The intended use of the modified Solid Silicone and Silicone Sponge Implants is unchanged from the pre-amendment and cleared MIRA Solid Silicone and Silicone Sponge Implants. These devices are used to "buckle" the sclera in retinal reattachment surgery.

Device Description

Solid Silicone and Silicone Sponge Implants are molded extruded silicone devices, available in a wide variety of shapes and sizes.

AI/ML Overview

This 510(k) summary describes a device, "Solid Silicone and Silicone Sponge Implants," used in retinal reattachment surgery. The submission focuses on a change in the silicone material used in the device, demonstrating that the new material is substantially equivalent to the previously cleared material. Therefore, the acceptance criteria and supporting studies are centered on establishing this equivalence, primarily through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for the new silicone material)	Reported Device Performance (with new silicone material)
Material not substantially different from original Dow Corning material.	Physical testing performed by material supplier confirmed this. Results provided in FDA Master Files.
Non-toxic and biocompatible.	Testing demonstrated that the implants were non-toxic and biocompatible according to FDA "Tripartite Guidance" and "Table IV. Confirmatory Biological Testing" referenced in FDA "Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials."

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

The document does not explicitly state a "test set" in the context of clinical performance or a specific sample size of devices. The testing described is primarily material-level and biocompatibility testing.

Test Set Sample Size: Not specified for individual devices; testing was performed on the "new silicone material" and "sterilized finished devices manufactured with new silicone material."
Data Provenance: The physical testing results were provided by the "material supplier." Biocompatibility testing was performed on finished devices. No country of origin is specified for the raw data or testing facilities. The studies appear to be retrospective in the sense that they are evaluating a material change for an existing device rather than a de novo clinical trial.

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

This information is not applicable to the provided document. The ground truth for this submission is established through material specifications and standardized biocompatibility testing protocols, rather than expert consensus on clinical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication is typically associated with human review of imaging or clinical data, which is not the nature of the testing described here.

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

No. An MRMC study is a clinical study involving human readers evaluating cases, often in radiology or pathology. The provided document describes non-clinical material and biocompatibility testing.

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

No. This device is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Material Specifications: For the "material not substantially different" criterion, the ground truth would be the established physical and chemical properties of the previously cleared Dow Corning silicone material.
Standardized Biocompatibility Endpoints: For biocompatibility, the ground truth is defined by the specific endpoints and acceptable limits set forth in the FDA "Tripartite Guidance" and "Table IV. Confirmatory Biological Testing" (e.g., non-cytotoxic, non-sensitizing, non-irritating).

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable. There is no training set.

Summary

{0}------------------------------------------------

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Solid Silicone and Silicone Sponge Implants

JUN - 5 1996

1. APPLICANT

MIRA, Inc. 87 Rumford Avenue Waltham, MA 02154 Contact Person: Michael A. Warren 1-800-847-6472 (In MA, 617-894-2200) Telephone: Facsimile: 617-647-1855

Date of Summary Preparation: February 21, 1995

DEVICE NAME 2.

Proprietary Name:	Solid Silicone and Silicone Sponge Implants
Common/Usual Name:	Scleral Buckling Device
Classification Name:	Extraocular Orbital Implants

PREDICATE DEVICE 3.

MIRA, Inc. claims substantial equivalence of the Solid Silicone and Silicone Sponge Implants to currently marketed Solid Silicone (preamendment) and Silicone Sponge Implants (K780987A) manufactured and marketed by MIRA, Inc.

DEVICE DESCRIPTION 4.

Solid Silicone and Silicone Sponge Implants are molded extruded silicone devices, available in a wide variety of shapes and sizes.

{1}------------------------------------------------

INTENDED USE 5.

Comparison of Technological Characteristics of this Device to the 6. PREDICATE

Operational Principles .
The general operational principles are identical. Buckling implants are used to occupy space and provide compression for retinal reattachment. The change in materials has no impact on the function of these implants.
. Materials of Construction
1

The only difference between the modified Solid Silicone and Silicone Sponge Implants is the silicone material. This difference is minor and does not affect safety or effectiveness.

. Models Available
The models of Solid Silicone and Silicone Sponge Implants is unchanged.
Sterility Status ●
The Solid Silicone and Silicone Sponge Implants, like the currently marketed devices, are provided sterile.
1. TESTING
- . Non-clinical Testing

Non-clinical testing was performed to show that the new material used for the manufacture of MIRA Solid Silicone and Silicone Sponge Implants is not substantially

MIRA, Inc. 510(k) for Change in Silicone Material 2/21/95

{2}------------------------------------------------

different from that of the original Dow Corning material. Physical testing was performed by the material supplier with results provided in FDA Master Files.

Biocompatibility .

There is no change in biocompatibility. Sterilized finished devices manufactured with new silicone material were tested for biocompatibility according to FDA "Tripartite Guidance" and according to "Table IV. Confirmatory Biological Testing" referenced in FDA "Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials. Testing demonstrated that the implants were non-toxic and biocompatible.

MIRA, Inc. 510(k) for Change in Silicone Material

2/21/95

Regulation Number and Section

§ 886.3340 Extraocular orbital implant.

(a)
Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.(b)
Classification. Class II.