Search Results

This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictors are designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement.

This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.

The Interbody Innovations Cement Restrictors is a hollow curved rectangular frame that is machined from extruded Polyetheretherketone (PEEK). It contains tantalum inserts that serve as location and orientation markers for radiographs. The device is intended to be used in conjunction with standard PMMA

Let's break down the information provided in the 510(k) summary (K051371) to extract details regarding acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a Surgical Mesh, specifically a Cement Restrictor. These devices are typically cleared based on substantial equivalence to existing predicate devices, rather than extensive clinical efficacy studies with predefined acceptance criteria for performance metrics like accuracy, sensitivity, or specificity, as one might find for diagnostic AI algorithms. The "performance data" section for these types of devices usually focuses on material properties, biocompatibility, and mechanical characteristics.

Therefore, the interpretation of "acceptance criteria" and "study" will be tailored to what is relevant for this specific type of medical device submission.

Acceptance Criteria and Device Performance

For this device, the acceptance criteria are primarily related to material compliance and biocompatibility, as the function and design are substantially equivalent to existing cleared devices.

Study and Data Details

Given the nature of this device (a cement restrictor cleared via substantial equivalence), the "study" referred to in the document is primarily the demonstration of material equivalence and biocompatibility, rather than a clinical effectiveness study.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of clinical performance data for this type of 510(k). The "test" here refers to material and biocompatibility testing, which typically uses standardized samples of the material itself. The document does not specify the number of material samples tested.
   • Data Provenance: The biocompatibility certification (ISO 10993-1) is from the manufacturer of the PEEK-Optima material. ASTM F2026 compliance is a material standard. This data is likely retrospective, based on prior testing of the raw material. The country of origin for the material manufacturer is not specified.

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

   • Not applicable. "Ground truth" in the sense of expert consensus on diagnostic imaging is not relevant for this material and mechanical device submission. Material properties and biocompatibility are established through laboratory testing and standardized protocols, not expert clinical consensus review.

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

   • Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials. Material testing results are objective.

4. 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 not an AI/diagnostic imaging device.

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

   • Not applicable. This is not an AI/algorithm device.

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

   • The "ground truth" for this submission are material specifications (ASTM F2026) and biocompatibility standards (ISO 10993-1).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set is used.

Summary of the "Study" for K051371:

The "study" or performance data for the Interbody Innovations Cement Restrictor primarily consists of:

• Material Equivalence: Demonstration that the device is constructed of the same material (PEEK-Optima) as the predicate device(s) and that this material complies with ASTM F2026.
• Biocompatibility: Reliance on the manufacturer of the PEEK-Optima material having an FDA Device Master File and certifying biocompatibility to ISO 10993-1 requirements for implantable contact greater than 30 days.

This approach is typical for Class II devices that achieve market clearance through a 510(k) pathway by demonstrating substantial equivalence, often relying on material properties and existing predicate devices rather than new clinical effectiveness trials.

Ask a specific question about this device