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.

Device Description

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.

AI/ML Overview

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.

Specification	Acceptance Criteria (Predicate Device: Trimedyne 40 Watt OmniPulse)	Reported Device Performance (New Star Model 1000)
Laser source	Pulsed, solid-state Ho:YAG	Pulsed, solid-state Ho:YAG
Wavelength	2.1 microns	2.1 microns
Pulse width	350 microseconds nominal	350 microseconds nominal
Pulse Repetition Rate	5-25 Hz	5-12 Hz (Falls within the predicate's range)
Power Output	40 watts	10 watts (Lower than predicate, but this is a characteristic difference, not necessarily a failure to meet criteria)
Energy Range per Pulse	0.5-3.5 Joules	0.5-1.25 Joules (Falls within the predicate's range)
Electrical Service	220 VAC ± 10%, 30 amps, single phase, 50-60 Hz	115 VAC ± 10%, 10 amps, single phase, 50-60 Hz (Different electrical requirements, noted as a characteristic difference)
Cooling	Self-contained air/water	Self-contained air/water
Aiming Beam	5mW red HeNe	1.5 mW red HeNe (Lower power, noted as a characteristic difference)
Dimensions	39"L x 26"W x 47"H	21"L x 14"W x 31"H (Smaller dimensions, noted as a characteristic difference)
Weight	600 lbs.	115 lbs. (Lighter weight, noted as a characteristic difference)
Indications	Broad range of surgical indications (e.g., General, Orthopedic, Gastroenterological, Dermatologic, etc.)	Broad range of surgical indications, generally narrower than predicate but substantial overlap (e.g., General, Orthopedic, PLDD, Sclerostomy, Endosinus (ENT), Soft Tissue (Urology), Lithotripsy (Ureteral))

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.

Summary

{0}------------------------------------------------

K994273
JAN 20 2000	Summary of Safety and Effectiveness
Company Name:	New Star Lasers, Inc.11802 Kemper RoadAuburn, California 95603(916) 823-1434
Company Contact:	Donald V. JohnsonDirector, Regulatory & Quality Affairs
Date Prepared:	December 14, 1999
Device Name:
Trade Name:	New Star Lasers Model 1000 Holmium Laser System
Common Name:	Surgical Laser System
Classification Name:	Instrument, Surgical, Powered Laser21 CFR § 878.4810
Predicate Device:	Omni Pulse™ Holmium Laser System, Model 1210Trimedyne, Inc.Irvine, CaliforniaK992574

Device Description:

{1}------------------------------------------------

Intended Use/Indications:

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

Cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylrosternotomy (sp?), benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder 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, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

General Surgery of soft tissues, including:

skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors 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 ureteral calculi, and fragmentation of kidney calculi.

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

knee meniscectomy, knee synovectorny, 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 dacryocvstorhinostomy (DCR).
Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.

Comparison with Predicate Device:

See following table.

{2}------------------------------------------------

Specification	New Star Model 1000 10 WattHolmium Laser System	Trimedyne 40 Watt OmniPulseHolmium Laser System
Laser source	Pulsed, solid-state Ho:YAG	Pulsed, solid-state Ho:YAG
Wavelength	2.1 microns	2.1 microns
Pulse width	350 microseconds nominal	350 microseconds nominal
Pulse repetition rate	5-12 Hz	5-25 Hz
Power output	10 watts	40 watts
Energy range per Pulse	0.5-1.25 Joules	0.5-3.5 Joules
Electrical service	115 VAC ± 10%, 10 amps, singlephase, 50-60 Hz	220 VAC ± 10%, 30 amps, singlephase, 50-60 Hz
Cooling	Self-contained air/water	Self-contained air/water
Aiming beam	1.5 mW red HeNe	5mW red HeNe
Dimensions	21"L x 14"W x 31"H	39"L x 26"W x 47"H
Weight	115 lbs.	600 lbs.
Indications	General/Orthopedic Surgery,PLDD, Sclerostomy, Endosinus(ENT), Soft Tissue (Urology),Lithotripsy (Ureteral)	General/Orthopedic/Gastroenterological/Gastrointestinal/ Dermatologic/Genitourinary/ Gynecological/Otorhinolaryngological (ENT)Surgery, PLDD, Lithotripsy(urinary, urethral, kidney, gallbladder, and biliary/bile ductcalculi)
K Numbers	K912879, K920248, K921724,K933007, K942542, K945156	K992574

Technical Specifications Comparison

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 2000

Mr. Donald V. Johnson Director Regulatory & Quality Affairs New Star Lasers, Inc. 11802 Kemper Road Auburn, California 95603

K994273 Re:

Trade Name: Model 1000 Holmium Laser System Regulatory Class: II Product Code: GEX Dated: December 14, 1999 Received: December 20, 1999

Dear Mr. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

{4}------------------------------------------------

Page 2 - Mr. Donald V. Johnson

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Hypt Charles
L. James E. Dillard III

for

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

INDICATION FOR USE STATEMENT

K994273 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: New Star Lasers, Inc. Model 1000 Holmium Laser System

Indications for Use:

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:

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

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.

(Continued on following page)

(Please do not write below this line- Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General Restorative Devices (994273 510(k) Number

Prescription Use	☑
(Per 21 CFR 801.109)

Over-the Counter Use _

{6}------------------------------------------------

Indications for Use New Star Lasers, Inc. Model 1000 Holmium Laser System Page 2 of 2

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.

Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.

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.