(119 days)
Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty 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. Pathologic 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® Xpede™ 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.
The provided text is a 510(k) summary for a medical device, Kyphon® Xpede™ Bone Cement. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data to support substantial equivalence.
However, the questions posed (regarding acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment, specifically for an AI/ML powered device) are not applicable to the information provided in this document.
This document pertains to a Polymethylmethacrylate (PMMA) bone cement, which is a material used in surgical procedures. It is a traditional medical device, not an AI/ML powered diagnostic or assistive technology. The "acceptance criteria" and "study" described in the document relate to the physical and chemical properties of the bone cement, its biocompatibility, and its performance in cadaveric studies and clinical literature review to demonstrate safety and efficacy for its intended use, primarily by comparing it to already approved predicate devices.
Therefore, I cannot answer the questions as they are phrased because the information requested is for AI/ML device validation, which is not what this document describes.
To directly address the request, if we were to reinterpret the provided text in the context of "acceptance criteria" and "study" for this specific bone cement device, here's what could be extracted, noting that it will not fit the AI/ML framework:
Reinterpretation for a PMMA Bone Cement Device (Not AI/ML)
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria in a formal table or specific reported device performance metrics beyond qualitative statements about safety and efficacy. The study aims to show "substantial equivalence" to predicate devices, rather than meeting predefined numerical thresholds for a novel AI algorithm.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicates) | Reported Device Performance (from text) |
|---|---|
| Safe and efficacious for indicated uses | Retrospective clinical literature review of 5 articles examining PMMA bone cement in sacral vertebroplasty/sacroplasty procedure found clinical outcomes on 462 patients demonstrating safety and efficacy. |
| Extravasation rate comparable to published literature | Cadaver study showed calculated extravasation rate for Kyphon® Xpede™ Bone Cement was within the extravasation rate range of published sacroplasty literature. |
| Equivalent implant materials, sterilization methods, bacterial endotoxin testing, and pyrogen limits as predicate devices. | Stated as having "same or similar indications for use, intended use, materials and fundamental scientific technology as the predicates." Utilizes "equivalent implant materials, sterilization methods and bacterial endotoxin testing applying the same 20 EU/ml pyrogen limit specifications utilizing the gel clot test method as the predicate." |
2. Sample sizes used for the test set and the data provenance
- Test set (Clinical Literature Review): 5 articles reviewed, covering clinical outcomes for 462 patients.
- Test set (Cadaver Study): The document states "A cadaver study... was completed." It does not specify the number of cadavers or specific test cases.
- Data Provenance: Not explicitly stated, but clinical literature typically includes studies from various global regions. The cadaver study would have been performed by the manufacturer or a contracted lab. It is retrospective for the literature review and prospective for the cadaver study within the context of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cadaver Study: "The procedure and imaging review was performed by trained physicians." The exact number and specific qualifications (e.g., years of experience, specialty) are not provided.
- Clinical Literature Review: Ground truth is established by the findings and conclusions of the published clinical studies themselves. The experts involved would be the authors and peer reviewers of those articles.
4. Adjudication method for the test set
- Cadaver Study: Not explicitly described. It's stated that "trained physicians" performed the review, but the method for resolving discrepancies or reaching consensus (if multiple physicians were involved per case) is not detailed.
- Clinical Literature Review: The 'adjudication' would be inherent in the peer-review process of the scientific literature and the interpretation by the device manufacturer's team.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, this is not an MRMC study. This type of study is specifically relevant to diagnostic imaging systems or AI tools where human readers interpret images with or without AI assistance. The studies performed here are a literature review of clinical outcomes and a cadaveric study of the bone cement's physical behavior (e.g., extravasation).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical material (bone cement), not an algorithm or software. "Standalone performance" in this context would refer to the in-vitro and in-vivo properties of the cement itself, which were evaluated through material testing and the cadaver study.
7. The type of ground truth used
- Clinical Literature Review: The "ground truth" is derived from the reported clinical outcomes in peer-reviewed publications. This is a form of outcomes data and expert clinical assessment as reported in those studies.
- Cadaver Study: The "ground truth" for extravasation was established by direct observation and imaging review by trained physicians during the physical testing in cadaveric models.
8. The sample size for the training set
- Not applicable. This device is a material, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See point 8)
§ 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.”