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The VersaJet II Hydrosurgery System is intended for wound debridement (acute and chronic wounds, burns), soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgment, require sharp debridement and pulsed lavage irrigation.

The VersaJet II Hydrosurgery System uses a pressurized stream of sterile fluid to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. The device provides cutting, irrigation and evacuation in the same tool. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The debris and fluid are directed into the handpiece into a flexible tube, which carries the effluent to the drain or collection canister. The system employs two basic system components: the reusable power console and the single-use, sterile handpiece and tubing assembly. The primary change to the system is the design of the interface of the handpiece into the console. The new design is a simple, intuitive "key lock mechanism" design that improves the ease of connection of the handpiece to the console.

The provided text describes a 510(k) summary for the VersaJet II Hydrosurgery System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, primarily concerning design changes to the device's interface and performance specifications.

Therefore, it is not a study that assesses a device's performance against clinical acceptance criteria using patient data, nor does it involve ground truth established by experts or human readers.

The information requested in your prompt (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this type of regulatory submission and the non-clinical testing described.

The device is a medical instrument (hydrosurgery system) for wound debridement, and the "acceptance criteria" here refer to engineering design specifications and performance benchmarks established for the device itself, rather than clinical outcomes or diagnostic accuracy.

Here's the information that can be extracted or inferred based on the provided text, structured to address your points as much as possible, with explanations for why certain points are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are effectively the "Design Input Description" and the reported device performance is the "Result" from the "Summary of Non-Clinical Testing."

Biocompatibility testing was also conducted with the following results:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable in the context of patient data or diagnostic accuracy. The "test set" here refers to the physical units of the VersaJet II system and its components subjected to engineering design verification tests. The exact number of units tested is not specified but would be typical for product validation (e.g., a batch of handpieces, a console, etc.).
• Data Provenance: Not applicable in the context of clinical data. This is non-clinical engineering testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. The "ground truth" for these tests are objective engineering measurements and functional checks (e.g., measuring weight, force, pressure, noise level, confirming LED visibility, switch functionality, procedure duration, and cutting effectiveness). These are typically performed by trained engineers or technicians in a laboratory setting.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. The results are typically based on objective measurements meeting predefined engineering specifications.

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:

• MRMC Study: No. This is a physical medical device, not an AI or imaging diagnostic tool.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is not an algorithm. Its performance is inherent to its physical operation and is always used by a human operator.

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

• Type of Ground Truth: Engineering specifications and objective physical measurements. For example, a "low noise level" would have a defined decibel limit as its ground truth; "equivalent pressures" would be measured against the predicate device; "30 minutes average debridement procedure" indicates a performance endurance test against a set time.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set of data.

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

• Ground Truth for Training Set Establishment: Not applicable.

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