The KLS-Martin Resorb-X System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton.

The KLS-Martin Resorb-X System is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.

Device Description

The KLS-Martin Resorb-X resorbable plating system consists of all necessary Instrumentation to employ three diameters of screws with associated plates and meshes. The screws are Poly (D. L)-Lactid-Acid (PDLLA) and are available in diameters 1.6mm, 2.1mm and 2.4mm. The plates and meshes are the same material and vary in shape, size and thickness, and may be used with any of the above diameter screws to fixate.

The screws and plates are provided pre-sterilized by gamma irradiation and are not intended to be resterilized by the end user.

The screws are not intended to be used without a plate.

The screws require a pilot hole and this pilot hole must be tapped.

The plates are not intended to be used for fracture compression.

The Resorb-X system is not intended for use in the mandible.

AI/ML Overview

The provided text is a 510(k) summary for the Resorb-X Resorbable Plating System, which is a medical device application for market clearance. It primarily focuses on demonstrating substantial equivalence to predicate devices. This type of document, particularly from 2002, does not typically contain the detailed information required to describe the acceptance criteria and a study that proves the device meets those criteria in the context of software or AI performance.

Here's why and what information can be extracted:

Device Type: The Resorb-X system is a physical implant (plating system) made of Poly (D.L)-Lactid-Acid (PDLLA). Its performance criteria would be related to mechanical strength, biocompatibility, degradation rate, and clinical outcomes, not algorithmic performance.
510(k) Process: The 510(k) process for such devices relies heavily on demonstrating substantial equivalence to existing legally marketed predicate devices, often through bench testing and sometimes animal studies, but rarely through large-scale human clinical trials with detailed statistical performance metrics like sensitivity/specificity for diagnostic aids.
Date: The document is from 2002, a time when AI in medical devices, especially as a standalone or assistance tool for diagnosis, was not prevalent in regulatory submissions in the same way we see today.

Therefore, most of the requested fields related to acceptance criteria for AI performance and AI study details cannot be filled from this document.

However, I can extract the general indications for use and contraindications, which act as a form of "acceptance criteria" for the device's intended application.

Here's a breakdown of what can be inferred or explicitly stated from the provided text, and where gaps exist relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Indications/Safety)	Reported Device Performance (Inferred/Stated)
Intended Use: Fractures of the craniofacial skeleton (naso-ethomoidal, infraorbital, frontal sinus wall, midface); reconstructive procedures of midface/craniofacial skeleton.	The device is deemed "substantially equivalent" to predicate devices for these indications, implying similar expected performance and safety profile as established devices.
Contraindication: Not for use in the mandible.	Device design/material not suitable or tested for mandibular loads.
Contraindication: Not for full load-bearing situations.	Device design/material not suitable or tested for full load-bearing.
Contraindication: Not for areas of active infection.	Device may exacerbate infection or not integrate properly in infected tissue.
Contraindication: Not for patients with blood supply limitations.	Impaired healing or integration expected in compromised vascularity.
Contraindication: Not for patients with insufficient quantity or quality of bone.	Insufficient bone may lead to fixation failure.
Contraindication: Not for patients with latent infections.	Device may trigger or worsen latent infections.
Material/Sterilization: Poly (D. L)-Lactid-Acid (PDLLA), pre-sterilized by gamma irradiation.	Device meets material specifications and sterility requirements for its intended use.
Application Method: Requires pilot hole and tapping; screws not to be used without plate; plates not for fracture compression.	Device is designed for specific surgical techniques to ensure proper fixation.

Note: The FDA's substantial equivalence determination itself is the "acceptance criterion" for market clearance in a 510(k). The specific performance metrics (e.g., tensile strength, degradation rate, biocompatibility) for the device would have been compared to the predicate devices during the submission process, but these detailed engineering/biological performance criteria and their values are not present in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for AI/software performance. This device is a physical implant. Performance would typically be evaluated through bench testing (e.g., mechanical stress tests), biocompatibility testing (in vitro/in vivo animal models), and sometimes limited human clinical data or post-market surveillance. Such details are not included in this 510(k) summary, which focuses on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable for AI/software performance. Ground truth, in the context of AI, refers to expert-labeled data. For a physical implant, "ground truth" might relate to histological analysis, imaging results of healing, or clinical outcomes, typically assessed by surgeons or pathologists, but not in the format requested for AI validation.

4. Adjudication Method for the Test Set

Not applicable for AI/software performance. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human readers/experts in AI model validation. This concept doesn't apply to the regulatory submission for a physical implant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, not performed. MRMC studies are specifically designed to evaluate the impact of a diagnostic or interpretive tool (often AI-assisted) on human reader performance. This device is a physical fixation system, not a diagnostic or interpretive tool.

6. Standalone (Algorithm Only) Performance Study

No, not applicable. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

Not applicable in the AI sense. For a physical implant, "ground truth" would be established through:
- Bench Testing Data: Mechanical properties (e.g., strength, stiffness, fatigue life).
- Biocompatibility Testing: Histological analysis, inflammatory response markers (often in animal models).
- Degradation Studies: Material science analysis of how the polymer degrades over time in physiological conditions.
- Clinical Outcomes (if any were part of the predicate device's history or limited trials): Patient healing, absence of complications, device integrity from follow-up imaging (e.g., X-rays).
- The 510(k) relies on the "ground truth" established for the predicate devices through their own regulatory pathways and clinical experience.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the machine learning sense. Material properties, design principles, and manufacturing processes are developed through engineering and material science, not by training an algorithm on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not involve a "training set" for an algorithm.

Summary

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R011590

MAR 2 0 2002

510(K) SUMMARY (as required by 807.92 9(c))

Submitter of 510(K):

Regulatory & Marketing Service, Inc. (RMS) 3234 Ella Lane New Port Ritchey, Florida 34655

813-645-2855 Phone: Fax: 813-645-2856

Contact Person:

Art Ward

Date of Summary:

Trade Name:

Classification Name:

Predicate Device:

Resorb-X Resorbable Plating System

Plate, Fixation, Bone, Non-Spinal, Non-Metallic

K955729, K960988, K971870, K974309, K992158 - W. Lorenz Lactosorb® Trauma Plating System K972913 - Macropore Protective Sheet K974554 - Synthes Resorbable Fixation System K982139 - BioSorbFX, Bioabsorbable Fixation System K982531 - Howemedica Fixation System K993061 - Stryker Leibinger System

Device Description/ Comparison:

The screws and plates are provided pre-sterilized by gamma irradiation and are not intended to be resterilized by the end user.

The screws are not intended to be used without a plate.

The screws require a pilot hole and this pilot hole must be tapped.

The plates are not intended to be used for fracture compression.

The Resorb-X system is not intended for use in the mandible.

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The KLS-Martin Resorb-X System is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply Imitations, insufficient quantity or quality of bone, or latent infections.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2002

KLS-Martin L. P. C/O Mr. Arthur Ward Regulatory and Marketing Services 962 Allegro Lane Apollo Beach, Florida 33572

Re: K011590

Trade/Device Name: Resorb-X Resorbable Plating System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 21, 2001 Received: December 26, 2001

Dear Mr. Ward:

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.

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.

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Page 2 - Mr. Ward

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _h(0|1590

Device Name:

Resorb-X Resorbable Plating System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 4 (Per 21 CFR 801-109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Roses

(Division Sign-Off) (Thesion of Dental, Infection Control, and General Hospital Dev 5 10(k) Number -----

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.