The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Indications include:

Severe pronation .
Calcaneal valgus deformity .
Plantarflexed talus .
Failed correction with long term orthotic treatment .
Congenital and painful flatfoot deformity .
. Repair of tarsal coalitions
Subtalar instability .
Posterior tibial tendon dysfunction .
Paralytic flat foot deformity .

The Metasurg subtalar implants are intended for single use only.

Device Description

The Metasurg Subtalar Implant is a one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot. The implant is offered in 5 sizes ranging from 8mm to 12mm in diameter. The implant is used in the treatment of the talus relative to the calcaneus.

AI/ML Overview

The provided K111265 document is a 510(k) summary for the Metasurg Subtalar Implant. It describes the device, its intended use, and states that substantial equivalence has been demonstrated to other legally marketed devices.

However, the document does not contain any information regarding acceptance criteria or the results of a specific study proving the device meets acceptance criteria. 510(k) summaries typically focus on proving substantial equivalence to a predicate device based on similarities in intended use, technology, and performance, often relying on non-clinical testing (e.g., mechanical testing, biocompatibility) or comparison with existing clinical data of the predicate. They generally do not include detailed clinical study reports with specific acceptance criteria and performance metrics for the new device as would be seen in a PMA or a detailed clinical trial publication.

Therefore, I cannot provide the requested table or detailed information about a study proving the device meets acceptance criteria because that information is not present in the provided text.

Based on the available document, I can infer the following about the regulatory intent, although direct "acceptance criteria" as you've defined them for a clinical study are not present:

Implied "Acceptance Criteria" for 510(k) Equivalence (not performance criteria):

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance (Implied from K111265)
Substantial Equivalence to Predicate Device:- Similar intended use- Similar technological characteristics- Similar material composition (titanium alloy)	Documentation is provided which demonstrates the Metasurg Subtalar Implant to be substantially equivalent to other legally marketed devices. The device is a one-piece titanium implant for the sinus tarsi, intended to treat hyperpronated foot and stabilize the subtalar joint by blocking excessive pronation. Made of Titanium Alloy (Ti 6Al-4V ELI).
Biocompatibility:- Material commonly used in implants	Titanium Alloy (Ti 6Al-4V ELI) is a well-established and accepted biocompatible material for implantable devices, implying it meets biocompatibility requirements. (No specific test results provided in this summary).
Mechanical Performance:- Meets strength/durability for intended use	While not detailed, for orthopedic implants, there's an implicit requirement for sufficient strength and durability. The K111265 typically relies on non-clinical performance data (e.g., mechanical testing) to show it performs as safely and effectively as a predicate. (No specific test results reported in this summary).

Regarding the specific questions you asked, based solely on the provided K111265 document:

A table of acceptance criteria and the reported device performance:
- As explained above, the document does not present specific clinical acceptance criteria or performance metrics from a dedicated study. The "performance" described is in the context of demonstrating substantial equivalence to a predicate device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical "test set" or associated data provenance is mentioned in this 510(k) summary. 510(k)s often rely on non-clinical (e.g., bench) testing and comparison to existing predicate devices rather than new clinical trials.
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 information is not applicable and not present, as no clinical test set or ground truth establishment process is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable; no clinical test set or adjudication process is mentioned.
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 medical device (implant), not an AI diagnostic/imaging device that would typically undergo MRMC studies involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No clinical ground truth is described in this 510(k) summary. The "ground truth" for a 510(k) is effectively the safety and efficacy track record of the predicate device, which the new device aims to be equivalent to.
The sample size for the training set:
- Not applicable; implants do not typically have "training sets" in the context of AI or machine learning.
How the ground truth for the training set was established:
- Not applicable.

In summary, the provided 510(k) summary (K111265) for the Metasurg Subtalar Implant focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting results from a clinical study with specific acceptance criteria for performance.

Summary

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K111265

/1,

510(k) Summary

AUG - - 9 9 2011

Date Prepared:	May 3, 2011
Sponsor:	Metasurg16350 Park Ten Place, Suite 101Houston, TX 77084
Company Contact:	Joshua ScottPhone: (281) 398-5656Fax: (281) 398-5660
Device Trade Name:	Metasurg Subtalar Implant
Classification Name:	Smooth & threaded metallic bone fixation fasteners (21CFR 888.3040, Product Code HWC, Class II)
Common Name:	Subtalar Arthrorisis Implant
Substantial Equivalence:	Documentation is provided which demonstrates the MetasurgSubtalar Implant to be substantially equivalent to other legallymarketed devices.
Device Description:	The Metasurg Subtalar Implant is a one-piece device made oftitanium intended to be implanted into the sinus tarsi of the foot.The implant is offered in 5 sizes ranging from 8mm to 12mm indiameter. The implant is used in the treatment of the talusrelative to the calcaneus.
Intended Usage:	The Metasurg subtalar implant is indicated for use in thetreatment of the hyperpronated foot and stabilization of thesubtalar joint. It is designed to block forward, downward andmedial displacement of the talus, thus allowing normal subtalarjoint motion but blocking excessive pronation and the resultingsequela.
	Indications include:• Severe pronation• Calcaneal valgus deformity• Plantarflexed talus• Failed correction with long term orthotic treatment• Congenital and painful flatfoot deformity• Repair of tarsal coalitions• Subtalar instability• Posterior tibial tendon dysfunction• Paralytic flat foot deformity
	The Metasurg subtalar implants are intended for single use only.
Material:	Titanium Alloy (Ti 6Al-4V ELI)

Section 5 - Page 1 of 1

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Metasurg % Mr. Joshua Scott 16350 Park Ten Place Suite 101 Houston, Texas 77084

9 2011 માંદિ

Re: K111265

Trade/Device Name: Metasurg Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 19, 2011 Received: July 20, 2011

Dear Mr. Scott:

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

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Page 2 - Mr. Joshua Scott

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): 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 go to http://www.fda.gov/AboutlTDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: Pending_ K11/ 265

Device Name: Metasurg Subtalar Implant

Indications for Use:

Indications include:

Severe pronation .
Calcaneal valgus deformity .
Plantarflexed talus .
Failed correction with long term orthotic treatment .
Congenital and painful flatfoot deformity .
. Repair of tarsal coalitions
Subtalar instability .
Posterior tibial tendon dysfunction .
Paralytic flat foot deformity .

The Metasurg subtalar implants are intended for single use only.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WIRTE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number. 12111256

Section 4 - Page 1 of 1

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.