(64 days)
KYPHON® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. 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.
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 is a 510(k) premarket notification for the KYPHON® HV-R® Bone Cement. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own performance against specific acceptance criteria. Therefore, most of the requested information regarding a device performance study is not present in this document.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
This document does not establish new acceptance criteria or report specific device performance metrics from a new study. Instead, it claims substantial equivalence to previously cleared devices (KYPHON® HV-R® Bone Cement (K093828) and KYPHON® Xpede™ Bone Cement (K102397)). The "performance" being demonstrated here is that the new device shares fundamental scientific technology, equivalent implant materials, and sterilization methods with the predicates.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as new criteria. The inherent "acceptance criterion" is demonstrably substantially equivalent to predicate devices. | "The design features, device materials, chemical composition, device performance, packaging of the device materials, manufacturing and sterilization methods are substantially equivalent to the previously cleared KYPHON® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone Cement (K102397 S.E. 2/28/2011)." |
| Updated indication does not raise new safety/effectiveness issues. | "The updated indication does not raise new issues of safety or effectiveness." |
| Intended use identical to predicates. | "The intended use for KYPHON® HV-R® Bone Cement has not changed and is identical to the predicates..." |
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 document does not describe a new clinical or performance study with a test set. The claim is based on equivalence to existing devices.
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. No new test set or ground truth establishment by experts is described for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No new test set or adjudication method is described.
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 device is bone cement, not an AI-assisted diagnostic tool, 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 device is bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No new ground truth data is generated or used for this submission. The "ground truth" for the substantial equivalence claim resides in the prior clearance of the predicate devices based on their established performance and safety profiles.
8. The sample size for the training set:
Not applicable. This document pertains to a medical device (bone cement), not a machine learning model, so there is no concept of a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for this device submission.
In summary: The provided document is a 510(k) submission where the primary argument for clearance is substantial equivalence to already legally marketed predicate devices. It does not contain information about a new performance study with acceptance criteria, test sets, expert adjudication, or AI performance metrics. The information focuses on the technical characteristics and intended use being similar to the predicates, thereby concluding that the device does not raise new questions of safety or effectiveness.
§ 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.”