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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 intearal light source intended to for use by qualified surgeons only. The surgeon is able to articulate the distal member of the device by means of hand actuated rotation knob. The surgeon directly controls the amount of articulation and tissue dissection. A small light source is attached to the distal tip of the articulation member, which remains illuminated for a minimum of four (4) hours. Multiple models of the Dissector™ are available with varving shaft lengths to accommodate surgeon preference and differing patient habitus.

The provided text is a 510(k) Summary for a medical device called the AtriCure Dissector™. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample size, ground truth, or expert involvement in such a study.

The document does mention:

• "Appropriate product testing was conducted according to the Design Control requirements as defined in 21 CFR 820.30 to evaluate conformance to product specification and substantial equivalence to the legally marketed device."
• "These activities included Risk Analysis, Process Verification, and Biocompatibility Testing."
• "Biocompatibility testing was conducted according to ISO 10993-1 to confirm that the modified Dissector™ is safe for limited use (<24 hrs) as a patient contacting device."

This indicates that internal testing was performed to ensure the device met its design specifications and was biocompatible. However, it does not provide the specific performance acceptance criteria or the results of those tests in a way that can be presented in the requested table format.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with specific acceptance criteria as you've outlined.

Here's a breakdown of why each specific point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "conformance to product specification" but doesn't list the specifications or the performance metrics.
2. Sample sized used for the test set and the data provenance: Not provided for performance testing. Biocompatibility testing is mentioned but without sample sizes or provenance details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance testing details are not provided.
4. Adjudication method for the test set: Not applicable. Performance testing details are not provided.
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 surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a human-operated surgical device.
7. The type of ground truth used: Not applicable. Performance testing details are not provided.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable. (See #8).

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