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The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons in women with congenital absence of the vagina who have failed first-line non-surgical treatment with conventional vaginal dilators. The set is used in conjunction with a laparoscopic surgical procedure to create and enlarge the vaginal cavity via continuous traction between the abdomen and vulva, and to maintain the vaginal canal after surgery.

The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons to be placed in the vagina to enlarge the vaginal cavity and maintain the vaginal canal after laparoscopic-assisted creation of a neo-vagina.

This is a 510(k) premarket notification for a medical device, which is an application seeking substantial equivalence to a legally marketed predicate device. This type of submission generally does not include detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies as would be found in a De Novo or PMA submission. The focus of a 510(k) is to demonstrate that the new device is as safe and effective as (substantially equivalent to) an existing device.

Therefore, many of the requested details about acceptance criteria and specific study designs are typically not found within a 510(k) summary. I will extract the information that is present and note where the requested information is not available due to the nature of a 510(k) submission.

Here's the breakdown of the information provided in the document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: A 510(k) does not typically define explicit acceptance criteria in the same way a clinical trial or performance study for a novel device would. Instead, the "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has "similar basic features, design, and intended uses" and that "minor differences...raise no new issues of safety and effectiveness."
• Reported Device Performance: The document states: "The KSEA Neo-vagina Surgery Set and Accessories is substantially equivalent to the predicate device since the basic features, design, and intended uses are similar. The minor differences between the KSEA Neo-vagina Surgery Set and Accessories and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function, or intended use of the devices."

Table of (Implied) Acceptance Criteria and Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided in a 510(k) summary. A 510(k) application focuses on demonstrating equivalence to existing devices, often through comparative analysis of device specifications, materials, and intended use, rather than a clinical trial with a "test set" in the context of an AI/algorithm.

3. 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)

• This information is not applicable/not provided. Ground truth establishment by experts is typically part of studies for novel devices or AI algorithms. This 510(k) is for a surgical instrument set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable/not provided. Adjudication methods are relevant for studies where expert consensus on interpretations (e.g., from images) is needed.

5. 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

• This information is not applicable/not provided. MRMC studies are specific to evaluating diagnostic devices, especially those incorporating AI, and are not part of a 510(k) for a surgical instrument set. The device described is a set of physical surgical instruments, not an AI or diagnostic tool.

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

• This information is not applicable/not provided. There is no algorithm or AI component in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• This information is not applicable/not provided. As this is a surgical instrument set and not a diagnostic or AI device, the concept of "ground truth" for performance evaluation in a structured study is not directly relevant in the 510(k) summary provided.

8. The sample size for the training set

• This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• This information is not applicable/not provided. There is no "training set" or "ground truth" in the context of an AI/ML device for this submission.

Summary of the Study (Implied by 510(k) Process):

The "study" in a 510(k) context is a comparative analysis of the new device against a legally marketed predicate device(s).

• Design: The submission performs a comparison of the KSEA Neo-vagina Surgery Set and Accessories against two predicate devices: Bioteque America, Inc. (K003380) and Specialities REMEEX International, S.L. (K033310).
• Objective: To demonstrate that the new device is "substantially equivalent" to these predicates in terms of basic features, design, intended use, and technological characteristics, and that any differences do not raise new issues of safety and effectiveness.
• Methodology: The summary states that the devices are compared based on their design, intended uses, and technological characteristics (removable, reusable, biocompatible, autoclavable materials, range of sizes).
• Outcome: The conclusion is that the KSEA Neo-vagina Surgery Set and Accessories is substantially equivalent to the predicate devices.

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