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.

Device Description

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.

AI/ML Overview

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.

Summary

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APR - 4

960417 Attachment 14 510(k) Summary Statement for the Coherent SlimLine Single Lumen Aspiration Needle Set

I. General Information
لقابل المقابل المقابلة

تقابل المقابل الموقف الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ال

Submitter: Coherent Medical Group 3270 West Bayshore Road Palo Alto, CA 94303

Contact Person: Anne C. Worden

Summary Preparation Date: January 25, 1996

II. Names
Device Names: Coherent SlimLine Single Lumen Aspiration Needle Set.

Primary Classification Name: Laser Powered Surgical Instrument (and Accessories).

III. Predicate Devices

· Suction/Irrigation Probe (with long adapter/sizing sheath, short adapter and gasket) Accessory Kit marketed by Coherent Medical, Inc. (K923575, K902990)
LASE Surgical Kit (Model 1100 Discectomy Decompression Kit) manufactured by Clarus Medical Systems, Inc. (K913136)

IV. Product Description

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

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V. Indications for Use

VI. Rationale for Substantial Equivalence

The Coherent SlimLine Single Lumen Aspiration Needle Set and their delivery device accessories share the same indications for use, similar design features, components and materials, and therefore are substantially equivalent to the Suction/Irrigation Probe Accessory Kit marketed by Coherent Medical, Inc. (K923575, K902990), and to the cannulas, trocar, and trephine components included in the LASE Surgical Kit manufactured by Clarus Medical Systems, Inc. (K913136).

VII. Safety and Effectiveness Information

Physical testing was conducted to demonstrate performance of the Coherent SlimLine Single Lumen Aspiration Needle Set in accordance with product specifications. The component materials with expected and potential patient contact were tested to demonstrate acceptable biocompatibility. Sterility testing was conducted to validate that the SlimLine Single Lumen Aspiration Needles attain a sterility assurance level (SAL) of 10-6 when sterilized in accordance with the directions provided in the Instruction Guide.

VIII. Conclusion

The Coherent SlimLine Single Lumen Aspiration Needle Set was found to be substantially equivalent to the cannula, trocar and trephine components provided in the LASE Surgical Kit manufactured by Clarus Medical Systems, Inc. The Coherent SlimLine Single Lumen Aspiration Needle Set shares the same indications for use, similar design features, and similar functional features as the currently marketed Coherent Irrigation/Suction Probe Accessory Kit, and the cannula, trocar and trephine components provided in the currently marketed LASE Surgical Kit. The physical test results demonstrated that the Coherent SlimLine Single Lumen Aspiration Needle Set have acceptable performance characteristics.

Regulation Number and Section

§ 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.