(87 days)
The LPS Intercalary component is intended for use in primary and revision knee joint replacement and in oncology cases with the Limb Preservation System (LPS). The previously cleared indications for use for this system are the following:
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., osteosarcoma, chondrosarcoma, 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, tibial stems, metaphyseal sleeves, and the non-porous coated straight and bowed stems are intended for cemented use only.
The intercalary component serves as a segmental component in the previously cleared Limb Preservation System (LPS, K003182). The dovetail intercalary component is a 3piece assembly 55 mm in length. The three pieces are comprised of a male segment, a female segment and a connecting pin. The male-female parts connect as a dovetail connection and locked with a pin screwed through both segments. The dovetail intercalary component is made of cobalt chrome.
The provided text is a 510(k) summary for a medical device called the "LPS Lower Extremity Dovetail Intercalary." This document is a regulatory submission to the FDA, primarily focused on establishing substantial equivalence to a previously cleared device. It does not describe a clinical study or performance testing with specific acceptance criteria that demonstrate the device meets those criteria.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance studies cannot be extracted from this document, as they are not present.
The 510(k) summary explicitly states: "The substantial equivalence of the LPS Dovetail Intercalary is substantiated by its similarity in sterilization, packaging and indications for use to the LPS (K003182 cleared on June 27, 2001). The design and materials of the LPS Dovetail Intercalary have been modified from the existing LPS Intercalary component cleared in K003182, however DePuy believes this new component is substantially equivalent."
This indicates that the primary "study" or evidence for this device is a comparison to a predicate device (K003182) to demonstrate substantial equivalence, rather than a de novo clinical study with new performance criteria.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not describe specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, mechanical strength thresholds) for the device itself, nor does it report device performance against such criteria. The focus is on substantial equivalence to a predicate device rather than de novo performance testing against new metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or data provenance from a performance study is described.
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)
- Cannot be provided. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set requiring adjudication is described.
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
- Cannot be provided. This device is a total knee prosthesis component, not an AI or imaging device, so an MRMC study is not relevant and not discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This device is a physical implant, not an algorithm. Standalone performance for an algorithm is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. As no specific performance study is detailed, no ground truth type is mentioned.
8. The sample size for the training set
- Cannot be provided. This device is a physical implant, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable (see point 8).
§ 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.