The GOTFRIED PC.C.P system is a plate and screw system, made of stainless steel, which utilizes dynamic femoral neck screws. The plate accepts two neck screws (length ranging from 90 mm to 140 mm) having barrel (sleeve) diameter of 9.3 mm and shaft diameter of 6.4 mm, and three 4.5 mm cortical screws (length ranging from 31 to 43 mm).

AI/ML Overview

This 510(k) summary describes a medical device, the GOTFRIED PC.C.P, which is a surgical implant. The submission focuses on demonstrating substantial equivalence to predicate devices and provides information on the device's design, intended use, and biomechanical testing.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics commonly associated with AI/ML-driven diagnostics (e.g., sensitivity, specificity, accuracy against a referent standard).

Instead, the "study" referred to in this document is a biomechanical test that compares the GOTFRIED PC.C.P to other compression hip screw systems. The "acceptance criteria" here would be related to the performance of the device in these biomechanical tests in terms of bending and torsional stiffness and ultimate loads to failure, with the goal of demonstrating it is at least equivalent to predicate devices.

Given the nature of the provided document (a 510(k) summary for a surgical implant device), many of the requested elements are not applicable or cannot be extracted. The prompt implies a request for information typically found in submissions for diagnostic or AI/ML-driven devices.

Here's an attempt to answer the questions based on the available information, noting where information is absent or non-applicable:

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

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Equivalent in bending stiffness	"at least equivalent to other compression hip screw systems" (Specific numerical values or thresholds are not provided.)
Equivalent in torsional stiffness	"at least equivalent to other compression hip screw systems" (Specific numerical values or thresholds are not provided.)
Equivalent in ultimate loads to failure	"at least equivalent to other compression hip screw systems" (Specific numerical values or thresholds are not provided.)

Note: The document states the device's biomechanical characteristics are "at least equivalent" to other systems, but it does not specify the precise numerical acceptance thresholds or the exact performance values observed for the GOTFRIED PC.C.P or the comparator devices in these specific biomechanical tests.

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

This information is not provided in the document. Biomechanical tests typically involve a small number of devices or components tested under controlled laboratory conditions, not patient data sets.

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 biomechanical test on a surgical implant. Ground truth in this context would be the physical measurements of material properties and structural integrity, not expert interpretation.

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

This is not applicable to a biomechanical test.

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

This is not applicable as this is a surgical implant, not an AI-driven diagnostic device. No MRMC study was mentioned.

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

This is not applicable as this is a surgical implant, not an algorithm.

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

For the biomechanical study mentioned, the "ground truth" would be established by physical measurements and engineering principles to determine bending stiffness, torsional stiffness, and ultimate loads to failure. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This is not applicable. This is a surgical implant and does not involve AI/ML training data.

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

This is not applicable. This is a surgical implant and does not involve AI/ML training data or its associated ground truth establishment.

Summary of the Study Mentioned:

The document refers to "biomechanical test results" which conclude that "the biomechanical characteristic of the GOTFRIED PC.C.P is at least equivalent to other compression hip screw systems in terms of bending and torsional stiffness and ultimate loads to failure." This serves as evidence for substantial equivalence, a regulatory pathway for medical devices. The specific methodology, sample size (for the biomechanical tests), and detailed results are not provided in this 510(k) summary but would have been part of the full submission to the FDA.

Summary

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JAN 1 4 1999

510(k) Summary

GOTFRIED PC.C.P PERCUTANEOUS COMPRESSION PLATING OF HIP FRACTURES

510(k) Number K983814

Submitter's Name:

EFRATGO LTD. HI TECH BIO-SURGICAL 10 Ben Gurion St. Kyriat Bialik 27000, Israel Tel: 972-4-870-2887 Fax: 972-4-870-6610

Contact Person:

Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth St, NW Washington, DC 20004 Tel: (202) 637-5794 Fax: (202) 637-5910

Trade Name:

GOTFRIED PC.C.P (PERCUTANEOUS COMPRESSION PLATING OF HIP FRACTURES)

Classification Name:

Proximal Femoral Fixation Implant Device

Classification:

The FDA has classified these devices in Class II (product code 87 JDO). Proximal femoral fixation implant devices are reviewed by the Orthopedic and Rehabilitation Devices Branch.

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Intended Use:

The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.

Device Description:

Substantial Equivalence:

The GOTFRIED PC.C.P is substantially equivalent to the Synthes Proximal Femoral Nail (PFN), cleared under K970097, and the Zimmer Versa-Fx Femoral Fixation System, cleared under K954555, in terms of intended use, material and design. Moreover, based on biomechanical test results, the biomechanical characteristic of the GOTFRIED PC.C.P is at least equivalent to other compression hip screw systems in terms of bending and torsional stiffness and ultimate loads to failure.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 1999

Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Representing Efratgo, Limited Hi Tech Bio-Surgical 555 13th Street, NW Washington, DC 20004-1109

K983814 Re: Gotfried Percutaneous Trade Name: Compression Plating System Regulatory Class: II Product Code: JDO Dated: October 28, 1998 Received: October 28, 1998

Dear Mr. Kahan:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ಕ್ಕಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Mr. Jonathan S. Kahan

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General 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): K983814

Device Name:

GOTFRIED PC.C.P (PERCUTANEOUS COMPRESSION PLATING OF HIP FRACTURES)

Indications for Use:

The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983814

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.