(199 days)
The OsteoFab Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. OPSCDs may be used to fit pre-planned virtual defects in the instance of single stage cranioplasty procedures.
An OsteoFab® Patient Specific Cranial Device (OPSCD) is built individually for each patient to correct defects in cranial bone. OPSCDs are constructed with the use of the patient's CT scan and computer aided design is used to determine the geometry of each implant. OPSCDs are built by laser sintering polyetherketone (PEKK) polymer in Oxford Performance Materials' OsteoFab® process. OPSCDs are attached to native bone with commercially available cranioplasty fixation systems and are a non-load bearing, single use device. OPSCDs are provided non-sterile.
Here's a breakdown of the acceptance criteria and study information for the OsteoFab Patient Specific Cranial Device (K180064), based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meeting existing product release criteria (for OPSCDs designed to fit pre-planned virtual defects). | All acceptance criteria were met, showing that OPSCDs used in single-stage cranial surgeries can successfully fill a defect that did not exist prior to the surgical procedure. OPSCDs were designed to fit pre-planned virtual defects and function as intended. |
| Successful shipment without damage to the devices. | All acceptance criteria were met. |
| Successful fixation of the implants onto the skull models. | All acceptance criteria were met. |
| Satisfactory fit on skull models. | All acceptance criteria were met. |
| Verification of the process of using OPSCDs for single-stage cranioplasty procedures (where the defect is not present at the time of the CT scan). | The End-to-End Simulation test successfully verified this process. Implants were designed to K121818 specifications, manufactured with the same process, inspected, shipped, and fit tested on skull models. Fit testing mimicked typical single-stage cranioplasties using commercially available marking guides. |
| The OPSCD is considered as safe and as effective as the predicate device and performs as well as the marketed predicate device. | Based on the results of the performance bench testing, this conclusion was reached. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: "Worst-case, representative cranial cases were selected for end-to-end simulation testing." The document does not specify a numerical sample size for the test set (number of cases/implants tested).
- Data Provenance: The study was a "bench test" simulation. The specific country of origin for the "worst-case, representative cranial cases" or skull models is not mentioned. It is a prospective test, as it was conducted to demonstrate the device's performance for this specific 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not mention the use of experts to establish ground truth for the bench testing. The "acceptance criteria included meeting existing product release criteria, successful shipment... successful fixation... and satisfactory fit." This suggests a set of objective, measurable criteria rather than expert consensus on subjective aspects.
4. Adjudication method for the test set
- Adjudication methods like 2+1 or 3+1 (typically used for expert reviews) are not applicable here, as expert ground truth establishment is not described for the bench test. The acceptance was based on meeting predefined objective criteria.
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
- No, an MRMC comparative effectiveness study involving human readers or AI assistance was not done. This device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable to the OsteoFab Patient Specific Cranial Device. It is a physical medical device, not an algorithm. The "design process" does use computer-aided design, but the "performance" discussed is related to the physical fit and functionality of the implant, not an algorithm's classification accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the bench testing was based on pre-defined, objective engineering and fit criteria ("existing product release criteria, successful shipment without damage, successful fixation, and satisfactory fit"). It's a form of objective performance criteria met in a simulated environment, rather than clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set
- The concept of a "training set" is not applicable in the context of this device's performance testing. This device is a custom-manufactured implant based on patient-specific CT data and a cleared manufacturing process, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for 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).