(123 days)
OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.
OSSDSIGN Craniopluq003 is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators.
Here's an analysis of the provided text regarding the acceptance criteria and study for the OSSDSIGN Cranioplug.
Upon reviewing the provided FDA 510(k) summary, it's important to note that this document describes a medical device (a burr hole cover) and its non-clinical testing, not a diagnostic AI/ML device. Therefore, many of the requested categories, such as data provenance, expert adjudication, MRMC studies, standalone performance with ground truth for AI, etc., are not applicable as this is not an AI/ML product.
The document focuses on demonstrating the substantial equivalence of the "OSSDSIGN Cranioplug" (subject device) to a legally marketed predicate device ("OSSDSIGN Cranioplug") through bench and biological performance testing.
Acceptance Criteria and Device Performance for OSSDSIGN Cranioplug
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied/Direct) | Reported Device Performance (OSSDSIGN Cranioplug003) |
|---|---|---|
| Energy absorption, flap reattachment | Sustained deformation energy comparable to predicate device. | Sustained deformation energy of 0.06 J (same as predicate). |
| Flap Fixation Dynamic Load | No flap deformation after simulating 50 years of sleep with hourly repositioning, comparable to predicate device. | No flap deformation. All Cranioplug models tested. |
| Cytotoxicity | No evidence of causing cell lysis or toxicity (ISO 10993-5 compliant). | No evidence of causing cell lysis or toxicity. |
| In vivo implantation (Biocompatibility) | Biocompatibility, adequate resorption rate, and osteoconduction (ISO 10993-6 compliant). | In vivo studies show biocompatibility, adequate resorption rate and osteoconduction. |
| Mechanical Performance | Meet mechanical performance for safety and efficacy (implicitly comparable to predicate). | The device provides mechanical performance for safety and efficacy. |
| Biologic Performance | Meet biologic performance for safety and efficacy (implicitly comparable to predicate). | The device provides biologic performance for safety and efficacy. |
Note: The acceptance criteria are largely implied based on establishing substantial equivalence to the predicate device. The goal is to demonstrate that the new device performs as safely and effectively as the predicate.
Regarding AI/ML Specific Questions (Not Applicable to this Device):
The following questions are not applicable to the OSSDSIGN Cranioplug as it is a physical medical implant (burr hole cover), not an AI/ML diagnostic or assistive device.
2. Sample size used for the test set and the data provenance: Not applicable. This involves physical device testing, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device involves expert annotations; for this physical device, "ground truth" is established by physical measurements and biological assays.
4. Adjudication method for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, "ground truth" is derived from standardized physical testing methods (e.g., universal testing machine, dynamic load simulation) and biological assays (cytotoxicity, in vivo implantation results/histology).
8. The sample size for the training set: Not applicable. This device does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Study (Non-Clinical for a Physical Device):
The study described is a non-clinical evaluation to demonstrate the substantial equivalence of the OSSDSIGN Cranioplug (subject device) to its predicate device (an earlier version of the Cranioplug, K140309).
Key aspects of the study:
- Objective: To show that the subject device is as safe and effective as the predicate device, despite minor differences in materials (Titanium grade) and dimensions (titanium thickness, additional size).
- Methodology: Bench testing and biological performance testing.
- Bench Testing:
- Energy absorption, flap reattachment: Devices installed in an anatomical model and tested in a Universal Testing Machine to a 2mm displacement to determine deformation energy.
- Flap Fixation Dynamic Load: Three Cranioplugs fixating a flap in an anatomical model, tested with an 8.5 kg head weight simulating 50 years of sleep with hourly repositioning.
- Biological Performance:
- Cytotoxicity: ISO elution method (ISO 10993-5) using extracts in IX MEM at 37°C for 24 hours.
- In vivo implantation: A 52-week sheep implantation study, compliant with ISO 10993-6.
- Bench Testing:
- Results: The subject device met the performance standards demonstrated by the predicate device in all tests.
- Energy absorption was identical to the predicate (0.06 J).
- No flap deformation observed under dynamic loading.
- No evidence of cytotoxicity.
- Biocompatibility, adequate resorption rate, and osteoconduction were observed in vivo.
- Conclusion: Nonclinical tests demonstrate that OSSDSIGN Cranioplug003 is as safe and effective as its legally marketed predicate device.
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).