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Reprocessed Ultrasonic Scalpels are indicated in general and endoscopic surgery to cut and coagulate soft tissue when hemostasis is desired with a minimal risk of burns.

Device Description

Reprocessed Ultrasonic Scalpels are hand-held instruments designed to be used as part of an ultrasonic surgical system. These devices cut and coagulate tissue when attached to the ultrasonic hand piece and electrosurgical generator.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Reprocessed Ultrasonic Scalpels by Alliance Medical Corporation

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance and Evidence
Safety:
- Biocompatibility (no adverse biological reactions)	Bench and laboratory testing included "Biocompatibility"
- Freedom from contamination (adequate reprocessing)	Bench and laboratory testing included "Reprocessing Validation" and "Sterilization Validation." The description states, "All removal of adnorom visible of and functionally tested prior to packaging, labeling, and sterilization operations." (Likely a typo and should refer to "removal of adherent visible soil"). This implies testing confirmed effectiveness of cleaning and sterilization processes.
- Minimal thermal injury	The intended use states: "cut and coagulate soft tissue when hemostasis is desired with a minimal risk of burns." The document asserts "Reprocessed Ultrasonic Scalpels perform as originally intended" (which includes minimal thermal injury as per the original device's claims). No direct test result for thermal injury is provided beyond this assertion.
Effectiveness/Performance:
- Function as originally intended (cut and coagulate tissue)	Bench and laboratory testing included "Function Tests." The conclusion states, "Performance testing demonstrates that Reprocessed Ultrasonic Scalpels perform as originally intended." The reprocessing process includes ensuring devices are "functionally tested prior to packaging, labeling, and sterilization operations." The claim is that the reprocessed devices "do not differ from the legally marketed predicate device(s)" in technological features, performance specifications, and method of operation.
- Equivalence to predicate device for stated indications	The core argument for 510(k) clearance is "substantial equivalence" to predicate devices (Ethicon Endo-Surgery Ultrasonic Scalpels K980099, K993054). The submission states, "The intended use and technological features of the reprocessed devices do not differ from the legally marketed predicate device(s). Both the reprocessed device(s) and the predicate device(s) have the same materials and product design. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation."

2. Sample Size and Data Provenance for Test Set

Test Set Description: The document refers to "Bench and laboratory testing" and "Performance testing." It lists categories of tests: Biocompatibility, Reprocessing Validation, Sterilization Validation, and Function Tests.
Sample Size: The document does not specify the exact sample size for each test category. It generally refers to "tooling" and "testing."
Data Provenance: The testing was conducted by Alliance Medical Corporation through "Bench and laboratory tooling." No information is given about external collaborators or country of origin other than the company's location in Phoenix, Arizona, USA. The nature of these tests suggests they are internal, prospective studies conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth of Test Set

The document does not indicate the involvement of external experts or a formal "ground truth" establishment process by experts for the performance testing.
The tests described are primarily engineering and laboratory-based, comparing the reprocessed device to its original specifications or known predicate characteristics. Decisions about "performance as originally intended" would likely be made by R&D engineers and quality assurance specialists within Alliance Medical Corporation, based on pre-defined criteria derived from the original device's specifications.

4. Adjudication Method for Test Set

There is no mention of an adjudication method (like 2+1 or 3+1) for the test set. Given the nature of the bench and laboratory tests (e.g., sterilization validation, function tests), these typically involve objective measurements against pass/fail criteria rather than expert review and adjudication of subjective outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This device is a medical instrument (ultrasonic scalpel), not an imaging or diagnostic AI-powered device that would typically involve human-in-the-loop performance studies. The 510(k) submission focuses on demonstrating that the reprocessed device performs identically to its predicate.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical surgical instrument; it does not involve algorithms or AI in its direct operation. Performance is assessed based on its physical characteristics and functional capabilities after reprocessing.

7. Type of Ground Truth Used

The "ground truth" for the performance testing is implicitly the original design specifications and performance characteristics of the predicate (new) device. The testing aims to confirm that the reprocessed device meets or equals these established benchmarks.
- Biocompatibility: Likely against established ISO standards for medical devices.
- Reprocessing Validation: Against parameters proven to remove contaminants.
- Sterilization Validation: Against established sterilization sterility assurance levels (e.g., SAL of 10^-6).
- Function Tests: Against the functional capability of a new, unused ultrasonic scalpel (e.g., cutting efficacy, coagulation performance, tip integrity).

8. Sample Size for the Training Set

Not applicable. This is a reprocessed physical device, not a machine learning or AI algorithm, so there is no concept of a "training set."

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

Not applicable. As there is no training set, there is no ground truth for it to be established.

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