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The Taylor TENS electrode is designed to be used in monitoring applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient's skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance, which can cause the pickup of 60 cycle neise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures. The Taylor TENS electrode is for Health Care Professionals only. It is intended for single patient use only.

The Taylor TENS Electrode is intended to be used as an ECG or stimulating electrode. The electrode is a Silver/ Silver Chioride conductive coated carbon filled polymer, with an attached leadware. The adhesive that is being used is a hypo-allergenic hydrogel which allows for an adequate hold to the patient. This product meets all of the applicable AAM Standards.

Here's an analysis of the provided text in relation to acceptance criteria and study details for a medical device:

The provided document (K954951 for the Taylor TENS Electrode) is a 510(k) Summary of Safety and Effectiveness from 1995. This type of document is generally quite brief and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with extensive acceptance criteria as might be expected for newer, more complex devices or those requiring a PMA.

Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, HRMR studies, detailed ground truth methods) are not present in this summary. The summary is primarily a regulatory filing, not a detailed scientific paper on device performance.

Acceptance Criteria and Study Details for K954951 (Taylor TENS Electrode)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided summary. The summary mentions "Comparative testing was done," but no details on the number of units tested or patients/subjects involved are given.
• Data Provenance: Not specified. It's internal testing by Taylor Industries, Inc. The country of origin of the data is not mentioned, nor is whether it was retrospective or prospective. Given the nature of a 510(k) in 1995 for a simple electrode, it's highly likely to be internal, prospective bench testing rather than a large clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the summary. For a simple electrode, "ground truth" would likely refer to objective measurements of electrical conductivity, adhesion strength, or impedance, rather than expert-derived diagnoses.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically relevant for studies involving human interpretation of images or complex diagnostic outputs. For an electrode, performance is usually assessed via objective, quantifiable measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is for evaluating the impact of a diagnostic aid on human reader performance, which is not relevant for a TENS electrode.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, in a sense. The "comparative testing" described is essentially a standalone performance assessment of the device (the electrode itself) against the predicate device. There is no "human-in-the-loop" component for an electrode's primary function.

7. The Type of Ground Truth Used

• The summary implicitly points to objective performance measurements related to electrical conductivity, impedance, and possibly adhesion, as well as adherence to "accuracy requirements as specified in the contents of the premarket notification submission" and "applicable AAM Standards." It's not based on expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device is not an AI/ML algorithm that requires a "training set." The performance is inherent to its physical design and materials.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. No training set for this device.

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