(76 days)
CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is a in-syringe vacuum mixing system prepacked with bone cement powder. The subject device is for single use and helps control monomer fumes during the preparation of the cement. The subject device pre-packed with DePuy 1 Bone Cement is available in a single 60g or 100g unit and also in unit packs of 5. Each single unit (device) pack consists of 1) syringe barrel filled with bone cement powder; 2) central mixing rod; 3) locking plate; 4) filter/vacuum hose; 5) vacuum pump adapter; 6) monomer cartridge with glass ampoules containing bone cement liquid; and 7) plastic disposal bag.
The provided text describes a 510(k) premarket notification for a bone cement dispenser, the CEMVAC Ultra pre-packed with DePuy 1 Bone Cement. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report with specific performance metrics against those criteria.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device conformance cannot be fully addressed from the provided text.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a tabular format. Instead, it relies on demonstrating comparable performance to predicate devices. The implicit acceptance criterion is that the new device performs at least as well as, or equivalently to, the predicate devices in terms of key mechanical properties of the bone cement.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compatibility and Stability of DePuy 1 Bone Cement powder with CEMVAC Ultra device | "DePuy 1 Bone Cement powder has been found to be compatible and stable in the CEMVAC Ultra device." |
| Compressive Strength of mixed cement (compared to predicate/traditional mixing) | "Comparable DePuy 1 Bone Cement compressive... strengths were obtained for bowl and spatula and CEMVAC Ultra mixed cements." (Implies the strength is not significantly worse than the existing, approved mixing method or predicate devices). |
| Flexural Strength of mixed cement (compared to predicate/traditional mixing) | "Comparable DePuy 1 Bone Cement... flexural and impact strengths were obtained for bowl and spatula and CEMVAC Ultra mixed cements." (Implies the strength is not significantly worse than the existing, approved mixing method or predicate devices). |
| Impact Strength of mixed cement (compared to predicate/traditional mixing) | "Comparable DePuy 1 Bone Cement... flexural and impact strengths were obtained for bowl and spatula and CEMVAC Ultra mixed cements." (Implies the strength is not significantly worse than the existing, approved mixing method or predicate devices). |
| Monomer Fume Control | The device "helps control monomer fumes during the preparation of the cement." (This is a functional benefit described, but no specific quantitative acceptance criteria or performance metrics related to fume reduction are provided in this summary.) |
Study Information
The document describes testing focused on the mechanical properties of the bone cement when prepared using the CEMVAC Ultra system compared to traditional methods ("bowl and spatula") and, implicitly, to predicate devices. This testing is used to support the claim of substantial equivalence.
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Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes (number of tests, number of cement batches, or number of devices) used for the compatibility, stability, compressive, flexural, or impact strength testing.
- Data Provenance: The testing was conducted internally by DePuy Orthopaedics, Inc. and DePuy International Ltd, as they are the manufacturers/sponsors. The country of origin for the data is not explicitly stated beyond the manufacturing locations (Indiana, USA, and Blackpool, England). The nature of the testing (e.g., lab bench testing of material properties) implies it is conducted in a prospective manner to evaluate the new device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device. The "ground truth" for mechanical property testing of bone cement is established through standardized material testing procedures (e.g., ISO standards for bone cements), not through expert consensus or interpretation of images. The results of these tests are objective measurements.
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Adjudication method for the test set:
- This question is not applicable. Since the "ground truth" is based on objective material testing measurements rather than expert interpretations, an adjudication method for reconciling expert opinions is not relevant.
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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:
- This is not applicable. An MRMC study is relevant for diagnostic imaging devices involving human interpretation (readers) and clinical cases. This device is a bone cement mixing and dispensing system, not an imaging or AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is a physical medical device, not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation lies in standardized material science testing and physical characterization of the bone cement properties (compressive, flexural, impact strengths, and stability/compatibility) as defined by relevant industry standards (e.g., ASTM, ISO standards for bone cements, though not explicitly cited in the summary).
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The sample size for the training set:
- This is not applicable. There is no "training set" in the context of this device, as it is not an AI/ML device that requires machine learning training data.
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How the ground truth for the training set was established:
- This is not applicable for the same reason as point 7.
§ 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.”