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The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.

The SightFix consists of a rigid endoscope and a flexible holding arm. The rigid endoscope of the SightFix contains an optic and a light fiber. The SightFix endoscope is designed to be used with the camera SightCam and the light source SightLight manufactured by WORLD OF MEDICINE Lemke GmbH. In addition, the use of adapters allows an easy attachment of standard 180W endoscopic light sources (halogen, xenon, quartz) to the endoscope. The holding arm of the SightFix is a manually operated endoscope holder to ensure an optimal positioning of the endoscope. Both the rigid endoscope and some components of the holding arm are autoclavable.

The provided text describes a 510(k) submission for a device called "SightFix." This submission primarily focuses on establishing substantial equivalence to predicate devices rather than detailing independent performance criteria and an accompanying study with specific acceptance criteria that would typically be found in a primary clinical trial or performance evaluation.

Therefore, many of the requested sections about acceptance criteria, sample sizes, expert ground truth, MRMC studies, and standalone performance cannot be directly extracted from the provided text. The document primarily relies on compliance with international and European safety standards for its performance data.

Here's a breakdown based on the available information:

Acceptance Criteria and Device Performance

Study Information

1. Sample sizes used for the test set and the data provenance:

• Not explicitly stated. The document refers to compliance with standards, which would involve testing, but the specific sample sizes for such tests or the provenance of any performance data are not provided. The strategy is based on substantial equivalence, not a direct clinical performance study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not stated. This information would typically be relevant for a clinical performance study with human interpretation (e.g., imaging studies), which is not the primary basis of this 510(k) submission.

3. Adjudication method for the test set:

• Not applicable/Not stated. See point above.

4. 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:

• No. This is not an AI-assisted device. The device is an endoscope and holder.

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

• Not applicable. This device is a medical instrument (endoscope and holder), not an algorithm or AI system. Its performance is inherent to its physical design, materials, and manufacturing, tested against standards for safety and function, not as a standalone algorithmic performance.

6. The type of ground truth used:

• Compliance with recognized standards and substantial equivalence. The "ground truth" here is that the device meets established safety and sterilization standards and is functionally similar to legally marketed predicate devices, which are presumed safe and effective.

7. The sample size for the training set:

• Not applicable/Not stated. This concept is typically relevant for machine learning algorithms, which this device is not.

8. How the ground truth for the training set was established:

• Not applicable/Not stated. See point above.

Summary of Approach:

The 510(k) submission for SightFix relies on demonstrating substantial equivalence to existing predicate devices (MGB LAPALUX Telescope, Robotrac™ Retractor Arm, and KSEA Endoscope Holder) in terms of intended use, design, material, and technological characteristics. Additionally, it highlights compliance with relevant international and European safety and sterilization standards. This approach, common for medical devices, means that a detailed, independent clinical study with specific performance acceptance criteria and associated sample sizes, expert ground truth, and comparative effectiveness (as one might see for diagnostics or AI devices) is generally not required or presented in such a submission. The performance is assessed against the established safety and functional profiles of the predicate devices and the relevant standards.

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