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The Textronics™ ECG Electrode is intended for use in general electrocardiograph monitoring and recording procedures.

The Textronics™ ECG Electrode is indicated for use with most ECG instruments on the market. It is indicated for applications including resting ECGs, exercise ECGs, and/or ambulatory monitoring. The device is indicated for both prescription and over-the-counter use.

The Textronics ™ ECG Electrode consists of electrodes, an exterior housing for the electrodes that makes contact with the patient, and a means of connecting the device to an ECG instrument. The Textronics™ ECG Electrode has textilebased electrodes made of electrically conductive yarns knitted together with electrically non-conductive yarns. The conductive yarns are silver coated polyamide (nylon). The non-conductive yarns can include cotton, spandex, polyester, and/or nylon. The Textronics™ ECG Electrode's textile-based electrodes have an exterior housing made of fabric, which can be made out of common textile materials, including polypropylene, nylon, Lycra® Spandex, polyester, and/or cotton. This fabric exterior housing can take the shape of a variety of garments, such as chest straps, wrist bands, shirts, bras, or vests. The Textronics™ ECG Electrode connects to ECG instruments via a conductive snap.

Here's an analysis of the provided information regarding the Textronics™ ECG Electrode's acceptance criteria and substantiating study:

This 510(k) summary does not provide explicit acceptance criteria in the typical sense of quantitative thresholds (e.g., minimum sensitivity, PPV). Instead, the "acceptance criteria" are implied to be "functional as intended" and "clarity and resolution of the tracings were observed to be substantially equivalent to the commercially available electrodes."

The study is a comparative performance study against commercially available ECG electrodes.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "ECGs were recorded," implying multiple recordings, but no specific number of patients or recordings is provided.
• Data Provenance: Not explicitly stated, but the study was conducted "in the lab." This suggests a controlled environment, likely in the US where Textronics, Inc. is located. It is a prospective study as the device was tested against existing commercial electrodes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not stated.
• Qualifications of Experts: Not stated.

The evaluation of "clarity and resolution" would typically involve expert interpretation, but the document does not specify who performed this assessment or their qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not stated. Given the qualitative nature of the performance assessment ("observed to be substantially equivalent"), it's possible a formal adjudication process was not used, or at least not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This type of study is not described. The assessment focuses on the device's technical performance in generating ECG tracings, not on human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: Yes, in the sense that the performance data presented is for the device itself.
  • The Textronics™ ECG Electrode was "tested in the lab using ECG recording devices with the commercially available ECG electrodes and the Textronics ™ ECG Electrode used simultaneously."
  • "ECGs were recorded, and the tracings were compared."
  • The device's output (ECG tracings) was directly assessed for functionality, clarity, and resolution.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance is effectively concurrent comparison to commercially available, predicate ECG electrodes. The "ground truth" for what constitutes a "functional" and "clear, resolute" ECG tracing is established by the accepted performance of these predicate devices. It is based on expert observation/interpretation of these comparative tracings, rather than pathology or long-term clinical outcomes.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The Textronics™ ECG Electrode is a hardware device (electrode), not an AI algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this hardware device.

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