The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold 100 is indicated for use in conjunction with standard of care burn treatment(s).

Device Description

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

The provided document describes the FDA 510(k) clearance for the OrthoGold 100 device, an extracorporeal shock wave device. The information details the device's indications for use, a comparison to a predicate device, and performance data including non-clinical, animal, and clinical studies.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated through the clinical study's primary endpoint, which showed a statistically significant improvement in the time to epithelialization. The safety was also assessed by monitoring adverse events.

Acceptance Criteria (Implicit)	Reported Device Performance
Efficacy: Show significant reduction in wound healing time for superficial partial thickness second-degree burns.	Efficacy Met: Mean time to ≥95% epithelialization was significantly shorter for the ESWT group (9.6 ± 1.7 days) vs. control (12.5 ± 2.2 days), with p<0.0005. This demonstrates a clear improvement in wound healing time.
Safety: No significant increase in adverse events (e.g., cardiac, neurological, dermal, allergic reactions, infections) compared to standard of care.	Safety Met: "There were no reported cardiac, neurological, dermal, or allergic reactions." Clinically apparent burn wound infection (9% ESWT vs. 14% control, p=0.99) and postburn bacteremia/other nosocomial infections (8% ESWT vs. 16% control) did not differ significantly between groups. This indicates a comparable safety profile to standard of care.
Biocompatibility/Electrical Safety/EMC: Meet relevant performance standards.	Met: "The OrthoGold 100™ was tested for electrical safety and electromagnetic compatibility and pressure field measurements. In addition, probe cover testing and transport verification and validation was also conducted. The testing demonstrated that the OrthoGold 100™ met performance requirements..."

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: A prospective randomized controlled study with 44 patients in each group (treatment and control).
- Data Provenance: The document does not explicitly state the country of origin. It was a prospective study.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document describes a clinical trial evaluating the device's effect on wound healing (epithelialization). The "ground truth" here is the clinical outcome (time to 95% epithelialization and occurrence of adverse events), which would have been assessed by treating physicians and study personnel. The document does not specify the number or qualifications of experts involved in establishing this clinical "ground truth" beyond implying that qualified medical professionals conducted the study.
Adjudication Method for the Test Set:
- The document describes a clinical trial measuring objective outcomes (time to epithelialization, infection rates). It does not explicitly mention an adjudication method for subjective assessments, as the primary endpoint (epithelialization time) is a measurable clinical outcome.
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:
- No. This device is an extracorporeal shock wave device for treating burns, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a physical therapy device; it does not have an "algorithm-only" mode of operation in the context of AI. Its "performance" is its therapeutic effect, which is measured clinically.
The Type of Ground Truth Used:
- The primary ground truth for efficacy was clinical outcomes data related to wound healing, specifically the mean time to ≥95% epithelialization.
- For safety, the ground truth was recorded adverse events (cardiac, neurological, dermal, allergic reactions, infections).
The Sample Size for the Training Set:
- The document does not mention a "training set" in the context of machine learning. The clinical study described is a traditional randomized controlled trial to assess the device's efficacy and safety for its intended use, not to train a machine learning algorithm.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there was no mention of a machine learning training set for this device. The clinical study design serves as the primary evidence for its performance.

Summary

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August 28, 2020

Tissue Regeneration Technologies, LLC % Jennifer Daudelin Official Correspondent M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, New York 10018

Re: K200926

Trade/Device Name: OrthoGold 100 Regulation Number: 21 CFR 878.4685 Regulation Name: Extracorporeal Shock Wave Device for Treatment of Chronic Wounds Regulatory Class: Class II Product Code: PZL Dated: August 26, 2020 Received: August 27, 2020

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200926

Device Name

OrthoGold 100

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
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CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Tissue Regeneration Technologies, LLC

Section 5: 510(k) Summary

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.

The safety and effectiveness of the OrthoGold 100™ is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).

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: 347-954-0395Fax: 703-562-9797Email: jdaudelin@msquaredassociates.com
Date Prepared:	April 6, 2020
Proposed Class:	II
Proprietary Name:	OrthoGold 100™
Common Name:	Extracorporeal shock wave device for treatment of chronic wounds
Classification Name:	Extracorporeal shock wave device for treatment of chronic wounds
Regulation Number:	21 CFR 878.4685
Product Codes:	PZL
Predicate Device:

Manufacturer	Device Name	510(k) Number	Procode	Class
Tissue RegenerationTechnologies, LLC	OrthoGold 100TM	K191961	PZL	II

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Tissue Regeneration Technologies, LLC

Indications for Use

Device Description

Performance Data – Non-Clinical

The OrthoGold 100™ has been evaluated through non-clinical performance testing. The OrthoGold 100™ was tested for electrical safety and electromagnetic compatibility and pressure field measurements. In addition, probe cover testing and transport verification and validation was The testing demonstrated that the OrthoGold 100™ met performance also conducted. requirements and is substantially equivalent to the predicate device.

Product Characteristic	Predicate DeviceOrthoGold 100	Subject PredicateOrthoGold 100	Comparison
510(k) Number	K191961	To be assigned	NA
Indications for Use	Intended for treatment of chronic,full-thickness diabetic foot ulcerswith wound areas measuring nolarger than 16 cm2, which extendthrough the epidermis, dermis,tendon, or capsule, but withoutbone exposure. The OrthoGold 100is indicated for adult (22 years andolder), diabetic patients presentingwith diabetic foot ulcers greaterthan 30 days in duration and isindicated for use in conjunctionwith standard diabetic ulcer care.	The OrthoGold 100™is indicated to provideacoustic pressureshockwaves in thetreatment of superficialpartial thicknesssecond degree burns inadults (22 years andolder). The OrthoGold100 is indicated for usein conjunction withstandard of care burntreatment(s).	Both the subject and predicatedevice are intended to applyacoustic waves to dermalwounds

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

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Product Characteristic	Predicate DeviceOrthoGold 100	Comparison
Modes of Action	Unfocused pressure pulses	Similar
Mechanisms of Action	Extracorporeally induced unfocused pressure pulses	Similar
Maximum andMinimum intensitysettings	1 to 16	Similar
Number and size oftreatment applicatorheads	OP155Size: 230 x Ø 70 mm	Similar
Operating mode	Continuous	Similar
Pulse repeat rate (1/s)	1 - 8 Hz	Similar
Number of pulses (minand max)	300 - 1300	Similar
Maximum operatingtemperature	Room temperature	Similar
Type of acoustic wavegeneration	Electro hydraulic, spark gap under water caused bydischarge of high voltage condensers	Similar

Performance Data -Animal

A study investigated the role of ESWT on the early proinflammatory response using a severe, full-thickness and highly inflammatory cutaneous burn wound in a murine model. Various wound-healing parameters were measured and leukocyte infiltration quantitated. The study demonstrated that ESWT of burn wounds 1hour post wounding significantly blunts some immune responses in the wound and attenuates activity at the wound margin. The authors speculate that ESWT may be a potential therapeutic modality to treat severe wounds wherein excessive inflammatory responses involving increased levels of inflammatory cells, proinflammatory cytokines and proteases may become self-resolving allowing wound healing to progresses by way of normal physiological repair processes. The study supports the safe and effective use of the OrthoGold in second-degree burn.

Performance Data – Clinical

A prospective randomized controlled study of 44 patients in each group) demonstrated that treatment with the OrthoGold 100 device in addition to standard of care was safe and effective to treat superficial second-degree burn wounds. Adult patients presenting with superficial second-

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degree burns involving the epidermis and extending into the dermis were included in the study. Patients were excluded with first degree burns, second degree deep dermal and third-degree burns. In addition, the exclusion criteria included patients with insulin dependent diabetes mellitus, dialysis dependent renal failure, ongoing systemic therapy for malignancy, dermatologic disease, ongoing corticosteroid therapy, and active drug abuse. The control group included 18 males and 4 females who received standard of care burn treatment, which consisted of wound debridement and daily antiseptic dressing changes. The treatment group included 14 males and 8 females who underwent the same standard of care burn treatment in addition to ESWT administered within 24 hours of burn wound debridement. The ESWT group received a single application of unfocused shock wave therapy to the study burn.

Results showed that the mean time to ≥95% epithelialization of the treated burns was significantly shorter for those treated with the OrthoGold device compared to standard of care alone, 9.6 ± 1.7 days for the ESWT group versus 12.5 ± 2.2 days for the control group (p<0.0005). Study patients were monitored carefully during the follow-up period for cardiac, neurological, dermal, or allergic reactions or adverse events. There were no reported cardiac, neurological, dermal, or allergic reactions. Clinically apparent burn wound infection occurred in both groups, 9% in the ESWT group patients and 14% in the control group patients and did not differ significantly between study groups (p=0.99). Postburn bacteremia and other nosocomial infections occurred in 8% and 16% of patients, ESWT and control group respectively, and did not differ significantly between study groups. Limitations of this study include a modest sample size, lack of long-term follow-up. no assessment of quality of life outcomes measures, and no illustrative use of doppler imaging and burn wound histology.

The data from this study establishes the efficacy of the subject device to treat superficial partial thickness second degree burns and the safety of the device as shown with the lack of adverse events.

Substantial Equivalence

The OrthoGold 100™ has the same design features as compared with the predicate system. The bench testing, animal and clinical data demonstrates that the performance characteristics of the OrthoGold 100™ are equivalent to those of the other legally marketed extracorporeal shock wave

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devices, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Different questions of safety and effectiveness were not raised between the subject and predicate devices.

Regulation Number and Section

§ 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.

(a)
Identification. An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use.
(4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life.
(7) Physician labeling must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) A detailed summary of the device's technical parameters;
(iii) Validated methods and instructions for reprocessing of any reusable components; and
(iv) Instructions for preventing hearing loss by use of hearing protection.
(8) Patient labeling must include:
(i) Relevant contraindications, warnings, precautions, adverse effects, and complications;
(ii) Information on how the device operates and the typical course of treatment;
(iii) The probable risks and benefits associated with the use of the device;
(iv) Post-procedure care instructions; and
(v) Alternative treatments.