(10 days)
The AtriCure dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.
The AtriCure dissector™ is a hand held, single use, surgical articulated dissector with integral light source.
The provided text is a 510(k) summary for the AtriCure dissector™, a surgical device. It does not describe a study that proves the device meets specific acceptance criteria in the way an AI/software device submission would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through product testing and material suitability.
Therefore, many of the requested elements for an AI/software device study, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable or not provided in this document.
However, I can extract the information that is present and indicate where the requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predicate Device Equivalence | The AtriCure dissector™ is substantially equivalent to the Stryker Knifelight Lighted Knife (K961122). |
| Indications for Use Equivalence | The indications for use are substantially equivalent to the predicate device. |
| Basic Overall Function Equivalence | The basic overall function is substantially equivalent to the predicate device. |
| Material Equivalence | The materials used are substantially equivalent to the predicate device. |
| Biocompatibility | Testing was conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials. |
| Conformance to Product Specification | Appropriate product testing was conducted to evaluate conformance to product specification. |
| Substantial Equivalence to Predicate Devices | Appropriate product testing was conducted to evaluate substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/software device being evaluated with a test set of data. The "testing" refers to product testing for device function and biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for an AI test set is not relevant for this type of medical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 not an AI-assisted device for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth as typically understood for AI evaluation is not relevant here. The "ground truth" for this device would be its ability to perform its intended mechanical and lighting functions safely and effectively, which is assessed through engineering and biocompatibility testing against predefined specifications and predicate device equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/software device that undergoes a training process.
9. How the ground truth for the training set was established
Not applicable.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.