(87 days)
The reprocessed harmonic scalpels are indicated to be used for cutting of soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired. The instrument can be used as an adjunct to, or a substitute for, electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator and torque wrench and are intended to be used in soft tissue surgery for simultaneous cutting and coagulation of vessels and tissue. The instrument has a scissor handle with hand control capabilities consisting of MIN and MAX buttons. The handle housing has an integrated mechanism for limiting the force that can be applied when closing the distal mechanism. The instrument has an 18 cm shaft length, 8.5 mm shaft diameter, active blade length of 18 mm, and utilizes a straight blade and clamp arm. Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission.
The provided text describes a 510(k) premarket notification for a Reprocessed Harmonic Scalpel by SterilMed, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device, not on proving the de novo effectiveness of a new device through clinical trials. Therefore, much of the information typically requested for AI/algorithm performance studies (like sample size for test/training sets, expert qualifications, MRMC studies, etc.) is not applicable to this type of regulatory submission.
The "acceptance criteria" here refer to the demonstration of functional and safety characteristics for the reprocessed device to be deemed substantially equivalent to the original predicate device.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional and Safety Requirements) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Functional Characteristics: Performance equivalent to predicate device for cutting and coagulation. | "Representative samples of reprocessed harmonic scalpels were tested to demonstrate appropriate functional characteristics." (Specific characteristics not detailed in this summary, but the conclusion of substantial equivalence implies these were met.) |
| Cleaning Procedures: Efficacy of cleaning to remove biological contaminants. | "Process validation testing was performed to validate the cleaning... procedures." (Specific metrics/results not detailed, but implied successful validation.) |
| Sterilization Procedures: Efficacy of sterilization to achieve sterility assurance levels. | "Process validation testing was performed to validate the ... sterilization procedures." (Specific metrics/results not detailed, but implied successful validation.) |
| Device Packaging Integrity: Maintenance of sterility and physical protection during transport and storage. | "Process validation testing was performed to validate the ... device packaging." (Specific metrics/results not detailed, but implied successful validation.) |
| Manufacturing Process Quality Controls: Visual and functional inspection of all products. | "In addition, the manufacturing process includes visual and validated functional testing of all products produced." (Implies an ongoing quality control system is in place and verified.) |
| Substantial Equivalence: Similarities in functional design, principle of operation, materials, indications for use, and methods of construction to the predicate device. | "The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic WAVE™ harmonic scalpels. This conclusion is based upon the devices' similarities in functional design (principle of operation), materials, indications for use and methods of construction." (This is the overarching conclusion the studies aimed to support.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document states "Representative samples of reprocessed harmonic scalpels were tested." However, specific sample sizes for functional, cleaning, sterilization, or packaging validation tests are not provided in this summary.
- Data Provenance: The studies were conducted by SterilMed, Inc. However, the country of origin for the data (e.g., where the testing was physically conducted) is not explicitly stated. The nature of the testing (functional, cleaning, sterilization, packaging) indicates this would be prospective testing conducted specifically for this submission, rather than retrospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission is for a reprocessed medical device, not an AI/algorithm-based diagnostic or clinical decision support system. "Ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant here. The ground truth would be established by objective measurements and validated processes (e.g., microbial load counts for sterilization, force measurements for functional testing, material analysis).
4. Adjudication method for the test set
- Not Applicable. As this is not a diagnostic AI system, expert adjudication for resolving discrepancies in interpretations is not relevant. The studies involve objective measurements and validation of physical, chemical, and functional properties.
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 reprocessed physical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a reprocessed physical device, not an algorithm or software. Standalone algorithm performance is not relevant.
7. The type of ground truth used
- Objective Measurements and Validated Processes: The "ground truth" for the device's performance is established through:
- Validated functional testing: Objective measurements against predefined specifications for cutting, coagulation, and mechanical integrity, likely benchmarked against predicate device performance.
- Validated cleaning processes: Demonstrating reduction of contaminants to acceptable levels.
- Validated sterilization processes: Achieving a specified sterility assurance level (e.g., 10^-6 for terminally sterilized devices).
- Validated packaging integrity: Ensuring sterile barrier and physical protection.
- Visual inspection and manufacturing quality controls: Conformance to physical and material standards.
8. The sample size for the training set
- Not Applicable. As this is not an AI/algorithm-based device, there is no "training set." The focus is on verifying the performance of the reprocessed devices against established specifications and predicate device characteristics.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
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