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Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

This document is a 510(k) clearance letter from the FDA for "D'Arc Eye Care System Sunglasses." It primarily focuses on regulatory approval rather than technical performance studies. There is no information provided regarding acceptance criteria or a study proving the device meets them.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text. The document is strictly a regulatory approval notice, stating the device is substantially equivalent to legally marketed predicate devices.

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M&R Reusable Electrodes are intended for singlepatient/multiple-application use in TENS ("traditional" TENS, NMES ("traditional" NMES , microcurrent TENS, etc.) or interferential, high-volt pulsed galvanic, functional electrical stimulation, etc.).

M&R Reusable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., various cloths, tapes, etc. with biocompatible adhesive, various electrical conductors, and various biocompatible conductive gels). The electrodes are available in models of various sizes with either direct pin lead wire connection or via an integral electrode "prewire" lead wire, and are compatible with all standard, marketed TENS and NMES stimulation devices.

This 510(k) submission (K963123) for the M&R Reusable Electrodes is a premarket notification for a Class II medical device, seeking to demonstrate substantial equivalence to a predicate device (Medi-Source, Inc. GeoHesive Reusable Electrodes K903402). The provided documents do not contain information about a study proving the device meets specific acceptance criteria in the sense of clinical performance or algorithm-driven metrics, as typically seen with AI/ML devices.

Instead, the acceptance criteria are implicit in the demonstration of substantial equivalence to the predicate device. For this type of device (reusable electrodes for TENS/NMES), substantial equivalence is primarily established by comparing device characteristics, materials, intended use, and safety features.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable to the type of submission provided.

Here's a breakdown based on the provided information:

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

The "acceptance criteria" here are the characteristics of the predicate device, and the "reported device performance" is how the M&R Reusable Electrodes compare to those characteristics. The submission aims to show that the new device is as safe and effective as the predicate.

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission does not describe a performance study with a test set of patient data. The "study" is a comparison of product characteristics to a legally marketed predicate device.

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

• Not Applicable. There is no "ground truth" established by experts for a test set in this type of submission. Substantial equivalence relies on engineering and material comparisons, and adherence to known safety principles for transcutaneous electrical stimulation.

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

• Not Applicable. No test set or human adjudication for performance is described.

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, not an AI-assisted diagnostic tool.

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.

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

• Implicit "Ground Truth": The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device (Medi-Source GeoHesive Reusable Electrodes K903402) and generally accepted scientific principles for transcutaneous electrodes. The M&R Reusable Electrodes demonstrate substantial equivalence by using similar materials, having similar indications for use, and presenting similar safety characteristics.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

• Not Applicable. No training set as per AI/ML context.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the substantive comparison presented in the "Device Comparison Chart" within the 510(k) submission. This chart systematically compares the M&R Reusable Electrodes to the predicate device (Medi-Source GeoHesive Reusable Electrodes K903402) across various critical characteristics:

• Number of Models: The M&R device offers significantly more models (37 vs 3), indicating broader options but not necessarily performance difference.
• Electrode Sizes/Shapes: M&R offers a wider variety of sizes and shapes, which fall within the same functional category as the predicate.
• Electrode Construction: Both devices utilize common materials (polyester, polyethylene foam, tricot, vinyl, conductive films with or without Ag/AgCl coating, biocompatible adhesive, biocompatible gel) that are well-established in the industry for such applications. The M&R device provides a broader range of material combinations but remains within accepted norms.
• Stimulator Compatibility: Both devices are compatible with "Common, marketed TENS & NMES devices," establishing functional equivalence.
• Lead Wire Connector Types: M&R offers the same standard connector type as the predicate and an additional standard type, ensuring compatibility.
• Labeled as reusable or single-use disposable?: Both are labeled as "Reusable/for single-patient, multiple-application use."
• Indications For Use: Both are intended for "TENS and NMES," with M&R specifying a broader range of common stimulation modalities falling under TENS/NMES.
• Stated potential adverse reactions: Both list "Skin irritation," indicating similar safety profiles.

Conclusion from the "Study": The comparison demonstrates that the M&R Reusable Electrodes are substantially equivalent to the predicate device. While they offer more variety in models, sizes, shapes, and construction materials, these differences do not raise new questions of safety or effectiveness. The fundamental technological characteristics, intended use, stimulator compatibility, reusability, and potential adverse reactions are either identical or functionally equivalent to the predicate, thus "proving" they meet the implicit acceptance criteria for safety and effectiveness for a Class II device of this type through the substantial equivalence pathway.

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M&R Disposable Electrodes are intended for single-patient/singleapplication use in TENS ("traditional" TENS, microcurrent TENS, etc.) and NMES ("traditional" NMES, interferential NMES, high-volt pulsed galvanic NMES, functional electrical stimulation (FES), etc.) applications.

M&R Disposable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., cloth with biocompatible adhesive, conductive rubber, and biocompatible conductive gel). The electrodes have a direct lead wire pin connection design and are compatible with all standard, marketed TENS and NMES stimulation devices.

The provided text describes a 510(k) premarket notification for M&R Disposable Electrodes. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, the information typically requested in a study design and results section is not explicitly available in this document.

However, I can extract information related to the comparison with predicate devices, which serves as the basis for demonstrating equivalence.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not applicable or available:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, the "acceptance criteria" are typically met by demonstrating that the new device shares fundamental technological characteristics and has similar or identical intended use, design, and performance features to the predicate devices. The "performance" is implicitly deemed acceptable if substantial equivalence is proven.

No explicit quantitative performance metrics or acceptance criteria are presented in the document itself. The comparison table focuses on qualitative and quantitative characteristics for substantial equivalence.

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

This document does not describe a "test set" in the context of a clinical performance study. The 510(k) submission relies on a comparison to predicate devices, which are already legally marketed. There is no mention of a new clinical study with a specific sample size, data provenance, or study design.

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 "test set" or explicit "ground truth" establishment by experts is described for this 510(k) submission.

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

Not applicable. No "test set" or adjudication method is described.

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 is not an AI-enabled device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI-enabled device, and no standalone algorithm performance study is mentioned.

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

Not applicable in the context of a new clinical study. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI-enabled device requiring a training set.

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

Not applicable. This is not an AI-enabled device.

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