FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Nasal septal repair
Orbital floor reconstruction
Tympanic membrane repair
Dialysis shunt anchoring
Durameter repair
Staged repair of omphalocoel
Lengthening of extraocular muscles
As a protective sheathing to help facilitate neural regeneration and tendon anastomosis
As a protective sheathing to help facilitate osteogenesis
Other uses deemed appropriate by the using surgeon

Caution: The American Academy of Oral Maxillofacial Surgeons recommends against the use of silicone products for permanent treatment of Temporo Mandibular Joint Disease.

Device Description

The AART Silicone Sheeting is manufactured from a medical grade silicone elastomer intended for long term implantation. The sheeting will be provided reinforced or non-reinforced in three sizes of varying thicknesses. The AART Silicone Sheeting is intended to be used for various surgical and non-surgical applications and may be trimmed by scalpel or scissors where additional shaping by the surgeon may be necessary.

AI/ML Overview

The provided document is a 510(k) summary for the "AART Silicone Sheeting." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for the new device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from this document as it does not contain the specifics of a performance study in the way you've outlined for AI/medical device performance evaluation.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

None provided. This document is a 510(k) summary demonstrating substantial equivalence, not a detailed performance study with quantitative acceptance criteria and results for the AART Silicone Sheeting itself. The substantial equivalence argument is based on the material, design, function, and performance being similar to the predicate device.

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

Not applicable / Not provided. No specific "test set" or clinical study data for the AART Silicone Sheeting is described in this document. The submission is a comparison to a predicate device.

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

Not applicable / Not provided. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not applicable / Not provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable / Not provided. This document does not describe an MRMC study or any study involving human readers with or without AI assistance. The device is a silicone sheeting for physical applications, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable / Not provided. This device is a physical medical implant/sheeting, not an algorithm or AI product.

7. The Type of Ground Truth Used

Not applicable / Not provided. No performance data requiring ground truth is presented for the AART Silicone Sheeting. The substantial equivalence argument relies on the properties and intended use being similar to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable / Not provided. As this is not an AI/algorithm-based device, there is no concept of a "training set."

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

Not applicable / Not provided. No training set data or ground truth establishment is mentioned.

Summary of what the document does provide regarding the device and its regulatory pathway:

Device Name: AART Silicone Sheeting
Intended Use: Various surgical and non-surgical applications (short term and long term), including nasal splinting, wound dressing, management of scarring, nasal septal repair, orbital floor reconstruction, etc. (See Attachment 1 for full list).
Predicate Device: Seare Biomedical Silicone Sheeting
Substantial Equivalence Claim: Based on similar function, design, performance, materials, intended uses, sizes, thicknesses, and options of reinforcement/non-reinforcement as the predicate device.
Sterilization: Gamma Radiation (minimum 25kGy) to a sterility assurance level (SAL) of 10⁻⁶.
Regulatory Decision: The FDA found the device substantially equivalent to the predicate (K022223 letter). This means it can be marketed under general controls.

Summary

Regulation Number and Section

§ 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.