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The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy).

The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy), and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The PhotonBlade 3 (Model No: 0730-101-000) and PhotonBlade 3 Smoke Evacuation (Model No: 0730-102-000) devices are sterile, single use, electrosurgical devices have a monopolar electrode at the distal end, which delivers radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode is located at the distal end of a rotatable and extendable shaft. The devices have integrated LED-based illumination. In addition, the PhotonBlade 3 Smoke Evacuation features integrated smoke evacuation tubing for removal of smoke generated by electrosurgery when connected to a smoke evacuation universal connector attaches the device to an IEC 60601 compliant electrosurgical generator.

The provided text is a 510(k) Summary for the Stryker Instruments PhotonBlade 3 and PhotonBlade 3 Smoke Evacuation devices. It discusses the regulatory clearance process and comparison to predicate devices, but does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria.

While it mentions "pre-defined acceptance criteria for the above tests were met" in the "Performance Testing" section, it does not explicitly state what those acceptance criteria were for each test, nor does it provide a detailed study design or results from such a study.

Therefore, I cannot extract the information requested. The document primarily focuses on establishing "substantial equivalence" to a predicate device based on similar indications for use and technological characteristics, and by referencing compliance with various standards and general performance testing without providing the specific details of a study that directly proves the device meets predefined acceptance criteria for its performance metrics.

To specifically address your questions, the following would need to be present in the document:

1. A table of acceptance criteria and reported device performance: This would require a table explicitly listing criteria (e.g., "minimum lumen output 50 lumens") and the actual measured performance (e.g., "Device A measured 65 lumens").
2. Sample size and data provenance for the test set: The document vaguely mentions "simulated use life testing," "coag verification test," etc., but no sample sizes or origin of data (e.g., animal, human, in vitro, country).
3. Number and qualifications of experts for ground truth: This type of information is usually relevant for studies involving subjective assessment (e.g., image interpretation). For a device like an electrosurgical unit, ground truth often comes from objective measurements or established physical/biological parameters. The document does not provide this.
4. Adjudication method for the test set: Not applicable based on the type of device and testing described.
5. MRMC comparative effectiveness study: Not conducted or mentioned. This type of study is typically for diagnostic aids involving human interpretation.
6. Standalone performance: The described "performance testing" implies standalone testing of the device's physical and electrical characteristics, but the specific metrics and study details are missing.
7. Type of ground truth used: Ground truth would be based on objective measurements against established engineering, physical, and biological standards (e.g., thermal spread in porcine tissue). The document describes what was tested but not the specific "ground truth" values used for comparison or how they were established.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How ground truth for the training set was established: Not applicable.

The closest the document comes to providing performance data related to "acceptance criteria" is under "Performance Testing," which states: "All pre-defined acceptance criteria for the above tests were met. Results from the the subject devices perform as intended and support a determination of substantial equivalence to the predicate." However, it fails to specify what those acceptance criteria were or the actual results that met them.

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