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K Number
K992174
Device Name
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
Manufacturer
PILLING WECK SURGICAL
Date Cleared
2000-03-23

(269 days)

Product Code
DXC
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.

Device Description

Aortic Spoon Jaw Clamp

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Aortic Spoon-Jaw Clamp" (K992174). This letter grants clearance based on substantial equivalence to a legally marketed predicate device.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it predates the modern requirements for clinical performance studies in many device clearances.

The 510(k) pathway, especially in the year 2000, primarily focused on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a device already on the market. This often relied on bench testing, materials characterization, and comparisons of technological characteristics and intended use, rather than extensive clinical studies with specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information based on the given text.

To answer your specific points, based on the provided document:

  1. A table of acceptance criteria and the reported device performance: Not available in this document.
  2. Sample size used for the test set and the data provenance: Not available in this document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
  4. Adjudication method for the test set: Not available in this document.
  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 device is a surgical clamp, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical clamp, not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available in this document. Substantial equivalence for this type of device would likely have been based on comparison of design, materials, and functional performance with a predicate device, rather than detailed clinical ground truth.
  8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
  9. How the ground truth for the training set was established: Not applicable.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).