(52 days)
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease including
- osteoarthritis
- traumatic arthritis, and
- avascular necrosis (not applicable to Physica TT Tibial Plate);
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and
- Treatment of fractures that are unmanageable using other techniques.
Additional indications for Physica LMC component are:
- Moderate varus, valgus, or flexion deformities.
In patients with preserved and well functioning collateral ligaments, Physica PS, PS Pro and HPS components are also indicated for:
- Absent or not-functioning posterior cruciate ligament;
- Severe antero-posterior instability of the knee joint.
Additional indications for Physica HPS component are:
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Moderate varus, valgus, or flexion deformities.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use.
Tibial liners can be used with cemented or uncemented tibial or femoral components.
This 510(k) submission aims at introducing the Physica CR Porous Femoral components as part of the subject Physica system. The subject device components are intended to be used without cement, articulating with other components of the cleared Physica system. The Physica system (including subject Physica CR Porous Femoral components) is intended for a total knee replacement.
Physica CR Porous Femoral components are designed based on the cemented Physica CR Femoral components already cleared (K151266). They are made of CoCrMo (ISO 5832-4 / ASTM F75) and are intended to replace the condyles of the distal femur. The femoral components are available in ten sizes (left and right) and are intended to replace the condyles of the distal femur. The femoral components are available in left and right versions and have an asymmetric anterior flange (to adapt left and right knees) with symmetric condyles for the articulation with the tibial liner.
This FDA 510(k) clearance letter pertains to a medical device, specifically the Physica CR Porous Femoral components for total knee replacement, not an AI/Software as a Medical Device (SaMD).
Therefore, the requested information (acceptance criteria and study that proves the device meets the acceptance criteria), which is typically associated with the validation of AI/SaMD, is not directly applicable to this document. The document describes the device, its intended use, and indicates that substantial equivalence to predicate devices was demonstrated through non-clinical mechanical testing and comparisons.
Here's how I can describe the information requested if this were an AI/SaMD, and then explain what the provided document does say in terms of device performance:
As this document describes a physical medical device (knee implant) and not an AI/SaMD, the requested information regarding acceptance criteria and studies for AI/SaMD performance validation (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, training set details) is not present in the provided text.
However, I can interpret your request in the context of the provided document by outlining the performance evaluation conducted for this physical device as presented in the 510(k) summary.
Acceptance Criteria and Study for Physica CR Porous Femoral Components (Non-AI/SaMD Context)
The primary method to demonstrate "acceptance criteria" and "device performance" for this type of medical device in a 510(k) submission is through substantial equivalence to legally marketed predicate devices, supported by non-clinical (mechanical) testing and material characterization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Mechanical Performance) | Reported Device Performance (from document) |
|---|---|
| Fatigue Strength: Device withstands cyclic loading without failure. | Fulfilled: Mechanical testing for fatigue (ASTM F3210-22e1) was performed on worst-case components/constructs, demonstrating that "the device performance fulfilled the intended use." |
| Biocompatibility/Material Conformity: Materials used are safe for implantation. | Fulfilled: PoroTi coating conforms to FDA Guidelines and referenced standards. Materials (CoCrMo, ISO 5832-4 / ASTM F75) are standard and cleared. |
| Design Equivalence/Functionality: Design features allow for intended use and articulation. | Fulfilled: Subject components have "same sizes, dimensions and design features of Physica CR Femoral components" (a cleared predicate), with minor differences (cement pockets) addressed by Design Control Activities. |
| Overall Intended Use: Device is suitable for knee arthroplasty as specified. | Fulfilled: "Mechanical tests demonstrated that the device performance fulfilled the intended use, and that the device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "worst case components or constructs" were used for mechanical testing. It does not specify a numerical sample size for these tests.
- Data Provenance: The data comes from non-clinical mechanical testing conducted on physical components of the device, likely performed in a laboratory setting by the manufacturer (Limacorporate S.p.A. in Italy). It is not retrospective or prospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This question is not applicable as the ground truth for a physical medical device like a knee implant is established through objective engineering standards and mechanical test results, not through expert consensus on diagnostic images or clinical outcomes in the same way as an AI/SaMD. The "experts" involved would be engineering and material science professionals conducting and interpreting the tests.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in evaluating subjective assessments (e.g., image interpretation). Mechanical testing results are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a physical knee implant, not an AI or a system that assists human readers. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical knee implant, not an algorithm.
7. The Type of Ground Truth Used
- For mechanical performance: The ground truth is defined by established engineering standards (e.g., ASTM F3210-22e1 for fatigue testing) and material specifications (e.g., ISO 5832-4 / ASTM F75 for CoCrMo, FDA Guidelines for PoroTi coating). The "ground truth" is that the device must meet these predetermined, objectively measurable criteria.
- For substantial equivalence: The ground truth is the performance and characteristics of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI. Its design is based on established engineering principles and prior device designs.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8. The design and development process for a physical implant involves engineering principles, CAD, materials science, and testing against known biomechanical principles, rather than AI training data.
§ 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.