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The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / AP, CM, FA, PU and SP series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).

Well Life Self Adhesive Electrode / CM, FA, PU, and SP series are non-sterile, disposable laminated, flexible structures composed of the following three main construction layers: First Layer – the exterior layer which may be made of the following different type of material coated with adhesive : white fabric(CM), white foam(FA), printed plastic film(PU) or silicon pad(SP). Second Layer - Conductive plastic film. Third Layer – Biocompatible conductive hydrogel coupling media. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation and muscle-stimulation devices. For the electrical connection, Well Life provides two different types: 1 > Snap Series Snap connection 1.65" standard size of mail. Snap is provided to connect to the wire female snap. 2> Wire Series Lead wire assembly 4.5" ~ 6" wire with .080 in. diameter female socket connected to one side of the wire.

The provided text describes the submission for a 510(k) premarket notification for the "Well Life Self Adhesive Electrode / CM, FA, PU, and SP series." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel device that requires extensive clinical studies with new acceptance criteria.

Therefore, many of the requested points regarding acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly present in this type of submission. This is typical for a 510(k) for a Class II medical device where substantial equivalence is demonstrated primarily through technological characteristics and adherence to recognized performance standards and biocompatibility tests.

Here's an analysis of what information is available from the provided text, structured as per your request, explaining why certain points are not found:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not explicitly stated for the device itself. The submission relies on the pre-existing qualification of the Axelgaard gel and the adherence to an electrical performance standard (ANSI/AAMI EC12). The sample size, provenance, and study design for proving the biocompatibility of the gel or for the electrical standard's development are not detailed in this submission. This is because the component (Axelgaard gel) itself was already cleared in other 510(k)s (K983741 and K000947).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable in this context. For a 510(k) submission based on substantial equivalence to a predicate device and adherence to industry standards, "ground truth" as established by medical experts for a diagnostic or AI device is not typically required or presented. The "ground truth" here would be the validated performance of the materials used and the adherence to technical standards.

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

• Not applicable in this context. Adjudication methods are relevant for studies involving subjective interpretation of data (e.g., medical images) by multiple human readers, often used to establish a robust ground truth for AI model development or evaluation. This is not the type of study presented here.

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

• No MRMC study was done or is relevant. This type of study assesses the impact of AI assistance on human reader performance, which is not applicable to a self-adhesive electrode.

6. 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. Therefore, "standalone algorithm performance" is not a concept that applies.

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

• The "ground truth" in this submission is indirectly established by:
  • Prior regulatory clearance: The use of Axelgaard gel, which has already been proven suitable through previous 510(k) clearances (K983741 and K000947).
  • Standardized testing: Compliance with the requirements of the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 for skin contact and ANSI/AAMI EC12 for electrical performance. The ground truth essentially relies on the validity and acceptance of these established standards and guidelines.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device and submission. This device is not an AI algorithm.

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

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

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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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The Gemore Reuseable Self Adhesive Electrode / Wire series, Snap series, and Double side series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Gemore Reuseahle Self Adhesive Electrode / Wire series, snap series, and double side series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).

Gemore Reuseable Self Adhesive Electrode / Wire series and Double side series and Double side series are non-sterile, disposable laminated, flexible structures composed of materials commonly used in this application:

First Layer – White spun faced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylenc substrate, coated with biocompatible adhesive. Second Layer - Conductive plastic film.

Third Layer – Biocompatible conductive hydrogel coupling media

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices.

For the electrical connection, Gemore provides three different types:

Snap Series – Snap connection – 1.65" standard size of mail. Snap is provided to connect to the wire female snap.

Wire Series – Lead wire assembly – 4.5" ~ 6" wire with .080 in. diameter female socket connected to one side of the wire.

Double side series – adhesive gel was also provided at the reverse side of skin contact. With this adhesive side, the electrode can be mounted on the electricity conductive sufface of device without additional lead wire or snap.

The provided text describes a 510(k) submission for the "Gemore Reuseable Self Adhesive Electrode / Wire series, Snap series, and Double side series." However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K052875 and K050788) for the purpose of a 510(k) clearance. This involves showing that the new device is as safe and effective as existing legally marketed devices, rather than meeting specific quantifiable performance targets derived from a clinical study with detailed acceptance criteria.

The information provided relates to:

• Biocompatibility: The gel used meets skin sensitivity testing criteria specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1.
• Electrical Safety: Electrical safety testing was conducted according to ANSI/AAMI EC12.

Since there is no detailed performance study with explicit acceptance criteria provided in the document, I cannot fill out the requested table or answer most of the questions.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of performance metrics. The criteria are implicitly tied to demonstrating equivalence to predicate devices and meeting established safety standards (biocompatibility, electrical safety).
• Reported Device Performance:
  • Biocompatibility: The gel used for skin contact "passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact."
  • Electrical Safety: "We have conducted and completed the electrical safety testing according to the chosen performance standard, ANSI/AAMI EC12. The testing report was included in this submission."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No specific "test set" for performance evaluation is described. The biocompatibility and electrical safety tests would have involved specific samples, but the details of these are not provided in this summary.

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. No expert review for a "test set" to establish ground truth is described.

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

• Not applicable.

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. This device is an electrode for neurostimulation, not an AI-assisted diagnostic tool involving human readers.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable for a performance study. For safety, the ground truth for biocompatibility is defined by established international standards (ISO 10993-1) and for electrical safety by ANSI/AAMI EC12.

8. The sample size for the training set

• Not applicable. No "training set" is described as this is not a machine learning device.

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

• Not applicable.

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The ProStim Reusable Neurostimulation Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. ProStim Reusable Neurostimulation Electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

ProStim Reusable Neurostimulation electrodes arc non-sterile, disposable laminated. flexible structures composed of materials commonly used in this application: First Layer-White spun laced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive. Second Layer- Conductive plastic film. Third Layer-Biocompatible conductive hydrogel coupling media. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices. Lead wire assembly - 6" wire with .080 in. diameter female socket connected to one side of the wire.

The provided document describes the ProStim Reusable Neurostimulation Electrodes and its 510(k) summary for market clearance. The study presented focuses on demonstrating substantial equivalence to predicate devices, primarily through impedance testing and biocompatibility assessments, rather than a clinical efficacy study with human readers or outcomes data.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the impedance testing or biocompatibility tests. It only states that the gels "have passed" the required tests and that impedance values "were comparable."

• Test Set Sample Size: Not explicitly stated for either biocompatibility or impedance testing in this summary.
• Data Provenance: Not explicitly stated. The biocompatibility tests refer to file numbers for the specific gels, implying these are existing test results for components rather than a new study specific to the ProStim device's final configuration. The impedance testing is described as being performed for the subject device in comparison to predicate devices, but details on where or when this was conducted are not provided.

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

Not applicable. The study did not involve human expert interpretation or ground truth establishment in the context of clinical images or diagnoses. The "ground truth" for biocompatibility is established by standardized testing protocols, and for effectiveness, it's defined by impedance measurements against predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical study with human readers requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an electrode for neurostimulation, not an AI-powered diagnostic tool. The submission is a 510(k) for substantial equivalence based on technological characteristics and safety/effectiveness data, not a clinical efficacy study involving human readers.

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

Yes, in a conceptual sense. The "performance" of the device was assessed on its intrinsic characteristics (biocompatibility and electrical impedance) without human intervention in the measurement of these characteristics, or human interpretation as part of a diagnostic workflow. The device itself is a component in a system where a human typically applies it and uses it with an electrical stimulator.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For Biocompatibility: The "ground truth" was established by the results of standardized in vitro and in vivo tests for cytotoxicity, sensitization, and primary skin irritation as specified by the "Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact."
• For Effectiveness (Impedance): The "ground truth" was indirectly established by the electrical impedance values of legally marketed predicate devices. The acceptance criterion was that the subject device's impedance values were "comparable" to these predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The safety and effectiveness data were generated through specific tests and comparisons to predicate devices, not through a learning phase.

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

Not applicable, as no training set was used.

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SOF-PACH™ Reusable Cutaneous Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. SOF-PACH™ Reusable Electrodes are designed and intended to be used with marketed. Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation).

These electrodes will include the precaution statement: Federal Law restricts the device to sale by or on the order of a licensed practitioner or therapist.

SOF-PACH™ Reusable Neurostimulation Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application:

First layer - Various cloths, tapes, etc. including Tricot/polyester fabric, polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive.

Second layer Electrically conductive carbon coated with or without Ag/AgCl, and Activated Carbon Mesh material.

Third layer Biocompatible conductive hydrogel coupling media (CATHAY's Gel) which has passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization and Primary Skin Irritation Tests.

The electrodes are designed for single-patient/multiple application use. They have a low profile construction designed for comfort under clothing and utilize tan-tone fabric for reduced visibility. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrodes have two different types of contact points that can be used to link the stimulation device to the electrodes. These contact points are compatible with standard marketed Neurostimulation devices.

1. Lead wire assembly 6" wire with .080 inch diameter recessed female socket connected to one side of the wire. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898
2. Male snap assembly Two-part sensor and stud mated together.

This document is a 510(k) summary for the SOF-PACH™ Reusable Neurostimulation Electrodes (K020735). It describes the device, its technological characteristics, and how its safety and effectiveness were established by comparison to predicate devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "CATHAY's Gel has passed the required skin sensitivity testing criteria" and "point-to-point impedance testing for all manufacturers' electrodes (including SOF-PACH™) ranged from 125-250 ohms". However, the specific sample sizes for these tests (both for the gel biocompatibility and the impedance testing) are not explicitly stated in the provided text.

Data Provenance: The document does not specify countries of origin for the test data. The biocompatibility tests are likely conducted in a lab setting, and impedance tests on the devices themselves. There is no indication of retrospective or prospective patient data, as the tests are on the device itself and its components, not involving human subjects in a clinical trial for effectiveness.

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

This type of information is not applicable to this 510(k) submission. The "ground truth" for this device's acceptance criteria relies on standardized material testing (biocompatibility) and direct physical measurement (electrical impedance), not on expert clinical interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the acceptance criteria are based on standardized tests and direct measurements, not on subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a neurostimulation electrode, and its safety and effectiveness are established through testing its physical and material properties, and comparison to predicate devices' stated characteristics, not through analyzing human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI or software algorithm.

7. The Type of Ground Truth Used

The ground truth for the safety criteria (skin irritation/sensitivity) was established by passing standardized biocompatibility tests (Cytotoxicity, Sensitization, and Primary Skin Irritation Tests) as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1.

The ground truth for the effectiveness criteria (impedance) was established by direct electrical measurement using a standard voltmeter (point-to-point impedance at 1 K-Hz). The acceptance was based on comparability to predicate devices.

8. The Sample Size for the Training Set

This is not applicable. This submission describes a physical medical device, not an algorithm that requires a training set. The device itself is manufactured, and its components and final product are tested.

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

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

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