Search Results

For use in cutting, vaporizing and coagulating soft tissue for clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surger y

Accu-Pulse is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications).

The document provided is a 510(k) summary for the Accu-Pulse CO2 Surgical Laser System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove device performance is not available in the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with corresponding device performance metrics from a study. Instead, it provides a "Table of Substantial Equivalence" which compares the Accu-Pulse to two predicate devices on various features. This table implicitly defines the acceptable range of performance as being comparable to the predicate devices.

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

The document explicitly states: "Performance Data: None. The specifications and intended use of the Accu-Pulse Surgical Laser System are the same or very similar to those of the Tru-Pulse™ pulsed CO2 laser. Because of this, performance data were not required."

Therefore, there was no separate test set used, and no data provenance information is available.

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

As no performance data or test set was required, there were no experts used to establish ground truth for a test set.

4. Adjudication method for the test set

Not applicable, as no test set was used.

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 medical device for surgical applications, not a diagnostic AI system involving human readers.

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

Not applicable. This device is a laser system, not an algorithm. The document mentions "Software Validation" for its internal control system, but this is a technical validation of the software's functionality, not a standalone performance study in the context of user interaction or diagnostic outputs.

7. The type of ground truth used

Not applicable, as no performance study was conducted requiring ground truth. The basis for acceptance was substantial equivalence to a predicate device.

8. The sample size for the training set

Not applicable, as this is a hardware device submission, not an AI/machine learning model that would require a training set of data.

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

Not applicable, as no training set was used.

Ask a specific question about this device