(76 days)
The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal thermal injury is desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures and other open procedures.
The Ultrasonic Curved Shears is an instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The instrument has a working length of 9cm, an active blade length of 16mm, and utilizes a curved blade and clamp arm. The Ultrasonic Curved Shears device allows for the cutting and coagulation of vessels up to and including 5mm in diameter. The Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are designed to operate with the Harmonic™ Generator 300 (GEN04) and Harmonic™ Blue Hand Piece (HPBLUE).
The provided documentation describes the reprocessing of an Ultrasonic Curved Shears device and its substantial equivalence to a predicate device. The information details the acceptance criteria through performance testing, but not a specific study with a quantitative measure against criteria in a table format as requested.
Here's an analysis of the provided information, addressing your points:
1. A table of acceptance criteria and the reported device performance
The document lists categories of performance testing but does not provide specific quantitative acceptance criteria or detailed reported performance values. It states generally that "Performance testing demonstrates that Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist perform as originally intended."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated performance (safety and effectiveness) |
| Validation of reprocessing | Demonstrated performance (safety and effectiveness) |
| Sterilization Validation | Demonstrated performance (safety and effectiveness) |
| Function test(s) | Demonstrated performance (safety and effectiveness) |
| Packaging Validation | Demonstrated performance (safety and effectiveness) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any of the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
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 provided in the document. The performance tests appear to be laboratory and bench testing, not clinical studies involving human observers for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The testing described is technical performance testing, not a clinical trial with 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
An MRMC comparative effectiveness study was not conducted. This document describes the reprocessing of a surgical instrument, not an AI-assisted diagnostic or therapeutic device that would involve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to the device described. The device is a reprocessed surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Function test(s)," the ground truth would likely be the original design specifications and performance characteristics of the predicate device. For "Biocompatibility," "Validation of reprocessing," "Sterilization Validation," and "Packaging Validation," the ground truth is established by adherence to recognized standards and protocols for reprocessing, sterilization, and packaging of medical devices. No clinical outcomes data or pathology is mentioned for establishing ground truth in this context.
8. The sample size for the training set
This is not applicable as the device is a reprocessed physical instrument, not an AI model.
9. How the ground truth for the training set was established
This is not applicable as the device is a reprocessed physical instrument, not an AI model.
Summary of the Study:
The study described is a series of bench and laboratory tests designed to demonstrate that the Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist performs as originally intended by the manufacturer of the predicate device (Harmonic Focus Curved Shears and Torque Wrench, K063192). The core of the argument for substantial equivalence relies on:
- Identical Design and Materials: The reprocessed device is stated to have identical design, materials, intended use, mechanism of action, mechanical design, size, and materials as the predicate device.
- Reprocessing Validation: Ascent Healthcare Solutions' reprocessing procedure includes removal of soil, decontamination, and individual functional testing of each reprocessed unit.
- Performance Testing Categories: The testing covered Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), and Packaging Validation.
The conclusion is that these tests demonstrate safety, effectiveness, and substantial equivalence to the predicate device. The document does not provide the granular details of the specific acceptance criteria (e.g., a specific force requirement for a function test) or the quantitative results of these tests, but rather states that performance was "demonstrated."
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