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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.

2. Sample Size for Test Set and Data Provenance

• MRI Safety: The testing was conducted using the largest sizes available in the market (2.8g) for both Gold and Platinum Eyelid Weight Implants. While the specific number of individual implants tested for each condition (force, heating, artifact) is not explicitly stated, it implies at least one sample of each type and weight was used for the respective tests. The provenance of the data is from non-clinical laboratory testing specific to the device.
• Biocompatibility: Not directly referenced as a "test set" in the traditional sense for diagnostic performance. It involved chemical characterization and cytotoxicity testing. The sample size for these tests (e.g., number of replicates, specimens) is not specified but would follow the requirements of the ISO 10993 standards. Data provenance is from laboratory testing.
• Sterility and Shelf-Life: The testing involved validation protocols based on standards like ISO 11135-1 and ASTM standards for package integrity. The sample sizes for these validation activities are not explicitly detailed but are typically defined by the respective standards (e.g., for bioburden, sterility validation, accelerated aging studies). Data provenance is from laboratory testing (in-house or contract sterilizer).

3. Number of Experts and Qualifications for Ground Truth

This document does not pertain to the diagnostic performance of an AI/ML device or a device requiring expert interpretation for its primary function. Therefore, there were no "experts used to establish ground truth" in the context of clinical outcomes or diagnostic accuracy. The ground truth for the non-clinical tests is based on objective measurements and adherence to established engineering and material science standards and protocols.

4. Adjudication Method

Not applicable, as this is not a study requiring human adjudication of clinical or diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable, as this is not a study assessing human reader performance.

6. Standalone (Algorithm Only) Performance

Not applicable, as this is a physical medical implant, not an AI/ML algorithm.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests described is based on:

• Objective Measurements: For MRI safety (deflection angles, temperature changes, artifact dimensions), sterility (SAL, residual levels), and shelf-life (dimensional stability, package integrity).
• Established Standards and Protocols: Adherence to international standards (ISO, ASTM) for methods, acceptance criteria, and measurement techniques.
• Material Characterization: For biocompatibility, the ground truth is based on the chemical composition of the materials and their known biological responses, validated by specific in-vitro tests (cytotoxicity, leachable tests).

8. Sample Size for Training Set

Not applicable, as this is not an AI/ML algorithm requiring a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as this is not an AI/ML algorithm requiring a training set.

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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:

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

• MRI Safety Review: The testing was conducted on "the largest available sizes of 2.8g" for both gold and platinum Contour™ Eyelid Weight Implants. No specific number of samples (implants) is given beyond this, but it implies at least one of each (gold and platinum, 2.8g).
  • Data provenance: The tests were conducted according to specific ASTM and internal SOPs. The location (e.g., country of origin) of the testing lab is not specified, but it's presumed to be a controlled laboratory environment. The data is prospective, generated specifically for this submission.
• Biocompatibility: Testing was performed on "the Gold and Platinum Contour™ and ThinProfile™ Eyelid Weight Implants." No specific number of samples is provided.
  • Data provenance: Testing was conducted in accordance with ISO standards and Nelson Labs SOPs. The data is prospective.
• Sterility and Shelf-life:
  • Sterilization validation: Uses biological indicators (BI Spore Strips). No specific number of BIs or device units is given.
  • Shelf-life testing: While real-time aging of 36 months is mentioned, no specific number of packaged units tested is provided.
  • Data provenance: Conducted according to ISO and ASTM standards. The data is prospective.

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

Not applicable. This device is not an AI/diagnostic software. The "acceptance criteria" here refer to engineering and material performance specifications rather than diagnostic performance assessed against a ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. This is not a diagnostic device with an "adjudication method" in the typical sense for clinical studies. The results are objective measurements from laboratory tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a physical implant, not a diagnostic imaging or AI system.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's acceptance is based on:

• Standardized laboratory measurements and physical properties (e.g., MRI-induced heating, force, artifact size).
• Compliance with recognized international and national standards (e.g., ISO, ASTM, USP) for biocompatibility, sterility, and packaging.
• Expert interpretation of these test results against established safety and performance thresholds defined in the standards and regulatory guidance.

8. Sample Size for the Training Set:

Not applicable. This is a physical implant; there is no "training set" in the context of AI or machine learning.

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

Not applicable.

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