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Endoscopes are designed to visualize anatomy through natural and man-made openings in body cavities.

Retraction Sheaths are used to form an artificial working access. The introduction of a telescope permits illumination and observation of the operating site. The rotatable stopcock permits continuous irrigation. The retraction sheaths are used in endoscopic plastic surgery in endo-faceliff, eyebrow and forehead lift specialties.

The Obturator (mandrin) is used in conjunction with the sheath for atraumatic insertion into body cavities.

The Optical Retractors are used to maintain a subcutaneous space during surgical procedures for plastic/cosmetic and reconstructive surgery. They can be combined with an endoscope to visualize the tissue and anatomic structures.

The Optical Holders with optical retractors allow single-handled maintenance of subcutaneous pocket while providing traction. One hand is free for dissection. The optical holder or a guide holds the endoscope in position under the blade of the retractor.

Suction/Irrigation Instruments are used to keep the operating site and the endoscope free of blood and secretion: at the same time it serves as a retractor to hold tissue out of the instrument is used in endoscopic surgery of the nose, nasal sinuses, and in endoscopic plastic surgery.

The Micro Grasping Forceps with HF are used to grasp and to coagulate small blood vessels.

The HF Coagulation Suction Aspirator suctions and coagulates while holding tissue out of the way during the endoscopic operation, e.g. of the larynx in connection with CO2 lasers, in mediastinoscopy or in plastic surgery.

The Bipolar Coagulation Suction Tube (bipolar aspiration tube) is used for aspiration and coagulation of small lesions.

The Bipolar Coagulation Instrument is designed for used in plastic/cosmetic and reconstructive surgery to coagulate small blood vessels that bleed from blunt dissection of subcutaneous tissue. Smoke caused by cauterization of tissue is evacuated from the operative site when used in conjunction with the suction applicator.

Bipolar electrodes are used to coagulate and to remove or destroy tissue by the use of bipolar HF current.

The EPS instruments consist of endoscopes, irrigation/suction cannulas/ sheaths and holders for the endoscope, retractors, forceps, and electrodes (in addition to the exempt dissectors, elevators; probes, and forceps).

The provided document is a 510(k) summary for "EPS. Instruments for Endoscopic Plastic Surgery." This document focuses on establishing substantial equivalence to existing devices rather than proving a novel device meets specific performance criteria through a study. Therefore, standard acceptance criteria and study designs typically associated with AI/ML or new therapeutic devices are not applicable here.

Here's a breakdown of why and what information is provided:

No Acceptance Criteria or Performance Study:

The core statement in the document (Section 5.0) is "No data generated." and "No clinical tests performed." (Section 6.0). This explicitly states that no performance data or clinical tests were conducted to establish acceptance criteria or demonstrate the device meets them.

The submission relies on demonstrating substantial equivalence to existing, legally marketed devices. This means the manufacturer is asserting that their new device is as safe and effective as a predicate device already approved by the FDA, based on similar technological characteristics and intended use, rather than proving performance against quantitative benchmarks.

Therefore, the following aspects of your request cannot be answered from the provided text as they are not relevant to a 510(k) submission based on substantial equivalence without performance data:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

Information Available from the Document:

While a performance study wasn't conducted, the document does contain information relevant to its submission:

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

As noted, no performance data was generated or submitted. The criteria for acceptance in a 510(k) substantial equivalence submission (without performance data) revolve around demonstrating that the device has:

• Same intended use as the predicate device(s).
• Same technological characteristics as the predicate device(s) OR if different, that the differences do not raise new questions of safety and effectiveness.

The document claims: "The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals." (Section 7.0) and "The bipolar instruments are developed to conform to the standards IEC601-2-18." (Section 5.0). These are statements of design and adherence to standards rather than reported device performance from a specific study.

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

None. No test set or data was used since no performance studies were conducted.

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

N/A. No ground truth was established as no performance study was conducted.

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

N/A. No adjudication was performed.

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:

No. This type of study is completely irrelevant to this 510(k) submission, which is for surgical instruments, not an AI/ML-driven diagnostic or assistive technology.

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

No. This device category (surgical instruments) does not involve algorithms or AI.

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

N/A. No performance data or ground truth was used.

8. The sample size for the training set:

N/A. No training set was used.

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

N/A. No ground truth for a training set was established.

In summary, this 510(k) submission for surgical instruments relies solely on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, without presenting any new performance data or clinical test results.

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