(168 days)
The GSI, Inc. Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.
The GSI Mammary Sizer is designed to be used during plastic and reconstructive surgery when it is desirable to determine the correct volume and/or symmetry of mammary implants prior to implantation. The device is constructed of smooth semi-elastomeric polyurethane. The device consists of a balloon and balloon tubing used for filling the sizer. There is an attachment to prevent fluid leakage and a female luer lock at the proximal end of the filler tube.
The provided text describes the "Mammary Sizer" device and mentions "Testing Results and Conclusions" that include "biocompatibility, material strength, and volume rating." However, it does not provide specific acceptance criteria or details of a study that proves the device meets those criteria.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document is a 510(k) summary, which typically provides a high-level overview. Detailed testing protocols and results, including specific acceptance criteria and study designs, are usually found in the full 510(k) submission, which is not provided here. The summary states that the device is "substantially equivalent" to a predicate device, and the testing mentioned (biocompatibility, material strength, volume rating) likely supports this claim of substantial equivalence for safety and effectiveness, but the specifics of how these were tested against defined criteria are missing.
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General Surgical Innovations, Inc. 3172A Porter Dr. Palo Alto, CA. 94304
SMDA Summary Attachment B
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510(K) SUMMARY
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850 USA
Summary of Safety and Effectiveness
Contact Person
Theresa M. Nazaroff General Surgical Innovations, Inc. 3172A Porter Dr. Palo Alto, CA 94304
Device Name
Mammary Sizer
Substantial Equivalence and Conclusions
The Mammary Sizer which is proposed for use in the sub-glandular of sub-muscular tissue plane is substantially equivalent to Mentor's Volume Sizer for Mammary Implants that are marketed for use in the area of plastic and reconstructive surgery.
Intended Use
The GSI, Inc. Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.
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Device Description
The GSI Mammary Sizer is designed to be used during plastic and reconstructive surgery when it is desirable to determine the correct volume and/or symmetry of mammary implants prior to implantation. The device is constructed of smooth semi-elastomeric polyurethane. The device consists of a balloon and balloon tubing used for filling the sizer. There is an attachment to prevent fluid leakage and a female luer lock at the proximal end of the filler tube.
Testing Results and Conclusions
Testing performed to support the appropriateness of the Mammary Sizer for its intended use include biocompatibility, material strength, and volume rating.
Nazareff
Theresa M Nazaroff
General Surgical Innovations, Inc.
March 30, 1996
N/A