(77 days)
The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the following cemented systems: the Vanguard™, Ascent™, and Maxim® knee systems, as well as the Biomet® Tibial Augmentation Components, Stemmed Tibial Components, Offset Tibial Trays and Offset Tibial Tray Adaptors. The Regenerex™ Porous Titanium Sleeve Augments are indicated for use with following uncemented system: the Vanguard™ Non-Cemented Porous Coated Knee Components.
Specific indications are as follows:
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
These are single use implants. Cemented and uncemented applications.
The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the OSS™ system.
Specific indications are as follows:
- Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Ligament deficiencies.
- Tumor resection.
- Trauma.
These are single use implants. Cemented applications only.
The Regenerex™ Porous Titanium Sleeve Augments are truncated cones with a centrally located bore that are composed of titanium alloy (Ti-6Al-4V) per ASTM F1580-95 that is approximately 67% porous. The augments are designed for attachment to selected commercially available Biomet® tibial base plates and stemmed femoral components using cement. The devices are intended for fixation into either the proximal tibia or distal femur in cases of severe bone loss.
The provided text is a 510(k) summary for the Regenerex™ Porous Titanium Sleeve Augments, a medical device. This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a predicate device already legally marketed.
Therefore, this document does not describe the acceptance criteria and a study that proves the device meets those acceptance criteria in the way you've requested for a typical AI or diagnostic device. Instead, it focuses on demonstrating substantial equivalence to existing, legally marketed devices.
Here's an explanation based on the provided text, addressing your points where possible, and noting where the information is not present due to the nature of a 510(k) submission for a non-diagnostic implant:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document because this is not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy.
The closest analogue is the claim of "substantial equivalence" to predicate devices. The document states:
| Criterion | Reported Device Performance |
|---|---|
| Technological Characteristics | "The technological characteristics (material modification, design, sizing, indications) of the Regenerex™ Porous Titanium Sleeve Augments are similar to or identical to the predicate devices." |
| Intended Use | "The results indicated that the device was functional within its intended use." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable/not provided. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."
Non-clinical testing involved "previous non-clinical laboratory testing and engineering justification," but specific sample sizes or data provenance for these tests are not detailed in this summary.
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):
This information is not applicable/not provided. There was no clinical testing performed as a basis for substantial equivalence, and the device is an implant, not a diagnostic tool requiring expert ground truth for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not provided for the reasons stated above.
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:
This information is not applicable/not provided. This device is a passive surgical implant, not an AI-powered diagnostic tool, and therefore no MRMC study, AI assistance, or human reader improvement is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. This device is a passive surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/not provided. As explained, no clinical studies were performed, and the evaluation was based on non-clinical laboratory testing and engineering justification to demonstrate similarity to predicate devices, not on ground truth for diagnostic accuracy.
8. The sample size for the training set:
This information is not applicable/not provided. This device is a passive surgical implant and does not involve AI or a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
This information is not applicable/not provided for the reasons stated above.
Summary regarding the device:
The Regenerex™ Porous Titanium Sleeve Augments are femoral and tibial knee augments made of titanium alloy. They are designed as single-use implants for fixation into the proximal tibia or distal femur in cases of severe bone loss, intended for use with specific cemented and uncemented knee systems.
The basis for market clearance (510(k)) is substantial equivalence to existing predicate devices (Regenerex™ Knee Augments and Trabecular Metal™ Tibial and Femoral Cone Augments). Regulatory clearance was granted based on non-clinical laboratory testing and engineering justification demonstrating that the device and its intended use are functional and similar to the predicate devices. No clinical testing was performed or submitted as a basis for substantial equivalence.
§ 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.