(241 days)
Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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. Cemented and uncemented applications. The Regenerex™ femoral augments are indicated for use with the Vanguard™ Total Knee System. The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
Painful and disabled 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. Revision of previously failed total joint arthroplasty. Trauma. These are single use implants. These devices are for cemented use only.
The Regenerex™ Ultra Porous Construct- Titanium Knee Augments are designed for attachment to selected commercially available Biomet® tibial base plates and femoral components using bolts, cement or a combination of both (depending on the augment). The augments are manufactured to interface with selected femoral and tibial Biomet® components. The femoral augments come in nine (9) different sizes that correspond with the sizes of the femoral components. The thickness options for the femoral augments vary from 5mm to 15mm. The tibial augments are available in 10° wedge and block form. The block augments are available in three (3) thicknesses for nine (9) tibial sizes. The OSS femoral augments are available in a 3,5mm thick anterior flange augment. The OSS tibial augments are available in monoblock and block form. The monoblocks are only available in 10mm thicknesses for three tibial sizes, while the block augments are available in 10mm and 20 mm sizes for three tibial sizes.
The provided document is a 510(k) premarket notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments. The content primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing a detailed study proving the device meets specific performance acceptance criteria.
Therefore, many of the requested details about acceptance criteria, specific study design, and performance metrics are not present in this document. The document states:
"Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." (Page 1)
"Clinical Testing: None provided as a basis for substantial equivalence." (Page 1)
This means the submission relies on non-clinical testing and comparison to predicates, not specific clinical performance studies with detailed acceptance criteria as one might find for a novel device requiring more extensive validation.
Given the information provided, here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical functionality within intended use (This is a high-level summary, specific granular criteria are not detailed in the document) | "The results indicated that the device was functional within its intended use." (Page 1) |
Missing: Specific quantifiable acceptance criteria (e.g., tensile strength, fatigue life, wear rate thresholds) and the exact numerical performance results for these criteria. The document only provides a general statement of functionality.
2. Sample size used for the test set and the data provenance
Not provided. The document mentions "non-clinical laboratory testing" but does not specify the sample size, type of test specimens, or the provenance of any data used for these tests. It is implied these were laboratory tests on the device itself, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Since the testing was non-clinical and no clinical data was presented, there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission.
4. Adjudication method for the test set
Not applicable/Not provided. No clinical test set requiring adjudication by experts was presented.
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 medical implant (knee augments), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. As mentioned above, this is a physical implant, not an algorithm.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" would be established by standard engineering and material science specifications, predicate device performance data, and regulatory standards for mechanical and material properties of implants. However, the document does not detail these specific standards or how the device's performance compared against them. It only states it was "functional within its intended use."
8. The sample size for the training set
Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission as it is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable/Not provided. As above, no training set was involved.
In summary: The provided 510(k) notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments relies heavily on a comparison to predicate devices and general non-clinical laboratory testing to assert substantial equivalence. It does not contain the detailed performance data, acceptance criteria, sample sizes for patient data, or expert review methodologies that would be typical for clinical studies validating a new diagnostic or AI-driven device. The statement "Clinical Testing: None provided as a basis for substantial equivalence" is key in understanding the limited scope of detailed performance data in this particular document.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.