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Electrodes with silver conductive as Glove style, Wristbands Style, Wrist sleeve, Elbow Pads Style and Knee Pads Style, Elbow Sleeve, are intended for use with legally marketed TENS stimulating device. The electrodes with silver conductive will deliver stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include such as hands (gloves), feet (socks), wrist, elbow and knee.

Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.

This document is a 510(k) Summary for a medical device (Electrodes with silver conductive) and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding detailed study design, ground truth establishment, reader studies, and sample sizes for training and test sets is not available in this type of regulatory submission.

The document primarily relies on bench testing and a comparison of technical specifications to a previously cleared predicate device to assert safety and effectiveness.

Here's the information that can be extracted or inferred from the provided text, along with an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, "acceptance criteria" predominantly revolve around demonstrating substantial equivalence to a predicate device, as well as meeting basic biocompatibility standards and electrical resistance specifications. The performance is reported in terms of these comparisons.

Regarding the specific questions you asked for deeper study details:

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 document relies on bench testing and comparison to a predicate device, not a large-scale clinical test set for performance evaluation in the way an AI/software device would. The "test summary" only mentions "Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards." These would involve in vitro (cell culture) and potentially in vivo (animal, not human) tests, but not a "test set" of human data in the context of device performance as you might expect for an AI algorithm. The provenance would be the lab where these biocompatibility tests were conducted.

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: There is no "ground truth" derived from expert consensus on patient data described, as this is a physical device (electrodes) and not an AI or diagnostic tool requiring such expert review of images or clinical outcomes.

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

• Not applicable/Not provided: See explanation for #3.

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 physical conductive electrodes, not an AI software. Therefore, MRMC studies are irrelevant here.

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

• Not applicable/Not provided: This is not an algorithm. Bench tests were done to evaluate electrical properties and biocompatibility.

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

• Not applicable/Not provided: For the physical and chemical properties assessed (e.g., impedance, biocompatibility), the "ground truth" is established by laboratory measurement standards (e.g., resistance meters, cell viability assays, irritation scores) rather than clinical expert consensus or pathology data.

8. The sample size for the training set

• Not applicable/Not provided: There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided: See explanation for #8.

Summary regarding the nature of this submission:

This document is a 510(k) Pre-market Notification, which primarily aims to demonstrate substantial equivalence to a predicate device already legally marketed. For devices like these electrodes, this often means showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "study" here is not a clinical performance trial in the sense of evaluating diagnostic accuracy or clinical outcomes, but rather a series of bench tests (e.g., impedance, physical dimensions) and biocompatibility tests to ensure the device performs as expected and is safe for contact with the human body, compared against established standards and the predicate device's performance.

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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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Inspirstar Glove Electrode is intended to for use with legally marketed electrostimulation devices such as TENS to deliver stimulation current for pain relief.

Inspirstar Glove Electrode is cutaneous electrode to be used with legally marketed TENS stimulating device. The glove electrodes will deliver the stimulation signals generated by the stimulator to the skin with which they are contact.

Inspirstar Glove Electrode is the conductive glove knitted from a continuous silver coated nylon yarn into the form of the glove. The conductivity is derived from the silver material of nylon yarn. Nylon yarn provides elasticity which can ensure skin contact. Inspirstar Glove Electrode has the same conductivity for dry or wet usage. The entire glove electrode is conductive having the resistance of less than 7 ohms per inch consistently.

The provided document is a 510(k) summary for the Inspirstar Glove Electrode, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in this filing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The filing does not explicitly define "acceptance criteria" in a quantitative, measurable sense for the glove electrode's performance as a medical device. Instead, it focuses on demonstrating technological characteristics similar to a predicate device. The primary performance characteristic mentioned is conductivity.

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

The document states "Inspirstar Glove Electrode is tested to verify the device meets the design requirement. Predicate devices are also tested to support substantial equivalence." However, it does not specify the sample size of glove electrodes that were tested, nor does it detail the specific tests conducted beyond mentioning resistance measurement.

• Sample Size (Test Set): Not specified.
• Data Provenance: The document does not provide details on the specific data provenance (e.g., country of origin, prospective or retrospective) for the testing. It's implied the testing was conducted by or for Inspirstar Inc. for this 510(k) submission.

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

This information is not applicable/not provided in this type of 510(k) submission for a device like a glove electrode. Establishing "ground truth" with human experts is typically relevant for diagnostic devices that interpret complex data (e.g., medical images, physiological signals), where clinical consensus or pathology reports serve as the gold standard. For a conductive glove, the "ground truth" is based on physical property measurements and functional testing.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretation, which is not relevant for the performance assessment of a conductive glove.

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

This information is not applicable/not provided. MRMC studies are typically used for diagnostic imaging or equivalent interpretation devices to assess human-in-the-loop performance and usually involve multiple human readers interpreting cases with and without AI assistance. This device is a conductive electrode, not an AI or diagnostic interpretation device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This device is a physical electrode, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The Type of Ground Truth Used

For the Inspirstar Glove Electrode, the "ground truth" for its performance is based on physical property measurements, specifically:

• Resistance measurement: The resistance of the silver-coated nylon yarn (less than 7 ohms per inch).
• Functional performance: Its ability to act as a conductive electrode to deliver stimulation current when connected to a legally marketed TENS device.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Inspirstar Glove Electrode is a manufactured medical device, not an AI model that requires a "training set."

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

This information is not applicable as there is no "training set" for this type of device.

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