(93 days)
The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears 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 Coagulating 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). An audible and tactile mechanism is integrated into the handle housing to indicate full closure. The Ultrasonic Coagulating Shears is 18 cm long, shaft diameter of 8.5 mm, with an active blade length of 18 mm. The blade and clamp arm are straight allowing them to function through an incision without the use of a trocar. The Ultrasonic Coagulating Shears allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. The Ultrasonic Coagulating Shears is designed to operate with the Harmonic TM Generator 300 (GEN04) and the Hand Piece (HP054).
The provided document describes the 510(k) summary for Reprocessed Ultrasonic Coagulating Shears. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving a new device meets specific acceptance criteria through a clinical study. The performance data presented focuses on verifying that the reprocessed device performs as originally intended, matching the predicate device.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance that a new device would need to meet. Instead, the submission relies on demonstrating substantial equivalence to an existing predicate device (Harmonic Wave Coagulating Shears, K062000). The "acceptance criteria" are implied to be that the reprocessed device performs identically to the predicate device in terms of design, materials, intended use, mechanism of action, claims, clinical applications, patient population, and performance specifications.
| Acceptance Criteria (Implied for Reprocessed Device) | Reported Device Performance (Reprocessed Ultrasonic Coagulating Shears) |
|---|---|
| Identical design, materials, and intended use as predicate device. | "The design, materials, and intended use of Reprocessed Technological Ultrasonic Coagulating Shears are identical to the predicate characteristics: device." |
| Identical mechanism of action as predicate device. | "The mechanism of action of Ultrasonic Coagulating Shears is identical to the predicate device in that the same standard mechanical design, size, and materials are utilized." |
| No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation compared to predicate device. | "There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| Safe and effective. | "Performance testing demonstrates that Reprocessed Ultrasonic Coagulating Shears perform as originally intended. Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Ultrasonic Coagulating Shears) are safe, effective, and substantially equivalent to the predicate device as described herein." |
| Biocompatibility requirements met. | "Biocompatibility" test conducted. (Specific results not detailed in summary, but implied to be successful). |
| Reprocessing is validated. | "Validation of reprocessing" test conducted. (Specific results not detailed in summary, but implied to be successful). This also includes "removal of adherent visible soil and decontamination." |
| Sterilization is validated. | "Sterilization Validation" conducted. (Specific results not detailed in summary, but implied to be successful). |
| Components function appropriately. | "Function test(s)" conducted. "Each individual Ultrasonic Coagulating Shear is tested for appropriate function of its components prior to packaging and labeling operations." (Specific results not detailed in summary, but implied to be successful). |
| Packaging is validated. | "Packaging Validation" conducted. (Specific results not detailed in summary, but implied to be successful). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultrasonic Coagulating Shears." However, it does not specify the sample sizes used for these tests.
The data provenance is from bench and laboratory testing, not human clinical data. There is no information about country of origin, retrospective, or prospective nature of this "test set" in the context of clinical trials, as it's not a clinical trial.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and therefore not provided in the document. The study described is a series of bench and laboratory tests to confirm the physical and functional characteristics of a reprocessed device compared to its original specifications, not a study involving human or image-based ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document, as it's not a study involving human reader interpretation or adjudication. The "test set" here refers to physical items undergoing laboratory testing, not clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the substantial equivalence of a reprocessed medical device through bench and laboratory testing, not on the comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done
No, a standalone algorithm performance study was not done. This document concerns a reprocessed physical medical device (ultrasonic shears), not a software algorithm or AI-based device.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is the original specifications and performance of the new (predicate) ultrasonic coagulating shears. The reprocessed device is tested against these established standards to demonstrate that it performs "as originally intended." This includes:
- Biocompatibility standards.
- Validated reprocessing protocols.
- Sterilization efficacy.
- Appropriate function of components (mechanical, electrical, etc.).
- Packaging integrity.
8. The Sample Size for the Training Set
This information is not applicable. There is no training set in the context of machine learning or AI involved in this submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. Since there is no training set mentioned, there is no ground truth established for it in this context.
N/A