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The Lifecare HC-88 Series Conductive Garments are cutaneous electrodes to be used with legally marketed electrical stimulators (such as powered muscle stimulators and transcutaneous electrical nerve stimulators).

The knitted garment electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.

These body parts include hands (gloves), feet (socks), wrists / elbows (wristlets / elbow guards) and knees (kneecaps).

The single-patient reusable and non-sterile Lifecare HC-88 Series Conductive Garments are cutaneous. flexible, conductive garment/fabric electrodes.

They are passive devices acting as interface between electrical stimulators (such as powered muscle stimulators, interferential devices, galvanic device and transcutaneous electrical nerve stimulators) and a patient's skin. The signal is transmitted from the conductive knob through the cloth of conductive garment to the surface of the patient's skin.

The Lifecare HC-88 Series Conductive Garments are used in conjunction with electrical stimulators both in the home and physical therapy setting, and can stimulate large or multiple. They are knitted in different shapes, as gloves, socks, kneecaps and wristlets/elbow guards, and in different sizes.

The Lifecare HC-88 Series Conductive Garments are constructed with four basic components (materials): a metal conductive snap terminal; cloth knitted together with Spandex and Stainless-steel yarns that twisted and composed by Stainless-steel and Nylon fibers. The garments are not packaged with lead wire.

Impedance testing evaluated by the "Resistance meter of electronic multimeter" to measure the impedances of all conductive garments are below 5 ohms between each centimeter and evaluated by the "oscilloscope measuring circuit" to measure the total impedance of all conductive garments are below 50 ohms" . Even after over 20 times washing, the impedance of Lifecare HC-88 Series Conductive Garments are still within specification.

The garments are not compatible with MRI spectrometry.

The provided document is a 510(k) summary for the Lifecare HC-88 Series Conductive Garments. This device is a passive cutaneous electrode used with electrical stimulators. The document focuses on demonstrating substantial equivalence to a predicate device and addresses safety aspects like biocompatibility and impedance.

However, the 510(k) summary does not contain information about a study proving device performance against acceptance criteria in the context of diagnostic or AI-assisted medical devices. It is a report for a passive, non-AI medical device (conductive garments).

Therefore, it is not possible to extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types/establishment for training/test sets) because these concepts are generally applicable to studies for diagnostic devices with specific performance metrics or AI/ML-enabled devices, not a simple conductive garment.

Here's a breakdown of why the requested information cannot be provided from the given document:

• Acceptance Criteria & Reported Performance: The document provides impedance specifications, but these are specifications for the physical product, not performance criteria for a diagnostic or AI algorithm. It states "Impedance testing evaluated by the "Resistance meter of electronic multimeter" to measure the impedances of all conductive garments are below 5 ohms between each centimeter and evaluated by the "oscilloscope measuring circuit" to measure the total impedance of all conductive garments are below 50 ohms"." This is a design specification verification, not a clinical performance study.
• Sample Size (Test Set) & Data Provenance: Not applicable. There is no "test set" in the context of evaluating a diagnostic algorithm's performance.
• Number of Experts & Qualifications / Adjudication Method: Not applicable. These relate to establishing ground truth for diagnostic studies, which is not relevant for a conductive garment.
• MRMC Comparative Effectiveness Study: Not applicable. This type of study evaluates human reader performance, often with and without AI assistance, which isn't relevant for a passive garment.
• Standalone Performance: Not applicable. A conductive garment doesn't have "standalone performance" in the way an AI algorithm does.
• Type of Ground Truth: Not applicable. There is no diagnostic ground truth needed for this device.
• Sample Size (Training Set) & How Ground Truth for Training Set was Established: Not applicable. This refers to AI/ML development, which is not relevant here.

In summary, the provided text describes a 510(k) submission for a medical device (conductive garments) that is considered safe and effective based on substantial equivalence to a predicate device and adherence to manufacturing and biocompatibility standards, not through a performance study against specific acceptance criteria for a diagnostic or AI-enabled function.

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