(59 days)
OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.
The provided text is a 510(k) summary for a medical device called OSSDSIGN Cranial PSI. It outlines the device's characteristics and its substantial equivalence to a predicate device. However, it does not include the detailed information about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies that would be necessary to fully answer your request.
The document states that "Nonclinical tests demonstrate that Cranial PSI is as safe and effective as its legally marketed predicate device," and mentions "in vivo studies show biocompatibility, adequate resorption rate and osteoconduction." but doesn't provide the acceptance criteria for these.
Based on the provided text, I can only provide the following information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | In vivo studies show biocompatibility |
| Adequate Resorption Rate | In vivo studies show adequate resorption rate |
| Osteoconduction | In vivo studies show osteoconduction |
| Safety and Effectiveness | Nonclinical tests demonstrate as safe and effective as predicate device |
Note: The document implies these as critical performance aspects, but does not explicitly state quantitative acceptance criteria or detailed performance metrics.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: 52-week sheep implantation study. The exact number of sheep is not specified.
- Data Provenance: In vivo (animal study - sheep). The country of origin is not specified.
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 document. The study mentioned is an in vivo implantation study, which typically relies on pathological analysis rather than expert human interpretation of imaging.
4. Adjudication method for the test set:
This information is not provided in the document.
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 information is not provided in the document. The device, OSSDSIGN Cranial PSI, is a patient-specific implant for cranial reconstruction, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. As mentioned, the device is an implant, not an algorithm.
7. The type of ground truth used:
For the in vivo implantation study, the ground truth would typically be established through histopathological analysis of tissue samples from the implanted area to assess biocompatibility, resorption, and osteoconduction.
8. The sample size for the training set:
This information is not provided in the document. The device is a physical implant, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not provided in the document, as it's not relevant to this type of device.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).