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The Synergetics Disposable Speztler-Malis Standard Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

The Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps are sterile single use devices for use in electrosurgery. The forceps are a bayonet style and include a cord at the proximal end which allows for connection to a Malis bipolar electrosurgical generator.

The provided document is a 510(k) Summary for a medical device (Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps), a submission for regulatory clearance in the US. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way one might for a novel diagnostic algorithm or drug.

Therefore, the information requested, particularly regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for training set was established," is not applicable in the context of this 510(k) submission. These questions are more relevant to studies for AI/ML-driven diagnostic devices or clinical trials for drugs.

However, I can extract the relevant information regarding the device's technical characteristics comparison and regulatory testing, which serves a similar purpose of demonstrating safety and effectiveness for substantial equivalence.

Here's a breakdown based on the provided text, addressing the closest equivalents to your questions:

Device: Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) substantial equivalence determination, "acceptance criteria" are generally interpreted as demonstrating equivalent functional and safety characteristics to a legally marketed predicate device. The "performance" is the new device exhibiting these equivalent characteristics through non-clinical testing.

Summary of Non-clinical Testing:
Bench testing and comparative performance testing were conducted to demonstrate substantial equivalence to the predicate device. This included relevant electrical safety testing to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. The non-clinical testing indicated that the device performance is substantially equivalent to the predicate, and the slight differences (primarily the lack of irrigation feature) raise no new issues of safety and effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not specified for individual tests. The document refers to "bench testing" and "comparative performance testing," implying physical testing of the device. The sample size for these engineering tests would typically be determined by internal quality standards and statistical power requirements for specific tests (e.g., tensile strength, insulation integrity) but is not detailed in this summary.
• Data Provenance: The document implies the data comes from internal testing conducted by Synergetics, Inc., related to the manufacturing and design verification of the new device and comparison to the predicate. This is prospective testing performed for regulatory submission. Country of origin not explicitly stated, but the applicant's address is O'Fallon, MO, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not Applicable. This device is a physical electrosurgical tool, not an AI/ML diagnostic system or imaging device requiring expert interpretation for ground truth. "Ground truth" in this context would be engineering specifications and validated performance metrics (e.g., electrical resistance, material integrity).

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Tests would be based on objective measurements against engineering specifications and industry standards rather than expert adjudication.

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

• Not Applicable. This is a surgical instrument, not an AI/ML diagnostic aid. No human reader or AI assistance is involved in its direct function.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• For the "tests" performed (bench testing, comparative performance, electrical safety), the "ground truth" would be engineering specifications, industry standards (e.g., IEC 60601 series, ISO 11135, ISO 14971, ISO 11607-1), and the established performance characteristics of the legally marketed predicate device. The goal is to show the new device meets safety and performance standards and is substantially equivalent to the predicate.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. See point 8.

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