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K Number
K161318
Device Name
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
Manufacturer
TEDAN SURGICAL INNOVATIONS LLC
Date Cleared
2017-03-20

(313 days)

Product Code
GZT
Regulation Number
882.4800
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Phantom™ Fukushima and Mastability Neurological Holding Systems are intended to provide access and allow visualization of the surgical field, and to retract soft tissue during neurological cranial procedures.

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for the Phantom Fukushima Neurological Holding Systems and Phantom Mastability Neurological Holding Systems. The document states that the devices are substantially equivalent to legally marketed predicate devices and outlines the general controls provisions of the Act that apply.

However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy. It is a regulatory clearance document, not a performance study report.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample size used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method for the test set: Not present.
  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 relevant, as this is a surgical holding system, not an AI diagnostic device, and no such study is mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is a surgical holding system, not an AI diagnostic device.
  7. The type of ground truth used: Not present.
  8. The sample size for the training set: Not relevant, as this is a surgical holding system, not an AI diagnostic device.
  9. How the ground truth for the training set was established: Not relevant, as this is a surgical holding system, not an AI diagnostic device.

§ 882.4800 Self-retaining retractor for neurosurgery.

(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).