(70 days)
The metal backed patella is intended for patellar resurfacing to alleviate pain, instability and the restriction of motion.
The Triathlon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed;
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee.
These products are intended to achieve fixation without the use of bone cement.
The Triathlon® Metal Backed Patella is designed to offer patellar resurfacing when needed with the Duracon® or Triathlon® Total Knee Systems. The subject metal-backed patella is available in four sizes designed to fit the peripheral shape of the resected patella. The posterior surface of the patella features a porous coated metal back, with a preassembled polyethylene anterior surface.
This document is a 510(k) Summary for the Triathlon® Metal Backed Patella, a total knee joint replacement prosthesis. It outlines the device's description, intended use, indications for use, and claims substantial equivalence to a previously cleared device. Due to the nature of this document, which is a regulatory submission for a medical device that claims substantial equivalence rather than a study proving the device meets specific acceptance criteria, most of the requested information regarding acceptance criteria and a study proving performance is not present. This type of regulatory submission relies on comparison to a predicate device rather than presenting new clinical study data with defined acceptance criteria.
Therefore, many of the requested fields cannot be directly answered from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics tied to such criteria. The device is cleared based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance acceptance thresholds through a new clinical performance study.
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. The document does not describe a test set or clinical study with sample sizes. Substantial equivalence is typically established through comparative data on design, materials, manufacturing processes, and indications for use, often leveraging existing data and reputation of the predicate device.
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. No test set or ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there is no test set or clinical study.
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. This is a knee implant, not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is described as there is no clinical study to establish performance against a ground truth. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no training set for an algorithm in this context.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an algorithm in this context.
Summary of Relevant Information from the Document:
- Device Name: Triathlon® Metal Backed Patella
- Predicate Device: Howmedica Osteonics' Duracon metal-backed patella (cleared in K032418)
- Claim of Substantial Equivalence: The metal-backed patella is substantially equivalent to the predicate device because it is "similar in design, and has the same indications, intended use, and sterilization."
- Role of Document: This is a 510(k) summary, a regulatory submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, thereby permitting its sale without requiring a new Premarket Approval (PMA). This process does not typically involve new clinical studies with defined acceptance criteria for the new device as would be required for a PMA or for novel devices not based on substantial equivalence.
§ 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.