated industry standards and test methodologies for:

• Biocompatibility: Absence of cytotoxicity, irritation, and sensitization as per ISO 10993.
• Physical Performance: Compliance with ASTM E1104 for thermometer probe covers and sheaths.
• Chemical Composition: Levels of regulated substances meeting thresholds defined by IEC 62321 and EPA Method 3546.

8. The sample size for the training set

This section is Not Applicable. This device does not involve a "training set" as it's not an AI/ML model.

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

This section is Not Applicable. No training set was used.

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THE CARDIOBEEPER CB250 IS INDICATED FOR USE BY THE PATIENT IN TRANSMITTING ECG INFORMATION FROM A REMOTE LOCATION To A RECEIVING CENTER.

The CardioBeeper ® CB250 is a single-lead, compact, hand-held, battery powered, personal transtelephonic ECG transmitter enclosed in a billfold wallet. The device has been designed to enable the user to transmit a rhythm strip to a central receiving station using acoustic coupling. The ECG information is transmitted as a frequency modulation of the basic 1700Hz tone. The device is sealed (not hermetically) for life. There are no user-servicable parts inside. The batteries are not replaceable and the unit should be discarded after depletion.

The provided text describes a 510(k) summary for the Meridian Medical Technologies Ltd CardioBeeper® CB250. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for AI/software devices. Therefore, much of the requested information cannot be directly extracted from this type of regulatory submission.

However, based on the information available, here's a breakdown of what can be inferred or stated as not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a formal table of acceptance criteria and reported device performance in the way a clinical study report would. Instead, it focuses on demonstrating substantial equivalence based on design comparisons and technical specifications to legally marketed predicate devices.

The "performance" is implicitly deemed acceptable if the device's technical specifications are comparable to or improved over the predicate devices. The table provided (on page 1) is a comparison of technical specifications between the CardioBeeper® CB250 and two predicate devices (CardioBeeper® CB12L and CardioBeeper® CBII).

Acceptance Criteria (Inferred): The implicit acceptance criteria are that the CardioBeeper® CB250's technical specifications are either equivalent to or demonstrate improvements over the predicate devices, maintaining safety and effectiveness. For instance, the improved battery life and reduced current drain would likely be considered favorable, while maintaining critical electrical characteristics like CMRR, frequency response, system noise, and sensitivity indicates functional equivalence.

The "study" in this context is the detailed comparison and analysis of the device's design, materials, and technical specifications against the predicate devices, as presented in the 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. This 510(k) summary does not describe a clinical performance study using a test set of patient data. The substantiation for equivalence is based on device design and technical specifications, not an evaluation of diagnostic accuracy on a dataset.

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 / Not provided. No test set requiring expert-established ground truth is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No test set requiring adjudication is mentioned.

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 / Not provided. This device is a transtelephonic ECG transmitter, not an AI or imaging diagnostic aid. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

Not applicable / Not provided. This is a hardware device for transmitting ECG signals, not a standalone algorithm.

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

Not applicable / Not provided. As this is not a diagnostic device relying on interpretation, there is no "ground truth" in the traditional sense of medical diagnostic studies. The "ground truth" for this regulatory submission is the established performance and safety of the predicate devices.

8. The sample size for the training set

Not applicable / Not provided. This device does not involve machine learning or AI, and therefore no "training set" is relevant.

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

Not applicable / Not provided. As no training set is relevant, no ground truth for a training set was established.

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