(155 days)
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.