(192 days)
The LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:
- malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
- revision cases for a failed previous prosthesis requiring extensive resection and replacement;
- severe trauma requiring extensive resection and replacement.
The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The distal femoral component, the tibial components, and the non-porous coated straight and bowed stems are intended for cemented use only.
The LPS components are designed for the replacement of the mid-shaft portion of the femur. proximal, distal and/or total femur, and proximal tibia. Unlike primary hip and knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). A total femoral replacement is possible in those cases where no part of the femur can be salvaged.
The provided text is a 510(k) Summary for a medical device called LPS (Total Knee Prosthesis/Femoral Stem Prosthesis). This document details the device's intended use, description, and its claim of substantial equivalence to previously cleared devices.
Crucially, this document is a 510(k) Summary for a device (a prosthetic implant), not an AI/ML-driven medical device or software product that would typically involve acceptance criteria and a study proving its performance in the manner requested.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this type of medical device submission.
Here's an explanation based on the provided text, highlighting what is and isn't available:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable in the traditional sense for an AI/ML device. This document is for a physical orthopedic implant. Acceptance criteria for such devices typically revolve around mechanical testing, biocompatibility, sterilization validation, and conforming to relevant material standards. These are usually established through compliance with voluntary performance standards (as mentioned in section E) and internal company specifications, rather than clinical performance metrics like sensitivity, specificity, or AUC as seen in AI/ML products.
- Reported Device Performance: The document states that the substantial equivalence is based on:
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The equivalence claim is based on comparison to existing, already-approved devices, along with what would typically be non-clinical performance data (e.g., mechanical tests) which are not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is not a study requiring expert-established ground truth for an algorithm.
4. Adjudication Method 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 for a prosthetic implant, not an AI-assisted diagnostic tool.
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
- Not Applicable in the context of AI/ML. For a physical implant, "ground truth" might refer to established engineering principles, material science data, and clinical outcomes data from similar predicate devices, which are implicitly part of the substantial equivalence determination.
8. The sample size for the training set
- Not Applicable. There is no "training set" for a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable.
Summary of what can be gleaned from the document regarding "acceptance" for this specific device:
The "acceptance" in this context refers to the FDA's determination of substantial equivalence to legally marketed predicate devices. The "study" that proves this involves demonstrating:
- Design Similarity: The LPS is similar in design to the previously cleared LPS (K003182).
- Material Equivalence: The specified material (cobalt chrome) is similar to materials used in the S-ROM Noiles Rotating Hinge Knee (K870730).
- Indications for Use Alignment: The indications for use are similar to the Howmedica Global Modular Replacement System (GMRS) (K023087).
- Conformance with Standards: The determination was also based on "conformance with voluntary performance standards," which would involve non-clinical testing (e.g., mechanical strength, fatigue, wear) to ensure the device performs as expected for its intended use and materials. Specific criteria for these tests are not provided in this summary but would be part of the full 510(k) submission.
In essence, the "study" for this type of device is a comprehensive technical and comparative analysis against established benchmarks and predicate devices, rather than a clinical trial or algorithm performance evaluation.
§ 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.