(255 days)
The Freedom® Total Knee System is indicated for the following:
• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only).
The Freedom® Porous Tibial Base Plate and Cementless Femoral Components are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.
The Freedom® Porous Tibial Base Plate is a line extension of the Freedom® Total Knee System comprising of tibial base plate components for cemented or uncemented use in total knee arthroplasty. Freedom® Porous Tibial Base Plates are intended for use with existing, compatible Freedom® femoral and tibial liner components. Freedom® Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom® Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.
The provided document is a 510(k) premarket notification for a medical device, specifically the Freedom® Total Knee System - Porous Tibial Base Plate. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with strict acceptance criteria and performance analysis. Therefore, the information requested about acceptance criteria and a study proving the device meets them, typically found in a clinical trial report or a performance study for novel devices or software, is not directly applicable in the same way.
However, I can extract the information related to the non-clinical performance testing conducted to support the substantial equivalence claim. This testing serves as the "study" demonstrating that the device performs as intended and is similar to the predicate.
Here's an interpretation based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" for each test in the way a clinical trial might. Instead, the "acceptance" is implicitly defined by demonstrating that the subject device's performance is substantially equivalent to established performance standards or the predicate/reference devices. The "reported device performance" is summarized as the satisfactory completion of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Tibial Tray Fatigue: Device must withstand fatigue loading per ASTM F1800. | All necessary testing performed. (Implies satisfactory performance meeting the standard). |
| Residual Particle Characterization: Device must meet acceptable levels of residual particles per ASTM F1877, comparable to literature. | Results were shown to be substantially equivalent to values presented in the literature for the reference device (K030623). |
| Porous Surface Characterization: Porous structure must meet specifications for various characteristics per ASTM F1854, F1160, F1044, F1978, F1147. | All necessary testing performed. (Implies satisfactory performance meeting the standards). |
| Sterilization: Device must achieve a sterility assurance level (SAL) of 10^-6 per ISO 11137-2. | Sterilization per ISO 11137-2. (Implies successful sterilization to the required SAL). |
| Endotoxin: Device must meet acceptable endotoxin levels per AAMI ST72. | Endotoxin per AAMI ST72. (Implies acceptable endotoxin levels). |
| Biocompatibility: Device materials must be biocompatible per ISO 10993-1, ISO 10993-5. | Biocompatibility per ISO 10993-1, ISO 10993-5. (Implies successful demonstration of biocompatibility). |
| Modular Disassembly: If applicable, modular components must meet disassembly force requirements (leveraged from reference device). | Modular disassembly testing was leveraged from the reference device (K090411) as the subject device uses an identical tibial insert locking mechanism. (Implies that the design similarity ensures equivalent performance without new testing). |
2. Sample sized used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of implants or test coupons used for each non-clinical test (e.g., how many tibial trays were fatigue tested). It mentions that "All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards."
- Data Provenance: The tests are non-clinical (laboratory/mechanical testing), not human clinical data. Thus, terms like "country of origin" or "retrospective/prospective" are not applicable. The data originates from laboratory testing conducted by or for the manufacturer (Maxx Orthopedics, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "test set" here refers to physical specimens (implants/coupons) for non-clinical testing, not patient data requiring expert interpretation or ground truth establishment. The "ground truth" for these tests is defined by the technical specifications and requirements of the referenced ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the tests are non-clinical, mechanical, and material evaluations performed against established standards, not clinical data requiring adjudication by experts.
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 is not applicable. The device is a physical knee implant, not an AI software or diagnostic tool used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced ASTM and ISO standards. For example, the acceptable number of cycles for fatigue testing is defined by ASTM F1800. For residual particles, the "ground truth" is the acceptable range established in the literature for the reference device, as evaluated against ASTM F1877.
8. The sample size for the training set
This is not applicable. The device is a physical knee implant. There is no "training set" in the context of machine learning or AI. The manufacturing process is validated, and the device's design is based on engineering principles and existing predicate designs, not a data-driven training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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.