The P.F.C. Sigma Knee System (Size 1.5) is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

Device Description

The P.F.C. ® Sigma Knee System (Size 1.5) consists of:

1. Femoral components with an asymmetric trochlear groove;
1. Tibial inserts or All-Polyethylene Tibiae;
1. Femoral augmentation pieces;
1. Tibial Wedges.
  The device is a prosthetic device intended to replace the natural knee joint. The device is constructed of UHMWPE, Titanium and Co-Cr-Mo alloy.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (P.F.C. Sigma Knee System Size 1.5) and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to a predicate device based on performance tests.

However, the document does NOT contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the way described by your request (e.g., in terms of clinical performance, diagnostic accuracy, or human reader improvement with AI). This document focuses on demonstrating substantial equivalence for regulatory clearance, primarily through mechanical performance tests and comparison to a predicate device.

Therefore, I cannot populate the requested table and answer many of the specific questions as the information is not present in the provided text.

Here is what I can extract based on the provided text, and where I must state that the information is not available:

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

Acceptance Criteria (Not explicitly stated as numeric targets in the document)	Reported Device Performance (Summary statement)
Mechanical integrity and performance comparable to predicate device	"All testing concluded the device performed as well or better that the predicate device."
- Constraint against specified forces	Device underwent "Constraint Testing"
- Contact areas/stress under load	Device underwent "Contact Areas/Contact Stress between all Interfacing Components"
- Surface characteristics of articulating components	Device underwent "Surface Characteristics of Articulating Surfaces"
- Tibial insert/tray interlock holding strength	Device underwent "Tibial Insert/Tibial Tray Interlock Testing"
- Patellofemoral joint lateral stability	Device underwent "Lateral Stability of Patellofemoral Joint"

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

Sample size: Not specified. The document only mentions "Performance Tests" without detailing the number of units tested.
Data provenance: Not specified. This would typically relate to clinical trial data, which is not described here.

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: This type of information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the nature of the "Performance Tests" described for this knee prosthesis (which are mechanical tests).

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

Not Applicable: See point 3.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating AI/diagnostic tools and is not relevant to this mechanical device submission.

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

Not Applicable: This is an orthopedic implant, not an algorithm. Therefore, "standalone performance" in the context of AI algorithms does not apply. The device's "standalone" performance is assessed through the mechanical tests.

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

Not Applicable: For mechanical tests, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to the predicate device's established performance or accepted biomechanical standards. The document states that the testing concludes the device performed "as well or better than the predicate device."

8. The sample size for the training set

Not Applicable: This is not an AI device or a diagnostic device that would require a training set in the context of machine learning.

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

Not Applicable: See point 8.

Summary

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Johnson&Johnson
PROFESSIONAL, INC.
510(k) Summary
K971189

JUL 17 1997

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person: John D. Ferros Phone:(508) 880-8287 Fax: (508) 828-3212

Name of Device

Classification Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis has been placed in Class II by the FDA under 21 CFR 888.3560. This falls under the Orthopaedics panel/87.

Common Name: Semi-constrained total knee prosthesis.

Trade Name/Proprietary Name: P.F.C.® Sigma Knee System (Size 1.5)

Performance Standards: No performance standards have been developed as yet for this device.

Predicate Device

P.F.C.® Sigma Knee System

Description of Device

The P.F.C. ® Sigma Knee System (Size 1.5) consists of:

1. Femoral components with an asymmetric trochlear groove;
1. Tibial inserts or All-Polyethylene Tibiae;
1. Femoral augmentation pieces;
1. Tibial Wedges.

The device is a prosthetic device intended to replace the natural knee joint. The device is constructed of UHMWPE, Titanium and Co-Cr-Mo alloy.

Intended Use

The P.F.C.® Sigma Knee System (Size 1.5) is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surqical intervention.

Technological Characteristics Compared to Predicate Device

All the components of the P.F.C.® Sigma Knee System (Size 1.5) are identical to the components of the previously cleared P.F.C.® Sigma Knee System, except they are designed in a smaller size. All materials used in the P.F.C.® Sigma Knee System (Size 1.5) are also identical to the P.F.C.® Sigma Knee System.

Performance Tests

The following tests were conducted for a determination of substantial equivalence: Constraint Testing Contact Areas/Contact Stress between all Interfacing Components Surface Characteristics of Articulating Surfaces Tibial Insert/Tibial Tray Interlock Testing Lateral Stability of Patellofemoral Joint

All testing concluded the device performed as well or better that the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John D. Ferros Senior Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

JUL 1 7 1997

Re: K971189 P.F.C. Σ Sigma Knee System (Size 1.5) Regulatory Class: II Product Code: JWH Dated: June 30, 1997 Received: July 2, 1997

Dear Mr. Ferros:

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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

1. This device may not be labeled or promoted for non-cemented use.
1. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.

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Page 2 - Mr. John D. Ferros

Any non-cemented fixation of this device is 3. considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

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

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Page 3 - Mr. John D. Ferros

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,

Cella 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: P.F.C. Sigma Knee System (Size 1.5)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

PCOSEE

(Division Sign-Off) Division of General Restorative Devices 510(k) Number Ka 1189

Prescription Use X (Per 21 CFR 801.109)

OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.