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The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter.

The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 and SCD396, are sterile, single-use components to which the Sonicision Reusable Generator and Reusable Battery Pack attach. (The Sonicision Reusable Generator and Reusable Battery Pack are not included in this submission and will not be reprocessed by Medline ReNewal.) This component provides control for device functions such as selecting power levels, blade placement and position, grasping, coagulating and dissecting tissue. The Cordless Ultrasonic Dissection Devices can coagulate vessels up to 5 mm in diameter. Furthermore, they are designed to be inserted and extracted through a compatible 5 mm trocar when used endoscopically.

Here's an analysis of the acceptance criteria and study information based on the provided text:

The document is a 510(k) premarket notification for a reprocessed medical device, specifically the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Models SCD 391 and SCD 396. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving novel clinical effectiveness or superiority. Therefore, the testing described focuses on demonstrating that the reprocessed device performs as intended and is as safe and effective as the original, rather than establishing new performance benchmarks for all surgical devices.

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

The document doesn't provide a direct table of specific numerical acceptance criteria alongside reported performance for each test. Instead, it lists types of performance tests conducted to establish equivalence. The general acceptance criterion for all the tests is that the reprocessed device must demonstrate equivalence to the predicate device in terms of safety and effectiveness.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify the exact sample sizes (N numbers) used for each individual performance test. It only states that the functional characteristics "have been evaluated."
• Data Provenance: The data provenance is not explicitly stated. However, since this is a submission for a reprocessed device by Medline ReNewal, the testing would have been conducted by Medline ReNewal or their contracted testing facilities. Given the nature of performance testing for medical devices, it's generally done in a controlled laboratory environment. The origin of the reprocessed devices themselves would be from various healthcare facilities where they were originally used before being sent for reprocessing. The testing itself is prospective in the sense that Medline ReNewal performed these tests on their reprocessed devices.

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

This type of information (expert consensus, qualifications) is typically relevant for studies involving subjective interpretation, like imaging diagnostics or clinical endpoints, where human experts establish ground truth. For this submission, which is about the functional and safety equivalence of a reprocessed surgical instrument, the "ground truth" is established by direct physical and chemical testing against defined specifications or comparison to the performance of the new predicate device. Therefore, information about "experts establishing ground truth" in the clinical sense is not applicable or provided in this document.

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

Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or diagnostic accuracy studies where multiple readers interpret cases and disagreements are resolved. This document pertains to performance testing of a reprocessed surgical instrument, which involves objective laboratory measurements and comparisons to predetermined specifications or predicate device performance. Therefore, an adjudication method in this context is not applicable and not mentioned.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aids, especially those involving AI interpretation, where human readers interact with a system to make diagnoses. The Medline ReNewal device is a surgical instrument, not an AI diagnostic tool.
• Effect Size of AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

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

• Standalone Performance: Not applicable. This is a physical surgical instrument, not an algorithm or software. Its performance is inherent to its mechanical, electrical, and material properties when used by a surgeon.

7. The type of ground truth used

The ground truth for evaluating the safety and effectiveness of the reprocessed device is established through:

• Comparison to the predicate device's known performance: The fundamental scientific technology and intended use are considered identical to the predicate.
• Pre-defined specifications and standards: Each performance test (e.g., grasping/pulling force, cutting effectiveness, cleaning, biocompatibility, sterilization) would have acceptance criteria based on established engineering standards, regulatory requirements, and the expected performance of a new device.
• Objective laboratory measurements: Physical, chemical, and biological tests are performed to directly measure different aspects of the device's function and safety.

Essentially, the "ground truth" is objective measurement against established requirements and comparison to the original device's performance.

8. The sample size for the training set

This concept of a "training set" is relevant for machine learning or AI models. Since this is a physical medical device and not an AI or software product, there is no training set in the traditional sense. The development and validation of the reprocessing procedure would involve internal process development and verification, but it's not a "training set" for an algorithm.

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

Not applicable, as there is no training set for this type of device.

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