Search Results

KyphX® 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 balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemagioma and giant cell tumor.

Like the predicate devices, KyphX® HV-RTM Bone Cement is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/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.

The provided text is a 510(k) Premarket Notification Summary for a medical device (KyphX® HV-R™ Bone Cement) seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for an AI/ML medical device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Chemical Composition: Comparing the ingredients and their percentages.
• Mechanical Tests: Verifying equivalence as defined by ISO 5833:2002 ("Implants for Surgery - Acrylic resin cements").
• Biocompatibility: Meeting requirements for "Implant, Tissue/Dentin/Bone, Permanent Contact" as described in FDA Blue Book Memorandum #G95-1 and verified as substantially equivalent to the predicate device per ISO-10993.
• Sterilization: Describing sterilization methods and Sterility Assurance Levels (SAL).
• Intended Use: Showing that the intended use is substantially equivalent to predicate devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or not explicitly detailed in this type of submission, as it's not a study validating AI performance. The "acceptance criteria" here are implicitly the FDA's requirements for demonstrating substantial equivalence for this specific type of device.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "mechanical tests" and "biocompatibility tests" but does not detail the sample sizes or data provenance for these tests. It indicates the tests were done "in direct comparison" 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)

This is not applicable to this type of device submission. The "ground truth" here is defined by objective engineering and biocompatibility standards (ISO 5833:2002, ISO 10993, FDA G95-1 Memorandum) rather than expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. The assessment for substantial equivalence for this device is based on laboratory-derived physical and chemical properties and biocompatibility, not on human interpretation or adjudication processes typical for diagnostic AI devices.

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

This is not applicable. This is a bone cement device, not an AI/ML diagnostic tool, so no MRMC study would be performed for its clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a material-based medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by international standards and regulatory guidelines for bone cements and medical device biocompatibility, specifically:

• ISO 5833:2002 ("Implants for Surgery - Acrylic resin cements") for mechanical properties.
• ISO-10993 ("Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") for biocompatibility.
• FDA Blue Book Memorandum #G95-1 for biocompatibility requirements for permanent contact implants.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

This is not applicable. As it's not an AI/ML device, there is no training set or associated ground truth establishment process in the context of machine learning.

Ask a specific question about this device