(535 days)
The subject devices are single use components, intended for cemented use only. The indications for the use of these tibial trays, in keeping with those of other legally marketed Howmedica Osteonics tibial trays, are as follows:
Indications:
- . Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function.
- . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- . Revision of previous unsuccessful knee replacement or other procedure.
Additional Indications for Posterior Stabilized Components:
- . Ligmentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.
Howmedica Osteonics® Series 7000 AD Tibial Trays are intended for cemented fixation on the prepared proximal tibia and are designed to achieve total reconstructive replacement of the knee joint when used in conjunction with the Howmedica Osteonics® Total Knee Femoral, Patellar and Tibial Insert Components. The metallic tibial tray is manufactured from ASTM F75-92 CoCr alloy. The "pocketless" design of the fixation surface employs a roughened, arc-deposited ASTM F67-95 CP Titanium coating. The keeled stems of the Howmedica Osteonics® Series 7000 AD Tibial Tray employ a satin finish and are not coated with arc-deposited CP Titanium. Screw hole plugs, fabricated from low density polyethylene (LDPE), are located in the tibial tray screw holes.
The provided text is a 510(k) Premarket Notification Summary for a medical device, the Howmedica Osteonics® Series 7000 AD Tibial Tray. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving efficacy or performance through a typical clinical study with acceptance criteria and statistical analysis.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample size for test sets, expert involvement in ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for training.
Instead, the "study" demonstrating the device meets acceptance criteria is actually a comparison to a predicate device. The fundamental acceptance criterion for a 510(k) submission is "substantial equivalence" to a legally marketed predicate device.
Here's how the provided information relates to your request, noting the absence of the specific details you're looking for:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria in the typical sense of a performance study (e.g., sensitivity, specificity, accuracy thresholds) and reported statistical performance values. Instead, the acceptance criterion for regulatory approval is "Substantial Equivalence" to predicate devices.
| Acceptance Criterion (for 510(k) Substantial Equivalence) | Reported Device Performance (as presented in 510(k)) |
|---|---|
| Technological Comparison: The device must be equivalent to predicate devices in material, design, indications, shape, and intended use, with any differences not raising new questions of safety or effectiveness. | The subject device (Howmedica Osteonics® Series 7000 AD Tibial Tray) is stated to be "identical to the tibial tray of the predicate Howmedica Osteonics® Series 7000 Total Knee Tibial Components in all material and design aspects, indications, shape and intended use, with the exception of the arc-deposited CP Titanium coating and the absence of a "pocket" on the inferior side of the tray." |
The arc-deposited CP Titanium coating is stated to be "identical to the AD coating on the predicate Howmedica Osteonics® Omniflex™ AD Hip Stem."
The combination of CoCr substrate with CP Titanium coating is "similar to that of the predicate Maxim® Complete Knee System manufactured by Biomet, Inc., which offers a CoCr substrate coated with Titanium alloy." |
| Material Equivalence: Materials used must be equivalent or have demonstrated equivalent safety and performance. | The device uses ASTM F75-92 CoCr alloy and arc-deposited ASTM F67-95 CP Titanium coating, with keeled stems having a satin finish and screw hole plugs made of low-density polyethylene (LDPE). These materials are implicitly deemed equivalent due to their use in the cited predicate devices or by established medical device material standards. |
| Intended Use and Indications for Use Equivalence: The intended use and indications must be the same or sufficiently similar to predicate devices. | The document lists indications for use that align with those for total knee components, specifically stating they are "in keeping with those of other legally marketed Howmedica Osteonics tibial trays." |
| Performance (implicitly, through material and design equivalence): The device must perform as safely and effectively as the predicate devices. | This is demonstrated by the "Coating Characterization Summary" (mentioned but not detailed in the provided text) and the material and design comparisons. The conclusion is that "the substantial equivalence... is demonstrated." |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This type of information is typically found in clinical trial reports or performance studies, which are not part of this 510(k) summary. The "test set" here would conceptually be the device itself being compared to standards and predicates. There is no mention of a patient-based test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Ground truth establishment by experts is relevant for diagnostic devices or those requiring subjective clinical assessment. This device is a pre-formed orthopedic implant.
4. Adjudication method for the test set
Not applicable/Not provided. No formal adjudication method is mentioned as there isn't a "test set" of observations being interpreted.
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 is a hardware orthopedic implant, not an AI-assisted diagnostic device. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware orthopedic implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's design, materials, and intended use are compared against these known, approved products. In essence, the "truth" is that the predicate devices are safe and effective, and the new device is "substantially equivalent" to them. A "Coating Characterization Summary" is mentioned, which would involve material property testing and thus likely rely on scientific/engineering standards and measurements, rather than clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
Not applicable/Not provided. There is no "training set" in the context of device design approval for a hardware implant. The design process would involve engineering principles, materials science, and testing, but not machine learning training.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there's no training set, there's no ground truth established for one. The "truth" in this context is based on engineering specifications and comparison to existing, approved devices.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.