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The Transfer Technology PRO-TECH Delivery System electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator Transfer Technology's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), and MANS (Muscle and Neurological Stimulators)

Transfer Technology reusable neurostimulator electrodes are laminated flexible materials widely used in this application.
Top layer Vinyl tape or non-woven fabrics with biocompatible adhesive
Second layer Grade "A" pure tin or electrically conductive carbon with Ag or Ag/AgCl
Third layer 1.25" flexible vinyl tape with biocompatible adhesive laminated around the outer perimeter of electrode
Patient layer Conductive hydrogel Amgel AG703
Lead Wire Constructed of a silicone-insulated stainless steel yarn wire with a standard 080" recessed female contact crimped and then insulated to one end By design, the insulated contact prevents the conductive connection to earth or hazardous voltages as required in IEC 60601-1 Subclause 56 3(c) Wire assembly is in compliance with FDA performance standard 21 CFR Part 898

The provided text describes a 510(k) submission for the "PRO-TECH Delivery System Electrodes." This is a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria through quantitative performance metrics. Therefore, many of the requested sections are not applicable in this context.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" and "device performance" in the context of specific numerical metrics (like sensitivity, specificity, accuracy) is not applied to this type of device (electrodes) in a 510(k) submission as it would be for, say, an AI diagnostic tool. Instead, safety and effectiveness are established through substantial equivalence to predicate devices. The "performance" here relates to the materials used and the comparison to established predicate devices.

Study Details (Not Applicable for this type of 510(k) submission)

The provided document describes a 510(k) for neurostimulation electrodes. For such a device, the primary method of demonstrating safety and effectiveness is through a comparison to substantially equivalent predicate devices, rather than a clinical study with new performance data. Therefore, many of the requested study details are not relevant or present in this type of submission.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical test set data is provided. Non-clinical testing involved comparison of critical components.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review of performance data is described for a test set.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
4. 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 an electrode, not an AI diagnostic tool involving human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrode, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth as typically defined for diagnostic or AI performance is not relevant here. The ground for "substantial equivalence" is the established safety and effectiveness of the predicate devices.
7. The sample size for the training set: Not applicable. There is no AI component or "training set."
8. How the ground truth for the training set was established: Not applicable.

Explanation from the document:

• Non-clinical Testing: "The critical components used in Transfer Technology PRO-TECH Delivery System electrodes (Amgel AM703 K983741) are the same as used in the predicate devices. Therefore there is no reason to believe that the Transfer Technology PRO-TECH Delivery System electrodes will perform any different than the predicate device." This indicates that the "study" was primarily a component comparison and justification of equivalence based on shared materials and existing predicate data, rather than new performance testing.
• Clinical Testing: The document explicitly states "Not Applicable." This confirms that no clinical studies were performed to establish performance or safety for this 510(k) submission.

Conclusion:

The "study" demonstrating that the device meets acceptance criteria is based on the principle of substantial equivalence to already legally marketed and established predicate devices. The manufacturer argues that because their device uses the same critical components and has similar technological characteristics and intended use as these predicates, it is equally safe and effective. No new, independent performance study with defined acceptance criteria and data analysis (as would be expected for a novel diagnostic device or AI algorithm) was conducted or required for this 510(k) clearance.

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