(80 days)
CONFIDENCE High Viscosity Spinal Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).
CONFIDENCE High Viscosity Spinal Cement is self-curing, radiopaque, polymethyl methacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilisation of the vertebral body and pain relief.
The provided text describes a 510(k) summary for the CONFIDENCE High Viscosity Spinal Cement, which is a PMMA bone cement. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
However, the document focuses on regulatory approval and substantial equivalence based on comparable performance characteristics rather than detailing a specific study with defined acceptance criteria and device performance metrics in the way your request specifies. The text states:
"Chemical composition of the Medos International SARL CONFIDENCE High Viscosity Spinal Cement is similar to subject devices, and testing has confirmed the devices to have comparable performance characteristics."
And later:
"Based on the similarities in indications, intended use, design, materials, method of manufacture and the results of performance testing, Medos International SARL believes that the subject device CONFIDENCE High Viscosity Spinal Cement is substantially equivalent to the previously cleared devices."
This indicates that performance testing was conducted, but the details of that testing, including specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or multi-reader studies, are not provided in this document. This 510(k) summary is a high-level overview for regulatory purposes, not a detailed study report.
Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.
Here's how I would answer based on what is available (and clarifying what is not available):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated for specific metrics in this document) | Reported Device Performance (Not explicitly stated as specific metrics in this document) |
|---|---|
| Implicit Acceptance Criteria: | Implicit Reported Performance: |
| - Device has comparable chemical composition to predicate devices. | - Chemical composition is similar to predicate devices. |
| - Device exhibits comparable performance characteristics to predicate devices. | - Testing confirmed comparable performance characteristics to predicate devices. |
| - Device meets the safety and effectiveness profile of legally marketed predicate devices. | - The FDA determined the device to be substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in this document.
- Data provenance: Not specified in this document.
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 specified. The "performance testing" mentioned likely refers to bench or non-clinical testing rather than expert-adjudicated clinical data for this 510(k) submission, given the nature of the device (bone cement) and the focus on substantial equivalence to existing devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/not specified. The document does not describe a clinical study with an adjudication process.
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
- No. This is a bone cement, not an AI diagnostic device. Therefore, an MRMC study with AI assistance is not relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Given the device type (bone cement) and the context of a 510(k) for substantial equivalence, the "ground truth" for performance would likely be established through bench testing against recognized standards or direct comparison to predicate device performance metrics (e.g., mechanical properties like compression strength, setting time, radiopacity, wear resistance, etc. - though these specific metrics are not detailed here). There is no mention of pathology or clinical outcomes data being used as "ground truth" for this specific submission's comparative performance testing.
8. The sample size for the training set
- Not applicable/not specified. This is a physical medical device (bone cement), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/not specified. This is a physical medical device, not an AI algorithm.
§ 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.”