(156 days)
SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
SmartSet HV Bone Cement is a high viscosity bone cement which is equally suited for both digital and syringe use. It has a short dough time (approximately 1 minute), a setting time of 9 -11 mins and consequently a long working time. These handling characteristics make SmartSet HV Bone Cement ideally suited for use with modern cementing techniques and clinical applications. The subject device is for single use only and is available in either 20g or 40g single unit packs and 10 ×1 unit dispenser cartons. Each single unit (device) pack consists of a polymeric powder component and a monomeric liquid component.
This 510(k) premarket notification for the SmartSet HV Bone Cement does not include a study demonstrating the device meets acceptance criteria. Instead, the submission focuses on establishing substantial equivalence to predicate devices already on the market.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this document. The manufacturer's basis for substantial equivalence is primarily through similarities in design, materials, and intended use, rather than a performance study against predefined acceptance criteria for the new device.
Here's a breakdown of the information that can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided in the document. The submission does not detail specific acceptance criteria for performance metrics (e.g., mechanical strength, setting time within a specified range) that the SmartSet HV Bone Cement was tested against. It primarily discusses its handling characteristics (short dough time, setting time of 9-11 mins, long working time) as descriptive features, not as metrics with pre-defined acceptance limits.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. Since a formal study demonstrating the device meets acceptance criteria against a defined test set is not presented, there is no information on sample size or data provenance for such a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable / Not provided. Ground truth establishment is relevant for studies where AI algorithms or diagnostic tools are being evaluated against expert opinion or known states. This document describes a medical device (bone cement), not such a tool.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically for evaluating diagnostic tools or AI assistance for human readers. This document is for a medical device (bone cement).
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- Not applicable / No. This phrase is typically used for AI/algorithm performance. While the bone cement itself is a "standalone" device, the concept of "standalone performance" in this context refers to an algorithm's performance without human interaction for diagnostic or interpretive tasks. The document does not describe such an evaluation for the bone cement.
7. Type of Ground Truth Used:
- Not applicable / Not explicitly defined in this context. For a bone cement, "ground truth" would generally refer to established scientific and engineering principles for material properties, biocompatibility, and clinical performance. The document implies compliance with these principles through similarity to predicate devices, but doesn't detail a specific "ground truth" used in a study to validate acceptance criteria.
8. Sample Size for the Training Set:
- Not applicable / Not provided. Training sets are relevant for machine learning models. This document is for a medical device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided.
Summary of what the document does provide regarding the device and its justification:
The document establishes substantial equivalence by:
- Device Name: SmartSet HV Bone Cement
- Intended Use: Fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for various conditions (rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction, revision of previous arthroplasty).
- Design and Materials: High viscosity PMMA Bone Cement, equally suited for digital and syringe use. Consists of a polymeric powder component and a monomeric liquid component.
- Handling Characteristics: Short dough time (approx. 1 minute), setting time of 9-11 minutes, long working time.
- Predicate Devices:
- DePuy 1 Bone Cement (P960001/Supplement 3)
- Palacos R40 Bone Cement (P810020/Supplement 3)
- Basis for Equivalence: Similarities in design, materials, and intended use to the predicate devices. The document implies that because these characteristics are similar to already cleared devices, direct performance studies against new acceptance criteria for the SmartSet HV Bone Cement are not required for 510(k) clearance, as long as it meets general safety and efficacy standards based on the predicate.
§ 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.”