(89 days)
The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
The DFine SPACE CpsXL Bone Cement is a self-curing polymethylmethacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. DFine SPACE CpsXL Bone Cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liguid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N,Ndimethyl-p-toluidine as a promoter.
The provided text describes a 510(k) premarket notification for the "DFine SPACE CpsXL Bone Cement." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting an effectiveness study with specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not present in this document.
Here's an breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device. It does not typically involve setting specific performance acceptance criteria for a new clinical study.
The document states: "Based upon the testing and comparison to the predicate device and commercially available bone cements, the DFine SPACE CpsXL Bone Cement, performs as intended and is substantially equivalent to the predicate device." This is a general conclusion of substantial equivalence, not a report against specific performance criteria.
2. Sample sized used for the test set and the data provenance
This information is not provided in the document. The testing mentioned ("Physical, chemical and mechanical testing") is likely bench testing or non-clinical, not a clinical study with a "test set" in the context of human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document, as there is no mention of a clinical study or human expert review to establish ground truth for a test set.
4. Adjudication method for the test set
This information is not provided in the document, as there is no mention of a clinical study or adjudication process.
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
There is no mention of an MRMC study or AI assistance in this document. The device is a bone cement, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a bone cement, not an algorithm.
7. The type of ground truth used
This information is not directly provided for a "test set" because no clinical effectiveness study is described. The "ground truth" for demonstrating substantial equivalence for this type of device typically revolves around established performance characteristics of the predicate device and relevant industry standards for material properties and biomechanical performance. The document only mentions "Physical, chemical and mechanical testing."
8. The sample size for the training set
This information is not applicable as the device is a bone cement and would not typically have a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable as the device is a bone cement and would not typically have a "training set" in the context of machine learning or AI.
In summary: The provided document is a 510(k) summary for a medical device (bone cement) that focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and mechanical testing. It does not include the details of a clinical effectiveness study with acceptance criteria, human reader performance, or ground truth establishment as would be expected for a diagnostic AI 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.”