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The mammary sizer is designed for single use, temporary intraoperative placement in a surgically created pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.

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This document is a 510(k) clearance letter for a device called "Mammary Sizer." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth details. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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The Specialty Surgical Products Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

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The provided text is a 510(k) clearance letter from the FDA to Specialty Surgical Products, Inc. for their Mammary Sizer device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is a notification of substantial equivalence for a medical device and thus does not describe the technical details of the device's validation. It primarily focuses on regulatory aspects and the device's classification.

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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:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. 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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