(179 days)
The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of:
• Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
• Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
• Ligamentous instability requiring implant bearing surfaces with increased constraint;
• Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.
The Accin™ total knee system consists of a series of cobalt chrome femoral components, a series of cobalt chrome tibial tray components and a series of UHMWPE modular tibial bearing components.
The provided text describes a 510(k) premarket notification for the "Accin™ total knee system," a medical device, and its comparison to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as AI improvement effect size, standalone algorithm performance, training set details, ground truth establishment for training set, and AI/ML acceptance criteria) are not applicable.
However, I can provide information based on the available text regarding the testing and comparison of the Accin™ total knee system to its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific quantitative targets and the device's reported performance against those targets. Instead, it states that the device "meets the requirements of the current FDA Guidance documents on total knee arthroplasty product" and passed a series of tests. The "acceptance criteria" here implicitly refer to the requirements outlined in the FDA guidance documents and ASTM standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Requirements of FDA Guidance documents on total knee arthroplasty devices | "Testing has shown that the Accin™ total knee system meets the requirements of the current FDA Guidance documents on total knee arthroplasty product." |
| ASTM Standard F1800 | Tests were performed according to this standard. |
| ASTM Standard F2083 | Tests were performed according to this standard. |
| ASTM Standard F1223 | Tests were performed according to this standard. |
| Safety and Effectiveness | "Analysis has shown that the proposed device is equivalent to the predicate devices" in terms of safety and effectiveness, and "the minor differences in the proposed device will not impact the safety or effectiveness of the total knee system for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "numerous tests were performed on the Accin™ total knee system" but does not specify the sample size (number of devices or components tested) for these tests.
The data provenance is not explicitly stated in terms of country of origin or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, the "tests" likely refer to mechanical and material property testing in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the submission pertains to a physical medical device (a knee implant) and its mechanical/material performance, not an AI/ML algorithm that requires expert-established ground truth from data for diagnostic or prognostic purposes.
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as point 3. Testing for medical device equivalence typically involves engineering and materials science analyses, not expert adjudication of clinical cases.
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 question is not applicable as the submission is for a physical medical device, not an AI/ML powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the submission is for a physical medical device, not an AI/ML powered device.
7. The Type of Ground Truth Used
The "ground truth" for this medical device comes from established engineering and material science principles, FDA guidance documents, and ASTM standards for testing the mechanical properties, wear resistance, and biocompatibility of total knee arthroplasty devices. The equivalence is established by demonstrating that the new device meets these recognized standards and performs comparably to the predicate devices.
8. The Sample Size for the Training Set
This question is not applicable as the submission is for a physical medical device, not an AI/ML powered device. There is no "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters and symbols. The text includes 'K081127' followed by a number sign '#' and then '1/2'. The handwriting is somewhat cursive and the characters are clearly distinguishable.
OCT 1 7 2008
Summary of Safety and Effectiveness
| Submitter: | Michael KvitnitskyAccelerated Innovation, LLC1033 US Highway 46, Suite A204Clifton, NJ 07103 |
|---|---|
| Date Prepared: | April 18, 2008 |
| Device: | Accin™ total knee system |
| Classification: | 87 JWH - Prosthesis, Knee, Patellofemoraltibial, Semi-Constrained, Cemented,Polymer/Metal/Polymer - Class II (21 CFR 888.3560) |
| Predicate Device: | • Osteonics® Scorpio Posteriorly Stabilized Total Knee System (K962152)• Osteonics® Scorpio Posterior Cruciate Retaining Total Knee System (K974556)• Zimmer NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS);LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581) |
| Device Description: | The Accin™ total knee system consists of a series of cobalt chrome femoralcomponents, a series of cobalt chrome tibial tray components and a series ofUHMWPE modular tibial bearing components. |
| Intended Use: | The ACCIN Total Knee System components are for use in total knee arthroplastyas a result of:• Painful, disabling joint disease of the knee resulting from degenerativearthritis, rheumatoid arthritis or post-traumatic arthritis;• Post-traumatic loss of knee joint configuration and function• Moderate varus, valgus, or flexion deformity in which the ligamentousstructures can be returned to adequate function and stability;• Revisions of previous unsuccessful knee replacement or other procedure.Additional indications for posteriorly stabilized components:• Ligamentous instability requiring implant bearing surfaces with increasedconstraint;• Absent or non-functioning posterior cruciate ligament.These devices are single use only and are intended for implantation with bone |
Comparison to Predicates:
The Accin™ total knee system consists of a series of cobalt chrome femoral components, a series of cobalt chrome tibial tray components and a series of UHMWPE modular tibial bearing components. The system is similar to the Osteonics Scorpio® Posteriorly Stabilized Total Knee System, the Osteonics Scorpio® Posterior Cruciate Retaining Total Knee System and the Zimmer LPS-Flex Fixed Bearing Femoral and Articular Surface Components. The trochlear region of the femoral component is designed to articulate with the Accin™ patellar component, previously approved under K073120. The predicate systems and the proposed system are both for use in total knee replacement surgery. Both the predicate systems and the proposed system have femoral components made from cobalt chrome and modular tibial bearing components made from UHMWPE. Both the predicate Scorpio Total Knee System and the proposed system have cobalt chrome tibial tray components.
. ...
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K081122 #2/2
Accelerated Innovation, LLC has determined that the minor differences in the proposed device will not impact the safety or effectiveness of the total knee system for its intended use. Analysis has shown that the proposed device is equivalent to the predicate devices.
Synopsis of Test Methods and Results:
Numerous tests were performed on the Accin™ total knee system. The tests performed can be found in the FDA guidance documents on total knee arthroplasty devices and ASTM Standards F1800, F2083 and F1223. Testing has shown that the Accin™ total knee system meets the requirements of the current FDA Guidance documents on total knee arthroplasty product.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
OCT 1 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardo Medical Corporation % Mr. Michael Kvitnitsky 1033 US Highway 46 East, Suite A204 Clifton, New Jersey 07103
Re: K081127 Trade/Device Name: ACCIN Total Knce System Regulation Number: 21 CFR 888.3560 Regulation Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Regulatory Class: Class II Product Code: JWH Dated: October 09, 2008 Received: October 10, 2008
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.
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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 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.
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 Form | |
|---|---|
| 510(k) Number (if known): | K081127 |
|---|---|
| --------------------------- | --------- |
Device Name: __Accin™ total knee system
Indications for Use:
The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid . arthritis or post-traumatic arthritis;
- Post-traumatic loss of knee joint configuration and function .
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability;
- . Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
- Ligamentous instability requiring implant bearing surfaces with increased constraint; .
- Absent or non-functioning posterior cruciate ligament. .
These devices 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)
Restorative. and Neurologica
Page 1 of 1
Number K681127
§ 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.