(57 days)
The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
This device is single-use implant intended for implantation with bone cement.
The ACS® LD Uni FB Knee System is a unicondylar knee replacement system. It is intended for patients with unicompartmental osteoarthritis and intact cruciate and collateral ligaments.
The ACS® LD Uni FB Knee System consists of the following components:
- ACS® Uni LD Femoral Component .
- Uni FB Tibial Component ●
- Uni FB PE-Insert ●
The provided text is a 510(k) summary for a medical device (ACS® LD Uni FB Knee System), which is a knee replacement system. This document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and performance testing, rather than establishing acceptance criteria and proving performance through a clinical study that would be typical for an AI/ML device or a novel diagnostic.
Therefore, the information required to populate the fields about acceptance criteria, study design, expert involvement, and ground truth, as typically found in submissions for AI/ML or diagnostic devices, is not present in this document. The provided text outlines engineering and material performance tests for a physical implant, not a data-driven system.
However, I can extract the information that is present and explain why other requested information is not applicable to this type of device submission.
Here's how to interpret the request in the context of the provided document:
Acceptance Criteria and Device Performance (as applicable to a physical implant):
The document doesn't define specific "acceptance criteria" in the sense of accuracy metrics (e.g., sensitivity, specificity) for a diagnostic device. Instead, "acceptance criteria" are implied by the successful completion of specified engineering and mechanical performance tests, demonstrating that the device performs as intended and is substantially equivalent to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets mechanical and material standards for knee implants, demonstrating substantial equivalence to predicates. | "All recommended testing has been performed for the worst-case configuration of the ACS® LD Uni FB Knee System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended." |
| Satisfies ASTM F1223 (Constraint Testing) | "o Medial-lateral and anterior-posterior displacement, rotary-laxity rotation" (Testing performed, implied satisfactory results) |
| Satisfies ASTM F2083 (Contact Area / Stress) | (Testing performed, implied satisfactory results) |
| Satisfies ASTM F3140-17 (Fatigue Testing Tibia) | (Testing performed, implied satisfactory results) |
| Satisfies ASTM F2083, ASTM F1814 (Interlocking Strength) | "O Anterior-posterior, posterior-anterior, medial-lateral-medial" (Testing performed, implied satisfactory results) |
| Demonstrates acceptable Range of Motion | "o Range of motion evaluation" (Testing performed, implied satisfactory results) |
Notes on the Study (as applicable to a physical implant, not an AI/ML system):
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as "sample size" in terms of patient data. The testing was performed on "test units representative of finished devices." The exact number of physical units tested per standard is not detailed.
- Data Provenance: Not applicable in the sense of patient data. The "data" comes from bench testing of physical implant components.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, not a diagnostic or AI/ML system requiring expert-adjudicated ground truth from medical images or clinical outcomes. Ground truth for mechanical testing is established by engineering standards and measurements.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication of results in the clinical or diagnostic sense. Tests follow standardized procedures (ASTM).
-
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 is a physical implant, not an AI/ML diagnostic or assistive device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering/Mechanical Standards. The "ground truth" is defined by the requirements and performance limits set by the referenced ASTM (American Society for Testing and Materials) standards for knee implants.
-
The sample size for the training set:
- Not Applicable. There is no "training set" for a physical implant. The design and manufacturing processes are developed based on engineering principles and material science, not machine learning training data.
-
How the ground truth for the training set was established:
- Not Applicable. (See point 7)
Summary regarding the provided document:
This document describes a 510(k) submission for a physical medical device (a knee implant). The FDA's review for such devices primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This involves:
- Similar intended use.
- Similar technological characteristics (materials, design).
- Performance testing (bench testing, not clinical trials or AI/ML evaluations) to demonstrate the device performs as intended and meets relevant engineering standards.
The questions provided in the prompt are highly tailored to the evaluation of AI/ML-based medical devices or diagnostic devices that rely on interpreting clinical data, images, or signals. Since the provided text pertains to a mechanical orthopedic implant, most of these questions are not relevant or applicable to its regulatory clearance process as demonstrated in this 510(k) summary.
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January 8, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Implantcast GmbH % Dave McGurl Director, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K203341
Trade/Device Name: ACS® LD Uni FB 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: November 12, 2020 Received: November 12, 2020
Dear Dave McGurl:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203341
Device Name ACS® LD Uni FB Knee System
Indications for Use (Describe)
The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
This device is single-use implant intended for implantation with bone cement.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 510(K) SUMMARY
| Device Trade Name: | ACS® LD Uni FB Knee System |
|---|---|
| Manufacturer: | implantcast, GmbHLüneburger Schanze 262164 Buxtehude, Germany |
| Contact: | Ms. Juliane HöppnerHead of Regulatory AffairsPhone: +49 4161 744 135Email: jhoppener@mcra.com |
| Prepared by: | Mr. Dave McGurlDirector, Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20005Phone: 202.552.5800dmcgurl@mcra.com |
| Date Prepared: | August 24, 2020 |
| Classification: | 21 CFR §888.3520, Knee joint femorotibial metal/polymer non-constrained cemented prosthesis |
| Class: | II |
| Product Code: | HSX |
| Predicate Devices: | Biomet Repicci II® Unicondylar Knee (K063515)Bodycad Unicompartmental Knee System (K163700, K181302)Medacta GMK® UNI (K161741)Zimmer Unicompartmental Knee System (K033363) |
Indications for Use:
The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
This device is single-use implant intended for implantation with bone cement.
Device Description:
The ACS® LD Uni FB Knee System is a unicondylar knee replacement system. It is intended for patients with unicompartmental osteoarthritis and intact cruciate and collateral ligaments.
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The ACS® LD Uni FB Knee System consists of the following components:
- ACS® Uni LD Femoral Component .
- Uni FB Tibial Component ●
- Uni FB PE-Insert ●
Substantial Equivalence:
The ACS® LD Uni FB Knee System is substantially equivalent to the predicate devices cited with respect to intended use, design, and materials.
Performance Testing:
All recommended testing has been performed for the worst-case configuration of the ACS® LD Uni FB Knee System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the ACS® LD Uni FB Knee System was characterized through the following tests:
- Constraint Testing (ASTM F1223)
- o Medial-lateral and anterior-posterior displacement, rotary-laxity rotation
- Contact Area / Stress (ASTM F2083)
- Fatigue Testing Tibia (ASTM F3140-17) ●
- o Interlocking Strength (ASTM F2083, ASTM F1814)
- O Anterior-posterior, posterior-anterior, medial-lateral-medial
- o Range of motion evaluation
Conclusion:
The ACS® LD Uni FB Knee System possesses the same intended use and technological characteristics as the predicate devices. Therefore, the ACS® LD Uni FB Knee System is substantially equivalent for its intended use.
§ 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.