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The New Star Lasers, Inc. Model 100 Holmium Laser System is indicated for the following:

Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/Gastrointestinal Surgery, including:

Cholecystectomy, lysis og adhesions, appendectomy, biopsy, pylrosternotomy (sp?), benign and malignant lestions, rectal polyps of sigmoid colon, gall blader calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.

Incision, excision, resection, ablation, coabulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, with or without an endoscope, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), corns, papillomas, and basal cell carcinomas.

General Surgery of soft tissues, including:

skin incision, tissue dissection, excision or external turnors and lesions, complete or partial resection of internal organs, turnors and lesions, and tissue ablation.

Genitourinary Surgery, including:

superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia.

Gynecological Surgery during open and endoscopic procedures.

Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, and fragmentation of kidney calculi.

Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including:

knee meniscectomy, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinecular release, and debridement of the degenerative knees.

Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinectomy), and dacryocystorhinostomy (DCR).

Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.

The New Star Model 1000 is a compact, portable, self-contained system that produces a beam of infrared radiation at 2,100 nm wavelength for treatment, and a visible Helium Neon (HeNe) laser beam at 632.8 nm for aiming. The system emits a pulsed laser beam, which is delivered to the treatment site using a fiber-optic delivery system.

The system consists of a laser console, unit fiber-optic delivery system, and a footswitch The system provides safety features that are designed to protect the user and patient from high voltages and laser emissions.

Please note: The provided text is a 510(k) summary for a medical device (New Star Lasers Model 1000 Holmium Laser System), which aims to demonstrate substantial equivalence to a predicate device. It primarily focuses on comparing technical specifications and indications for use, rather than presenting a performance study with acceptance criteria in the way a clinical trial or AI device study would.

Therefore, the requested information, particularly regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) for a diagnostic or AI device, is not present in the provided document. The 510(k) process relies on demonstrating substantial equivalence to a previously cleared device, not necessarily on proving specific performance against predefined acceptance criteria from a new clinical study for the device itself.

Based on the provided text, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to a legally marketed predicate device. This means its technological characteristics and indications for use are similar, and any differences do not raise new questions of safety or effectiveness. The critical performance comparison is against the predicate device's specifications.

Summary of Acceptance: The device was deemed "substantially equivalent" to the predicate device by the FDA (K994273), indicating it met the regulatory acceptance criteria for market clearance. This determination is based on the comparison of technological characteristics and indications for use. Key differences (like lower power, different electrical service, smaller size/weight) were not deemed to raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable / Not provided. The document describes a technological comparison for a laser system seeking 510(k) clearance, not a performance study involving a "test set" of data or patients in the typical sense this question implies for AI/diagnostic devices. The "test" is the comparison against the predicate device's specifications and indications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• Not applicable / Not provided. As above, this document does not describe a study involving human experts establishing ground truth for a test set. The "ground truth" for the 510(k) submission is the pre-existing FDA clearance of the predicate device and its established safety and effectiveness profile.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided. No test set or adjudication method is described in this regulatory submission.

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:

• Not applicable / Not provided. This is a hardware medical device (laser system), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

• Not applicable / Not provided. This is a laser system, not an algorithm. Its operation involves human medical professionals directly using the device for surgical procedures.

7. The Type of Ground Truth Used:

• Predicate Device Equivalence (Regulatory Ground Truth): The "ground truth" for this 510(k) submission is the regulatory clearance of the predicate device (Omni Pulse™ Holmium Laser System, Model 1210, K992574) and its established safety and effectiveness. The New Star Model 1000 demonstrated substantial equivalence to this predicate.

8. The Sample Size for the Training Set:

• Not applicable / Not provided. This document does not describe the development of an algorithm or AI model that would require a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable / Not provided. No training set is mentioned or implied.

In summary, the provided text is a 510(k) summary demonstrating substantial equivalence for a physical medical device (a holmium laser system). It is not a clinical study report for an AI or diagnostic device and therefore does not contain the specific performance metrics, sample sizes, expert ground truth establishment, or study designs typically associated with those types of devices.

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