(87 days)
The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.
The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common cranial burr holes, and its upper platform is in contact with the skull surface. It avoids the anti-cosmetic postoperative skin concavities. It does not require any specific surgical instrument for its handling or implantation. It is provided sterile, for a single use.
Two different sizes are presented:
- . FC050300, large size, for the most common burr holes, made with standard perforators (diameters 14/11 mm or 13/9 mm1).
- . FC050400, small size, for small burr holes (diameters from 12 mm to 10 mm), made with spherical drills.
The device functions like a clamp. An upper (epicranial) and a lower (subcranial) platform, joined by two cable ties, are tightened together with the help of non-implantable elements (handle and applier) and cover the burr hole.
The provided document is a 510(k) premarket notification for a medical device called "Cranial COVER". This type of document is and does not feature studies in the traditional sense you're asking about (e.g., studies for AI algorithms). The document instead reports on mechanical and performance testing to demonstrate substantial equivalence to predicate devices, which is a common regulatory pathway for medical devices.
Therefore, many of the requested categories for AI/clinical studies are not applicable to this document. I will extract the information that is present regarding the device's acceptance criteria and the engineering tests performed.
No information is available regarding:
- Sample sizes used for test set or data provenance in the context of an AI study.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Standalone (algorithm only) performance.
- Sample size for a training set.
- How ground truth for a training set was established.
Acceptance Criteria and Device Performance (Mechanical and Performance Testing)
The "Cranial COVER" is a physical medical device (burr hole cover), not an AI algorithm. Therefore, the "acceptance criteria" discussed are design specifications and performance metrics related to mechanical function, biomechanics, and biocompatibility, as opposed to diagnostic performance metrics like sensitivity, specificity, or AUC.
Here's a table summarizing the acceptance criteria (stated as "Goal" or implied by standard adherence) and the reported device performance from the "Discussion of mechanical and performance testing" section:
| Test | Acceptance Criteria / Goal | Reported Device Performance / Conclusion |
|---|---|---|
| A. Functional testing | ||
| A.1. Functionality of implantable parts (Breaking force of ratchet mechanism) | Determine the breaking force of the ratchet mechanism of the device's upper platform. (Implied: meeting breaking force specifications) | "All tested samples meet the specifications. Functionality of the devices is demonstrated. Results are comparable to the Cranial LOOP XL predicate device." |
| A.2. Functionality of the handle (Breaking force of ratchet mechanism) | Determine the breaking force of the ratchet mechanism between the handle and the lower platform (and cable ties). (Implied: meeting breaking force specifications) | Results not explicitly detailed in the table, but the overall conclusion for mechanical and performance testing states: "Mechanical and performance testing confirms that Cranial COVER performs as intended and that it is substantially equivalent to the predicate devices." |
| B. Biomechanical testing | ||
| B.1. Push-in (Resistance to sinking under pressure) | Simulate patient's pressure on the device and determine the force required to sink the devices up to a maximum of 2 mm. (Implied: adequate resistance, not sinking beyond 2mm under specified force) | "All tested samples meet the specifications. The devices have an adequate biomechanical behavior at push-in and pull-out. Results are better than those obtained with the Cranial LOOP XL predicate device. Both devices must be able to resist pull-out and push-in forces appropriately. However, the use of Cranial LOOP XL as a fixation element for the bone flap causes that these devices are subject to different force intensities. In general, it is reasonable to say that the Cranial COVER is subject to a less demanding situation than Cranial LOOP XL; the results obtained confirm this point." |
| B.2. Pull-out (Resistance to dislodgement) | Simulate pulling forces during implantation or caused by increased ICP, to determine the maximum force that 1) the device can withstand before sliding out from the burr hole, or 2) the handle can withstand before breaking. (Implied: retention under specified pull-out forces) | "All tested samples meet the specifications. The devices have an adequate biomechanical behavior at push-in and pull-out. Results are better than those obtained with the Cranial LOOP XL predicate device. Both devices must be able to resist pull-out and push-in forces appropriately. ... In general, it is reasonable to say that the Cranial COVER is subject to a less demanding situation than Cranial LOOP XL; the results obtained confirm this point." |
| C. Cadaver testing | ||
| Evaluation of simulated implantation in a clinical environment | Evaluation of the devices when simulating their implantation on the skull of patients in a clinical environment, following the procedures described in the products' Instructions for Use. (Goal: demonstration of correct implantation, absence of danger, fast/instrument-free implantation, proper profiles, stability, complete covering, ease of removal) | "Correct implantation is verified in a simulated real-life situation. The devices show adequate performance and safety. The results demonstrate that the Cranial COVER is equivalent, in terms of performance and safety and to the relevant extent, to the predicate device Cranial LOOP XL." |
| Overall Conclusion | Perform as intended and be substantially equivalent to predicate devices, particularly Cranial LOOP XL. | "All the setups applied in the tests simulate clinical service conditions and, in some cases, the worst case scenario. The results of the testing confirmed that both sizes of the Cranial COVER will perform as intended in the clinical setting, and that they are comparable to the predicate devices particularly to the Cranial LOOP XL (included in K132044)." |
Additional Applicable Information from the Document:
The document states:
- No clinical testing was deemed necessary to support substantial equivalence to predicate devices.
- Biocompatibility: The implantable parts are made of PEEK, which is "well established as an implantable thermoplastic material." The non-implantable parts are made of "biocompatible polymers." This is a qualitative assessment of material suitability.
- Sterility: The sterilization method is identical to the predicate device, Cranial LOOP XL, and the results are comparable. This implies meeting ISO 11137-1/2, ISO 11737-1/2 standards for sterilization.
- Standards Applied: The device adheres to several ISO standards related to sterilization (ISO 11137-1:2006, ISO 11137-2:2013, ISO 11737-1:2006, ISO 11737-2:2009) and biological evaluation of medical devices (ISO 10993-1:2009). Adherence to these standards serves as a form of acceptance criteria.
§ 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).