(71 days)
Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 - Slow Set) to provide radiopacity for imaging purposes.
Parallax™ Tracer Radiopaque Particles
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Characteristic) | Reported Device Performance |
|---|---|
| Substantially equivalent to Cranioplastic alone | Demonstrated to be substantially equivalent to Cranioplastic alone |
2. Sample size used for the test set and data provenance
The provided text does not include information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The non-clinical test results section broadly states "Performance testing demonstrated...", without specific details on the test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text does not include information regarding the number or qualifications of experts used to establish ground truth for a test set. This type of information is typically related to studies involving human interpretation or performance, which is not detailed here.
4. Adjudication method for the test set
The provided text does not include any information about an adjudication method for a test set.
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 was not performed or described in the provided text. The device is "Parallax™ Tracer Radiopaque Particles," an additive to a cranioplasty material, not an AI or diagnostic imaging device that would typically involve human reader performance studies in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical additive (radiopaque particles) to a cranioplastic material, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to performance studies of diagnostic algorithms is not directly applicable to this device. The "ground truth" in this context would likely refer to objective measurements of the functional characteristics of the combined material (Cranioplastic and Tracer Particles) compared to Cranioplastic alone. The text implies a comparison of "functional characteristics" to establish substantial equivalence.
8. The sample size for the training set
The provided text does not include information about a training set since this is not an AI or machine learning device.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).