(158 days)
The Scorpio® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: 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 the posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; absent or non-functioning posterior cruciate ligament. These products are intended to achieve fixation without the use of bone cement.
The device includes femoral and tibial components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
The provided text is a 510(k) Premarket Notification for the "Scorpio Total Knee System with Peri-Apatite Coating." This document, issued by the FDA in 2004, is primarily focused on demonstrating "substantial equivalence" of the device to a predicate device, rather than providing detailed acceptance criteria and a study proving those criteria were met in the way one might expect for a novel device or software.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with explicit numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device; or specific mechanical thresholds for an implant). Instead, the acceptance criteria are implicitly linked to demonstrating equivalence to the predicate device and meeting established standards for similar prostheses.
The "reported device performance" is summarized qualitatively:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate device | Achieved through risk analysis and R&D testing. |
| Compliance with Class II Special Controls Guidance Document (Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, January 16, 2003) | Testing performed in accordance with this guidance document, including porous coating characterization, baseplate fatigue, contact area/stress analyses, range of motion/constraint, locking mechanism testing, UHMWPe material properties. |
| Safety of Peri-Apatite® coating | Safety testing performed. |
| Effect of coating on pore size and volume | Summary of effect performed. |
| Overall safety and effectiveness for total knee replacement without bone cement | "The results demonstrate that the Scorpio Total Knee System with Peri-Apatite® coating is safe and effective for total knee replacement without bone cement." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes engineering and laboratory testing, not human-subject or clinical studies with "test sets" in the diagnostic or AI sense.
- Sample Size: Not specified in terms of number of devices or components tested, but implies multiple units for various tests (e.g., fatigue, material properties).
- Data Provenance: Not applicable in the context of human data. The testing refers to "research and development testing" likely performed in a laboratory setting by Howmedica Osteonics Corp.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the "ground truth" for the device's mechanical and material properties is established through standardized engineering tests and measurements, not expert human evaluation of cases.
4. Adjudication Method for the Test Set:
- Not applicable, as this refers to human expert judgment, which was not used to establish the "truth" for this type of device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not performed. This type of study is relevant for diagnostic devices (especially those involving image interpretation by humans). The submission is for a knee implant, which undergoes mechanical and material testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not a software algorithm or AI device. The device is a physical knee implant.
7. The Type of Ground Truth Used:
- The "ground truth" in this context refers to established engineering standards, material specifications, and physical measurements (e.g., strength, fatigue life, pore size, range of motion) as defined by the Class II Special Controls Guidance Document and general engineering principles for medical implants.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 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.