(16 days)
CEMEX SYSTEM bone cement is intended to be used for the fixation of plastic and metal joint prostheses to host bone.
CEMEX SYSTEM bone cement is indicated for the fixation of prostheses to bone in orthopaedic musculoskeletal procedures for osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, tramatic arthritis, congenital deformities, avascular necrosis, post-traumatic degenerative problems of the joint, sickle cell anemia, osteoporosis, collagen disease and for the revision of previous arthroplasty procedures.
The individual chemical constituents in Cemex System Fast bone cement are identical to those in the predicate Cemex System cement (#K000943). The liquid component contains methylmethacrylate, N-N dimethyl p-toluidine, and hydroquinone. The dry powder component contains polymethylmethacrylate, barium sulphate and benzoyl peroxide. The only difference is that the predicate Cemex System has a 2.7:1 powder-toliquid ratio compared to the 2.4:1 ratio the new Cemex System Fast product. The powder-to-liguid ratio reduction results in a quicker setting time to accommodate various application techniques.
This submission describes the "Exactech, Inc. Tecres Cemex® System Fast Bone Cement" and compares it to a predicate device, "Cemex System" (K000943). The primary difference is a change in the powder-to-liquid ratio, leading to a quicker setting time.
There is no study described in this document that proves acceptance criteria for device performance beyond direct comparison to the predicate device based on material composition and intended use. This is a 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical performance studies or establishing new acceptance criteria for efficacy. The details provided primarily focus on the device description, packaging, mixing/application, and sterilization, along with a statement of substantial equivalence to a predicate.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not explicitly present in the provided document.
Here's an attempt to address the request based on the information available:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence claim for a bone cement, the "acceptance criteria" revolve around the composition and intended function being nearly identical to the predicate, with the only notable performance difference being the setting time.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Cemex System Fast) |
|---|---|
| Intended Use: Fixation of plastic/metal joint prostheses to host bone. | Identical to Cemex System. |
| Indications for Use: Same orthopedic musculoskeletal procedures. | Identical to Cemex System. |
| Contraindications: Same conditions. | Identical to Cemex System. |
| Chemical Constituents: Identical to predicate. | Identical: Methylmethacrylate, N-N dimethyl p-toluidine, hydroquinone (liquid); Polymethylmethacrylate, barium sulphate, benzoyl peroxide (powder). |
| Sterility Assurance Level (SAL): Meets standards. | Powder: 10^-6 (EO); Liquid: 10^-3 (membrane filtration). (Implied to meet standards based on predicate equivalence). |
| Packaging: Identical to predicate. | Uses identical double blister pack with Tyvek® lids and heavy weight cardboard box. |
| Mixing & Application: Manual closed mixing, syringe application. | Same method, with transparency for inspection as per ISO 5833. |
| Powder-to-Liquid Ratio: Specific ratio for faster setting. | 2.4:1 (compared to 2.7:1 for predicate). This is the key distinguishing "performance" aspect. |
| Setting Time: Quicker than predicate. | Quicker due to reduced powder-to-liquid ratio (specific time not quantified in this document, but stated as the reason for the change). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No "test set" in the sense of a clinical or in-vitro performance study with a specific sample size is detailed in this document. Substantial equivalence is often based on material characterization and comparison to predicate device specifications.
- Data Provenance: Not applicable for a separate "test set." The substantial equivalence claim is based on the known characteristics and regulatory history of the predicate device (Cemex System, K000943).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth in this context is established by regulatory bodies and standards for bone cements, and by the manufacturer's internal product specifications and chemical analysis, not by a panel of external experts evaluating a "test set."
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There is no "adjudication method" described for a test set in this document, as the submission relies on demonstrating intrinsic material properties and design similarity to a predicate.
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
- MRMC Study: Not applicable. This device is a bone cement, not an AI-powered diagnostic or decision support tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this submission is the established regulatory acceptance and performance of the legally marketed predicate device (Cemex System, K000943). For the new device, the ground truth is established through its chemical composition matching the predicate and the design change (powder-to-liquid ratio) leading to a specific, understood physical property modification (quicker setting time), which is presented as an accommodation for various application techniques rather than a new primary therapeutic effect. Basic material characterization (e.g., setting time, mechanical properties if tested) would form part of the technical information provided for such a change, although not detailed in this summary.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. This is not an AI/machine learning device.
§ 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.”