(30 days)
For short term application the indications for use are: nasal splinting; wound dressings; management of hypentrophic or kcloid scarring; to prevent soft tissue fibrosis or bony ankylosis following surgical concction of trismus; temporary joint spacers; and laboratory uses. For long-term application the indications for use are: nasal septal repair; orbital floor reconstruction; tympanic membrane repair: dialysis shunt anchoring: duramater repair: staged repair of omphaloccic; for lengthening extra ocular muscles in select cases of strabismus; as a protective sheathing to help facilitate neural regeneration and tendon anastomosis; as a protective sheathing to help facilitate osteogenesis; guided tissue regeneration between teeth and gingival margin, or external ear canal for example; other uses deemed appropriate by the using surgeon. Warning: Not for permanent use in Temporo Mundibular Joint applications.
Seare Biomedical Silicone Sheeting is thate from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer Seare Biomer Sheeting is a flexible, translucent, medical grade silicone elastomer sheeting material designed for a variety of implant applications. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. Surface characteristics will varying degrees of texturing and porosity. The Silicone Sheeting may be readily trimmed with a knife or scissors. This trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable prosthesis for a specific surgical indication.
The provided document, K983041, is a 510(k) summary for the Seare Biomedical Silicone Sheeting. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria.
Therefore, this document does not contain information on acceptance criteria for device performance or a study proving the device meets such criteria in the way a clinical trial would.
Instead, the submission focuses on establishing substantial equivalence based on material, function, performance, and design to already approved Silicone Elastomer Sheeting products.
Here's a breakdown of why the requested information is absent from this specific K983041 document:
- A table of acceptance criteria and the reported device performance: Not applicable. This document does not establish performance criteria for a novel device, but rather asserts equivalence to existing ones.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of a performance study described here. The submission refers to the material, function, performance, and design of the device's characteristics compared to predicates.
- 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. While experts (engineers, material scientists) would have been involved in the design and manufacturing of the device, their role in establishing "ground truth" for a performance study for this type of 510(k) is not discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for a performance study is described.
- 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 a silicone sheeting material, not an AI-powered diagnostic or assistive technology.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices based on their materials, intended use, and history of safe marketing.
- The sample size for the training set: Not applicable. There is no training set as this is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
Key takeaway from the document:
- Clinical Tests: The document explicitly states "Clinical Tests: None." This indicates that no new clinical studies were conducted to prove the safety and effectiveness of this specific device for its 510(k) clearance.
- Substantial Equivalence: The basis for clearance is "Substantial Equivalence" to predicate devices (Dow Corning and Bentec Medical Silicone Elastomer Sheeting) in terms of material, function, performance, and design. The FDA's letter concurs with this finding.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.