(367 days)
The EAUM Total Knee System is intended for use in total knee arthroplasty surgery for the following indications: Painful. disabling joint disease of the knee resulting from noninflammatory degenerative ioint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid 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; Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The EAUM Total Knee System is intended for cemented use only.
The EAUM Total Knee System is a patellofemoroltibial knee prosthesis system for cemented total knee arthroplasty. The EAUM Total Knee System consists of the following components: Femoral Components - eight (8) sizes in cruciate-retained (CR) and posterior stabilized (PS) designs, each for left and right sides; Tibial Baseplate (Tray) - nine (9) sizes for use on either the left or right side; Tibial Insert Components - nine (9) sizes for use on either the left or right side, with thicknesses ranging from 6 mm to 24 mm, provided in CR and PS designs; Patellar Components - five (5) sizes in two designs (dome and sombrero); and EAUM Total Knee Instrumentation for use with the system implant components. The components are manufactured from C-Cr-Mo alloy conforming to ASTM F75, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) and UHMWPE conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, Type 1 (GUR 1020). The components are sterilized by gamma irradiation.
The provided document is a 510(k) summary for the EAUM Total Knee System, a medical device for total knee arthroplasty. It does not contain information on acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of an AI/ML algorithm or diagnostic tool. Instead, it demonstrates substantial equivalence to predicate devices through design comparisons, material comparisons, and performance testing against established international standards for orthopedic implants.
Here's an analysis based on the information provided, recognizing that the request's format is geared towards AI/ML device descriptions, which this document is not:
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML algorithm. Instead, for this orthopedic implant, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to relevant international performance standards.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance (as stated in document) |
|---|---|
| Intended Use: Similar to predicate devices | Aligned with indications for total knee arthroplasty (osteoarthritis, rheumatoid arthritis, post-traumatic loss, deformity, revision of failed procedures). |
| Operating Principles: Same as predicate devices | EAUM Total Knee System uses the same operating principles as predicate devices. |
| Basic Designs: Similar to predicate devices | Components are similar in overall shape and design (femoral, tibial baseplate, tibial insert, patellar components). Includes CR and PS designs. |
| Materials: Same or very similar to predicate devices | Co-Cr-Mo alloy (ASTM F75) for femoral and tibial baseplate components. UHMWPE (ASTM F648, GUR 1020) for tibial insert and patellar components. |
| Packaging & Sterilization: Similar to predicate devices | Similar packaging and sterilized by gamma irradiation. |
| Performance Testing: Conformance to relevant standards (ISO 7207-2, ASTM F2083, ISO 7207-1, ISO 21536, ISO 14879-1, ASTM F1800, ASTM F1223, ASTM F1814, ISO 14243-1) | "Performance testing was conducted to demonstrate substantial equivalence and included methods described in the following standards: ISO 7207-2. ASTM F2083. ISO 7207-1. ISO 21536. ISO 14879-1, ASTM F1800, ASTM F1223, ASTM F1814, and ISO 14243-1." (No specific numerical results are provided in the summary, just that tests were conducted and support substantial equivalence). |
| No New Issues of Safety or Efficacy: Differences in technological characteristics do not raise new issues. | "Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as this is a medical device (implant) submission, not an AI/ML algorithm or diagnostic tool that uses patient data in a "test set" in this manner. The "test" mentioned relates to physical and mechanical testing of the implant.
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 information is not relevant to an orthopedic implant submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For an orthopedic implant like the EAUM Total Knee System, the "ground truth" for demonstrating safety and effectiveness is primarily established through:
- Established engineering and biological principles: Conformance to internationally recognized standards (e.g., ISO, ASTM) for materials, design, and mechanical performance.
- Clinical history of predicate devices: The long-term performance and safety record of the substantially equivalent predicate devices inform the acceptability of the new device.
- Material properties: Established safety and biocompatibility of the materials used (Co-Cr-Mo alloy, UHMWPE).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes a submission seeking substantial equivalence to legally marketed predicate devices. The study to "prove the device meets acceptance criteria" is primarily an engineering and comparative analysis, rather than a clinical trial with patient outcomes or an AI model validation.
The key components of this "study" are:
- Design Comparison: Detailed comparison of the EAUM Total Knee System's femoral components, tibial baseplate, tibial insert, and patellar components to those of the predicate devices (DePuy Sigma Knee Femoral Adapter, Triathlon Total Knee System, Scorpio® NRG™ Knee System Components). This comparison covered overall shape, design features (e.g., CR/PS designs, stabilizing keel), and physical dimensions (AP/ML, thickness).
- Material Comparison: Verification that the materials used (Co-Cr-Mo alloy, UHMWPE) conform to established ASTM standards (ASTM F75, ASTM F648) and are the "same or very similar" to those in predicate devices.
- Performance Testing: Physical and mechanical testing was conducted on the device to demonstrate substantial equivalence. The summary states these tests "included methods described in the following standards: ISO 7207-2, ASTM F2083, ISO 7207-1, ISO 21536, ISO 14879-1, ASTM F1800, ASTM F1223, ASTM F1814, and ISO 14243-1." While specific results are not detailed in this summary, the completion of these tests according to recognized standards is key to demonstrating performance characteristics suitable for the intended use.
- Intended Use Comparison: Confirmation that the indications for use are the same as or very similar to the predicate devices.
The conclusion drawn from this combination of comparative analysis and performance testing against recognized standards is that "Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy," thereby establishing substantial equivalence and implicitly meeting the "acceptance criteria" for market clearance.
§ 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.