(98 days)
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.
§ 886.5700 Eyelid weight.
(a)
Identification. An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).(1) The external eyelid weight is adhered to the outer skin of the upper eyelid.
(2) The implantable eyelid weight is implanted into the upper eyelid.
(b)
Classification. (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. The special controls for the external eyelid weight are:(i) Testing demonstrating the biocompatibility of the device; and
(ii) Labeling must include the following information:
(A) Specific instructions regarding the proper placement, sizing, and removal of the device; and
(B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment.
(2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are:
(i) Testing demonstrating the biocompatibility of the device;
(ii) Testing demonstrating the sterility and shelf life of the device;
(iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment.
(iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.