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The Cell Robotics, Inc. unnamed Er: YAG Surgical laser is indicated for use in small and large joint Arthroscopy, including microdiscectomies, endoscopic procedures and general surgical procedures for cutting (incision / excision), vaporizing and coagulation of soft tissues, including skin, subcutaneous tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

The Cell Robotics Er:YAG Surgical Laser is an Er:YAG laser producing laser emission at 2940nm. The laser consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the swing arm and the handpiece, which houses the laser.

The provided text is a 510(k) summary for the Cell Robotics Er:YAG Pulsed Surgical Laser System. It focuses on establishing substantial equivalence to a predicate device and does not contain specific details about acceptance criteria, a study proving device performance against those criteria, or the methodology of such a study.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

   • Not applicable / Not provided. The document states "Nonclinical Performance Data: None" and "Clinical Performance Data: None". The basis for clearance is substantial equivalence to a predicate device, not performance against specific acceptance criteria presented in a study within this document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable / Not provided. No test set or performance data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable / Not provided. No ground truth or expert involvement for test data is mentioned.

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

   • Not applicable / Not provided. No adjudication method for test data is mentioned.

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 / Not provided. This device is a surgical laser, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

   • Not applicable / Not provided. This is a physical surgical device, not an algorithm.

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

   • Not applicable / Not provided. No ground truth data is mentioned or used for device performance assessment in this submission. The "ground truth" for regulatory clearance is the substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

   • Not applicable / Not provided. There is no indication of a training set as this is not a machine learning device, nor is a study involving performance data mentioned.

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

   • Not applicable / Not provided. No training set is mentioned.

Summary based on the document:

The Cell Robotics Er:YAG Pulsed Surgical Laser System was cleared based on its substantial equivalence to a predicate device, the Schwartz Electro-Optics TriLase2940 (K954013). The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." Therefore, the document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any associated data regarding sample sizes, ground truth, or expert involvement.

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