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K Number
K971252
Device Name
SEVRAIN CRANIAL CLAMP
Manufacturer
IKONOS CORP.
Date Cleared
1998-07-06

(459 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

The SCC-100 is indicated for the re-auachment of the bone flap after a craniotomy.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text only contains an FDA 510(k) clearance letter for the "SCC-100" device without any details about acceptance criteria or a study proving its performance. The letter simply states that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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).