The Medical Aesthetic Nd.YAG Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology for: . the removal of unwanted hair in Fitzpatrick skin types I-V.

Device Description

ALTUS Medical Aesthetic Nd: YAG Laser Kits are comprised of the following main components: . a laser system console (including software and control electronics); . a control and display panel; . a permanently attached fiberoptic-coupled handpiece; . a skin cooling device integrated into the handpiece; . a finger-operated exposure switch (handswitch) integrated into the handpiece . (footswitch option available) . a remote interlock connector (disables laser when treatment room door is opened).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ALTUS Medical Aesthetic Nd:YAG Laser.

Based on the provided document, the acceptance criteria and the study conducted are described in a very high-level manner, primarily focusing on demonstrating substantial equivalence to predicate devices for regulatory approval.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or device performance metrics in a clear, tabulated format typically seen for rigorous clinical studies. Instead, it relies on the concept of "safety and effectiveness" demonstrated through clinical data for hair removal.

Acceptance Criteria Category	Specific Acceptance Criteria (as implied)	Reported Device Performance (as implied)
Safety	Safe for indicated use in Fitzpatrick skin types I-V.	Demonstrated to be safe through clinical data.
Effectiveness	Effective for removal of unwanted hair in Fitzpatrick skin types I-V.	Demonstrated to be effective through clinical data.
Principle of Operation	Operates under principles of selective photothermolysis (for 1064 nm wavelength).	Performance data provided to demonstrate operation under selective photothermolysis.
Substantial Equivalence	Shares similar indications for use, design features, and functional features as predicate devices.	Found to be substantially equivalent to predicate devices for hair removal/reduction.

It's important to note that these are implied criteria and performance statements based on the regulatory summary. The document lacks specific quantitative thresholds for safety (e.g., adverse event rates) or effectiveness (e.g., percentage of hair reduction over a specific period).

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

The document states: "clinical data was provided to demonstrate that the Acme Medical Aesthetic Nd:YAG Laser is safe and effective when indicated for the removal of unwanted hair in Fitzpatrick skin types I-V in the medical specialties of general and plastic surgery and dermatology."

Sample Size for Test Set: Not specified. The document does not provide any numerical details regarding the number of subjects or treatments included in the clinical data.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified. The wording "clinical data was provided" suggests a study was conducted, which could be prospective, but no details are given to confirm this.

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

Not specified. The document does not mention the involvement of experts in establishing ground truth for the clinical data. For hair removal studies, ground truth is typically assessed by clinical observation and possibly standardized photography, but the process and personnel involved are not detailed here.

4. Adjudication Method for the Test Set

Not specified. Given the lack of information on experts and ground truth establishment, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a laser system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A (Not Applicable). The device is a physical laser system for treatment, not an algorithm. Therefore, a "standalone algorithm performance" study is not relevant in this context.

7. The Type of Ground Truth Used

Based on the indication "removal of unwanted hair," the ground truth would inherently be clinical assessment of hair reduction/removal. This would likely involve:

Visual inspection.
Possibly standardized photography with hair counts in treated areas versus control areas.

However, the specific methods for establishing this ground truth are not detailed in the provided text.

8. The Sample Size for the Training Set

Not applicable/Not specified. This device is a laser system, not an AI/machine learning model that undergoes a "training phase" with a training dataset in the same way. The performance data and clinical data described are for validating the device's efficacy and safety rather than training an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not specified. As there is no described training set for an AI/ML algorithm, the method for establishing its ground truth is not relevant here.

Summary of missing information:

The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices for market clearance. As such, it provides very high-level information about the clinical data. It lacks specific details commonly found in a detailed clinical study report, such as:

Exact number of subjects and treatments.
Specific endpoints and quantitative measures of effectiveness (e.g., percentage of hair reduction).
Follow-up periods.
Details on adverse event reporting and rates.
Methodology for clinical assessment or "ground truth" establishment.
Expert involvement or adjudication processes.

Summary

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K 99179p

Attachment 17 510(k) Summary Statement for the e Medical Aesthetic Nd:YAG Laser Kit

I. General Information

Submitter:	ALTUSMedical, Inc.1181 Chess Drive, Suite BFoster City, CA 94404
Contact Person:	Michael Levernier
Summary Preparation Date:	May 24, 1999

II. Names

	ALTUS
Device Names:	Medical Aesthetic Nd:YAG Laser

Primary Classification Name:

Laser Powered Surgical Instrument (and Accessories)

III. Predicate Devices

· Star Medical LightSheer Diode Laser System (K973324);
Cynosure Apogee Long Pulse Infrared Laser (K971737); and .
· Candela GentleLase GL Dermatological Laser (K981351).

IV. Product Description

ALTUS

Medical Aesthetic Nd: YAG Laser Kits are comprised of the following main components:

· a laser system console (including software and control electronics);
a control and display panel; .
a permanently attached fiberoptic-coupled handpiece; .
a skin cooling device integrated into the handpiece; .
a finger-operated exposure switch (handswitch) integrated into the handpiece . (footswitch option available)
· a remote interlock connector (disables laser when treatment room door is opened).

V. Indications for Use

ALTUS

The == Medical Aesthetic Nd. YAG Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. The Medical Aesthetic Nd: YAG Laser is indicated for the removal of unwanted hair in Fitzpatrick skin types I-V.

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VI. Rationale for Substantial Equivalence

The Acme Medical Aesthetic Nd YAG Laser shares the same general indications for use. and therefore is substantially equivalent for use in hair removal/reduction to the Star Medical/Coherent LightSheer Diode Laser System (K973324), the Cynosure Apogee Long Pulse Infrared [LPIR] Laser (K971737), and the Candela GentleLase GL Dermatological Laser (K981351).

VII. Safety and Effectiveness Information

Performance data was provided to demonstrate that the 1064 nm wavelength of the Acme Medical Aesthetic Nd:YAG Laser operates under the principles of selective photothermolysis. In addition, clinical data was provided to demonstrate that the Acme Medical Aesthetic Nd:YAG Laser is safe and effective when indicated for the removal of unwanted hair in Fitzpatrick skin types I-V in the medical specialties of general and plastic surgery and dermatology.

VIII. Conclusion

The Acme Medical Aesthetic Nd: YAG Laser was found to be substantially equivalent to the Star Medical/Coherent LightSheer Diode Laser System (K973324), the Cynosure Apogee Long Pulse Infrared [LPIR] Laser (K971737), and the Candela GentleLase GL Dermatological Laser (K981351). The Acme Medical Aesthetic Nd:YAG Laser shares similar indications for use, design features, and similar functional features as, and thus are substantially equivalent to, the currently marketed predicate devices.

Performance data and clinical study results demonstrated that the Acme Medical Aesthetic Nd:YAG Laser is safe and effective for the removal of unwanted hair in Fitzpatrick skin types I-V in the medical specialties of general and plastic surgery and dermatology.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 2000

Mr. Michael Levernier Director, Clinical Development Altus Medical, Inc. 821 Cowan Road Burlingame, California 94010

Re: K991798

Trade Name: Altus Medical Aesthetic Nd:YAG Laser Regulatory Class: II Product Code: GEX Dated: January 11, 2000 Received: January 12, 2000

Dear Mr. Levernier:

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.

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Page 2 - Mr. Michael Levernier

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 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,
to colly

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

Enclosure

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Attachment 2 Indications For Use Statement as Requested by FDA

510(k) Number (if Known): _ _ K 9917998_______________________________________________________________________________________________________________________________________ ALTUS Device Name: Medical Aesthetic Nd: YAG Laser

Indications For Use:

ALTUS

. the removal of unwanted hair in Fitzpatrick skin types I-V.

(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	K991798

Prescription Use(Per 21 CFR 801.109)	X
------------------------------------------	---

Over-The-Counter Use
----------------------	--

(Optional Format 1-2-96)

Attachment 2 - Page 1

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.