Satyrne's InterFlex Mandibular Fixation System is intended for the stabilization and rigid fixation of fractures and reconstructive procedures of the mandibular skeleton. Each device is intended for single use only in conjunction with other titanium and titanium alloy implants.

Device Description

Satyrne InterFlex Mandibular Fixation System is a new bone plate system for use in oral and maxillofacial surgery. The design includes plates of different thicknesses that are secured to the mandibular bony tissue using bone screws of varying lengths and designs. The bone plates and bone screws will be manufactured of commercially pure (CP) titanium or Ti6Al4V alloy in compliance with ASTM F67 and ASTM F136.

AI/ML Overview

This document is a 510(k) summary for the Satyrne InterFlex Mandibular Fixation System, which is a bone plate system. The device is being submitted for substantial equivalence to existing predicate devices, not requiring extensive new clinical studies to prove effectiveness. Therefore, many of the requested elements regarding acceptance criteria and performance studies are not directly applicable in the typical sense for a brand new AI or software device.

However, based on the provided text, here's an analysis of what information can be extracted regarding the device's "acceptance criteria" and "study":

1. A table of acceptance criteria and the reported device performance

For this type of device (bone plates), acceptance criteria are typically met through mechanical testing demonstrating equivalent or superior performance to predicate devices. The document states:

Criterion	Acceptance Metric (Implied)	Reported Device Performance
Substantial Equivalence (Mechanical)	Similar or equivalent mechanical properties to predicate devices.	"Based on mechanical test results, the Satyrne InterFlex Mandibular Fixation System is substantially equivalent to the legally marketed Stryker Leibinger Universal CMF System K022185 and the Synthes Mandibular Modular Fixation System K954385."
Material Composition	Use of commercially pure (CP) titanium or Ti6Al4V alloy in compliance with ASTM F67 and ASTM F136.	"The bone plates and bone screws will be manufactured of commercially pure (CP) titanium or Ti6Al4V alloy in compliance with ASTM F67 and ASTM F136." "The plates and screws are made of the same material as predicate devices."
Design/Shapes	Contains various shapes of plates and screws similar to predicate devices.	"The system contains various shapes of plates and screws similar to predicate devices."

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 refers to "mechanical test results." For mechanical testing of medical devices, the "test set" typically refers to the number of physical samples of the device tested, not necessarily a patient-based dataset.

Sample Size: Not specified in the provided text.
Data Provenance: Not specified, but generally, mechanical testing is conducted in a lab environment. The document is a 510(k) submission from the US (Albuquerque, NM, with FDA in Rockville, MD), so the testing would likely be performed in the US or by a contracted lab. It's a "retrospective" comparison in the sense that its performance is being compared to already marketed (predicate) devices.

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 to a submission based on substantial equivalence through mechanical testing. "Ground truth" in this context would be defined by engineering specifications and material standards, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Mechanical test results are objective measurements against established standards, not subjective interpretations requiring adjudication.

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 device is a physical implant, not an AI or imaging diagnostic tool. An MRMC study is irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance, as implied by the substantial equivalence argument, is:

Mechanical Performance Standards: Demonstrated equivalence to the mechanical performance of legally marketed predicate devices through engineering tests.
Material Standards: Compliance with ASTM F67 (CP titanium) and ASTM F136 (Ti6Al4V alloy).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of the Study that Proves Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "mechanical test results." These tests demonstrated that the Satyrne InterFlex Mandibular Fixation System is substantially equivalent in its mechanical properties to the predicate devices: the Stryker Leibinger Universal CMF System (K022185) and the Synthes Mandibular Modular Fixation System (K954385). Furthermore, the device's materials (CP titanium or Ti6Al4V alloy) comply with established ASTM standards (F67 and F136), and its design (various plate and screw shapes) is similar to those of the predicate devices. The 510(k) process accepts this comparison as sufficient evidence for market clearance for devices of this type, as it indicates that the new device performs as safely and effectively as legally marketed devices.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters, "K072463". The characters are written in black ink on a white background. The characters are all uppercase and are of varying sizes and thicknesses. The characters are slightly slanted to the right.

3 510(k) Summary

Submitter Contact Information:

Satyrne Medical 1909 Gold Ave. SE #1 Albuquerque, NM 87106 (505) 620-3856

Contact Person: Scott T. Lovald Summary prepared 8/24/2007

NOV 2 9 2007

Trade Name: InterFlex Mandibular Fixation System

Device Classification: Class II Common Name: Bone Plates Regulation Number: 21 CFR 872.4760 Classification Product Code: 76 JEY

Predicate Devices

Stryker Instruments -Universal CMF System (K022185) Synthes - Mandibular Modular Fixation System (K954385)

Device Description

Intended Use

Substantial Equivalence

Based on mechanical test results, the Satyme InterFlex Mandibular Fixation System is substantially equivalent to the legally marketed Stryker Leibinger Universal CMF System

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K022185 and the Synthes Mandibular Modular Fixation System K954385. The plates and screws are made of the same material as predicate devices. The system contains various shapes of plates and screws similar to predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the logo. The seal is black and white.

NOV 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott Lovald CTO Satyrne Medical 1909 Gold Avenue SE #1 Albuquerque, New Mexico 87106

Re: K072463

Trade/Device Name: InterFlex Mandibular Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 26, 2007 Received: August 31, 2007

Dear Mr. Lovald:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Lovald

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use 2

510(k) Number (if known):

Device Name: InterFlex Mandibular Fixation System

Indications for Use:

1 Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K022463

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.