(91 days)
Coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
Tru-Pulse™ Pulsed CO2 Surgical laser is an Rf excited gas-slab pulsed CO2 laser which produces 1-10 watts average power
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tru-Pulse CO2 Surgical Laser System:
Based on the provided K970804 510(k) Summary, no specific acceptance criteria or study demonstrating device performance against those criteria are presented.
The submission is a 510(k) Pre-market Notification seeking substantial equivalence to a predicate device. In this type of submission, the primary goal is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not necessarily to independently prove performance against specific acceptance criteria through a dedicated study.
Here's a breakdown of the requested information based on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This indicates that no specific performance metrics or acceptance thresholds were established or measured for this submission. The basis for clearance is substantial equivalence to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not applicable, as no dedicated performance study using a test set was conducted for this 510(k) submission.
- Data Provenance: Not applicable.
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, as no dedicated performance study with ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no dedicated performance study with adjudication was conducted.
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
- No MRMC study was done. The device in question is a surgical laser, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A standalone performance study was not done. The device is a physical surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no dedicated performance study with ground truth was established for this submission.
8. The sample size for the training set
- Not applicable, as this is a physical medical device (surgical laser), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as this is a physical medical device (surgical laser).
Summary of the 510(k) Submission:
The K970804 submission for the Tru-Pulse™ CO2 Surgical Laser relies entirely on substantial equivalence to an existing predicate device, the UltraPulse® Pulsed CO2 Laser manufactured by Coherent.
- Predicate Device: UltraPulse® Pulsed CO2 Laser manufactured by Coherent.
- Basis for Equivalence: The intended use of the Tru-Pulse™ is stated as "the same or similar" to the predicate device for various clinical applications (dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open and endoscopic general surgery).
- Performance Data: Crucially, the document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This signifies that the substantial equivalence argument was not supported by new performance studies specific to the Tru-Pulse™ device demonstrating its performance against predefined criteria. Instead, it likely relied on the established safety and effectiveness of the predicate device and the similarity of the new device's design and intended use.
§ 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.