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K Number
K061651
Device Name
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
Manufacturer
APPLE MEDICAL CORP.
Date Cleared
2006-10-20

(129 days)

Product Code
HGI
Regulation Number
884.4120
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Fischer Cone Biopsy Excisor." This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and grants permission to market it.

The document does NOT contain the following information that you requested:

  • A table of acceptance criteria and reported device performance. The FDA clearance letter does not detail the specific performance metrics or acceptance criteria used in the substantial equivalence determination. It focuses on regulatory compliance rather than detailed device efficacy or safety study results in this letter.
  • Sample size used for the test set and data provenance. This information would typically be found in the device's 510(k) submission, not the clearance letter.
  • Number of experts used to establish the ground truth and their qualifications. Again, this level of detail about study design is not in this document.
  • Adjudication method.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs. without AI assistance. This device is a surgical excisor, not an AI-assisted diagnostic tool, so such a study would not be applicable.
  • If a standalone performance (algorithm only) was done. Not applicable as it's not an algorithm.
  • The type of ground truth used.
  • The sample size for the training set.
  • How the ground truth for the training set was established.

Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text. The FDA letter only states that the device is "substantially equivalent" for its indicated uses to previously marketed devices.

§ 884.4120 Gynecologic electrocautery and accessories.

(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).