(21 days)
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is indicated for cemented use only.
The proposed device is part of the NexGen system of semiconstrained, nonlinked knee prostheses.
The provided text is for a 510(k) premarket notification for a medical device, the NexGen® Prolong™ All-Poly Patella. This document concerns the substantial equivalence of the device to a predicate device, not a study proving it meets specific acceptance criteria in the way one might expect for a novel diagnostic device.
Here's an analysis based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
The provided text does not list specific acceptance criteria or quantitative performance metrics for the NexGen® Prolong™ All-Poly Patella. Instead, it relies on the concept of substantial equivalence to a predicate device.
The "performance" criteria are essentially that the device is "safe and effective and is substantially equivalent to the predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Determined to be safe and effective |
| Substantial Equivalence to Predicate Device (K933785) | Substantially equivalent to the predicate device |
| Intended Use unchanged | Does not change the intended use |
| Fundamental Scientific Technology unchanged | Does not change the fundamental scientific technology |
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 explicitly states: "Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device."
However, no specific sample size for a test set is mentioned, nor is the provenance of any data (e.g., country of origin, retrospective/prospective). The assessment appears to be based on non-clinical performance (design assurance testing) and direct comparison to the predicate device, rather than a clinical trial with a defined patient sample.
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 submission is not based on a study requiring expert-established ground truth for a test set (e.g., interpreting medical images). It's a device modification where substantial equivalence is claimed through non-clinical testing and comparison to an established predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As there's no clinical test set with human interpretation requiring ground truth establishment, no adjudication method was used.
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 total knee prosthesis, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated in terms of "ground truth" for a clinical study. The determination of safety and effectiveness for substantial equivalence was based on:
- Non-Clinical Performance: "Performance testing completed as part of the design assurance process." The "ground truth" here would be engineering specifications, material properties, and biomechanical testing standards met during design assurance.
- Comparison to Predicate Device: The predicate device itself (Zimmer NexGen Knee System, K933785) provides the "ground truth" for established safety and effectiveness.
8. The sample size for the training set
Not applicable. This device is a physical knee prosthesis, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an algorithm was used.
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K072281 lpg1/2)
SEP - 6 2007
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Brandon Hipsher, RACSenior Associate, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | August 15, 2007 |
| Trade Name: | NexGen ® Prolong ™ All-Poly Patella |
| Common Name: | Total Knee Prosthesis |
| Classification Nameand Reference: | Knee joint patellofemorotibial metal/polymer/metalsemiconstrained cemented prosthesis21 CFR § 888.3560 |
| Predicate Device: | NexGen Knee System, manufactured by Zimmer,Inc., K933785, cleared January 30, 1995 |
| Device Description: | The proposed device is part of the NexGen systemof semiconstrained, nonlinked knee prostheses. |
| Intended Use: | This device is indicated for patients with severeknee pain and disability due to:- Rheumatoid arthritis, osteoarthritis,traumatic arthritis, polyarthritis.- Collagen disorders and/or avascular necrosisof the femoral condyle.- Post-traumatic loss of joint configuration,particularly when there is patellofemoralerosion, dysfunction or prior patellectomy.- Moderate valgus, varus, or flexiondeformities.- The salvage of previously failed surgicalattempts or for a knee in which satisfactorystability in flexion cannot be obtained at thetime of surgery.This device is indicated for cemented use only. |
:
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K072281 (pg 212)
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
Except for a change in material, the NexGen Prolong All-Poly Patella is identical to the predicate device. This modification does not change the intended use or fundamental scientific technology.
Non-Clinical Performance and Conclusions:
Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
SEP - 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Mr. Brandon Hipsher, RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw. IN 46581
Re: K072281 Trade/Device Name: NexGen® Prolong™ All-Poly Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer Semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 15, 2007 Received: August 16, 2007
Dear Mr. Hipsher:
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 (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.
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Page 2 -- Mr. Brandon Hipsher, RAC
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbere Buchur
Mark N. Me kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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h072281 lpg 1/1)
Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Prolong™ All-Poly Patella
Indications for Use:
- · This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. l
- Collagen disorders and/or avascular necrosis of the femoral condyle. The ।
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities. -
- The salvage of previously failed surgical attempts or for a knee in which --satisfactory stability in flexion cannot be obtained at the time of surgery.
- · This device is indicated for cemented use only.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
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)
Aubane Buchs
Division Sign-Off
Division of Ge I. Zestorauve. and Neurological Devices
510(k) Number K072281
Page 1 of 1
§ 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.