The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

AI/ML Overview

This document is a 510(k) summary for the OrthoGold 100™ therapeutic massager. It does not provide information specific to an AI/ML device, therefore, many of the typical acceptance criteria and study details for such devices are not applicable.

Here's the breakdown of the requested information based on the provided text:

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

The document does not specify quantitative acceptance criteria in the typical sense of a human-in-the-loop or standalone AI performance study (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through various performance tests.

Acceptance Criteria (Implied)	Reported Device Performance
Device meets design specifications.	Verification and validation testing was performed and demonstrated that the OrthoGold 100™ meets the design specifications.
Device is safe and effective for its intended use.	All tests required by the verification and validation plan were completed and passed.
Software is validated to an appropriate level of concern.	The OrthoGold 100™ software was validated and demonstrated to be of a Moderate level of concern.
Risks are mitigated to an acceptable level.	Hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level.
Conformance to general safety requirements.	The OrthoGold 100 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2005.
Conformance to electromagnetic compatibility requirements.	The OrthoGold 100 was tested and demonstrated to conform to the electromagnetic compatibility requirements of IEC 60601-1-2:2014 (4th Ed.) and 60601-2-36.
Applicator displacement, force, and penetration depth are equivalent to predicate device.	In-vitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the Dermablate predicate device. Maximum penetration depth of 25.4 mm at energy level 16 (predicate: 30mm). Energy flow density PIIT [mJ/mm2] 0.00017 - 0.04403 at energy level 1 - 16 (predicate: 0.018-0.25). Peak compressional acoustic pressure pc [MPa] 9.27 at energy level 16 (predicate: 13.4). Other parameters shown to be "Similar" or "Equivalent" to predicate.
Probe cover and transport verification/validation performed.	Probe cover testing and transport verification and validation was also conducted.
Overall substantial equivalence to predicate device.	The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to the predicate device.

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

Not applicable. This device is a therapeutic massager, not an AI/ML diagnostic tool that would typically use a "test set" of patient data for performance evaluation. The testing involved in-vitro performance measurements, electrical safety, and electromagnetic compatibility.

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

Not applicable. As this is not an AI/ML diagnostic device, there was no need for experts to establish ground truth on a test set of medical images or patient data.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication of ground truth was used.

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 is not an AI/ML assisted device for human readers.

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

Not applicable. This is a physical medical device (therapeutic massager), not a standalone algorithm.

7. The type of ground truth used

For the in-vitro performance testing, the "ground truth" was established by objective measurements against known physical standards and comparison data from the predicate device. For example, measurements of applicator displacement, force, and penetration depth would have physical accuracy.

8. The sample size for the training set

Not applicable. This product is a physical device, not an AI/ML model that requires a training set. The "training" for such a device would refer to its engineering, design, and manufacturing processes.

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

Not applicable. As above, this is not an AI/ML device.

Summary

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December 21, 2018

Tissue Regeneration Technologies, LLC % Jennifer Daudelin, MSJ Regulatory Consultant III M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, New York 10018

Re: K182682

Trade/Device Name: OrthoGold 100TM Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: September 26, 2018 Received: September 26, 2018

Dear Jennifer Daudelin:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182682

Device Name OrthoGold 100

Indications for Use (Describe) The OrthoGold 100 is intended for the activation of connective tissue.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Tissue Regeneration Technologies, LLC

OrthoGold 100™

The following information is provided as required by 21 CFR § 807.87 for the Tissue Regeneration Technologies, LLC 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Sponsor:	Tissue Regeneration Technologies, LLC251 Heritage WalkWoodstock, GA 30188
Contact:	Jennifer A. Daudelin, M.S.J.M Squared Associates, Inc.575 Eighth Avenue, Suite 1212New York, NY 10018Ph: 703-562-9800 x251Fax: 703-562-9797Email: jdaudelin@msquaredassociates.com
Date Prepared:	September 24, 2018
Proposed Class:	I
Proprietary Name:	OrthoGold 100TM
Common Name:	Therapeutic Massager
Classification Name:	Massager, Therapeutic, Electric
Regulation Number:	21 CFR 890.5660
Product Codes:	ISA
Predicate Device(s):
Manufacturer	Device Name	510(k) Number	Procode	Class
Asclepion LaserTechnologies GmbH	Dermablate Effect	K081541	ISA	I

Indications for Use

The OrthoGold 100™ is intended for the activation of connective tissue.

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Device Description

Performance Data

Verification and validation testing was performed and demonstrated that the OrthoGold 100™ meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed. The OrthoGold 100™ software was validated and demonstrated to be of a Moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. The OrthoGold 100 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2005; as well as the electromagnetic compatibility requirements of IEC 60601-1-2:2014 (4th Ed.) and 60601-2-36. In-vitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the Dermablate predicate device. In addition, probe cover testing and transport verification and validation was also conducted. The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to the predicate device.

Product Characteristic	Subject Device	Predicate Device	Comparison
	OrthoGold 100TM	Dermablate Effect
510(k) Number	To be assigned	K081541	NA
Indications for Use	Activation of connective tissue	Activation of connective tissue	Identical
Modes of Action	Unfocused pressure pulses	Radial (unfocused) pressurewaves, or extracorporeal pulseactivation respectively	Similar
Mechanisms of Action	Extracorporeally inducedunfocused pressure pulses	Pneumatically generatedvibrations + unfocused pressurepulses	Equivalent
Maximum and Minimumintensity settings	1 to 16	Specific Value Not Available	Similar
	Subject Device	Predicate Device	Comparison
Product Characteristic	OrthoGold 100™	Dermablate Effect
Number and size oftreatment applicator heads	OP155Size: 230 x ø 70 mm	Specific Value Not Available	Similar
Maximum and minimumdisplacements ofapplicator heads	Not Applicable	Specific Value Not Available	NA
Type of application (e.g.,continuous vibration at afixed frequency);	Continuous at various frequencies	Specific Value Not Available	Similar
Maximum and minimumvibration frequency	Frequency of 1 - 8 Hz in steps of0.5 Hz	Specific Value Not Available	Similar
Driving Power	High voltage 2 - 7 kVCapacitor: 0,2 uF	Specific Value Not Available	Similar
Power Supply	115 VAC	Specific Value Not Available	Similar
Maximum applicatorforce	Not Applicable	Specific Value Not Available	NA
Maximum applicatordisplacement	Not Applicable	Specific Value Not Available	NA
Maximum penetrationdepth	25.4 mm at energy level 16	30mm (3cm)	Similar
Energy flow densityPIIT [mJ/mm2]	0.00017 - 0.04403at energy level 1 - 16	0.018-0.25	Similar
Operating mode	Continuous	Specific Value Not Available	Similar
Projectile mass (g)	Not Applicable	Specific Value Not Available	NA
Pulse repeat rate (1/s)	1 - 8 Hz	1-11 Hz	Similar
Number of pulses (minand max)	500 - 2000	Specific Value Not Available	Similar
Maximum operatingtemperature	Room temperature	Specific Value Not Available	Similar
Type of acoustic wavegeneration	Electro hydraulic, spark gapunder water caused by dischargeof high voltage condensers	Ballistic technology, pressurizedair pulses accelerate a projectilewithin a guiding tube	Similar
Peak compressionalacoustic pressurepc [MPa]	9.27at energy level 16	13.4	Similar
Peak rarefactionalacoustic pressurepcr[MPa]	-1.52at energy level 16	Specific Value Not Available	Similar
Description of the spatialdistribution of theacoustic pressure andintensity	Unfocused acoustic pressure field,see pressure measurements	Specific Value Not Available	Similar
Positive peak pressureamplitude (MPa)pc [MPa]	0.43 - 9.27at energy level 1 - 16	13.4	Similar
	Subject Device	Predicate Device	Comparison
Product Characteristic	OrthoGold 100™	Dermablate Effect
Negative peak pressureamplitude (MPa)$pcr[MPa]$	-0.17 to -1.52at energy level 1 - 16	Specific Value Not Available	Similar
Derived focal acousticpulse energy (mJ)$EbT [mJ]$	0.022 - 2.278at energy level 1 - 16	Specific Value Not Available	Similar
Derived pulse intensityintegral, integrated overtotal temporal integrationlimits$PIIT [mJ/mm2]$	0.00017 - 0.04403at energy level 1 - 16	Specific Value Not Available	Similar
Rise time (ns)(10% - 90%) tr [us]	1.89 - 0.28at energy level 1 - 16	Specific Value Not Available	Similar
Compressional pulseduration (us)$tFWHMpc [uS]$	1.23 - 0.77at energy level 1 - 16	Specific Value Not Available	Similar

The table below compares the OrthoGold 100 characteristics to the predicate device.

Tissue Regeneration Technologies, LLC OrthoGold100TM

510(k) Summary Page 2 of 4

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Tissue Regeneration Technologies, LLC OrthoGold100TM

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Technological Characteristics and Substantial Equivalence

The OrthoGold 100™ has the same indications for use and similar design features as compared with the predicate system. The bench testing demonstrates that the performance characteristics of the OrthoGold 100™ are equivalent to those of other legally marketed therapeutic massagers, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate device would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.

Regulation Number and Section

§ 890.5660 Therapeutic massager.

(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.