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510(k) Data Aggregation
(35 days)
Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with
The Klassic Knee System is intended for prosthetic replacement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic Knee System is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®. which are indicated for cementless use.
The purpose of this 510(k) is to add size 5, 10mm Sombrero Patella components in Standard Poly and E-Link Poly to be used in conjunction with the Klassic® Knee System during total knee replacement. The components are manufactured from ultrahigh molecular weight polyethylene or Vitamin E blended ultrahigh molecular weight polyethylene with a 40mm diameter and 10mm thickness.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the product submitted in K190280:
The document (K190280) describes a 510(k) submission for new sizes of patella components (size 5, 10mm Sombrero Patella in Standard Poly and E-Link Poly) to be added to the existing Klassic® Knee System. The primary method of demonstrating substantial equivalence is through engineering analyses and comparison to predicate devices that are already cleared.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Conformance | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be within acceptable limits for knee prosthetic components. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of conformance. This implies they meet the same or similar conformance standards as the previously cleared predicate devices (K150105 & K180159). |
| Contact Area | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be within acceptable limits for knee prosthetic components to ensure proper articulation and wear characteristics. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of contact area. This implies they maintain appropriate contact area similar to the previously cleared predicate devices. |
| Contact Stress | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be within acceptable limits to prevent material degradation and ensure longevity of the implant. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of contact stress. This suggests the contact stresses are within acceptable physiological and material limits, comparable to the predicate devices. |
| Mechanical Strength | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be sufficient to withstand the physiological loads and stresses experienced in a knee joint over the expected lifespan of the implant. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of mechanical strength. This implies the new components possess adequate strength comparable to the predicate devices. |
| Peg Geometry | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be consistent with the existing Klassic Knee System to ensure proper fixation and compatibility. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of peg geometry. This ensures the pegs are properly sized and shaped for intended use and fixation within the larger Klassic Knee System. |
| LAL Testing | Compliance with LAL (Limulus Amebocyte Lysate) testing requirements for orthopedic implants, typically to ensure absence of endotoxins. The specific acceptance criteria for LAL are standardized but not detailed here. | The subject components are in "compliance with LAL testing requirements for orthopedic implants." This indicates they passed the standard LAL test, demonstrating a safe level of endotoxins. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a clinical study with a "test set" in the traditional sense of patient data. Instead, it relies on engineering analyses and comparison to predicate devices. Therefore:
- Sample Size for Test Set: Not applicable as it's not a clinical study with patient data. The "test set" would be the specific physical components (size 5, 10mm Sombrero Patellae) that were subjected to the engineering analyses. The number tested is not specified but would typically be one or more samples per analysis to ensure consistency.
- Data Provenance: Not applicable as it's engineering analysis, not patient data from a specific country or collected retrospectively/prospectively. The analyses are performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For engineering analyses, "ground truth" is established through engineering principles, material science, and regulatory standards, not by expert consensus on clinical images or outcomes.
- Qualifications of Experts: The analyses would be performed by qualified engineers or technicians with expertise in biomaterials, biomechanics, and medical device testing, but this is not a ground truth establishment by clinical experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no ambiguous patient data requiring adjudication. The results of the engineering analyses are typically objective measurements and calculations compared against established criteria or predicate device performance.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a medical device for knee replacement components, not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, this is not an AI/algorithm-driven device. It's a physical orthopedic implant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" in this context refers to the established performance characteristics and safety profile of the predicate devices (size 1-4 Sombrero Patellae, K150105 & K180159), as well as established engineering and material science principles and regulatory standards for orthopedic implants. The new device components are deemed substantially equivalent if they meet these established engineering performance benchmarks or demonstrate comparable performance to the predicates.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable.
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(28 days)
Klassic Knee System-Sombrero Patella
The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Sombrero Patella component will be used in conjunction with the Klassic Knee System during total knee replacement. The component is manufactured from ultrahigh molecular weight polyethylene in four diameters and two thicknesses.
This is a 510(k) premarket notification for a medical device called the "Klassic Knee System," specifically discussing the Sombrero Patella component. 510(k) submissions don't typically include a study of device performance against acceptance criteria in the way a clinical trial or AI/software validation would. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training sets) are not applicable to the information provided in this 510(k) summary.
However, I can extract the information relevant to the preclinical testing and the determination of substantial equivalence.
Here's a breakdown of the available information in the requested format, with an emphasis on what is and isn't applicable for a 510(k) submission of this type:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category / Test | Specific Criteria Acknowledged (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Premarket Acceptance | Substantial Equivalence to Predicate | Determined to be Substantially Equivalent to predicate devices. |
| Preclinical Testing | Comparable Contact Stress | Engineering analyses indicated comparable contact stress to predicate devices. |
| Comparable Mechanical Strength | Engineering analyses indicated comparable mechanical strength to predicate devices. | |
| Material | Ultrahigh Molecular Weight Polyethylene | Manufactured from ultrahigh molecular weight polyethylene, same material as predicate. |
| Geometry | Similar Dimensions & Design | Explicitly stated as substantially equivalent to predicate in geometry. |
| Method of Fixation | Similar Fixation Mechanism | Explicitly stated as substantially equivalent to predicate in method of fixation. |
2. Sample Size used for the test set and the data provenance
- Not Applicable in the traditional sense of a clinical or performance study. This is a 510(k) submission relying on preclinical engineering analyses and comparison to predicate devices, not a test set of patient data.
- The "test set" here would refer to the designs and materials of the Sombrero Patella and the predicate devices being physically and/or computationally analyzed. The document doesn't specify a numerical "sample size" for these analyses.
- Data Provenance: The analyses were performed internally by the manufacturer (TJO - Total Joint Orthopedics). This is preclinical, in-house engineering data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The "ground truth" for a 510(k) of this nature is substantial equivalence to a predicate device based on material, design, and performance characteristics (evaluated through engineering analyses, not expert consensus on patient outcomes). The experts involved would be the engineers and regulatory professionals conducting the analyses and preparing the submission. No external panel of clinical experts is described for determining a "ground truth" for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in clinical trials or studies with human readers/raters where a consensus or tie-breaking mechanism is needed. This submission focuses on engineering analysis.
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 mechanical knee implant, not an AI/software device. MRMC studies are completely irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical knee implant, not an algorithm or software. Standalone performance as described is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate devices (Klassic Knee Domed Patella (K112906) and Zimmer Natural Knee All Polyethylene Patella (K934695)). The new device is considered "substantially equivalent" if it meets similar performance characteristics as demonstrated by engineering analyses. There is no mention of pathology or clinical outcomes data for this specific submission for the Sombrero Patella.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of a 510(k) mechanical device submission. This concept applies to machine learning algorithms.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or justification for the Klassic Knee System's Sombrero Patella component meeting acceptance criteria is primarily a demonstration of substantial equivalence to two legally marketed predicate devices: the Klassic Knee Domed Patella (K112906) and the Zimmer Natural Knee All Polyethylene Patella (K934695).
This demonstration was achieved through preclinical engineering analyses. These analyses directly compared the Sombrero Patella to the previously cleared TJO Domed Patella in terms of:
- Contact stress
- Mechanical strength
The submission also asserts substantial equivalence based on similarities in:
- Intended use
- Material (ultrahigh molecular weight polyethylene)
- Geometry
- Method of fixation
The conclusion drawn from these analyses and comparisons (which are summarized in a "Design Control Activities Summary" not provided in full) was that "the Sombrero Patella met the pre-determined acceptance criteria for the verification activities" and is "substantially equivalent to the predicate devices." The FDA's review of this submission resulted in a determination of substantial equivalence, allowing the device to be marketed.
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