(88 days)
The Orthogenesis LPS is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- 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 of the proximal and/or distal femur;
- patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
- revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.
The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.
The Orthogenesis LPS Proximal Tibial Replacement system is designed to be implanted for the The Orthogenesis Er of Proximal Troul'se primary knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). It consists of a titanium tibial replacement, a polyethylene tibial bearing component, Orthogenesis LPS stems and Segments.
The provided text is a 510(k) summary for a medical device called the Orthogenesis LPS Proximal Tibial Replacement. This document is a premarket notification to the FDA, demonstrating that the device is substantially equivalent to a legally marketed predicate device.
Crucially, a 510(k) summary does not typically include detailed studies proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or a PMA submission. The focus of a 510(k) is to establish substantial equivalence to a predicate device, often relying on design comparisons, material testing, and conformance to voluntary performance standards, rather than direct human clinical outcome studies for acceptance criteria performance.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not present in this 510(k) summary.
Here's a breakdown of what can be extracted and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Implied by Substantial Equivalence and Testing) |
|---|---|
| Material Biocompatibility: Materials used (titanium, polyethylene) are known to be biocompatible and are used in predicate devices. | Device uses titanium and polyethylene, consistent with predicate devices and established medical device standards. |
| Mechanical Strength/Durability: Device components should withstand physiological loads for intended use. | Substantial equivalence is based on "product testing and conformance with voluntary performance standards" (para. E). Specific tests and criteria are not detailed in this summary. |
| Sterilization Efficacy: Device can be effectively sterilized. | "Sterilization" is listed as a basis for substantial equivalence (para. E). Specific methods and validation are not detailed. |
| Packaging Integrity: Device packaging maintains sterility and integrity. | "Packaging" is listed as a basis for substantial equivalence (para. E). Specific methods and validation are not detailed. |
| Clinical Performance: Device should perform as intended to replace portions of the tibia in specific indications (e.g., metastatic disease, severe arthropathy). | Substantially equivalent to predicate devices (S-ROM Noiles Rotating Hinge Knee, K896048 and K905810; Orthogenesis LPS system) for "use, design, materials, sterilization and packaging" (para. E). No clinical performance metrics (e.g., success rates, complication rates) are provided as acceptance criteria to be met by a specific study. |
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 / Not Provided. This 510(k) summary does not describe a clinical test set in the sense of a patient cohort or data set used to evaluate the device's performance against clinical acceptance criteria. The "product testing" mentioned likely refers to bench testing of materials and mechanical properties, not human clinical data.
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 / Not Provided. Ground truth for a clinical test set is not specified because a clinical test set is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No adjudication method is described as a clinical test set is not detailed.
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
- No. This device is a prosthetic implant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a prosthetic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. As no clinical test set is described, no specific type of ground truth is mentioned. The "ground truth" for a 510(k) in this context is primarily the established safety and effectiveness of the predicate device, which the new device aims to be substantially equivalent to, based on non-clinical data.
8. The sample size for the training set
- Not Applicable / Not Provided. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As no training set is relevant, no ground truth establishment for it is described.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) framework):
The "study" in this context is the Substantial Equivalence Determination process outlined in the 510(k) submission.
- Basis of Equivalence: The manufacturer, DePuy, Inc., asserts that the Orthogenesis LPS Proximal Tibial Replacement is substantially equivalent to the S-ROM Noiles Rotating Hinge Knee (K896048 and K905810) and the Orthogenesis LPS system.
- Evidence for Equivalence: This determination was based on:
- A detailed device description: Comparing the new device's features to the predicate.
- Product testing: Likely referring to bench testing for mechanical properties, material compatibility, and other engineering specifications, demonstrating that the device meets relevant performance standards (though specific results or criteria are not detailed in this summary).
- Conformance with voluntary performance standards: Implies that the device has been tested against recognized industry standards applicable to knee prostheses.
- Comparison of Indications for Use, design, materials, sterilization, and packaging to the predicate devices.
Conclusion: The FDA's issuance of a letter stating substantial equivalence (K011810) on SEP - 7 2001, effectively serves as the "proof" within the 510(k) regulatory pathway that the device meets the necessary criteria (which are primarily about being as safe and effective as a legally marketed predicate device). This approval does not typically involve the presentation of new clinical data from human studies unless there's a significant difference from the predicate device that raises new safety or effectiveness questions.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.