(63 days)
KYPHON™ HV-RTM Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty or vertebroplasty procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
Kyphon™ HV-R™ Bone Cement is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.
This document describes the premarket notification (510(k)) for the KYPHON™ HV-R™ Bone Cement. It's important to note that this device is a medical implant (bone cement), and therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical and literature-based performance validations, not studies involving AI or imaging software performance.
The provided text does not contain information related to an AI/ML device, nor does it discuss acceptance criteria and studies demonstrating AI performance. Instead, it focuses on the substantial equivalence of a bone cement product based on its material properties, indications for use, and a review of clinical literature and cadaveric testing.
Therefore, I cannot extract the information required for the prompt's specific questions regarding AI/ML device performance and testing (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone AI performance, training set details).
The information that can be extracted relevant to the bone cement device is as follows:
Acceptance Criteria and Device Performance (for the Bone Cement):
The document doesn't present an explicit "acceptance criteria table" in the typical sense for mechanical or biological properties with specific numerical targets. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, supported by:
- Technological Characteristics Comparison: The subject device has "the same or similar indications for use, intended use, materials and fundamental scientific technology" as the predicates. This implies that the performance characteristics (e.g., strength, setting time, radiopacity, biocompatibility) are expected to be similar or within acceptable ranges.
- Performance Data:
- Clinical Literature Review: Examination of potential benefits and associated risks of using PMMA bone cement in sacral vertebroplasty/sacroplasty procedure.
- Cadaver Study: Evaluation of extravasation behavior during sacroplasty procedures, aiming to minimize risk. The calculated extravasation rate with the new device was "within the extravasation rate range of the predicate."
Summary of Device Performance (as stated in the document):
| Performance Aspect | Reported Device Performance |
|---|---|
| Clinical Efficacy/Safety (Literature Review) | Five articles reviewed provided clinical outcomes of 462 patients demonstrating safety and efficacy of PMMA bone cement when used in the sacrum. |
| Extravasation Behavior (Cadaver Study) | Extravasation rate with the KYPHON™ HV-R™ Bone Cement was within the extravasation rate range of the predicate. Surgical procedure steps and imaging needed to minimize extravasation risk were defined. |
Regarding the AI/ML specific questions from the prompt:
Since this document is about bone cement, not an AI/ML device, none of the following AI/ML-specific questions can be answered from the provided text:
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.”