The Fractora is composed of a console, hand held applicator, and disposable tip, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins.

AI/ML Overview

The provided 510(k) summary for the Invasix Ltd. Fractora device does not contain the detailed information requested regarding specific acceptance criteria, a study proving the device meets those criteria, or most of the other parameters you've asked for.

The document is a typical 510(k) submission which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance study results against pre-defined acceptance criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., specific thresholds for ablation depth, resurfacing percentage, or safety outcomes). The acceptance criterion implicitly seems to be "similar output and intended use as the predicate device" and raising "no new issues of safety or effectiveness."
Reported Device Performance:
- Bench Testing Performance Data: The submission states "bench testing performance data" was presented, but the specifics and their outcomes are not included in the summary.
- Histology Data: The submission states "histology data" was presented, but the specifics and their outcomes are not included in the summary.
- Substantial Equivalence Claims:
  - Intended use is identical to the predicate device (Matrix RF applicator).
  - Technological characteristics are similar (delivers bipolar RF energy through multi-electrode pins).
  - Main output parameter (energy per pin) is identical to the predicate.
  - Minor differences in number of pins and array dimensions may slightly affect the number of pulses required.

Acceptance Criteria (Implicit)	Reported Device Performance
Identical intended use to predicate device	Fractora's intended use ("for dermatological procedures requiring ablation and resurfacing of the skin") is identical to the predicate device, Matrix RF applicator.
Similar technological characteristics to predicate device	Fractora delivers bipolar RF energy to the skin via an array of multi-electrode pins, resulting in heating for ablation and resurfacing. The predicate device uses similar technological characteristics.
Identical main output parameter (energy per pin) to predicate device	The main output parameter (energy per pin) is identical for Fractora and the predicate device.
No new issues of safety or effectiveness compared to predicate	Based on analysis, Invasix Ltd. believes no significant differences exist and Fractora should raise no new issues of safety or effectiveness. (This is a conclusion made by the submitter, not a performance metric from a study explicitly comparing safety/effectiveness outcomes). Specific bench testing and histology data were presented but not detailed in this summary document.

2. Sample sized used for the test set and the data provenance:

Not provided. The document refers to "bench testing performance data" and "histology data" but does not specify the sample sizes used for these tests or whether they were conducted on humans, animals, or ex-vivo tissue, nor their provenance (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:

Not provided. The summary does not describe any study involving expert ground truth establishment.

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

Not provided.

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 done (based on provided text). This device is a medical device for dermatological procedures, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its function and was not conducted.

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

Not applicable/Not done (based on provided text). This device is not an algorithm, but a physical device (console, hand-held applicator, disposable tip). Standalone algorithm performance is not relevant.

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

Partially inferred: The document mentions "histology data," which implies some form of pathological or microscopic examination was used as a basis for evaluating the device's effects on tissue. However, the specific type of ground truth (e.g., expert interpretation of histology, specific measurements) is not detailed.

8. The sample size for the training set:

Not applicable/Not provided. This is not an AI/machine learning device, so a "training set" in that context does not apply. If "training set" refers to data used for device design and optimization, it's not specified.

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

Not applicable/Not provided. As above, no training set for an AI model is mentioned.

In summary, the provided 510(k) summary primarily focuses on demonstrating substantial equivalence based on intended use and technological characteristics, along with a general statement about bench testing and histology data. It does not provide the detailed performance study information, acceptance criteria, or ground truth establishment methods typically associated with clinical trials or AI/diagnostic device evaluations.

Summary

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K10246/

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Invasix Ltd. Fractora

JUN - 2 2011

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter's information

Name:	Invasix Ltd.
Address:	Apolo building, POB 533, Yokneam 20692, Israel
Contact:	Dr. Amir Waldman VP Regulatory Affairs

Device information

Trade/Proprietary name:	Fractora
Classification name:	Device, Electrosurgical Cutting and Coagulation andAccessories (21CFR §878.4400)
Product code:	GEI

Predicate device

Matrix RF applicator (K073572).

Intended use:

The Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Device Description:

Performance data:

In this submission bench testing performance data as well as histology data presented.

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Substantial Equivalence:

Intended use equivalence

Fractora's intended use is identical to the intended use of the predicate device: Matrix RF applicator.

Technological equivalence

The Fractora hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin. The predicate device uses similar technological characteristics.

The main output parameter that determines the ablative and coagulative effects is energy per pin, which is identical for Fractora and the predicate device. Minor differences in the number of pins, and array dimensions, may slightly affect the number of pulses required to cover the treatment area.

The Fractora is substantially equivalent to its predicate device. The data in this 510(k) submission demonstrate that the Fractora device has similar output and intended use as other predicate device. Therefore is substantially equivalent to its predicate devices.

Based upon an analysis of the overall performance characteristic for the device. Invasix Ltd. believes that no significant differences exist between the Fractora and the predicate device. Therefore the Fractora should raise no new issues of safety or effectiveness.

March 25, 2011

Date

Dr. Amir Waldman,

VP Regulatory Affairs Invasix Ltd.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Invasix Ltd. % Dr. Amir Waldman Vice President Regulatory Affairs Apolo Building, P.O. Box 533 Yokneam 20692 Israel

JUN - 2 2011

Re: K102461

Trade/Device Name: Fractora Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 26, 2011 Received: May 27, 2011

Dear Dr. Waldman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuunce of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Amir Waldman

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vour

for Cett. N
No ca. N P.S.

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)_ K102461

Device Name___ Fractora

Indications For Use:

Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109) OR

Over The Counter Use_

(Optional Format 1-2-96)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102461

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.