The Right Angle Laser Fiber and Optilase Lasers are indicated for a wide variety of I no Right , trying incision, excision, resection, vaporization, ablation, coagulation, Surglour asso moraumy of benign prostatic hyperplasia (BPH) and other urological conditions.

Device Description

The Right Angle Laser Fiber is a fiber optic Nd:YAG energy delivery system consisting of: r ne right kingth of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector.

The Optilase laser systems are continuous-wave Nd:YAG energy sources equipped with an aiming beam, adjustable power output, and a fiber optic connector.

AI/ML Overview

The provided text describes a medical device submission (510(k)) for Right Angle Laser Fibers and Optilase Nd:YAG Laser Systems. The information focuses on the device description, intended use, and a clinical study comparing Visual Laser Ablation of the Prostate (VLAP) using the device to Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH).

However, the document does not provide the specific acceptance criteria or detailed results of the study that would allow for a table comparing acceptance criteria to reported device performance. It simply states that the clinical data show the devices are "safe and effective."

Therefore, I cannot populate the table or provide detailed answers to many of the questions as the specific information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document	The document states "The clinical data show that the Trimedyne Right Angle Laser Fibers and Optilase Nd:YAG Laser Systems are safe and effective for treatment of Benign Prostatic Hyperplasia (BPH)." However, specific metrics, thresholds, or comparisons to acceptance criteria are not provided.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document. The study is described as "prospective, controlled and well-matched," but the number of participants is not mentioned.
Data Provenance: The country of origin is not explicitly stated for the clinical study. It is a "prospective, controlled and well-matched study."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study compares VLAP to TURP, implying a direct clinical outcome comparison rather than an expert-driven ground truth for a discrete test set.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

An MRMC study was not done. This study is a clinical comparison of two surgical procedures (VLAP vs. TURP), not an AI-assisted diagnostic or interpretative system being evaluated by human readers. The devices described are surgical lasers and fibers, not AI algorithms for interpretation.

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

This is not applicable as the devices are surgical instruments, not standalone AI algorithms.

7. The type of ground truth used:

The "ground truth" implicitly used is clinical outcomes for Benign Prostatic Hyperplasia (BPH) treatment, comparing the effectiveness of VLAP (using the device) to TURP. Specific outcome measures (e.g., symptom scores, flow rates, re-operation rates) are not detailed in this summary.

8. The sample size for the training set:

Not applicable. The clinical study described is a comparison of surgical procedures. There is no mention of a "training set" in the context of an AI algorithm.

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

Not applicable for the same reasons as point 8.

Summary

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954j97

MAR 11 1990

Summary of 510(k) Safety and Effectiveness Information Trimedyne® Right Angle Laser Fibers and Optilase® Nd:YAG Laser System Models 1000, 4000, and 1000-100 (PL100)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

I.	Submitter Information:	Trimedyne, Inc.P.O. Box 57001Irvine, CA 92719-7001714/559-5300714/559-1330 (facsimile)
	Contact Person:	Susan H. GambleDirector, Regulatory Affairs & Quality Assurance

Summary Date: October 2, 1995

II. Device Name

Right Angle Laser Fibers:

Proprietary:	Not yet selected
Common:	Laser fiber

Classification: Accessory to Laser-powered Instrument (unclassified)

Optilase Lasers:

Proprietary:
• Optilase® Model 1000 Nd:YAG Laser System• Optilase® Model 4000 Nd:YAG Laser System• Optilase® PL100 Model 1000-100 Nd:YAG Laser System
Common:
Neodymium Yttrium Aluminum Garnet (Nd:YAG) laser system

Classification: Laser-powered Instrument

III. Predicate Device

The predicate devices for the intended use are various configurations of the Trimedyne Right Angle Laser Fiber cleared under 510(k) number K944204 and the Trimedyne Optilase Nd:YAG Laser Systems cleared under 510(k) numbers K922497 and K932883.

TRIMEDYNE, INC 2801 BARRANCA ROAD P.O. BOX 57001, IRVINE (CA 92619-7001 714 559-5300, FAX 714 559-1330 800 - 33-5273

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IV. Device Description

The Optilase laser systems are continuous-wave Nd:YAG energy sources equipped with an aiming beam, adjustable power output, and a fiber optic connector.

V. Intended Use

Viewing scopes, which can be either flexible or rigid, may be used for visualization during laser procedures.

Technological Characteristics VI.

There are no technological characteristics differences between the devices cleared under this 510(k) and the predicate devices with regard to the intended use.

VII. Nonclinical Tests

No nonclinical tests were submitted in this Premarket Notification.

VIII. Clinical Tests

A prospective, controlled and well-matched study was undertaken to compare visual laser ablation of the prostate (VLAP) to transurethral resection of the prostate (TURP).

IX. Conclusions Drawn from Testing

The clinical data show that the Trimedyne Right Angle Laser Fibers and Optilase Nd:YAG Laser Systems are safe and effective for treatment of Benign Prostatic Hyperplasia (BPH).

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.