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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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This indication for use for the 'Lid Chain Eyelid Weight Implant' is for the "Restoration of dynamic lid closure in paralytic lagophthalmos due to facial nerve paralysis"

Lid Chain Eyelid Weight Implant

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Lid Chain Eyelid Weight Implant." This type of document establishes substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies to prove effectiveness and safety with specific acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a specific study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The 510(k) pathway primarily focuses on demonstrating that a new device is as safe and effective as an already legally marketed device (the predicate device). This often involves:

• Comparison to a predicate device: Showing that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, demonstrating that those differences do not raise new questions of safety or effectiveness.
• Performance data (often non-clinical): This might include bench testing, material characterization, and sometimes small clinical usability studies or animal studies, to support the substantial equivalence claim. However, it's not the same as a large-scale, controlled clinical trial to prove efficacy against pre-defined acceptance criteria.

In summary, based on the provided document, I cannot fulfill your request for the following reasons:

1. Acceptance Criteria and Reported Device Performance: This document does not specify acceptance criteria or report performance data from a study for the "Lid Chain Eyelid Weight Implant." It's a clearance letter based on substantial equivalence.
2. Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): This information is not present as the device approval pathway (510(k)) does not typically require the detailed clinical study structure implied by these questions.
3. Ground Truth Type and Training Set Details: There is no mention of an algorithm or AI model, thus no training set or ground truth establishment for such a model. The device is a physical implant.

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The MedDev Contour Design Gold Eyelid Implants intended use is for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

MedDev's Contour Design Gold Eyelid Implants are spherically radiused parts of gold (at McdDCV S Ource) which conform to the curvature of the eye globe. They are available in twelve sizes ranging from 0.6 grams in 0.2-grams in 0.2-gram increments. All product tworo olzoo ranging trone or substantially equivalent to the predicated devices mentioned Specifications are the barns of Suzen the predicated MedDev devices and the proposed above. The occasion Gold Eyelid Implants is that the devices will now be supplied sterile to end users.

MedDev's Contour Design Gold Eyelid Implants can be implanted into the eyelid using the Medical techniques depicted in the product brochure. This technique is the same or substantially equivalent to techniques used for the predicated devices.

Implants are made of 99.99% pure gold. They are designed in a receinigular onapo with a opners spherical radius of 12.7 mm to conform to the shape of the good. The implant, allowing the surgeon to secure the implant to the tarsus or orbital septum.

The MedDev Contour Design Gold Eyelid Implants are spherically radiused gold implants designed to conform to the curvature of the eye globe. They are used for the gravity-assisted treatment of protracted or permanent lagophthalmos, typically resulting from facial paralysis.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The submission relies on substantial equivalence to predicate devices rather than defining specific quantitative acceptance criteria or performance metrics for the device itself. The primary change in the proposed device is that it will now be supplied sterile, whereas previous MedDev Contour Design Gold Eyelid Implants were non-sterile.

The acceptance criteria for the re-submitted device are implicitly based on maintaining all other characteristics and performance features of the predicate devices. The study provided focuses on asserting that the proposed device is "the same or substantially equivalent" to the predicate devices across various attributes.

2. Sample Size for Test Set and Data Provenance

No specific test set or clinical study data is referenced in the provided document for the evaluation of the device's functional performance or efficacy. The submission relies on the established safety and effectiveness of its own pre-amendment non-sterile version and the cleared Labtician Lid Load™ Gold Eyelid Weight Implants (K983607).

The "study" presented is a comparison table asserting substantial equivalence. It does not involve a test set of patients or data provenance in the traditional sense of a clinical trial. The data provenance is effectively the regulatory approval of the predicate devices.

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

Not applicable. No ground truth was established by experts for a test set in this submission. The "ground truth" for the claims of equivalence lies in the established properties and regulatory acceptance of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication in this submission.

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

Not applicable. This device is an implant, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical implant. The concept of an "algorithm only" performance study is not applicable.

7. Type of Ground Truth Used

The ground truth used for this submission is the established safety and effectiveness of the predicate devices (MedDev's own pre-amendment non-sterile Contour Design Gold Eyelid Implants and Labtician Lid Load™ Gold Eyelid Weight Implants). The primary ground truth for the new aspect of the device (sterility) is the validation of the steam sterilization process to achieve a Sterility Assurance Level (SAL) of 1 x 10-6.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device.

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SutureGroove Gold Eyelid Weights are indicated for the gravityassisted treatment of the functional defects of lagophthalmos resulting from facial paralysis. This is intended to protect against corneal exposure keratitis and improve cosmesis

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is primarily a 510(k) clearance letter for the "Suture Groove™ Gold Eyelid Weight Implant," stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the regulatory classification, general controls, and indications for use.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, details on MRMC studies, standalone performance, training set information, or ground truth establishment. This information is typically found in a clinical study report or a premarket submission summary, which is not present in the given text.

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Labtician Lid Load External Eyelid Sizing Weights are used by the physician to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos.

Labtician Lid Load External Eyelid Sizing Weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid using until the proper eyelid closure is attained. Because the levator muscle seems to strengthen after the weight is added, the optimal weight for implantation is ususally that which holds lid about 1.0 mm lower than the normal lid as the patient looks straight ahead.

The corresponding implantable gold eyelid weight is then prescribed for implantation.

Sizing weights are not designed to be implanted, and are provided nonsterile and are re-usable following cleaning with soap and water and/or alcohol and rinsing with tap water.

Labtician Lid Load External Eyelid Sizing Weights are spherically radiused strips of pure tantalum (99.5%), constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments.

A Labtician Lid Load External Eyelid Sizing Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or other suitable adhesive.

The physical specifications and materials used in the construction of Labtician Iid Load External Eyelid Sizing Weights are identical to the EyeClose External Eyelid Weights, with the exception that Labtician Lid Load External Eyelid Sizing Weights are unpainted.

Labtician Lid Load External Eyelid Sizing Weights are constructed of pure tantalum (99.5%). The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded.

This document is a 510(k) Summary for the Labtician Lid Load External Eyelid Sizing Weights. It describes the device, its intended use, and claims substantial equivalence to a predicate device, the EyeClose External Eyelid Weights (K940974).

No specific acceptance criteria or details of a study demonstrating the device meets such criteria are provided in the provided text. The submission focuses on establishing substantial equivalence based on similar design, materials, and intended use as the predicate device, rather than presenting a performance study with defined acceptance criteria.

The information requested in the prompt, such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, is not available in this 510(k) summary. This type of regulatory submission typically does not involve clinical performance studies with detailed statistical analysis as would be required for novel devices or those demonstrating significant technological differences. The claim of substantial equivalence implies that the device is as safe and effective as the predicate device, obviating the need for extensive new performance data.

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