(125 days)
NP Cements / NP Cements System are intended to be used for the fixation of artificial joint prostheses to the host bone.
The NP Cements and NP Cements System are PMMA, radiopaque bone cements, containing color additives to impart a green color, designed for the fixation of prosthesis to the living bone. The devices contain the same individual chemical constituents, but are supplied in different ways:
- NP Cements are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use.
- NP Cements System stores the powder and liquid components separately within a closed syringe-like device that serve as both mixing chamber and extrusion device. The device is provided with a vacuum tube and a cannula with the pusher rod. The product is packaged in a double blister, the external blister is sealed with a Tyvek lid, and then placed in an aluminum bag.
The devices are sold disposable and sterile. The NP Cements are available in a low and high viscosity version. The NP Cements System are also available in a low and high viscosity version.
This document is a 510(k) Summary for a medical device called "NP Cements / NP Cements System." It focuses on demonstrating that the new device is substantially equivalent to a previously cleared predicate device, "Tecres Cemex Isoplastic."
Here's an analysis of the acceptance criteria and study information provided, focusing on what is present and what is not present given the nature of this submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a typical quantitative pass/fail table format, as one might find for a software algorithm or diagnostic test. Instead, it demonstrates performance by comparing various characteristics of the new device to the predicate device and by stating that the device meets the requirements of the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA."
Here's a breakdown of the performance aspects mentioned:
| Characteristic/Requirement | Reported Device Performance (NP Cements / NP Cements System) | Equivalence/Compliance |
|---|---|---|
| Indications for Use | "NP Cements /NP Cements System are intended to be used for the fixation of artificial joint prostheses to the host bone." | Same as predicate device (Tecres Cemex Isoplastic). |
| Main Components | Polymethylmethacrylate (PMMA), Methylmethacrylate (MMA), Barium Sulphate | Same as predicate device. |
| Other Components | Benzoyl peroxide, N,N-Dimethyl-p-toluidine, Hydroquinone | Same as predicate device. |
| Color Additives | Pigments (FD&C Blue No.1 and FD&C Yellow No.5) | Different from predicate (predicate had none). |
| Mixing/Application | Manual; Syringe-like device (System version) | Same for Manual; Different for System version (predicate was manual only). |
| Powder Sterilization Method | Gamma-ray irradiation (manual); Ethylene Oxide (system) | Same for manual; Different for system (predicate was Ethylene Oxide). |
| Sterility Assurance Level (SAL) - Powder | 10^-6 | Same as predicate device. |
| Liquid Sterilization Method | Filtration | Same as predicate device. |
| SAL – Liquid | 10^-3 | Same as predicate device. |
| Shelf Life | 2 years | Different from predicate (predicate was 5 years). |
| Biocompatibility | Performed to show device materials are safe, biocompatible and suitable for intended use, considering ISO 10993 and FDA Draft Guidance. | Claimed to be safe, biocompatible, and suitable for intended use. |
| Mixing and application characteristics (e.g., dough time, setting time) | Testing performed in accordance with special controls guidance document. | Claimed to be substantially equivalent and meet special controls guidance. |
| Chemical composition (e.g., residuals, molecular weight and polymer structure, glass transition temperature) | Testing performed in accordance with special controls guidance document. | Claimed to be substantially equivalent and meet special controls guidance. |
| Thermal properties (e.g., polymerization temperature) | Testing performed in accordance with special controls guidance document. | Claimed to be substantially equivalent and meet special controls guidance. |
| Mechanical properties (e.g., modulus and flexural properties, static compression and bending, fatigue testing, fracture toughness and viscoelasticity) | Testing performed in accordance with special controls guidance document. | Claimed to be substantially equivalent and meet special controls guidance. |
| Sterilization Cycles | Validated following international standards. | Claimed to be validated. |
| Shelf Life Stability | Established in ongoing stability studies. | Claimed to be established. |
Important Note: This type of 510(k) submission for a physical medical device (bone cement) does not involve the same kind of performance metrics (sensitivity, specificity, AUC) or study designs (e.g., expert reads, MRMC studies) as AI/ML software or diagnostic tests. The "performance data" here refers to the physical and chemical properties of the material itself.
For the following points (2-9), most are not applicable or not provided in this specific document because it describes a physical material, not an AI/ML or diagnostic device that relies on human interpretation of data/images.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided: This document describes laboratory testing of a bone cement, not a clinical study on a test set of data. The "tests" are on batches of the material.
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/Not provided: This is not a diagnostic device where "ground truth" is established by human experts. The ground truth for material properties is established through standardized laboratory measurements and analytical chemistry.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided: Adjudication methods are relevant for expert consensus on ambiguous medical cases, which is not relevant for bone cement material properties.
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/Not provided: This is a physical bone cement, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided: This is a physical bone cement, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For material properties: The "ground truth" is established through standardized physical, chemical, and mechanical testing methods as outlined in the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement." This would involve precise measurements (e.g., tensile strength, setting time, polymerization temperature) using calibrated equipment, not expert consensus or pathology in a clinical sense.
8. The sample size for the training set
- Not applicable/Not provided: There is no "training set" in the context of material characterization for a physical medical device. The "training" would be the initial formulation and manufacturing process development, followed by quality control testing of manufacturing batches.
9. How the ground truth for the training set was established
- Not applicable/Not provided: As above, there isn't a "ground truth for a training set" as understood in AI/ML development. The "ground truth" for the material's properties is inherent in its physical and chemical nature, measured against established industry and regulatory standards.
§ 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.”