The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OrthoGold 100 is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

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 is a 510(k) Premarket Notification from the FDA regarding the OrthoGold 100 device. While it attests to the device's substantial equivalence based on non-clinical performance and a literature review, it does not contain the kind of detailed information typically found in a clinical study report for an AI/device performance evaluation that would include acceptance criteria, specific performance metrics for the device, and detailed information about test sets, ground truth establishment, or multi-reader studies.

Therefore, I cannot extract the specific information requested in your prompt regarding:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study details (effect size of human reader improvement with AI).
Standalone (algorithm only) performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document discusses "Performance Data – Non-Clinical" (electrical safety, EMC, pressure field measurements) and "Performance Data – Clinical" which refers to a literature review demonstrating successful clinical use and efficacy. It states:

Clinical Performance: "A literature review represents the published literature with the subject device through systematic, comprehensive literature searches and those articles known to the manufacturer. These studies demonstrate the successful clinical use with the OrthoGold technology in 224 diabetic foot ulcers. The studies show significant results in complete wound healing and reduction of wound area. The data from these studies establish the efficacy of the subject device to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure and the safety of the device as shown with the lack of adverse events."

This describes the basis for efficacy and safety claims, but not a specific study with defined acceptance criteria and performance metrics for a device (especially an AI-driven one, which this is not) against a held-out test set as per your prompt's requirements. The OrthoGold 100 is an extracorporeal shock wave device, not an AI/software as a medical device (SaMD) that would typically have the metrics and study designs you are asking for.

The core of this document is a 510(k) submission seeking substantial equivalence to a predicate device, not necessarily a de novo clinical trial proving novel performance against specific statistical targets like an AI model would need.

Summary

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November 26, 2019

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

Re: K191961

Trade/Device Name: OrthoGold 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: October 28, 2019 Received: October 29, 2019

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 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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Indications for Use

510(k) Number (if known)

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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Section 5: 510(k) Summary

K191961

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: 703-562-9800 x251Fax: 703-562-9797Email: jdaudelin@msquaredassociates.com
Date Prepared:	November 25, 2019
Proposed Class:	II
Proprietary Name:	OrthoGold 100TM
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(s):
Manufacturer	Device Name	510(k) Number	Procode	Class
Sanuwave, Inc.	dermaPACE System	DEN160037	PZL	II
Reference Device:Tissue RegenerationTechnologies, LLC	OrthoGold 100TM	K182682	ISA	I

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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.

ProductCharacteristic	Subject DeviceOrthoGold 100	ReferencePredicateOrthoGold 100	Primary Predicate DevicedermaPACE System	Comparison
510(k) Number	To be assigned	K182682	DEN160037	NA
Indications forUse	Intended for treatment ofchronic, full-thicknessdiabetic foot ulcers withwound areas measuring nolarger than 16 cm2, whichextend through theepidermis, dermis, tendon,or capsule, but withoutbone exposure. TheOrthoGold 100 is	Activation ofconnectivetissue	Intended for the treatment ofchronic, full-thickness diabetic footulcers with wound areas measuringno larger than 16 cm2, whichextend through the epidermis,dermis, tendon, or capsule, butwithout bone exposure. ThedermaPACE System is indicated foradult (22 years and older), diabeticpatients presenting with diabetic	Identical

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

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ProductCharacteristic	Subject DeviceOrthoGold 100	Primary Predicate DevicedermaPACE System	Comparison
	indicated for adult (22years and older), diabeticpatients presenting withdiabetic foot ulcers greaterthan 30 days in durationand is indicated for use inconjunction with standarddiabetic ulcer care.	foot ulcers greater than 30 days induration and is indicated for use inconjunction with standard diabeticulcer care.
Modes of Action	Unfocused pressure pulses	Focused pressure	Similar
Mechanisms ofAction	Extracorporeally induced unfocused pressurepulses	Extracorporeally induced focusedpressure pulses	Similar
Maximum andMinimumintensity settings	1 to 16	1 to 6	Similar
Number and sizeof treatmentapplicator heads	OP155Size: 230 x ø 70 mm	1 applicator (size not available)	Similar
Operating mode	Continuous	Continuous	Similar
Pulse repeat rate(1/s)	1 - 8 Hz	1-4 Hz	Similar
Number of pulses(min and max)	300 - 1300	500 to Specific Value NotAvailable	Similar
Maximumoperatingtemperature	Room temperature	Specific Value Not Available	Similar
Type of acousticwave generation	Electro hydraulic, spark gap under watercaused by discharge of high voltagecondensers	Electro hydraulic, spark gap underwater caused by discharge of highvoltage condensers	Similar

Performance Data - Clinical

A literature review represents the published literature with the subject device through systematic, comprehensive literature searches and those articles known to the manufacturer. These studies demonstrate the successful clinical use with the OrthoGold technology in 224 diabetic foot ulcers. The studies show significant results in complete wound healing and reduction of wound area. The data from these studies establish the efficacy of the subject device to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure and the safety of the device as shown with the lack of adverse events.

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Substantial Equivalence

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