The Biocellulase SmoothShapes device is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local hlood circulation, and temporary reduction in the appearance of cellulite.

Device Description

The SmoothShapes system consists of a main console unit and an applied part (massage head with rollers) which is connected to the main console by an umbilical. The main console unit contains the powersupply, hardware, transformers, fuses, cooling fan, mains-input connection, and the key-switch. The massage head, which is placed against the patient's skin, contains the rollers, LEDs, and laser diodes. The massage head rollers are mobilized in rotation and sliding back and forth. The patient massage is generated by the vacuum introduced to skin fold between the two rollers. The rollers in combination with the vacuum manipulate and smooth out the skin which facilitates tissue mobilization. The laser light provides topical heating which increases tissue temperature.

AI/ML Overview

The provided text is a 510(k) Summary for the Biocellulase SmoothShapes device, which is a regulatory submission to the FDA. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance rather than presenting a detailed clinical study for novel performance claims or acceptance criteria in the way a clinical trial report would.

Therefore, much of the requested information regarding detailed acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, and ground truth methodologies is not explicitly available in this summary. The submission relies on demonstrating similarity to already approved devices.

Here's an analysis based on the provided text:

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

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Intended Use: Relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite.	The document states, "Based on its technological characteristics and the nonclinical testing, the Biocellulase SmoothShapes system is as safe and effective as the abovenamed predicate devices, for the intended use." This implies the device is expected to achieve these outcomes at a comparable level to the predicates, but no specific performance metrics (e.g., % reduction in cellulite appearance, pain scale reduction) are provided.
Safety: Electrical safety, maximal skin temperature rise limits.	Electrical safety testing was performed. Tissue block testing was performed "to confirm maximal skin temperature rise." No specific numerical thresholds or results are provided in this summary.
Technological Characteristics: Vacuum, rollers, LEDs, and laser diodes for tissue manipulation and heating.	The device description outlines these components and their functions. The comparison to predicate devices states, "The SmoothShapes is substantially equivalent to the predicates with respect to intended use and technological characteristics."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not explicitly available. The submission highlights "nonclinical testing" (electrical safety and tissue block testing). These are typically bench tests or in vitro studies, not clinical trials with human subjects for efficacy. The text does not describe any clinical test set or data provenance in the context of device performance for its intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not explicitly available. Since no clinical test set for efficacy is described, there's no mention of experts establishing ground truth for such a set. For the nonclinical testing, the "experts" would likely be engineers or technicians performing the safety tests, but their qualifications are not detailed.

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

Not applicable/Not explicitly available. No clinical test set requiring 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:

Not applicable. This device is a therapeutic device (massager/shaper with light-induced heating), not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC study and AI assistance are not relevant to this submission.

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

Not applicable. This device is a physical therapeutic device with specific mechanisms of action, not a software algorithm.

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

For the nonclinical testing: The ground truth for electrical safety would be adherence to relevant electrical safety standards. For tissue block testing, the ground truth would be the measured temperature and its comparison to accepted safety thresholds.
For the intended use claims: The submission relies on substantial equivalence to predicate devices that presumably had established their efficacy through clinical data or historical use. The device itself does not present new clinical data that would require "ground truth" to be established for novelty.

8. The sample size for the training set:

Not applicable/Not explicitly available. Since no clinical study for efficacy is described in the summary, there is no mention of a training set for machine learning or similar applications.

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

Not applicable/Not explicitly available. For the reasons mentioned above.

In summary:

This 510(k) submission is a "summary of safety and effectiveness" for a physical device seeking clearance based on substantial equivalence to legally marketed predicate devices. It focuses on comparing technological characteristics and intended use, along with basic non-clinical safety testing. It does not contain the details of a clinical efficacy study with human subjects, which would typically include acceptance criteria defined by performance metrics, detailed sample sizes, expert involvement, and ground truth establishment methods for clinical outcomes.

Summary

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K0536!!

Biocellulase. Inc. SmoothShapes

MAR I 5 2006

December 27, 2005

510K Summary of Safety and Effectiveness Biocellulase - SmoothShapes December 27, 2005

1. Sponsor Name Biocellulase, Inc.
  21 Park Ave. Newton, MA. 02458 Telephone 617 733 7077 Contact Individual: Robert Nagel
1. Device Name Proprietary Name: SmoothShapes Common/Usual Name: massager/shaper Classification Name: massager, vacuum, light induced heating

3. Identification of Predicate or Legally Marketed Device

் LPG USA, Inc. Endermology/Therapeutic Massager Vibrator -K990445
Syneron Medical, Ltd.- VelaSmooth Shaper K050397
ব . Device Description

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tissue mobilization. The laser light provides topical heating which increases tissue temperature.

ട. Intended Use

The Biocellulase SmoothShapes is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

6. Comparison to Predicate Devices

The SmoothShapes is substantially equivalent to the predicates with respect to intended use and technological characteristics.

7. Nonclinical Testing

Electrical safety testing and tissue block testing (to confirm maximal skin temperature rise) is performed on the SmoothShapes device.

8. Conclusion

Based on its technological characteristics and the nonclinical testing, the Biocellulase SmoothShapes system is as safe and effective as the abovenamed predicate devices, for the intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

Biocellulase, Inc. c/o Mr. Robert Nagel President 21 Park Avenue Newton, Massachusetts 02458

Re: K053611

Trade/Device Name: SmoothShapes 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: NUV Dated: February 14, 2006 Received: February 14, 2006

Dear Mr. Nagel:

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 such 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 issuance 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); good manufacturing practice requirements as set

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Page 2 - Mr. Robert Nagel

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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

elmee

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Biocellulase, Inc. SmoothShapes

Premarket Notification December 27, 2005

Indications for Use

510(k) Number (if known): KO536 I l

Device Name: Smooth Shapes

Indications For Use:

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

el.gmb.

(Division Sign Off Division of General, Restorative, and Neurological Devices

510(k) Number_ K053611

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

000016

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.