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K Number
K972332
Device Name
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
Manufacturer
AESCULAP, INC.
Date Cleared
1998-01-16

(207 days)

Product Code
GXN
Regulation Number
882.5330
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Aesculap's CRANIOFIX Titanium Clamp System is intended for use in refixation of cranial bone flaps after craniotomy.

Device Description

The CRANIOFIX Titanium Clamp System consists of a sterile, titanium implant (CRANIOFIX Clamp) and associated nonpowered neurosurgical instruments. The CRANIOFIX Titanium Clamp (FF100T) consists of two 10mm 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. During the craniotomy refixation, the lower disk comes to rest against the inner surface of the cranium and the bone plug. The upper disk comes to rest against the outer portion of the cranium and bone plug.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Aesculap CRANIOFIX Titanium Clamp System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria.

Here's why the requested information cannot be fully provided based on the input:

  • No detailed performance data or acceptance criteria are present. The document focuses on technological characteristics, intended use, and substantial equivalence to market approval.
  • No clinical study summaries, sample sizes, or expert involvement are mentioned. The text only states that the device "will be manufactured in accordance with ISO and German Din Standards" and that Aesculap has "ISO 9001 certification," which are quality system certifications, not performance criteria for the device itself.
  • The document is a pre-market notification (510(k)) for substantial equivalence, not a clinical trial report. Substantial equivalence claims generally rely on comparisons to existing legally marketed devices, not necessarily on new, extensive performance studies with specific acceptance criteria outlined in the submission itself.

Therefore, for each of the requested points, the answer is that the information is not available in the provided 510(k) summary.

Detailed Breakdown of Missing Information:

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

    • Not available. The document states "No applicable performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices." It mentions manufacturing to ISO and German Din Standards, but these are quality system standards, not specific device performance acceptance criteria.

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

    • Not available. No test sets or study data are described in this 510(k) summary.

  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 available. This information would be relevant to studies involving ground truth establishment, which are not detailed here.

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

    • Not available. No test sets or adjudication methods are mentioned.

  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 available. This device is a titanium clamp system, a physical medical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable.

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

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

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

    • Not available. No studies requiring ground truth are described.

  8. The sample size for the training set:

    • Not available. No training sets are mentioned, as this is not an AI/machine learning device.

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

    • Not available. Not applicable.

In summary, the provided 510(k) document is a declaration of substantial equivalence for a physical medical device (titanium clamp system) and does not include the detailed performance study information, acceptance criteria, or AI-related metrics that are being requested.

§ 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).