(238 days)
OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.
Cranioplug consists of a titanium (Ti) mesh plate with a biocompatible ceramic. Cranioplug implants are sized to mate with standard 14 mm burr holes common in surgical procedures. Each implant includes the completely formed Ti and fully cured CaP components in one device.
The document does not describe acceptance criteria for an AI/ML powered device, but rather for a Burr Hole Cover (OssDsign Cranioplug). The sections of the document describing testing (pages 4 and 5) outline bench performance characteristics and material composition tests for the OssDsign Cranioplug and its predicates.
Therefore, many of the requested fields are not applicable (N/A) as they relate to software performance evaluation, not a physical medical device.
Here's an interpretation based on the provided document for the OssDsign Cranioplug:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Compressive Strength | Comparable to predicate (Stryker Injectable Cement) | Both devices showed compressive strength of approximately 19 MPa. |
| Falling Load | Comparable to predicate (Stryker QuikFlap) withstanding loads below 30 cm drop height. (Implied: must sustain a falling load equivalent to or better than predicate) | Subject device and QuikFlap sustained falling loads below 30 cm. |
| 12 Hour Load | No plastic deformation after 12 hours under 7.5 kg load, comparable to predicate (Stryker QuikFlap). (Implied: must not deform under prolonged load) | No deformation of subject device or QuikFlap. |
| Dissolution Test | Dissolve less than 25% after 6 weeks, comparable to predicate (Stryker Injectable Cement). | Subject device and Stryker Injectable Cement dissolved less than 25% after 6 weeks. |
| Cytotoxicity | No evidence of causing cell lysis or toxicity. | No evidence of causing cell lysis or toxicity. |
| Sensitivity | Classified as a nonirritant compared to control articles. | Classified as a nonirritant as compared to the sponsor provided control article and nonirritant as compared to the negative control article. (This implies non-irritancy is the acceptance criteria). |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample sizes for each test. For the physical properties (compressive strength, falling load, 12-hour load), small sample sizes of devices are typical. For the biological tests (dissolution, cytotoxicity, sensitivity), multiple samples would be tested to ensure consistency.
- Data Provenance: Not explicitly stated, but these are laboratory bench and animal (rabbit) tests conducted for a medical device. It is generally understood to be prospective data generated specifically for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
N/A - The "ground truth" for these tests is based on objective measurements and established scientific standards (e.g., ISO standards, material properties, biological responses) rather than expert consensus on interpretive tasks. The "experts" would be the scientists and engineers conducting and analyzing these tests.
4. Adjudication Method for the Test Set
N/A - Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when discrepancies arise in expert interpretations of medical images or diagnoses, not for objective physical or biological bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A - This type of study is for evaluating the performance of diagnostic or screening devices, often involving human readers interpreting outputs (e.g., images). The OssDsign Cranioplug is a physical implantable device, not an interpretive one.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done
N/A - This concept applies to AI/ML algorithms. The OssDsign Cranioplug is a physical medical device.
7. The Type of Ground Truth Used
- Bench Performance Tests (Compressive Strength, Falling Load, 12 Hour Load): Objective physical measurements against established engineering principles and comparison to predicate device performance.
- Biological Tests (Dissolution, Cytotoxicity, Sensitivity): Objective biological responses measured against established ISO standards and comparison to control articles.
8. The Sample Size for the Training Set
N/A - "Training set" refers to data used to train AI/ML algorithms. The OssDsign Cranioplug is a physical device and does not involve AI/ML.
9. How the Ground Truth for the Training Set was Established
N/A - As above, this is not applicable to a physical medical 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).