The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "RTS Flexible 1st MPJ Implant w/Grommets." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as typically understood for a new clinical efficacy study, is largely not applicable in this context.

Here's why and what information can be extracted based on the document:

No specific acceptance criteria or performance metrics are provided in terms of statistical thresholds for diagnostic accuracy, sensitivity, specificity, etc. This device is a surgical implant, not a diagnostic AI device. The "performance data" referred to are related to engineering, cleaning, packaging, and sterilization validation, not clinical performance metrics.
No "study" as a clinical trial comparing device performance to acceptance criteria in the manner of an AI/diagnostic device is presented. The "study" here is essentially the demonstration of substantial equivalence.

However, I can extract the relevant information that is present in the document based on your request, highlighting where the requested details are not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (explicitly stated in the document)	Reported Device Performance (as per the document)
None explicitly stated as clinical performance metrics (e.g., sensitivity, specificity, accuracy) for statistical thresholds.	No clinical performance metrics are reported.
Substantial Equivalence to Predicate Device (Futura Biomedical, Flexible Great Toe Implant, K981194) in:	Demonstrated.
- Intended Use	Same
- Indications for Use	Same
- Similar Dimensions	Yes
- Similar Geometry	Yes
- Similar Materials	Yes
- Principals of operation	Same
- Cleaning validation	Performed, results demonstrate substantial equivalence.
- Packaging validation	Performed, results demonstrate substantial equivalence.
- Sterilization validation	Performed, results demonstrate substantial equivalence.
- Engineering analysis	Performed, results demonstrate substantial equivalence.

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

Not Applicable. This document describes a 510(k) submission for a surgical implant, not a study involving a "test set" of data for algorithm performance. The "performance data" mentioned refers to engineering and validation testing (e.g., cleaning, packaging, sterilization), not clinical outcome data or diagnostic performance data. Therefore, there's no "sample size" or "data provenance" in the context of an AI/diagnostic algorithm test set.

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

Not Applicable. As above, no "test set" for expert-derived ground truth is described in this 510(k) submission.

4. Adjudication method for the test set

Not Applicable. No test set or related adjudication method is mentioned.

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 a surgical implant, not a diagnostic AI device. Therefore, MRMC studies and concepts of human reader improvement with/without AI assistance are not relevant to this submission.

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

Not Applicable. This is a surgical implant. There is no algorithm or AI component involved.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. The "ground truth" in this context is the predicate device and its established safety and effectiveness. The current device aims to demonstrate "substantial equivalence" to this predicate, rather than generating new primary ground truth for clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not Applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not Applicable. There is no training set or associated ground truth establishment process for a training set in this submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles facing right, suggesting a sense of community and health.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 8, 2016

In2Bones USA, LLC % Ms. Louise Focht President ENMED International, Inc. P.O. Box 249 Del Mar. California 92014

Re: K153609

Trade/Device Name: RTS Flexible 1st MPJ Implant w/Grommets Regulation Number: 21 CFR 888.3720 Regulation Name: Toe joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KWH Dated: August 8. 2016 Received: August 9, 2016

Dear Ms. Focht:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

Device Name: RTS Flexible 1st MPJ Implant w/Grommets

Indications for Use (Describe)

The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of:

Hallux limitus or hallux rigidus
· Painful rheumatoid arthritis
· Hallux abducto valgus associated with arthritis
· Unstable or painful joint from previous surgery

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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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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510(k) Summary of Safety and Effectiveness

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

I. Submitter

Date Prepared:	September 8, 2016
Device Submitter:	In2Bones USA, LLC
	6060 Poplar Avenue, Suite 380
	Memphis, TN 38119
Phone:	901-260-7931
Contact Person:	Louise Focht

II. Device

Proprietary Name:	RTS Flexible 1st MPJ Implant w/Grommets
Common Name:	Flexible Great Toe Implant
Classification Name:	Prosthesis, Toe, Constrained Polymer
Regulatory Class:	21 CFR 888.3720, Class II
Product Code:	87 KWH

III. Predicate Device

Predicate Device:	Futura Biomedical, Flexible Great Toe Implant
	K981194

IV. Device Description

V. Intended Use and Indications for Use

The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of: Hallux limitus or hallux rigidus, Painful rheumatoid arthritis, Hallux abducto valgus associated with arthritis, Unstable or painful joint from previous surgery

Comparison of technological characteristics with the predicate device VI.

The RTS Flexible 1* MPJ Implant w/Grommets and the legally marketed predicate device have the same intended use and indications for use, similar dimensions, geometry and materials. The In2Bones device and the predicate are both available in four sizes. The stems of the devices are

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fit into the intramedullary canals of the first metatarsal phalangeal joint. The devices are constrained and made of silicone elastomer. The devices also have proximal and distal grommets that may be used with the silicone implant.

VII. Performance Data

Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering analysis was also performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified

VIII. Conclusions

The RTS Flexible 1ª MPJ Implant w/Grommets when compared to the predicate have the same intended use and indications for use, technological characteristics, and principals of operation as the predicate device. Thus the RTS Flexible 1st MPJ Implant w/Grommets design characteristics do not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.