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The reprocessed harmonic scalpels are intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.

Harmonic scalpels are part of an ultrasonic system and are intended to be used in soft tissue surgery for simultaneous cutting and hemostasis. The system consists of a generator/foot switch, handle, connecting hose, and a scalpel blade. Only the handle and scalpel blade are reprocessed. The generator/foot switch and hose components of the device are not included as part of this submission.

Harmonic scalpels can be manufactured using aluminum with a nickel chrome alloy edge or a titanium alloy (with or without a coating). These scalpels are available in a variety of lengths, outer circumferences, angles and sharpness.

The provided document is a 510(k) premarket notification for reprocessed ultrasonic scalpels. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on functional and safety testing. However, it does not contain the detailed information typically found in a scientific study report, especially regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, or any comparative effectiveness studies with human readers.

Therefore, I cannot extract the requested information in full. I can provide what is available, which is very limited for most of your points.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be fully provided. The document states, "Representative samples of harmonic scalpels underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced."
• No specific acceptance criteria or quantitative performance results (e.g., in terms of cutting efficiency, thermal injury, or lifespan) are reported in this summary. The summary only generally states that testing was done to "demonstrate appropriate functional characteristics."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified. The document only mentions "Representative samples."
• Data provenance: Not specified, but generally, 510(k) testing for US market approval is conducted in the US or according to internationally recognized standards. The document doesn't specify if it was retrospective or prospective.

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)

• Not applicable / Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies where experts label data). For a physical medical device like a reprocessed scalpel, "ground truth" would be established through engineering specifications, material science testing, and functional performance benchmarks rather than expert consensus on interpretive data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable / Not specified. Adjudication methods are usually for resolving discrepancies in expert interpretations, which is not relevant here. Device testing would follow standardized protocols.

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 device is a reprocessed surgical scalpel, not an AI diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a reprocessed surgical scalpel, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not explicitly stated in detail. The "ground truth" for a reprocessed medical device would generally come from:
  • Original device specifications: Performance parameters of the new, original (predicate) devices.
  • Material properties: Chemical and physical analyses of the reprocessed materials.
  • Sterility and cleanliness tests: Microbiological and cleanliness standards.
  • Functional performance standards: Bench testing against established engineering and clinical performance criteria for cutting, coagulation, and overall integrity.
• The document mentions "Functional and Safety Testing" and "Process validation testing," implying these standards were used.

8. The sample size for the training set

• Not applicable for this type of device. "Training set" refers to data used to train machine learning models. This is a physical medical device, not an AI/ML product.

9. How the ground truth for the training set was established

• Not applicable for this type of device.

Summary of what is available (with caveats):

Specifics: No quantitative acceptance criteria or detailed performance metrics are provided in this summary. |
| Sample Size (Test Set) & Data Provenance | Sample Size: "Representative samples" (exact number not specified).
Data Provenance: Not specified (e.g., country, retrospective/prospective). |
| Number & Qualifications of Experts | Not applicable; device testing involved engineering/technical assessment, not expert interpretation of data. |
| Adjudication Method | Not applicable for this type of device testing. |
| MRMC Comparative Effectiveness Study | Not applicable; this is a physical surgical device, not an AI diagnostic tool. |
| Standalone Performance (Algorithm Only) | Not applicable; this is a physical surgical device, not an algorithm. |
| Type of Ground Truth Used | Implied to be based on: Original predicate device specifications, material properties, sterility/cleanliness standards, and functional performance benchmarks (e.g., cutting, coagulation efficiency). |
| Sample Size (Training Set) | Not applicable; this is a physical surgical device, not an AI/ML product. |
| How Ground Truth for Training Set Established | Not applicable; this is a physical surgical device, not an AI/ML product. |

In conclusion, the provided FDA 510(k) summary is designed to establish substantial equivalence for a reprocessed device based on general safety and effectiveness. It does not contain the detailed study design, acceptance criteria, and specific performance results that would be found in a comprehensive clinical or engineering study report. For such specifics, one would typically need to review the full 510(k) submission or associated test reports, which are not included here.

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