ERBIUM 2000 LASER FAMILY by PHANTOM TECHNOLOGIES, INC.

The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.

Device Description

Phantom Erbium lasers are composed of the following components:

a laser console .
a counterbalanced articulated arm and handpiece .
a control / display panel ●
a finger trigger or foot petal control ●
● a laser head w / beam optics
a CPU control system
. a power supply
an internal cooling system
Models range from 5 to 50 Watts average power.

AI/ML Overview

This 510(k) summary (K972915) for the Erbium 2000 Laser Family does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets them. This document is a premarket notification for substantial equivalence, not a clinical study report.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This document does not specify formal acceptance criteria in terms of specific performance metrics (like percentage of efficacy or adverse event rates) against which the device was measured. Instead, it refers to performance standards for safety and electrical compatibility, and claims substantial equivalence to predicate devices for its intended uses.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with electrical safety and laser radiation standards	UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10 & 1040.11 (Compliance is implied by listing these standards)
Performance for stated indications (excision, incision, ablation, vaporization, coagulation of soft tissue, skin resurfacing)	Substantially equivalent to predicate devices for these indications. The document does not provide specific performance data (e.g., success rates, tissue removal efficiency) for the Erbium 2000.

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

The document does not describe a specific test set or clinical study with a defined sample size for evaluating the Erbium 2000 Laser Family's clinical performance. As a 510(k) submission, the primary evidence presented for substantial equivalence often relies on comparison to existing, legally marketed predicate devices, rather than new, large-scale clinical trials.

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

This information is not available in the provided document. There is no mention of a test set or ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not available in the provided document, as no specific test set or clinical study involving adjudication is described.

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

This is not applicable. The device described is a surgical laser, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable. The device is a physical surgical laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not available. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting clinical trial data that would require a defined "ground truth."

8. The sample size for the training set

This information is not applicable/not available. Training sets are relevant for machine learning algorithms. The Erbium 2000 is a laser device, and its development would involve engineering and physical testing, not machine learning training.

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

This information is not applicable/not available.

Summary of the Study (as described in the document):

The document does not describe a "study" in the sense of a clinical trial used to prove the device meets specific performance criteria. Instead, it is a 510(k) Premarket Notification which argues for "substantial equivalence" of the Erbium 2000 Laser Family to previously cleared predicate devices.

The "study" or evidence provided to the FDA largely consists of:

Device Description: Detailing the components and functionality of the Erbium 2000.
Indications For Use: Stating the proposed clinical applications, which are broad surgical procedures for soft tissue and skin resurfacing.
Performance Standards Compliance: Declaring adherence to safety and electrical standards (UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10 & 1040.11). This demonstrates safety and electrical compatibility, but not clinical efficacy in terms of treatment outcomes.
Predicate Device Comparison: Listing numerous predicate devices (with K-numbers where known) for a range of laser systems. The core of a 510(k) is to demonstrate that the new device is as safe and effective as these previously marketed devices for the same intended use. This comparison is typically based on technological characteristics, intended use, and existing performance data of the predicate devices, rather than new clinical data for the submitted device itself.

In essence, the "proof" the device meets acceptance criteria is the FDA's determination of substantial equivalence to legally marketed predicate devices, implying that if the predicate devices were accepted, and the new device is sufficiently similar and meets relevant safety standards, it too can be accepted. The document does not provide a separate, dedicated clinical study report.

Summary

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K972915

DEC 1 9 1997

510(k) Summary Statement

Applicant:	Phantom Technologies, Inc.845 Commercial AvenuePalo Alto, California 94303
Contact:	James A. NationsPhone: 415-493-9155Fax: 415-493-9146
Device Name:	Erbium 2000Model AModel BModel CModel DModel E
Class of the device and panel:	Class IIInstrument, surgical, powered, laser79-GEX21 CFR 878.48
Performance Standards:	UL544, UL2601.1, IEC601.1, IEC82521 CFR 1040.10 & 1040.11
Reason for submission:	New laser system family withsubstantial equivalence.
Predicate Devices:	PfizerPfizerSchwartz Electro OpticsCoherentContinuum BiomedicalAesculap-MeditecHGMFotana/CandelaLaserscopeESC MedicalCoherentCoherentCoherentLaserscope	K904627 K905802 K954013 K960032 K961748 K964128UnknownK962902 K964016 K964532 K963339 K951812 K912029Unknown

Device Description:

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Phantom Erbium lasers are composed of the following components:

a laser console .
a counterbalanced articulated arm and handpiece .
a control / display panel ●
a finger trigger or foot petal control ●
● a laser head w / beam optics
a CPU control system
. a power supply
an internal cooling system

Models range from 5 to 50 Watts average power.

Indications For Use:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 19 1997

Mr. James A. Nations Director, Regulatory Affairs Phantom Technologies, Incorporated 845 Commerical Avenue Palo Alto, California 94303

Re: K972915

Trade Name: Erbium 2000 Laser Family, Models A, B, C, D, and E Regulatory Class: II Product Code: GEX Dated: November 13, 1997 Received: November 19, 1997

Dear Mr. Nations:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Quality System Regulation (OS) 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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.

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Page 2 - Mr. Nations

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

focollpe

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of of i

510(k) Number (if known):_K972915

Device Name: ERBIUM 2000 LASER FAMILY

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


	(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K972915

Prescription Use	X	OR	Over-The-Counter Use	____________________
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

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.