(66 days)
The Coherent SlimLine Single Lumen Aspiration Needle Set and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery, and for aspiration and/or irrigation of fluid and/or surgical debris.
The Coherent SlimLine Single Lumen Aspiration Needle Set and associated accessories are intended to be used to help deliver laser light energy from the Coherent SlimLine Family of fiber optic fibers used with the Coherent VersaPulse Family of Ho:YAG and Ho:YAG/Nd:YAG surgical lasers for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue and urinary calculi (including steinstrasse) in a variety of medical specialties.
Coherent SlimLine Single Lumen Aspiration Needle Set are comprised of the following main components:
- the handpiece assembly (with optical fiber locking nut and locking nut O-ring); .
- . the optical fiber stop;
- . aspiration needles (straight and curved needles of various lengths);
- aspiration needle locking nut (with locking nut O-ring); .
- . positioning trocars; and
- . a sterilization tray
The SlimLine Single Lumen Aspiration Needles are provided as non-sterile, ready to be sterilized devices that are either available individually or as a set of three aspiration needles in a sterilization tray.
The provided text does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the other specific details requested in the prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance).
The document is a 510(k) Summary Statement for a medical device submitted in 1996, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details of performance studies against specific criteria.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Missing): The document states "Physical testing was conducted to demonstrate performance of the Coherent SlimLine Single Lumen Aspiration Needle Set in accordance with product specifications." However, the specific product specifications and acceptance criteria are not detailed. We don't know what quantitative or qualitative thresholds the device had to meet.
- Reported Device Performance (Implicit): The conclusion states, "The physical test results demonstrated that the Coherent SlimLine Single Lumen Aspiration Needle Set have acceptable performance characteristics." This is a general statement of compliance, but no specific performance metrics or their values are reported.
2. Sample size used for the test set and the data provenance:
- Sample Size (Missing): The document does not specify the number of devices or tests conducted for physical testing, biocompatibility, or sterility validation.
- Data Provenance (Implied): The testing was conducted internally by Coherent Medical Group, likely in the USA, as this is a US FDA submission. The data would be prospective as it was generated for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This type of information is relevant for studies involving human interpretation (e.g., imaging studies, diagnostic devices). The testing mentioned (physical testing, biocompatibility, sterility) are objective laboratory tests that do not typically involve expert consensus for "ground truth."
4. Adjudication method for the test set:
- Not Applicable: Similar to point 3, adjudication methods are for resolving discrepancies in human interpretation, which is not relevant to the described testing.
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: This document describes a medical device (aspiration needle set) that delivers laser energy, not a diagnostic or AI-powered device that involves human interpretation or AI assistance. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No: This is not an algorithm or AI-based device.
7. The type of ground truth used:
- Objective Test Standards: For physical testing, ground truth would be established by validated test methods and established engineering standards. For biocompatibility, it would be based on recognized biological safety standards. For sterility, it would be a Sterility Assurance Level (SAL) of 10^-6 achieved through validated sterilization cycles.
8. The sample size for the training set:
- Not Applicable: There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable: No training set.
In summary, based only on the provided text, the specific details regarding acceptance criteria and a structured study demonstrating performance are largely absent. The document primarily serves to state that testing was conducted and found acceptable, supporting a claim of substantial equivalence to predicate devices, which is standard for 510(k) submissions. It does not provide the granular detail requested about specific performance metrics or study designs for device validation.
§ 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.