(14 days)
The Crystal , Record & Optima are generally intended for dermatological use. The device is specifically indicated for removal of hair by using selective light energy.
The Crystal & Record are two models of the same device. The Optima is an additional commercial name of the Record. The device applies photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a light source to the target tissue by a Treatment Handpiece that is in contact with the skin.
The provided text describes a 510(k) submission for the Crystal, Record, and Optima photoepilation systems. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics to fill out the table and answer all the requested questions.
The document states: "Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications." but does not elaborate on what those specifications are, how they were measured, or the results.
Therefore, many sections of your request cannot be fulfilled from the provided text. I will fill in what can be inferred or explicitly stated.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be fully provided. The document states "Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications," but it does not specify what those specifications are (the acceptance criteria) nor does it report the specific performance metrics achieved by the device.
2. Sample sized used for the test set and the data provenance:
- Cannot be provided. The document mentions "clinical data" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. The document does not describe how ground truth was established, nor does it mention any experts for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. The document does not describe any adjudication method.
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:
- Cannot be provided. The device is a photoepilation system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with AI assistance for human readers is not applicable or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided directly. The device, being a photoepilation system, operates as a standalone system by design (it's applied to the skin to remove hair). However, the document does not describe a formal "standalone performance study" in the context of diagnostic AI algorithms. It merely states that the device was tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. The document does not specify how "ground truth" (e.g., successful hair removal) was established for its clinical data.
8. The sample size for the training set:
- Cannot be provided. The document does not mention any training set, as it describes a medical device, not an AI model requiring a distinct training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is mentioned for this type of device.
Here is a summary of what can be extracted, and where information is missing:
The acceptance criteria and study data are explicitly not detailed in the provided 510(k) summary. The document states that "Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications" and that "No adverse affects have been detected." However, it does not list these specifications (acceptance criteria) or present the actual results from the bench and clinical studies that prove they were met.
| Aspect | Description from provided text / Status |
|---|---|
| Acceptance Criteria (Specific performance metrics) | Not provided. The document states "meet the required specifications" but does not define them. |
| Reported Device Performance | Not provided. The document states "Bench and clinical data demonstrate..." but does not present the specific results. |
| Sample Size (Test Set) | Not provided. "Clinical data" is mentioned, but sample sizes are absent. |
| Data Provenance (Test Set) | Not provided. |
| Number of Experts (Ground Truth - Test Set) | Not provided. |
| Qualifications of Experts (Ground Truth - Test Set) | Not provided. |
| Adjudication Method (Test Set) | Not provided. |
| MRMC Comparative Effectiveness Study (AI vs. without AI assistance) | Not applicable. This is a photoepilation system, not an AI diagnostic tool. |
| Standalone Performance Study (Algorithm only) | Implicitly "Yes" as a medical device, but no specific study details provided. |
| Type of Ground Truth Used (e.g., pathology, outcomes data) | Not provided. |
| Sample Size (Training Set) | Not applicable/Not provided. This is a medical device, not an AI model. |
| How Ground Truth for Training Set was Established | Not applicable/Not provided. |
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APR 2 9 2005
K 050950
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b))
Device Name
Device Name: Various models of the Crystal family photoepilation system. Trade / Proprietary Device Name: Crystal-512 Record-618 Optima-518
Establishment Name and Registration Number of Submitter
Name: Active Optical Systems Ltd. In process Registration Number: Contact person: Efraim Bidas or Gil Bidas Address: 24 Herzel st. Petach Tikva, Israel Tel: ++97239341682 Fax: ++97239302888
| Dev | evice Classificationof consideration of the country of the continues and | |
|---|---|---|
Product Code: Regulation Number: Common Name: Classification Name: GEX 878.4810 Pulsed light hair removal system Laser surgical instrument for use in general and plastic surgery and in dermatology. (21 CFR 878.4810) Class II
Reason for 510(k) Submission
Regulatory class:
Traditional 510(k) Submission
Identification of Legally Marketed Equivalent Devices
SkinStation K030897, StarLux K033549
Device Description
The Crystal & Record are two models of the same device. The Optima is an additional commercial name of the Record. The device applies photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a light source to the target tissue by a Treatment Handpiece that is in contact with the skin.
Indications for use
The Crystal, Record & Optima are generally intended for dermatological use. The device is specifically indicated for removal of hair by using selective light energy.
Safety & Effectiveness
The device has been designed verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications. No adverse affects have been detected.
Substantial Equivalency
It is Active Optical Systems' opinion that the Crystal, Record & Optima are substantially equivalent in terms of safety and effectiveness to the predicate devices.
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Image /page/1/Picture/13 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, represented by curved lines.
APR 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Active Optical Systems, Ltd. C/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K050950
Trade/Device Name: Crystal, Record & Optima Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 12, 2005 Received: April 15, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) fe device is substantially equivalent (for the indications ferenced above and nave decembers and marketed predicate devices marketed in interstate for use stated in the enclosure) to legars nament date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recure approval of a premarket approval application (PMA). alle Costience Act (11ct) that as novice, subject to the general controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of gencral controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is elassified (bee ass es) arols. Existing major regulations affecting your device FDA it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Courcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri 3 losames over device complies with other requirements of the Act that i DA has made a acternations administered by other Federal agencies. You must of any it cach statutes and regaraments, including, but not limited to: registration and listing (21 comply with an the Act stequirements, now and acturing practice requirements as set Crk Fart 807), labeling (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Mark Job
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manteang your ntial equivalence of your device to a legally premarked notification. "The PDF Intering sification 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), please If you desire specific advice tor your don't a long of ease note the regulation entitled, comact the Office of Compuner as (21 transmit (21CFR Part 807.97). You may obtain "Misoranding by reference to premainter to promainter the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octess http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indication for Use Form
510(k) Number (if known):
K 050950
DEVICE NAME: Crystal , Record & Optima
INDICATION FOR USE:
The Crystal , Record & Optima are generally intended for dermatological use. The I no or your , resear a sedicated for removal of hair by using selective light energy.
(Please do not write below this line - continue on another page if needed)
( Concurrence of CDRH, Office of Device Evaluation (ODE) )
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devic
Prescription Use ✗
(Per 21 CFR 801.109)
510(k) Number
OR
K050950
Over-the-Counter-Use __
§ 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.