(27 days)
Aesculap's CranioFix 2 System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
The CranioFix 2 Clamp System consists of sterile, titanium implants (Clamps) and associated manual instruments. The Clamps are available in three sizes: 11mm, 16mm, and 20mm. The clamp consists of two concave disks which are connected with a pin through the center. The pin is securely attached to the lower disk; the upper disk is loosely mounted onto the pin. Each disk has rows of teeth extending along the edge of the concave side. The disks are mounted onto the pin with the teeth of each one facing the teeth of the other. The CranioFix 2 Titanium Clamps have a sleeve securely attached on the end of the pin. During the fixation, the lower disk comes to rest against the inner surface of the cranium and the upper disk comes to rest against the outer surface of the cranium.
The provided text describes a 510(k) submission for the CranioFix 2 Titanium Clamp System. This is a medical device, not an AI/ML device, and therefore the majority of the requested information (related to AI performance metrics, sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable.
However, I can extract the relevant information regarding the performance data provided for this physical medical device.
Performance Data for CranioFix 2 Titanium Clamp System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent tensile strength to predicate device | Mechanical testing demonstrated equivalent tensile strength to the predicate CranioFix 2 device. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not specified.
- Data provenance: Not specified, but likely laboratory mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was mechanical testing, not a study requiring expert clinical assessment/ground truth.
4. Adjudication method for the test set
Not applicable. This was mechanical testing, not a study requiring adjudication.
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. This is a physical medical device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used
"Equivalent tensile strength to the predicate device" served as the evaluation criterion. This is based on objective mechanical measurements, not expert consensus, pathology, or outcomes data in the traditional sense.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
§ 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).