(78 days)
The OrthoGold 100 is intended for:
- Relief of minor muscle aches and pains
- · Temporary increase in local blood circulation
- · Activation of connective tissue
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.
The provided FDA 510(k) summary for the OrthoGold 100 device does not describe a study involving an artificial intelligence (AI) component or its acceptance criteria.
Instead, this document is a premarket notification for a Class I therapeutic massager, which is a physical device (a pulsed acoustic wave device). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance testing of the physical device to ensure it meets design specifications, safety standards, and is substantially equivalent to a predicate device.
Therefore, many of the specific questions you asked about AI-related acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to the information provided in this document.
Here's an analysis based on the document, focusing on the engineering and performance testing described for a Class I medical device, and explaining why the AI-related questions are not relevant here:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance results in the way one might see for an AI model's clinical endpoints. Instead, it describes various performance tests and compliance with standards as evidence of meeting design specifications and safety requirements.
Here's a summary of the performance claims:
| Acceptance Criteria Category/Test | Reported Device Performance/Conclusion |
|---|---|
| General Performance & Design Specifications | "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." (Page 5) |
| Software Validation | "The OrthoGold 100™ software was validated and demonstrated to be of a Moderate level of concern." (Page 5) |
| Hazard Analysis / Risk Management | "Hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level." (Page 5) |
| General Safety (Electrical Medical Equipment) | "The OrthoGold 100 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2005 (AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012)." (Page 5-6) |
| Electromagnetic Compatibility (EMC) | "The OrthoGold 100 was tested and demonstrated to conform to... the electromagnetic compatibility requirements of IEC 60601-1-2:2014 (4th Ed.)." (Page 5) |
| Particular Requirements for Extracorporeally Induced Lithotripsy | "The OrthoGold 100 was tested and demonstrated to conform to... IEC 60601-2-36 Edition 2.0: 2014-04." (Page 5-6) |
| Applicator Displacement, Force, and Penetration Depth (Invitro) | "Invitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the D-Actor 200 predicate device." (Page 5) Specific values are provided in the comparison table on page 7, showing characteristics like: - Max penetration depth: 25.4 mm at energy level 16 - Energy flow density: 0.00017 - 0.04403 mJ/mm2 at energy level 1-16 - Peak compressional acoustic pressure: 0.43 - 9.27 MPa at energy level 1-16. |
| Probe Cover Testing & Transport Verification/Validation | "In addition, probe cover testing and transport verification and validation was also conducted." (Page 5) – No specific results detailed, but implied successful. |
| Substantial Equivalence | "The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to the predicate device." (Page 5) "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." (Page 9) |
| Clinical Data | "Clinical performance data is not relied upon to establish the substantial equivalence of the subject and predicate device." (Page 6) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes engineering and laboratory performance testing, not a clinical trial or AI model validation using patient data. Therefore, the concept of "sample size for the test set" (referring to patient data) and "data provenance" (country, retrospective/prospective) is not applicable. The "test set" would be the device itself and its components undergoing various mechanical, electrical, and physical tests.
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)
This is not applicable as the document describes physical device testing for safety and performance, not diagnostic AI. "Ground truth" here relates to physical measurements and engineering specifications, established by standard test methods and calibrated equipment, not by medical experts interpreting data for diagnostic purposes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as above. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI model validation when multiple human readers assess data and their consensus forms the ground truth for comparison. This document describes physical device testing.
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
This is not applicable. An MRMC study is relevant for assessing the impact of a diagnostic AI tool on human clinician performance. The OrthoGold 100 is a therapeutic massager, not a diagnostic AI device, and the document explicitly states clinical data was not relied upon for substantial equivalence (Page 6).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question refers to the performance of a diagnostic algorithm without human interaction. The OrthoGold 100 is a physical therapeutic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on engineering specifications, verified physical measurements (e.g., force, penetration depth, acoustic pressure), and compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2). These are objective measurements and adherence to established safety and performance benchmarks for therapeutic medical devices, not clinical outcomes or expert consensus for diagnostic interpretation.
8. The sample size for the training set
This is not applicable. The OrthoGold 100 is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no AI training set.
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May 5, 2021
Tissue Regeneration Technologies, LLC % Cherita James Regulatory Consultant M Squared Associates, Inc. 127 West 30th St Floor 9 New York, New York 10001
Re: K210451
Trade/Device Name: OrthoGold 100 Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic massager Regulatory Class: Class I Product Code: ISA Dated: February 12, 2021 Received: February 16, 2021
Dear Cherita James:
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/cdrl/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 medical devices and radiation-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.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine 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)
The OrthoGold 100 is intended for:
- Relief of minor muscle aches and pains
- · Temporary increase in local blood circulation
- · Activation of connective tissue
Type of Use (Select one or both, as applicable) y Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for 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 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 30188Ph: 1-404-402-6844 |
|---|---|
| Contact: | Cherita JamesM Squared Associates, Inc.127 West 30th Street9th FloorNew York, New York 10001Ph: 347-536-1463Fax: 703-562-9797Email: CJames@MSquaredAssociates.com |
| Date prepared: | May 4, 2021 |
| Proposed Class: | I |
| Proprietary Name: | OrthoGold 100™ |
| Proprietary Name: | OrthoGold 100™ |
|---|---|
| Common Name: | Therapeutic Massager |
| Classification Name: | Massager, Therapeutic, Electric |
| Regulation Number: | 21 CFR 890.5660 |
| Product Codes: | ISA |
| Predicate Device: | Storz Medical D-Actor 200 Vibration Massage System K173692 |
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.
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The technology and performance testing of the OrthoGold 100™ have been cleared previously (K182682). There are no changes to the OrthoGold 100™ regarding device characteristics, software, and device performance since the previous clearance.
Indications for Use
The OrthoGold 100 is intended for:
- Relief of minor muscle aches and pains
- · Temporary increase in local blood circulation
- · Activation of connective tissue
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. Invitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the D-Actor 200 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.
The OrthoGold 100 is compliant with the following standards:
| Standard | Recognition Number |
|---|---|
| IEC 61846 First edition 1998-04, ultrasonics - pressure pulse lithotripters - characteristics offields | 9-7 |
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012(consolidated text) medical electrical equipment - part 1: general requirements for basic safetyand essential performance | 19-4 |
| IEC 60601-1-2:2014 Edition 4, Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - Collateral Standard: Electromagnetic disturbances- Requirements andtests | 19-8 |
| IEC 60601-2-36 Edition 2.0: 2014-04,Medical electrical equipment - Part 2-36: Particular requirements for the safety ofequipment for extracorporeally induced lithotripsy | 9-119 |
| DRAFT IEC 63045 ED1, Ultrasonics - Non-focusing pressure pulse sources - Characteristics offields | N/A |
There are no changes to the standards referenced in the previous submission present no changes to the previously cleared OrthoGold 100.
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Clinical Data
Clinical performance data is not relied upon to eastanblish the substantial equivalence of the subject and predicate device.
| Product Characteristic | Subject DeviceOrthoGold 100™ | Predicate DeviceD-Actor 200 | Comparison |
|---|---|---|---|
| 510(k) Number | K210451 | K173692 | NA |
| Indications for Use | Relief of minor muscle achesand painsTemporary increase in localblood circulationActivation of connective tissue | Relief of minor muscle achesand painsTemporary increase in localblood circulationActivation of connective tissue | Equivalent |
| 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 andMinimum intensitysettings | 1 to 16 | 1-5 bar | Similar |
| Number and size oftreatment applicatorheads | OP155Size: 230 x Ø 70 mm | 4: 6mmOD, 15mmOD,20mmOD, 35mmOD | Similar |
| Maximum andminimum displacementsof applicator heads | Not Applicable | 0.6 - 2.0 mm | NA |
| Type of application(e.g., continuousvibration at a fixedfrequency); | Continuous at variousfrequencies | Continuous at variousfrequencies | Similar |
| Product Characteristic | Subject DeviceOrthoGold 100TM | Predicate DeviceD-Actor 200 | Comparison |
| Maximum andminimum vibrationfrequency | Frequency of 1 - 8 Hz in stepsof 0.5 Hz | 1-21 Hz | Similar |
| Driving Power | High voltage 2 - 7 kVCapacitor: 0,2 uF | 1-5 bar | Similar |
| Power Supply | 115 VAC | 500 VA | Similar |
| Maximum penetrationdepth | 25.4 mm at energy level 16 | 32mm | Similar |
| Energy flow densityPIIT [mJ/mm2] | 0.00017 - 0.04403at energy level 1 - 16 | Values of ultrasonic pulse:5bar/0.284mJ/mm23bar/0.176mJ/mm2 | Similar |
| Operating mode | Continuous | Continuous | Similar |
| Projectile mass (g) | Not Applicable | 3 | NA |
| Pulse repeat rate (1/s) | 1 - 8 Hz | 1-21 Hz | Similar |
| Number of pulses (minand max) | 500 - 2000 | Variable | Similar |
| Maximum operatingtemperature | Room temperature | 10-40C | Similar |
| Type of acoustic wavegeneration | Electro hydraulic, spark gapunder water caused bydischarge of high voltagecondensers | Pneumatic/ballistic | Similar |
| Peak compressionalacoustic pressurepc [MPa] | 9.27at energy level 16 | 18.5 | Similar |
| Peak rarefactionalacoustic pressurepcr[MPa] | -1.52 at energy level 16 | 6.8MPa at 5 bar | Similar |
| Product Characteristic | Subject Device | Predicate Device | |
| OrthoGold 100TM | D-Actor 200 | Comparison | |
| Description of thespatial distribution ofthe acoustic pressureand intensity | Unfocused acoustic pressurefield, see pressuremeasurements | Specific Value Not Available | Similar |
| Positive peak pressureamplitude (MPa)pc [MPa] | 0.43 - 9.27at energy level 1 - 16 | 5 bar/18.5MPa3bar/13.4MPa | Similar |
| Negative peak pressureamplitude (MPa)pcr[MPa] | -0.17 to -1.52 MPaat energy level 1 - 16 | Values of ultrasonic pulse:5bar/6.8MPa 3bar/5.0MPa | Similar |
| Derived focal acousticpulse energy (mJ)EbT [mJ] | 0.022 - 2.278at energy level 1 - 16 | Values of ultrasonic pulse:5bar/6.5mJ3bar/2.4mJ | Similar |
| Derived pulse -intensityintegral, integrated over 0.00017 - 0.04403 mJ/mm2total temporalintegration limitsPIIT [mJ/mm2] | at energy level 1 - 16 | Values of ultrasonic pulse5bar/0.284mJ/mm23bar/0.176mJ/mm2 | Similar |
| Rise time (ns)(10% - 90%) tr [µs] | 1.89 - 0.28 at energy level 1 -16 | Ultrasonic pulse: 2.5µsSonic pulse: 25µs – 2.5ms | Similar |
| Compressional pulseduration (µs)tFWHMpc [µS] | 1.23 - 0.77 µs at energy level 1- 16 | Ultrasonic pulse: 5.0µsSonic pulse: 50µs – 5.0ms | Similar |
The table below compares the OrthoGold 100 characteristics to the predicate device.
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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
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K210451
the subject and predicate device would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.
§ 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.