(80 days)
The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- Correction of functional deformities;
- Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
These components are single use only and are intended for implantation with bone cement.
The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert.
Here's a breakdown of the acceptance criteria and the study details for the ACCIN UNI-Knee System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: The ACCIN UNI-Knee System must demonstrate equivalence to legally marketed predicate devices in terms of safety and effectiveness. | "Testing has shown that the proposed device is equivalent to the predicate device." Specifically, the submission states: "The results provided in the testing section of this submission demonstrate that the proposed ACCIN UNI-Knee System is equivalent to the predicate device Stelkast Unicondylar Knee System." |
| Compliance with Guidance Document: The tests performed must align with the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." | "Tests were performed on the ACCIN UNI-Knee System as compared to the Stelkast Unicondylar Knee System. The tests performed can be found in the guidance document entitled 'Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.'" |
| Intended Use Compatibility: The device must be suitable for use in unicompartmental knee arthroplasty for specified conditions. | The stated indications for use align with the intended purpose of the device for unicompartmental knee arthroplasty in cases of osteoarthritis, post-traumatic arthritis, functional deformities, revision surgeries, and as an alternative to tibial osteotomy. |
| Material Equivalence: The device's materials should be comparable to those of predicate devices. | The ACCIN system uses "Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert," which is compared to the Stelkast, EUIS, and Zimmer systems, noting that "The Zimmer product and the proposed ACCIN device have a metal tibial tray and a UHMWPE tibial insert; whereas the EUIS system and the Stelkast system have an all-polyethylene tibia." This implies that the materials chosen are acceptable within the context of predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the sample size used for the comparative testing between the ACCIN UNI-Knee System and the Stelkast Unicondylar Knee System.
Furthermore, the data provenance (e.g., country of origin, retrospective or prospective) is not mentioned in the provided text. The testing appears to be primarily in vitro or mechanical rather than human clinical data based on the nature of the device and the guidance document referenced.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided in the document. The study described is a comparison of a medical device (a knee prosthesis) to a predicate device, focusing on mechanical and material equivalence rather than interpretation of medical images or diagnoses requiring expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. As noted above, the study is not clinical in nature requiring adjudication of medical findings.
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
An MRMC study was not performed. This type of study is relevant for AI-assisted diagnostic devices and is not pertinent to the mechanical and material equivalence testing of a knee prosthesis.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study as typically understood for AI algorithms was not performed. The device is a physical knee prosthesis, not an algorithm. The testing described is intrinsic to the device itself (e.g., mechanical properties) in comparison to another physical device.
7. The Type of Ground Truth Used
The "ground truth" for this study is established by engineering and mechanical testing standards and the performance characteristics of the predicate device (Stelkast Unicondylar Knee System). The reference to the "Class II Special Controls Guidance Document" indicates that the tests performed and the criteria for success are based on established regulatory guidance for such devices. Therefore, the ground truth is derived from device performance specifications and comparison to a legally marketed equivalent.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided in the document. The study is not an AI/machine learning study that would involve a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided in the document, as there is no training set for this type of device submission.
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Summary of Safety and Effectiveness
| Submitter: | Michael KvitnitskyACCIN Corporation1033 US Highway 46, Suite A204Clifton, NJ 07103 |
|---|---|
| Date Prepared: | February 18, 2006 |
| Device: | ACCIN UNI-Knee System |
| Classification: | 87 HSX - Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, MetalPolymer, 21 CFR 888.3520, Class II |
| Predicate Device: | EIUS Unicompartmental Knee System - K033769 and K992287Stelkast Unicondylar Knee System - K0032824Zimmer Unicompartmental Knee System - K033363 |
| Device Description: | The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component andtibial tray and a polyethylene tibial insert. |
| Intended Use: | The ACCIN UNI-Knee System components are for use in Unicompartmental kneearthroplasty as a result of:Moderately disabling joint disease of the knee resulting from painful osteoarthritisor post traumatic arthritis; Correction of functional deformities; Revision of previous unsuccessful unicompartmental knee replacement or otherprocedure; As an alternative to tibial osteotomy in patients with unicompartmentalosteoarthritis. JUN - 2 2006 |
These components are single use only and are intended for implantation with bone cement.
Comparison to Predicates:
The ACCIN UNI-Knee system consists of cobalt chrome femoral and tibial components and a polyethylene insert. The device is similar to the Stelkast Unicondylar Knee System, the EUIS Unicompartmental Kryle system and the Zimmer High Flex Unicompartmental Knee System. All three devices are for use in unicompartmental knee replacement. The Zimmer product and the proposed ACCIN device have a metal tibial tray and a UHMWPE tibial insert; whereas the EUIS system and the Stelkast system have an all-polyethylene tibia.
ACCIN Corporation has determined that the minor differences in the proposed device will not impact the safety or effectiveness of the unicompartmental knee system for its intended use. Testing has shown that the proposed device is equivalent to the predicate device.
Synopsis of Test Methods and Results:
Tests were performed on the ACCIN UNI-Knee System as compared to the Stelkast Unicondylar Knee System. The tests performed can be found in the guidance document entitled "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial MetalPolymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The results provided in the testing section of this submission demonstrate that the proposed ACCIN UNI-Knee System is equivalent to the predicate device Stelkast Unicondylar Knee System.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2006
ACCIN Corporation % Mr. Michael Kvitnitsky 1033 US Highway 46 East Suite A204 Clifton, New Jersey 07013
Re: K060670
Trade/Device Name: ACCIN UNI-Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: March 06, 2006 Received: March 14, 2006
Dear Mr. Kvitnitsky:
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.
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
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Page 2 – Mr. Michael Kvitnitsky
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 Office of Compliance at (240)-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Hubert Lerner
for
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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Page 5 -- Mr. Michael Kvitnitsky
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OC Numbers:
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| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
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Indications for Use Form
510(k) Number (if known):_
Device Name: ACCIN UNI-Knee System
Indications for Use:
Indications for Use:
The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post . traumatic arthritis;
- Correction of functional deformities; .
- Revision of previous unsuccessful unicompartmental knee replacement or other . procedure:
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. .
These components are single use only and are intended for implantation with bone cement.
Prescription Use _ × (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
Herbert Lerner
Division of General, Restorative, and Neurological Devices
510(k) Number K060670
Page 2 of
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.