(71 days)
The indications for the use of these posteriorly stabilized total knee components, in keeping with those of other legally marketed Class II posteriorly stabilized total knee components, 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. .
- . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- . Absent or non-functioning posterior cruciate ligament.
Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components: Fabricated from cobalt chromium alloy, intended for cemented application to replace the articulating surface of the distal femur. Utilized when total knee replacement is indicated and the posterior cruciate ligament is non-functioning or absent. Available in right and left configurations, with three different interior surface textures (basic grit-blasted, waffle pattern, and MicroStructured® porous coating), and available with or without nitrogen ion implanted bearing surfaces.
Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component: A one-piece total knee replacement tibial component, fabricated from ultra-high molecular weight polyethylene (UHMWPE). Provides constraint needed to compensate for an absent or incompetent posterior cruciate ligament when used with the mating femoral component. Bearing surface employs a single medial lateral (M/L) radius, incorporates a posteriorly sloping, raised tibial eminence, a radiographic locator wire, and a swept back, keeled post. Intended for cemented fixation, with primary fixation achieved through interface of the bone cement with the tibial post.
Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert: Fabricated from ultra-high molecular weight polyethylene (UHMWPE). Assembled to the tibial tray component intraoperatively via a locking wire mechanism. Articulating surface area is identical to that of the Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component.
Osteonics® Scorpio Total Knee All-Polvethylene Patellar Components: Fabricated from ultra-high molecular weight polyethylene (UHMWPE), intended for application onto the surgically prepared posterior patella. Replace the patellar articulating surface of the knee joint and simulate the natural anatomy and function of the knee. Articular geometry is designed with a single medial lateral (M/L) radius. Overall geometry consists of an oval patellar button configuration with three fixation pegs in the anterior surface. Available in three design configurations - Concentric Dome, Medialized Dome, and Superior-Medialized Dome.
This document describes a 510(k) Premarket Notification for the Osteonics® Scorpio Posteriorly Stabilized Total Knee System. This is a medical device submission, and the content provided does not include information about acceptance criteria or studies demonstrating device performance in the way a diagnostic or AI device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested categories are not applicable to this type of submission. I will explain why each category is not applicable and what information is provided instead.
1. A table of acceptance criteria and the reported device performance
- Not applicable. This submission is for a medical implant (total knee system), not a diagnostic or AI device. Acceptance criteria in this context typically refer to performance measures like tensile strength, wear rates, and biomechanical stability, which are compared against known standards or predicate devices. The document states "applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs," but does not provide specific criteria or measured performance values in detail.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a medical device submission for an implant. Test sets and data provenance for clinical performance (like diagnostic accuracy) are not relevant here. Substantial equivalence is typically demonstrated through material testing, mechanical testing, and design comparison, rather than clinical efficacy studies on patient cohorts.
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. Ground truth establishment by experts is relevant for diagnostic accuracy studies. For an orthopedic implant, the "ground truth" relates to material properties, biomechanical function, and safety, which are assessed through engineering and manufacturing standards, not expert clinical interpretation of test data in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. This is not relevant for demonstrating substantial equivalence of a knee implant.
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. MRMC studies and the concept of "human readers improving with AI assistance" are specific to AI/diagnostic imaging devices. This document concerns a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. "Standalone performance" refers to the performance of an algorithm or AI without human intervention. This is not relevant to an orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the conventional sense of diagnostic devices. For this type of medical device, the "truth" is established by adherence to recognized standards for materials, manufacturing, and biomechanical performance. This would involve a combination of:
- Material specifications: Conformance to standards for cobalt-chromium alloy and UHMWPE.
- Mechanical testing: Demonstrating properties like fatigue strength, wear resistance, and fixation strength are comparable to the predicate device and within acceptable limits.
- Design comparison: Detailed analysis of geometric features, dimensions, and articulation to ensure similar bio-mechanical function to the predicate.
8. The sample size for the training set
- Not applicable. Training sets are used for machine learning models. This is an orthopedic implant.
9. How the ground truth for the training set was established
- Not applicable. As above, training sets are not relevant for this device.
Summary of Relevant Information from the Document:
The provided text is a 510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Scorpio Posteriorly Stabilized Total Knee System. The primary goal of a 510(k) is to demonstrate substantial equivalence to an already legally marketed device (predicate device), not to provide de novo effectiveness data in the way an AI or diagnostic tool would.
Key information relevant to what you're asking, interpreted for a medical implant context:
- Predicate Device Identification: The Scorpio system components are compared to various Osteonics® Series 7000 Total Knee components.
- Demonstration of Equivalence: The document states:
- "The Osteonics® Scorpio Posteriorly Stabilized Total Knee System components share the same materials, indications and intended use, surgical techniques, basic design features, and basic manufacturing methods of their respective predicate devices."
- "These components are substantially equivalent to predicate devices by virtue of providing for cemented application of the femoral, patellar, and all-polyethylene tibial components, security of fixation, proper load transfer, and a biomechanical function and range of motion which approximate the normal knee..."
- "Although the articulating surfaces of the subject devices differ slightly from that of their predicate devices, applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs."
This last sentence is the closest to addressing "acceptance criteria and study that proves the device meets the acceptance criteria." It implies that specific performance tests (e.g., wear, fatigue, stability) were conducted, and the results fell within an acceptable range, demonstrating equivalence to the predicate. However, the specific details of these tests, their acceptance thresholds, and the actual results are not provided in this summary document. This information would typically be found in more detailed sections of the 510(k) submission itself, which is not publicly available here.
§ 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.