(102 days)
The RTS® Lesser MTP Implant is intended for use in the treatment of:
- · Partial or complete dislocation of the lesser metatarsophalangeal joint
- · Pain associated with either rheumatoid or osteoarthritis
- · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
- · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
- · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
The In2Bones USA RTS® Lesser MTP Implant is a one-piece device manufactured from Medical Grade Silicone Elastomer. The implant is available in three sizes. The associated sterile instruments are made of medical grades of stainless steel and polymer materials
This document is a 510(k) premarket notification for the RTS® Lesser MTP Implant System, which is a medical device. As such, the information provided does not include the detailed acceptance criteria and study data typically associated with software or AI device performance. The focus of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/software device would.
However, I can extract the information related to performance testing that was conducted to support the substantial equivalence claim for this physical implant.
1. A table of acceptance criteria and the reported device performance
Since this is a physical implant and not a software/AI device, the "acceptance criteria" are not reported in terms of metrics like sensitivity, specificity, or AUC. Instead, the acceptance criteria are implicitly met by demonstrating that the device performs equivalently to the predicate devices in terms of its physical and material properties and its ability to withstand standard sterilization, cleaning, and packaging processes.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Cleaning Validation | Validations were performed on the cleaning of the implants and associated surgical instruments. |
| Packaging Validation | Validations were performed on the packaging of the implants and associated surgical instruments. |
| Sterilization Validation | Validations were performed on the sterilization of the implants and associated surgical instruments. |
| Biocompatibility | Not explicitly detailed in the summary, but implied by "Medical Grade Silicone Elastomer" and comparison to predicate devices made of similar materials. |
| Mechanical Performance | Engineering analysis including Finite Element Analysis was also performed. |
| Substantial Equivalence | The device was demonstrated to be substantially equivalent to predicate devices based on indications, materials, and geometry. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of human subjects or patient data. The performance testing refers to bench and in-vitro tests for cleaning, packaging, sterilization, and engineering analysis (Finite Element Analysis). Therefore, information on sample size, country of origin, or retrospective/prospective nature is not applicable in the way it would be for a clinical AI study.
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 applicable. Ground truth for clinical outcomes in a human study is not established here. The "ground truth" for the engineering performance and material properties would be established by standard engineering and material science methodologies, not by expert medical consensus in the way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no human "test set" or clinical adjudication process 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 is not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing mentioned (cleaning, packaging, sterilization, engineering analysis), the "ground truth" would be established by:
- Validated laboratory protocols and standards: For cleaning, packaging, and sterilization.
- Engineering principles and material science data: For Finite Element Analysis, comparing results against established material properties and design specifications.
- Predicate device characteristics: The fundamental "ground truth" for substantial equivalence is the existing legally marketed predicate device, whose safety and effectiveness have already been established.
8. The sample size for the training set
Not applicable. This is a physical implant, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
Summary of Device Performance (from the document):
The document states: "The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified." This overarching statement serves as the conclusion for meeting "acceptance criteria" in a 510(k) context. The specific tests performed were:
- Validations for cleaning of implants and surgical instruments.
- Validations for packaging of implants and surgical instruments.
- Validations for sterilization of implants and surgical instruments.
- Engineering analysis, including Finite Element Analysis.
The device is concluded to be substantially equivalent to the predicate devices (OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System and Integra Lesser Metatarsal Phalangeal Implant) based on similar indications, materials (Medical Grade Silicone Elastomer), and geometry.
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February 23, 2018
In2Bones USA, LLC % Christine Scifert Exec VP MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119
Re: K173491
Trade/Device Name: RTS Lesser MTP Implant System Regulation Number: 21 CFR 888.3720 Regulation Name: Toe joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KWH Dated: January 24, 2018 Received: January 26, 2018
Dear Ms. Scifert:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name RTS® Lesser MTP Implant System
Indications for Use (Describe)
The RTS® Lesser MTP Implant is intended for use in the treatment of:
- · Partial or complete dislocation of the lesser metatarsophalangeal joint
- · Pain associated with either rheumatoid or osteoarthritis
- · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
- · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
- · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
RTS® Lesser MTP Implant System January 24, 2018
| Company: | In2Bones USA, LLC6060 Poplar Ave, Suite 380Memphis, TN 38119901-260-7931 |
|---|---|
| Primary Contact: | Christine Scifert |
| Company Contact: | Rebecca Wahl |
| Trade Name: | RTS® Lesser MTP Implant System |
| Common Name: | Polymer toe Prosthesis |
| Classification: | II |
| Regulation Number: | 888.3720 - Toe Joint Polymer Constrained Prosthesis |
| Panel: | 87-Orthopedic |
| Product Code(s): | KWH |
Device Description: The In2Bones USA RTS® Lesser MTP Implant is a one-piece device manufactured from Medical Grade Silicone Elastomer. The implant is available in three sizes. The associated sterile instruments are made of medical grades of stainless steel and polymer materials
Indications for Use: The RTS® Lesser MTP Implant is intended for use in the treatment of:
- · Partial or complete dislocation of the lesser metatarsophalangeal joint
- · Pain associated with either rheumatoid or osteoarthritis
- · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
- · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
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Primary Predicate
- . K022886 – OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System Additional Predicate
- . K023531 - Integra Lesser Metatarsal Phalangeal Implant Reference Device
- K153609 In2Bones RTS® Flexible 1st MPJ Implant w/Grommets System .
The subject RTS® Lesser MTP Implant made of Silicone Elastomer has demonstrated to be substantially equivalent to the previously cleared OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System and the Integra Lesser Metatarsal Phalangeal Implant as the products are similar in indications, materials and geometry.
Performance Testing: Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering analysis including Finite Element Analysis was also performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified
Conclusion
The RTS® Lesser MTP Implant when compared to the predicate have the same intended use and indications for use, technological characteristics, and principals of operation. Thus the RTS® Lesser MTP Implant design characteristics do not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate device.
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.