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Aesculap's CranioFix and CranioFix2 System are intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

The CranioFix and CranioFix2 Clamp System consist 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 disks of the CranioFix Titanium Clamp (11mm) are solid (no drainage holes). The disks of the CranioFix Titanium Clamp (16mm and 20mm) have open areas for drainage. The CranioFix2 Titanium Clamp (11mm, 16mm, and 20mm) 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.

Here's an analysis of the provided text regarding the CranioFix Titanium Clamp System, focusing on the acceptance criteria and study information:

Based on the provided document, there is no performance data or studies presented for acceptance criteria. The document is a 510(k) summary for marketing clearance and primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting new performance study data against defined acceptance criteria.

Here's a breakdown of why and what information is present:

1. A table of acceptance criteria and the reported device performance

   • Not present. The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This indicates that there are no pre-defined performance metrics or acceptance criteria presented in this submission. The basis for clearance is "substantial equivalence" to previously cleared devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not present. No specific performance study with a test set is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not present. No ground truth establishment related to a device performance study is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not present. No adjudication method is mentioned as there's no performance study described.

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 present. This device is a titanium clamp system, not an AI or imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not present. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not present. No ground truth relevant to device performance is mentioned.

8. The sample size for the training set

   • Not present. No training set is mentioned as there's no performance study described.

9. How the ground truth for the training set was established

   • Not present. No ground truth for a training set is mentioned.

Summary of available information from the document:

• Intended Use: Fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
• Device Description: Sterile, titanium implants (Clamps) in 11mm, 16mm, and 20mm sizes, consisting of two concave disks connected by a pin. Design variations between CranioFix and CranioFix2 are described.
• Purpose for Submission: To gain marketing clearance for additions to the Clamp System and expansion of the indication for use statement.
• Performance Data: "No performance standards have been promulgated."
• Substantial Equivalence: Demonstrated to predicate devices:
  • Aesculap CranioFix Titanium Clamp System (K972332)
  • Aesculap Craniofacial Implant Set (K923705)

Conclusion:

The provided 510(k) summary for the CranioFix Titanium Clamp System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices, which is a common pathway for medical device clearance in the U.S. when a new device is similar enough to existing ones. This implies that the safety and effectiveness are established through the existing knowledge and clearance of the predicate devices.

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