(106 days)
Cobalt™ MV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck and of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
Cobalt™ MV Bone Cement is a methyl methacrylate-styrene copolymer based acrylic bone cement with a medium viscosity. Cobalt™ MV Bone Cement provides two separate, premeasured sterilized components that when mixed form fast-setting radiopaque bone cement for use in orthopedic surgery.
The provided text describes a 510(k) summary for a medical device, "Cobalt™ MV Bone Cement," and its subsequent FDA clearance. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures typically found in clinical trials for diagnostic or AI-powered devices.
This document specifically states: "Clinical Testing: None provided as a basis for substantial equivalence."
Instead, the submission for Cobalt™ MV Bone Cement relies on "Non-Clinical Testing" which "was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This means the substantial equivalence was based on demonstrating that the new device has similar technological characteristics and performance (likely mechanical, chemical, and biological) to previously cleared predicate devices, rather than a clinical study establishing specific performance metrics against a defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a clinical study. The acceptance criterion for 510(k) clearance is "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." No specific performance values (e.g., strength, setting time, biocompatibility results) are provided in this summary document.
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 as no clinical test set was used to establish performance for substantial equivalence. Non-clinical testing would have involved laboratory samples, not human data.
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 as no clinical test set with human data requiring expert ground truth was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical test set with human data was used.
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 as this is a bone cement, not an AI-powered diagnostic device, and no clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a bone cement, not an AI-powered algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For non-clinical testing, the "ground truth" would likely be established by validated physicochemical test methods and relevant ISO standards, not expert consensus or pathology in a clinical sense.
8. The sample size for the training set
- Not applicable as this is a bone cement, not a machine learning model, and no clinical study was performed.
9. How the ground truth for the training set was established
- Not applicable as this is a bone cement, not a machine learning model.
§ 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.”