(68 days)
Indications for Use:
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
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- Correction of varus, valgus, or post traumatic deformity.
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- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Ligament deficiencies. 4.
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- Tumor resections.
- Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with 6. head involvement, unmanageable using other techniques.
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- Revision of previously failed total joint arthroplasty.
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- Trauma.
The RS OSS Additional Components are intended for cemented use only.
- Trauma.
The RS OSS Additional Components are a series of components including distal femoral resurfacing components in 3cm resection lengths and distal femoral segmental components with either modular or elliptical bone interface surfaces in 7cm and 8.5cm resection lengths. The tibial tray components are non-modular in design with either short stems. The Proximal Tibial Sleeves have a modular design that utilizes either the short or long stem tibial travs to provide 3cm. 7cm or 9cm of resection height. The resection tibial tray provides a non-modular 9cm resection height. The tibial augments are either 10mm or 20mm augment sizes. The 20mm augments are side specific. The 15° tibial bearings have been included and the extension bumper design has been modified. These components are intended to expand the available options for the Reduced Size Orthopedic Salvage System.
The provided document is a 510(k) summary for the RS (Reduced Size) OSS (Orthopedic Salvage System) Additional Components. This document describes a medical device, specifically components for a joint replacement system (hip, knee, tibia, or total femur), and aims to demonstrate its substantial equivalence to previously marketed predicate devices.
Here's an analysis of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence to Predicate Devices (Implicit: The new components should perform mechanically similar to the predicate devices and meet established standards.) | "Mechanical testing and engineering justification demonstrate that the RS OSS Additional Components are substantially equivalent to the predicate components." |
| Material Equivalence to Predicate Devices (Implicit: Materials should be the same as or equivalent to predicate devices.) | "The RS OSS Additional Components are made from the same materials conforming to the same standards..." |
| Manufacturing, Packaging, and Sterilization Process Equivalence to Predicate Devices (Implicit: Processes should be the same as or equivalent to predicate devices.) | "...and utilize the same manufacturing, packaging and sterilization processes as the predicate devices." |
Explanation: The acceptance criteria for this type of 510(k) submission (a modification or expansion of an existing system) are largely based on demonstrating substantial equivalence to existing legally marketed predicate devices. This means showing that the new components perform at least as well as, and are as safe and effective as, the predicates. The "reported device performance" directly addresses this by stating that mechanical testing and engineering justification confirmed equivalence in critical areas.
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence to the predicate devices."
Therefore:
- Sample size for the test set: Not applicable, as no clinical testing was performed.
- Data provenance: Not applicable. The "testing" referred to is non-clinical (mechanical and engineering).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, no clinical testing, and therefore no "ground truth" established by experts in a clinical study context, was deemed necessary for this 510(k) submission. The equivalence was established through non-clinical means.
4. Adjudication method for the test set
Not applicable, as no clinical testing with a test set requiring adjudication was performed.
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 device is an orthopedic implant system, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an orthopedic implant system, not an algorithm, and does not involve AI or human-in-the-loop performance in that context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense of clinical ground truth. The "ground truth" for this device's acceptance is found in its demonstrated substantial equivalence to predicate devices through:
- Conformity to the same standards for materials.
- Utilization of the same manufacturing, packaging, and sterilization processes.
- Mechanical testing and engineering justification demonstrating equivalent performance.
This implicitly refers to established engineering and material science principles, and performance characteristics derived from testing against industry standards, rather than clinical outcomes or pathology.
8. The sample size for the training set
Not applicable. There is no "training set" mentioned or implied, as this is a physical medical device submission, not an AI/machine learning application.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.