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The Cardo Medical Total Knee System is indicated for use in individuals undergoing surgery for:

• 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;
• Revisions of previous unsuccessful knee replacement or other procedures.

Additional indications for posteriorly stabilized components:

• Ligamentous instability requiring implant bearing surfaces with increased constraint;
• Absent or non-functioning posterior cruciate ligament.

These devices are single use only and are intended for implantation with bone cement.

The Cardo Medical Femoral Cement Restrictor is only intended for use with Cardo Medical PS femoral components (previously cleared in K081127). The device is an optional accessory and is manufactured from UHMWPE.

The provided document, K101032 for the Cardo Medical Femoral Cement Restrictor, is a 510(k) premarket notification submission. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive new studies.

Therefore, many of the typical elements of a study proving acceptance criteria (like specific performance metrics, sample sizes, expert adjudication, or MRMC studies) are not present in this document.

Here's a breakdown of the information that can be extracted based on your request, and where details are not available or not applicable for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than establishing and testing against novel acceptance criteria.

2. Sample size used for the test set and the data provenance

No specific test set or data provenance in terms of patient data is mentioned. The submission states: "The Cardo Medical Femoral Cement Restrictor is a non-load-bearing plug that does not change the worst-case products for testing purposes, therefore the previous testing applies to these components." This indicates that no new primary clinical or performance testing was conducted for this specific device beyond what was covered by the predicate or the overall knee system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set requiring expert ground truth establishment for performance evaluation is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No new test set requiring adjudication is described.

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 device is a cement restrictor, not an imaging or diagnostic device that would typically involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For a physical device like a cement restrictor, "ground truth" typically refers to engineering specifications, material properties, and functional performance (e.g., ability to occlude, biocompatibility). These are implicitly addressed by similarity to the predicate and overall system testing, rather than through complex "ground truth" like in diagnostic AI.

8. The sample size for the training set

Not applicable. This device is a physical medical component, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not a machine learning algorithm.

Summary of the Study (as described in the 510(k) submission):

The "study" described in this 510(k) is primarily a comparative analysis for substantial equivalence rather than an independent performance study against novel acceptance criteria.

The submission states:

• Synopsis of Test Methods and Results: "The Cardo Medical Femoral Cement Restrictor is a non-load-bearing plug that does not change the worst-case products for testing purposes, therefore the previous testing applies to these components."
• Comparison to Predicates: The device "is substantially equivalent to the Howmedica Osteonics Tibial Tray Screw Hole Plugs (K032479), having the same technological characteristics. The device and its predicate are made of the same material, are used in total knee arthroplasty, and serve the same purpose: to occlude an opening to help prevent bone cement from migrating."
• Conclusion: "Cardo Medical, Inc. has determined that any differences in the proposed device will not impact the safety or effectiveness of the total knee system for its intended use."

Essentially, the "study" for this 510(k) is a declaration and justification that because the new device is technologically equivalent to a legally marketed predicate device (made of the same material, serving the same function, and being non-load-bearing), the safety and effectiveness are also considered equivalent, and no new, specific performance studies beyond what's already established for the predicate or the overall knee system are deemed necessary by the submitter. The FDA's clearance of the 510(k) confirms agreement with this claim of substantial equivalence.

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The Cardo Medical Ceramic Head components are for use in total hip arthroplasty as a result of:
• Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip,
• Correction of functional deformity,
• Avascular Necrosis,
• Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur,
• Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results.

These components are single use only and are intended for implantation with or without bone cement.

The previously cleared Cardo Medical Hip System consists of
• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) femoral stems,
• cobalt chrome (CoCr) femoral heads,
• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) acetabular shells,
• ultra-high molecular weight polyethylene (UHMWPE) acetabular inserts, and
• titanium alloy (Ti-6Al-4V) bone screws.

The proposed devices are a line extension to the previously cleared system to add 32mm and 36mm alumina ceramic femoral heads.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cardo Medical Ceramic Head:

The document describes a Premarket Notification Submission (510(k)) for the Cardo Medical Ceramic Head, a line extension to an existing total hip arthroplasty system. This submission aims to demonstrate substantial equivalence to previously cleared devices rather than prove novel safety and effectiveness. Therefore, the "acceptance criteria" and "study" described are focused on meeting the requirements for demonstrating substantial equivalence through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of how many individual devices were tested for each mechanical test. It refers to "technical reports for stem fatigue mechanical testing," "the push-in, push-out, lever-out and rotational torque forces for acetabular inserts," etc., implying standard engineering-level test matrices would have been used.

• Data Provenance: The nature of the tests (mechanical performance, material equivalence) suggests these were laboratory-based tests conducted by the manufacturer or a contract testing facility. The data is non-clinical and focused on the physical and mechanical properties of the device components. There is no information regarding country of origin of the data beyond it being part of a US FDA submission. It is prospective in the sense that the testing was performed to support this specific submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable for a non-clinical, mechanical testing study for substantial equivalence. "Ground truth" in this context is defined by established engineering standards and test methodologies, and the acceptance criteria are based on those standards and comparison to predicate devices, not on expert clinical consensus. The experts involved would be engineers and material scientists performing and interpreting the mechanical tests.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical tests have objective, measurable outcomes that either meet or do not meet specified criteria. There is no subjective interpretation requiring adjudication among human observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states under "Clinical Performance": "Clinical data and conclusions are not needed for this device." This is because the submission is for a material and dimensional modification (adding ceramic heads) to an already cleared system, relying on substantial equivalence to predicate devices and robust non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This is a medical device (a ceramic hip component), not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence is based on:

• Established engineering standards and test methods: The document mentions "required by the guidance document for ceramic heads."
• Comparison to legally marketed predicate devices: The "results indicate that the Cardo Medical ceramic femoral heads and inserts is equivalent to devices currently legally marketed." This implies that the performance of the predicate devices in these mechanical tests (or accepted ranges for such devices) served as the benchmark.

8. The Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8.

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