(135 days)
The Disc-O-Tech Confidence High Viscosity Bone 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 (hemangioma), and malignant lesions (metastatic cancer, myeloma).
The Confidence High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (20 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.
This document, a 510(k) summary for the "Confidence High Viscosity Bone Cement," describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) process is primarily a demonstration of "substantial equivalence" to a legally marketed predicate device, not typically a full clinical efficacy or performance study against predefined acceptance criteria in the way a PMA (Premarket Approval) might require.
Therefore, I cannot populate the requested table and answer many of your questions based solely on the provided text.
Here's a breakdown of why and what I can or cannot answer:
1. A table of acceptance criteria and the reported device performance
- No information in the provided text. The document describes the device's composition, intended use, and states its substantial equivalence to predicate devices based on various characteristics, but it does not specify quantitative acceptance criteria (e.g., "tensile strength must be > X MPa") or report specific performance data against such criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information in the provided text. This document is a regulatory submission for substantial equivalence, not a detailed study report. It does not mention any test set, sample sizes, or data provenance from a specific study.
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/No information in the provided text. Ground truth is typically relevant for studies evaluating diagnostic accuracy, machine learning algorithms, or clinical outcomes. This document does not describe such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/No information in the provided text. Same as above.
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/No information in the provided text. This device is a bone cement, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to its regulatory submission as described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/No information in the provided text. This device is a physical product (bone cement), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/No information in the provided text. See points 3 and 4.
8. The sample size for the training set
- Not applicable/No information in the provided text. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable/No information in the provided text. See point 8.
Summary of what the document does provide:
- Device Name: Confidence High Viscosity Bone Cement
- Applicant: Disc-O-Tech Medical Technologies Ltd.
- Date Prepared: January 2006
- Classification: Class II, PMMA Bone Cement (For Vertebroplasty), 21 CFR §888.3027
- Predicate Devices:
- Intended Use: For the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures, for painful vertebral compression fractures resulting from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
- System Description: Radiopaque, self-curing, high viscosity PMMA bone cement, two-component system (powder + liquid), contains 30.07% barium sulfate.
- Basis for Substantial Equivalence: Intended use, chemical composition, material properties, biocompatibility, principles of operation, technological characteristics, performance, and clinical application are substantially equivalent to predicate devices.
Conclusion:
The provided text serves as a 510(k) summary, demonstrating "substantial equivalence" of the new device to existing predicate devices. It focuses on comparing characteristics and intended use, rather than presenting a performance study against specific acceptance criteria. Therefore, the detailed information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth validation that you've requested is not present in this type of regulatory document.
§ 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.”