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Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

The Gold and Platinum Tapered Weight Eyelid Implants are implantable devices for the gravityassisted treatment of lagophthalmos by the addition of weight to the upper eyelid. The device is made of either 99.99% purity gold or platinum. Platinum devices can be implanted in patients who are allergic to gold. The Gold and Platinum Tapered Weight Eyelid Implants come in two thicknesses (thin and normal profiles) and in seven different weights ranging from 0.6 g to 1.8 g (in 0.2 g increments). The Gold and Platinum Tapered Weight Eyelid Implants are each provided as a sterilized product.

This document describes the premarket notification (510(k)) for Gold and Platinum Tapered Weight Eyelid Implants. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study for novel device acceptance criteria. Therefore, much of the requested information regarding clinical study design, ground truth, expert opinions, and sample sizes for diagnostic performance is not directly applicable or available in this document.

However, based on the provided text, I can extract and infer information relevant to the non-clinical acceptance criteria and the studies performed to meet them.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence to an existing device, the "acceptance criteria" are primarily established by demonstrating that the new device shares fundamental technological characteristics and performance (or equivalent performance) with the predicate device, especially considering any differences. The key performance metrics evaluated are MRI safety, biocompatibility, and sterility/shelf-life.

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Malhotra Platinum Segments are eyelid implants designed for the gravity-assisted treatment of lagophthalmos.

Sterile, single use, eyelid weight implant segments, used to treat Lagophthalmos to weigh down the upper eye lid to aid closure, used in combinations to achieve optimum result for each patient. The devices are made of 90% platinum 10% iridium, an industry standard alloy utilized for eyelid implants. The segments are rectangular in shape, contoured to the shape of the eye, with suture holes for both linking segments together in a chain and securing segments into position. Two sizes of segments are provided, with total weight customized for patient need by surgeon selection of segment combinations. The min/max combination range is from total 0.4g to total 2.0g. They achieve their intended purpose through gravity, weighing down the upper eyelid.

The provided document is a 510(k) summary for the Altomed Malhotra Platinum Segments, an eyelid implant. It focuses on demonstrating substantial equivalence to a predicate device (Heinz Kurz Platinum Implants) rather than proving specific performance metrics against pre-defined acceptance criteria for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of typical AI/ML medical device performance studies (sensitivity, specificity, reader studies, etc.). Instead, it focuses on material equivalence, biocompatibility, sterility, shelf life, and MRI compatibility.

Here's why the requested information cannot be extracted from this document:

• Type of Device: This device is a passive implant that treats lagophthalmos through gravity (weighing down the eyelid). It is not an AI/ML diagnostic or prognostic device that would have performance metrics like sensitivity, specificity, or require reader studies for its primary function.
• Regulatory Pathway: A 510(k) submission aims to show "substantial equivalence" to a legally marketed predicate device. This often involves demonstrating similar technological characteristics, intended use, and safety/performance profiles, rather than proving novel performance against a predefined set of acceptance criteria in a clinical study of AI performance.
• "Performance Data" Section: The "Performance Data" section (Section 7) describes testing for biocompatibility, sterility/shelf life, and MR compatibility. These are safety and engineering performance tests relevant to an implantable device, not diagnostic accuracy or clinical effectiveness involving human-AI interaction or AI-alone performance.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance studies based on the provided text.

If this were an AI/ML device submission, the "Performance Data" section would typically contain information such as:

• Acceptance Criteria Table: Define thresholds for metrics like sensitivity, specificity, AUC, etc.
• Study Design: Details on the prospective/retrospective nature, data provenance, sample size of the test set, and how ground truth was established (e.g., expert consensus with adjudication, pathology, clinical outcomes).
• Reader Studies (if applicable): Number and qualifications of readers, study design (e.g., MRMC), and results comparing human performance with and without AI assistance.
• Standalone Performance: AI algorithm performance without human intervention.
• Training Set Details: Sample size and ground truth establishment for the training data.

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The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

MedDev Contour™ and ThinProfile™ Eyelid Weight Implants were designed for the treatment of lagophthalmos, i.e. the inability of the eyelid to fully close. This condition is typically due to a degree of facial paralysis. The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. The density of their construct material (pure gold or platinum) provides the weight necessary to close the eyelid over the eye. The patient can use their functional orbital musculature to keep their eyes open, but have the gravitational assist from the Implant to close the eyelid.

The provided text describes the acceptance criteria and a study for the MedDev Contour™ and ThinProfile™ Eyelid Weight Implants.

1. Table of Acceptance Criteria and Reported Device Performance:

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