(507 days)
CORTOSS® Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Cortoss is a composite material that functions as a strengthening agent for injection into vertebral bodies with compression fractures or weakened bone stock. This injectable, nonresorbable synthetic material is generically referred to as a resin-based, bis-glycidal dimethacrylate (Bis-GMA) composite.
The provided document is a 510(k) summary for the CORTOSS® Bone Augmentation Material. It describes the device, its indications for use, and claims substantial equivalence to predicate devices based on performance and clinical data. However, the document does not contain acceptance criteria for specific performance metrics, nor does it detail a study that proves the device meets specific acceptance criteria in the way an AI/ML device submission would.
The document refers to "Performance testing was conducted to ensure that Cortoss met its design specifications and performed in a manner substantially similar to the predicate devices. In all instances, Cortoss functioned as intended." and "Human clinical studies were conducted in over 500 patients at 43 clinical sites to demonstrate the safety and effectiveness of Cortoss for the treatment of vertebral compression fractures." These are general statements of testing and clinical studies but do not provide the detailed information requested for an AI/ML device.
Therefore, most of the requested information cannot be extracted from the provided text because it pertains to the evaluation of an AI/ML device, which this product is not.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text in terms of specific performance metrics with predetermined thresholds. The summary generally states that "Cortoss met its design specifications and performed in a manner substantially similar to the predicate devices."
- Reported Device Performance:
- "In all instances, Cortoss functioned as intended."
- Clinical studies (described below) were conducted "to demonstrate the safety and effectiveness of Cortoss for the treatment of vertebral compression fractures."
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size:
- U.S.: 40 patients in two pilot studies.
- U.S.: 256 patients (162 Cortoss: 94 control) in a prospective, randomized, multi-center, pivotal, single-blind pivotal study.
- E.U.: over 300 patients in multi-center, single-arm, prospective studies.
- Data Provenance:
- U.S. (pilot and pivotal studies)
- E.U.: France, Italy, Sweden, and the UK (multi-center, single-arm, prospective study).
- Retrospective or Prospective: All clinical studies mentioned were prospective.
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 text. The concept of "ground truth" established by experts is typically relevant for diagnostic AI/ML devices, not for a bone augmentation material where "ground truth" would relate to patient outcomes and treatment efficacy observed by clinicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the text. Adjudication methods are typically used to establish ground truth in diagnostic studies, which is not the primary focus of this device. The pivotal U.S. study was "single-blind," implying that patients were unaware of their treatment arm, but it doesn't describe ground truth adjudication.
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
- A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is not mentioned as this device is a bone augmentation material and not an AI/ML diagnostic tool meant to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (bone augmentation material), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a bone augmentation material, "ground truth" refers to patient outcomes related to safety and effectiveness. The clinical data collected in "over 500 patients" demonstrated "safety and effectiveness...for the treatment of vertebral compression fractures." This would involve clinical assessments, imaging, and patient-reported outcomes (e.g., pain reduction, functional improvement), which could be considered the "outcomes data" ground truth for this type of device.
8. The sample size for the training set
- Not applicable. This is a medical device (bone augmentation material), not an AI/ML algorithm that requires a training set. The clinical studies mentioned are for validation/demonstration of safety and effectiveness, not for training an algorithm.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of an AI/ML training set.
§ 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.”