The Trilliant Surgical Subtalar Implant is indicated for the use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, downward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

Device Description

The Trilliant Surgical Subtalar Implant consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. It is available in six sizes, Ø7mm to Ø12mm in 1mm increments.

AI/ML Overview

The provided document, a 510(k) summary for the Trilliiant Surgical Subtalar Implant (K103183), describes the device and its substantial equivalence to predicate devices. However, it does not contain information related to acceptance criteria, device performance metrics, or the specific study details you've requested for proving acceptance criteria.

This 510(k) summary focuses on demonstrating that the Trilliiant Surgical Subtalar Implant is substantially equivalent to already legally marketed devices based on its intended use, design, materials, and function. The summary explicitly states:

"No clinical studies were performed" (Section 8. Clinical Test Summary).
"The following tests were conducted: Compression testing comparing predicate and Trilliant Surgical Subtalar Implant." (Section 7. Non-clinical Test Summary).

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study methodologies, and performance metrics as it is not present in the provided text.

Here's a breakdown of why each requested point cannot be answered based on the input:

A table of acceptance criteria and the reported device performance: Not provided. The document only mentions "compression testing" without detailing acceptance criteria or quantitative performance results.
Sample sized used for the test set and the data provenance: Not provided. The document mentions compression testing but doesn't specify sample sizes or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies are reported.
Adjudication method for the test set: Not applicable, as no clinical studies are reported.
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-powered diagnostic tool, and no clinical studies are reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical studies are reported. "Compression testing" would typically have a physical standard or engineering specification as a reference.
The sample size for the training set: Not applicable, as no AI/algorithm development is described.
How the ground truth for the training set was established: Not applicable, as no AI/algorithm development is described.

In summary, the provided 510(k) document is for a medical implant and relies on substantial equivalence to predicate devices, supported by non-clinical (compression) testing, rather than extensive clinical efficacy or AI-specific validation studies.

Summary

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510(k) Summary for the Trilliiant Surgical Subtalar Implant

K103183
p 1/3

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Trilliant Surgical Subtalar Implant

Date Prepared: October 22, 2010

1. Submitter:
  Trilliant Surgical LTD 602 Sawyer Street, Suite 120 Houston, TX 77007 Telephone: 214-288-1035

Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199

2. Trade name:	Trilliant Surgical Subtalar Implant
Common Name:	Subtalar spacer
Classification Name:	Screw, fixation, bone
	21 CFR section 888.3040
	HWC
	Class II

3. Predicate or legally marketed devices which are substantially equivalent:

The Trilliant Surgical Subtalar Implant is substantially equivalent to the following devices:

Subtalar MBA System, K960692 (Kinetikos Medical, Inc.) �
HyProCure Subtalar Implant System, K042030 (GraMedical Technologies, LLC) �
. Subtalar Arthroereisis Implant, K093820 (Memometal Technologies)

4. Description of the device:

Materials:

Ti-6Al-4V alloy per ASTM F136

Function:

The Trilliant Surgical Subtalar Implant blocks the posterior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation.

5. Substantial equivalence claimed to predicate devices

The Trilliant Surgical Subtalar Implant is substantially equivalent to the Subtalar MBA System, HyProCure Subtalar Implant System and Subtalar Arthroereisis Implant devices in terms of intended use, design, and materials used. The table below compares the features and characteristics of the Trilliant Surgical Subtalar Implant to these predicate devices.

DeviceNameItems	Trilliiant SurgicalSubtalar Implant	Subtalar MBASystem	HyProCureSubtalar ImplantSystem	SubtalarArthroereisisImplant
Sponsor	Trilliant, LTD	Kinetikos Medical,Inc.	GraMedicaMedicalTechnologies, LLC	MemometalTechnologie
510(k) Number	N/A	K960692	K042030	K093820

8 2011

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DeviceNameItems	Trilliiant SurgicalSubtalar Implant	Subtalar MBASystem	HyProCureSubtalar ImplantSystem	K103138SubtalarArthroereisisImplant
DeviceClassificationName	Screw, fixation,bone	Screw, fixation,bone	Screw, fixation,bone	Screw, fixation,bone
Product Code	HWC	HWC	HWC	HWC
Regulation #	21 CFR 888.3040	21 CFR 888.3040	21 CFR 888.3040	21 CFR 888.3040
Classification	II	II	II	II
Indications forUse	[1] see at end oftable	[2] see at end oftable	[3] see at end oftable	[4] see at end oftable
Implant material	Titanium alloy perASTM F136	Titanium alloy perASTM F136	Titanium alloy perASTM F136	Titanium alloy perASTM F136
DiameterLength	Ø - 7mm-12mmL - 12.75mm-19.50mm	Ø - 6mm-12mmL - 15mm		Ø - 6.5mm-11.5mm
Profile /anatomylocation	Threaded cylinder/ sinus tarsi	Threaded cylinder/sinus tarsi	Threaded cylinder/sinus tarsiSmooth cone /sinus canalis	Threaded cylinder/sinus tarsiShallow thread tosmooth cone /sinus canalis
Cannulated	Yes	Yes	Yes	Yes
Rounded nosefor ease ofinsertion	Yes	Yes	Yes	No
Packaged sterile	No, sterilized athospital	No, sterilized athospital	Yes	Yes

[1] The Trilliant Surgical subtalar implant is indicated for the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

[2] The KMI Subtalar MBA System™ is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is design to block the anterior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela:

Severely pronated foot. .
. Walking intemperance.
. Calcaneal stance position greater than 5°
. Manually correctable deformity
. Mid-tarsal breech (arch pain)
. Forefoot varus greater than 10°

[3] The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

[3] The Memometal Technologies' Subfix Arthroereisis Implant is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing subtalar joint motion but blocking excessive pronation and the resulting sequela.

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6. Intended Use:

K103138,p3/3

The Trilliant Surgical subtalar implant is indicated for the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

7. Non-clinical Test Summary:

The following tests were conducted:

Compression testing comparing predicate and Trilliant Surgical Subtalar Implant. ●

8. Clinical Test Summary

No clinical studies were performed

റ്റ. Conclusions Nonclinical and Clinical

The Trilliant Surgical Subtalar Implant is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle with three stylized wing segments, symbolizing health, services, and people. 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

Trilliant Surgical, Ltd. % The OrthoMedix Group, Inc. % Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, Texas 78681

FEB - 8 2", i

Re: K103183

Trade/Device Name: Trilliant Surgical Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 28, 2011 Received: February 3, 2011

Dear Mr. Webb:

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. J.D. Webb

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/AboutFDA/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/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 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.

Aley B. D.K
for

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 (if known): K |0 3 | 8 3

Device Name: Trilliant Surgical Subtalar Implant

Indications for Use:

· The Trilliant Surgical Subtalar Implant is indicated for the use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, downward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melkerson

(Division Sign-Off) rthopedic, Division di Surgical, Divisionative Devices

510(k) Number K/03/83

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.