(245 days)
Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments 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.
Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, and sterilized for an additional clinical use.
The provided text describes the substantial equivalence of a reprocessed surgical device, not an AI or diagnostic device, so many of the requested categories (like number of experts for ground truth, MRMC study effect size, sample size for training set, etc.) are not applicable and cannot be answered from the provided document.
However, I can extract the relevant acceptance criteria and performance information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical thresholds matched to reported performance data for each criterion. Instead, it describes various performance tests conducted to demonstrate equivalence to the predicate device. The general acceptance criterion is that the reprocessed device performs equivalently to the original predicate device across these tests.
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence to Predicate Device | The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices based on the following tests: simulated use; grasping/pulling force; cutting effectiveness/functionality; drop test; device integrity; cutting/coagulation evaluation for a prolonged period of time; thermal analysis characterization; tissue sticking; vessel burst pressure, seal quality and histopathology; electrical safety in accordance with IEC 60601-1; cleaning; protein, carbohydrates, and endotoxins and visual inspection; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability. |
| Safety and Cleaning (absence of harmful residues/pyrogens) | Cleaning; protein, carbohydrates, and endotoxins and visual inspection; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity. |
| Sterilization Efficacy and Device Stability | Sterilization validation; and product stability. |
| Electrical Safety (as per recognized standards) | Electrical safety in accordance with IEC 60601-1. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test set. It describes types of tests performed (e.g., simulated use, grasping/pulling force, cutting effectiveness). The "data provenance" is implied to be from laboratory testing conducted on the reprocessed devices, comparing them to the predicate devices. The document does not specify country of origin or whether the data was retrospective or prospective, though performance testing is inherently prospective for the reprocessed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to a reprocessed surgical instrument. The "ground truth" for these tests relates to measurable physical and functional properties, as well as biological safety, compared against the predicate device and established standards, rather than expert interpretation of images or clinical data.
4. Adjudication method for the test set
Not applicable for this type of device and testing. Test results are based on objective measurement against established specifications or predicate device performance.
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 for a surgical instrument, not an AI or diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly refers to the established performance characteristics and safety profile of the legally marketed predicate device, as well as recognized industry standards for safety (e.g., electrical safety, biocompatibility, sterilization efficacy) and functionality. For example, "cutting effectiveness" would be compared to a benchmark established by the new predicate device, and "vessel burst pressure" would have a defined acceptable range.
8. The sample size for the training set
Not applicable. This is a reprocessed surgical instrument, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this type of device submission.
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