(103 days)
Cobalt™ MV with Gentamicin Bone Cement is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.
Cobalt™ G-MV Bone Cement is a methyl methacrylate-styrene copolymer based acrylic medium viscosity bone cement with gentamicin. Cobalt™ G-MV Bone Cement provides two separate, premeasured sterilized components that when mixed form rapidly-setting radiopague bone cement for use in orthopedic surgery,
The provided 510(k) summary for K092152, Cobalt™ MV with Gentamicin Bone Cement, explicitly states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use. Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, the device's acceptance criteria and the study proving it meets those criteria are entirely based on non-clinical (bench) testing demonstrating substantial equivalence to predicate devices, not on clinical studies involving human subjects or AI performance. As a result, many of the requested details about acceptance criteria for AI/clinical studies are not applicable to this submission.
However, I can extract information related to the non-clinical testing if that is what you are referring to as "study." If you were expecting an AI device or a clinical trial report, this document does not contain that information.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance (Non-Clinical)
Since no specific numerical acceptance criteria (e.g., minimum tensile strength value) or detailed performance data (e.g., actual tensile strength measured) are provided in the summary, I will summarize what is stated about the non-clinical testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functionality within Intended Use (via non-clinical testing) | Demonstrated to be "functional within its intended use." This implies that the device met internal specifications and performed comparably to predicate devices in areas relevant to its function as bone cement (e.g., mechanical properties, handling characteristics). No specific quantitative metrics or thresholds are provided in this summary. |
| Substantial Equivalence to Predicate Devices | The technological characteristics were found to be "the same as, or similar to, the predicate devices" (Cobalt™ G-HV Bone Cement - K051532 and Simplex® P with Tobramycin Bone Cement - K014199). |
Details Regarding the "Study" (Non-Clinical Testing)
This section addresses the components of your request, noting where the information is not applicable due to the nature of this submission.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the 510(k) summary. Non-clinical studies typically use representative samples of the manufactured product, but the specific number of units tested is not disclosed here.
- Data Provenance: The testing was conducted by Biomet Manufacturing Corp. (applicant). It is non-clinical laboratory testing, not human data.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- N/A: As this is non-clinical laboratory testing of a material, there isn't a "ground truth" established by human experts in the way there would be for image analysis or diagnostic AI. The "truth" would be determined by objective measurements of physical and chemical properties.
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Adjudication Method for the Test Set:
- N/A: Not applicable for non-clinical material testing. Performance is evaluated against scientific standards and predicate device characteristics, not through expert adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- N/A: This is not an AI device or a diagnostic device evaluated by human readers. Therefore, an MRMC study is not relevant or performed.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- N/A: This is a physical medical device (bone cement), not an algorithm or AI system.
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Type of Ground Truth Used:
- For non-clinical testing of bone cement, the "ground truth" would be established by objective physical and chemical measurements according to recognized standards (e.g., ISO, ASTM standards for bone cement properties like mechanical strength, setting time, radiopacity, drug elution profile, etc.). The summary implies these types of tests were performed to show functionality and equivalence.
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Sample Size for the Training Set:
- N/A: This is not an AI device, so there is no "training set."
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How the Ground Truth for the Training Set Was Established:
- N/A: Not applicable.
In summary, the 510(k) K092152 for Cobalt™ MV with Gentamicin Bone Cement relies entirely on non-clinical laboratory testing to demonstrate substantial equivalence to legally marketed predicate devices, confirming its functionality for its intended use. No clinical trials or AI performance evaluations were conducted or submitted as part of this premarket notification.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”