(132 days)
The Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects resulting from compression fracture, in order to provide stabilization of the collapsed vertebral body and pain relief. The following modifications are being made: Change to the formulation of the bone cement liquid component.
The provided text is a 510(k) premarket notification for a medical device: Vertebroplastic™ Radiopaque Bone Cement. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and testing results as would be typical for software or AI/ML-based devices.
Therefore, much of the requested information cannot be extracted directly from this document. The device is a physical bone cement, not a software or AI/ML device, so concepts like "test set," "training set," "ground truth experts," "adjudication method," and "MRMC study" are not applicable in the way they would be for digital health technologies.
However, I can extract information related to the device description and the basis of substantial equivalence.
Here's an attempt to answer the questions based on the provided text, noting where the information is not applicable or available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device based on "technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization)" and "intended use and indications for use."
Therefore, a table of acceptance criteria and reported device performance as commonly understood for digital health devices cannot be created directly from this text. The "performance" assessment is qualitative, comparing the modified device to its predicate.
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. This is a physical bone cement, not a software or AI/ML device that would undergo testing with a "test set" of data. The "study" mentioned is a comparison of characteristics to a predicate device.
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. The concept of "ground truth for a test set" is not relevant to the substantial equivalence review of this physical device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or a test set requiring adjudication in this context.
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. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The review focuses on material properties and chemical composition compared to a predicate, not on clinical outcomes or diagnostic accuracy requiring "ground truth" as typically defined for AI/ML devices.
8. The sample size for the training set
Not applicable. This is a physical bone cement, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of what can be extracted from the document regarding the "study" for this device:
The "study" or justification for this device meeting its criteria is a demonstration of substantial equivalence to previously cleared predicate devices.
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Predicate Devices:
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Basis of Substantial Equivalence:
- Technological Characteristics: Chemical composition, material properties, performance characteristics, manufacture, packaging, and sterilization. (The document mentions a "Change to the formulation of the bone cement liquid component" as the modification being made.)
- Intended Use and Indications for Use: The intended use and indications for use are stated to be similar (identical) to the predicate Vertebroplastic™ Radiopaque Bone Cement (K043406).
In essence, the "acceptance criteria" here implicitly are that the modified device's characteristics and intended use are sufficiently similar to the predicate devices such that it raises no new questions of safety or effectiveness. The "study" involves comparing the modified formulation against the established properties of the cleared predicate devices. Specific quantitative performance data from a clinical trial or bench test proving performance against strict numerical acceptance criteria are not presented in this summary, as is typical for 510(k)s seeking substantial equivalence for material modifications.
§ 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.”