Patient Contoured Mesh - PEEK (PCM-P) is a custom shaped PEEK panel that is pre-shaped to fit the anatomy of the patient using a CT based model of the patient. Patient Contoured Mesh - PEEK (PCM-P) is fixated using standard KLS Martin's titanium plates and screws in sizes 1.0mm through 2.3mm

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Patient Contoured Mesh – PEEK (PCM-P)". This type of document is typically for premarket notification and focuses on establishing substantial equivalence to previously cleared predicate devices. It does not contain information about studies proving the device's performance against specific acceptance criteria, nor does it describe clinical trials with human subjects or detailed performance metrics as would be found in a clinical study report.

Instead, the document asserts substantial equivalence based on intended use, technological characteristics, and material composition to highlight similarities and differences with predicate devices.

Therefore, many of the requested details about acceptance criteria, study sizes, expert qualifications, and ground truth establishment are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

Not Available. The document does not specify quantitative acceptance criteria or report specific performance metrics for the PCM-P device. The approval is based on "substantial equivalence" to predicate devices, meaning it is considered as safe and effective as existing legally marketed devices, not necessarily meeting a new set of defined performance criteria through a dedicated study in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. This document does not describe a clinical performance study with a test set. The device is custom-shaped based on individual patient CT scans.

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)

Not Applicable / Not Available. This device is a custom implant. While medical professionals (e.g., surgeons, radiologists) would be involved in patient selection and providing CT data, the document does not describe a "ground truth" establishment process for a performance study in the typical sense of diagnostic or AI device evaluation.

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

Not Applicable / Not Available. There is no performance study described that would require an adjudication method for a test set.

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-assisted diagnostic tool.

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

Not Applicable. This is a physical custom-shaped implant. While the shaping process uses CT data, the document does not discuss "algorithm only" performance in the context of diagnostic or AI systems. The design process involves human input (e.g., surgeon's input on desired shape).

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

Not Applicable / Not Available. For custom implants, the "ground truth" is generally considered to be the patient's actual anatomy derived from imaging (like CT scans) and the clinical need assessed by a surgeon. This is not a diagnostic device where a "ground truth" is established for disease presence.

8. The sample size for the training set

Not Applicable. This device is a custom-made implant based on an individual patient's CT scan. There isn't a "training set" in the context of machine learning. Each implant is designed fresh for each patient.

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

Not Applicable. As there's no training set in the machine learning sense, this question is not relevant to the information provided.

Summary

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pge 142

kls martin LP.

DEC 1 9 2007
510(K) SUMMARY
Submitter:	KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378
Contact Person:	Jennifer DamatoDirector RA/QA
Date of Summary:	18 August 2006
Device Name:	Patient Contoured Mesh – PEEK (PCM-P)
Trade Name:	PCM - P
Common Name:	Preformed Plate
ClassificationName and Number:	Plate, Cranioplasty, Preformed, Non-Alterable(CFR 882.5330)
Regulatory Class:	II
Predicate Devices:	Patient Contoured Mesh (PCM) (K062570)Stryker Patient Specific Polymer Implant (K043250)Stryker Custom TI Implant (K052871)Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199)Synthes (USA) Patient SpecificCranial/Craniofacial Implant (K033868)
Intended Use:	Patient Contoured Mesh – PEEK (PCM-P) isintended to replace bony voids in the cranialand/or craniofacial skeleton

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Device Description:

Technological Characteristics:

Similarities to Predicate

Patient Contoured Mesh - PEEK (PCM-P), Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868) are patient specific implants that are manufactured from PEEK.

Differences to Predicate

Patient Contoured Mesh - PEEK (PCM-P) is manufactured from PEEK, the previously cleared Patient Contoured Mesh (PCM) (K062570) is manufactured from titanium and Stryker Patient Specific Polymer Implant (K043250) is manufactured from surgical simplex P radiopaque bone cement.

Substantial Equivalence:

Patient Contoured Mesh - PEEK (PCM-P) is substantially equivalent in intended use and patient specificity to the Patient Contoured Mesh (PCM) (K062570), Stryker Patient Specific Polymer Implant (K043250), Stryker Custom Ti Implant (K052871), Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2007

KLS-Martin, L.P. % Ms. Jennifer Damato Director RAQA 11239-1 St. Johns Industrial Parkway South Jacksonville, FL 32246

K072707 Re:

Trade/Device Name: Patient Contoured Mesh -PEEK (PCM-P) Regulation Number: 21 CFR 882.5330 Regulation Name: Performed non-alterable cranioplasty plate Regulatory Class: Class II Product Code: GXN, GXP Dated: November 16, 2007 Received: November 19, 2007

Dear Ms. Damato:

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

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Page 2 - Ms. Jennifer Damato

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Patient Contoured Mesh - PEEK (PCM-P)

Indications For Use:

Patient Contoured Mesh - PEEK (PCM-P) is intended to replace bony voids in the cranial and/or craniofacial skeleton

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

No Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Салвае вожело

(Division Sign Division of General, Restorative, and Neurological Devices

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510(k) Number K022707

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).