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The Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid)is to inset tracheobronchial stents during ENT procedures

The Stent Forceps/(Bronchoscope(Flexible or Rigid) consists of a hand controlled forcep with a specially designed grasping tip to restrain the bronchial limbs of the Y Stent and mechanically hold the stent limbs together for insertion into the trachea. Once positioned, the forceps are released and the bronchial limbs of the stent return to their Y position. The Forceps is then withdrawn.

This 510(k) summary describes a traditionally cleared medical device, not an AI/ML-powered device. Therefore, the typical acceptance criteria and study design elements requested in your prompt (such as sample size, ground truth, expert adjudication, MRMC studies, or standalone performance) are not applicable.

The document describes the Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid)), which is a mechanical device used in ENT procedures. The clearance is based on a determination of substantial equivalence to an existing legally marketed device, rather than performance against pre-defined acceptance criteria through a clinical study.

Here's an adaptation of your requested table and information based on the provided document:

Acceptance Criteria and Device Performance (for a Traditional Mechanical Device)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size used for the test set and the data provenance:

• Not Applicable. This is a mechanical device cleared via substantial equivalence, not an AI/ML algorithm that requires a test set of data. The performance is assessed against the predicate device's established safety and effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No ground truth for a test set was established as this is a mechanical device clearance through substantial equivalence. The FDA reviewers assessed the substantial equivalence claim.

4. Adjudication method for the test set:

• Not Applicable. No test set requiring expert adjudication was used.

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. MRMC studies are relevant for AI-assisted diagnostic or interpretative devices, not for mechanical surgical instruments.

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

• Not Applicable. This is a mechanical device; there is no algorithm or standalone performance in the context of AI.

7. The type of ground truth used:

• Not Applicable. For this type of device, the "ground truth" for clearance is the established safety and effectiveness of the legally marketed predicate device. The comparison establishes that the new device shares fundamental characteristics and risks with the predicate.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device; there is no training set as would be found in AI/ML development.

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

• Not Applicable. No training set or ground truth in the AI sense was established for this mechanical device. The substantial equivalence determination relies on comparing the device's design, materials, and intended use to a predicate device already on the market.

Summary Explanation:

The document is a 510(k) premarket notification for a medical device that is not an AI/ML product. The Pilling Weck Surgical Y Stent Forceps is a mechanical surgical instrument. Its clearance is based on demonstrating substantial equivalence to a previously legally marketed device (the Karl Storz Stent Applicator Forceps), as permitted under Section 510(k) of the Federal Food, Drug, and Cosmetic Act.

For such devices, the "acceptance criteria" are effectively the requirements for establishing substantial equivalence: the device must have the same intended use and similar technological characteristics to a predicate device, and any differences in technological characteristics must not raise new questions of safety or effectiveness. There are no performance metrics like sensitivity, specificity, or AUC, nor are there concepts of test sets, training sets, ground truth establishment by experts, or MRMC studies, which are specific to the evaluation of AI/ML software as a medical device (SaMD).

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• to coagulate and transect vascular tissue simultaneously; .
• to perform spot coagulation of bleeding vessels; -
• to be used in open. surgical procedures; -

The VersaStat™ MULTIPOLAR Sciators are non-starile, reuseble surgical devices with an insulated coating to schieve the congulation function. This device will be uvaliable in various sizes and shapes similar to conventional surgical sciaeors. One shaft incorporates three pole connectors that create the shillity of current flow for one or both blades willzing a monepolar or a bipolar mode. Located on the cables (monopolar and bipciar) is a switch allowing the use of either one blade or both blades as a cautery surface.
The VersaStat™ MULTIPOLAR Scissors are designed for we only with the VersaStat™ MULTIPOLAR Cables, either monopolar or bipolar, when connected to the uppropriate electrosurgical generator.

I apologize, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) summary for the VersaStat™ Multipolar Scissors and Cables, dated February 11, 1998. It details:

• Indications for Use: To coagulate and transect vascular tissue simultaneously, perform spot coagulation, and be used in open surgical procedures.
• Device Description: Reusable surgical devices with an insulated coating for coagulation, available in various sizes/shapes, with three pole connectors for monopolar or bipolar mode via a switch on the cables.
• Directions for Use: Includes compatibility, how to connect and use with an electrosurgical generator, and a pretest for electrical activity.
• Contraindications: Not for contraceptive coagulation of fallopian tubes, but can achieve hemostasis after transection.
• Warnings and Precautions: Emphasizes understanding electrosurgical principles, compatibility, no sharpening/repair, no abrasive cleaning, and caution with high power.
• Cleaning and Sterilization Recommendations: Instructions for enzyme cleaning, brushing, rinsing, and steam/ETO sterilization.
• FDA Clearance Letter: Acknowledging the 510(k) notification and determining substantial equivalence to previously marketed devices.

This information describes the device, its intended use, how to operate it, and its regulatory clearance based on substantial equivalence. However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details on experts used for ground truth or their qualifications.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Results of standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is from 1998 and pertains to a physical surgical device, not an AI/software device that would typically involve the detailed performance study information you are requesting. The 510(k) process for such devices at that time primarily relied on demonstrating substantial equivalence to a predicate device, often through bench testing, design specifications, and compatibility, rather than the extensive clinical performance studies typical for modern AI/ML medical devices.

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SPECIFIC INDICATION OF USE: PATENT DUCTUS ARTERIOSUS INTERRUPTION
INTENDED USES: intended for use for General Pediatric Surgery where visualization in confined anatomic spaces minimizing tissue trauma are needed. These instruments are designed to be used in Video-Assisted Thoracoscopic Surgery (VATS). Where size constraints are limiting and immature tissues are potentially vulnerable to mechanical injury.
INDICATIONS: Pediatric Thoracoscopic Procedures Patent Ductus Arteriosus Interruption (PDA)
CONTRA INDICATIONS: For PDA patients with a ductal diameter over 1 cm calcification, presence of a transcatheter device within the ductal lumen, patients with dense pleural adhesions.

These instruments are equivalent to Thoracoscopy instruments for adult sizes but have a reduced dimension with a modified geometric configuration to meet reduced size requirements. These are modifications therefore of equivalent surgical instruments that can be used in general pediatric surgery but also have been designed specifically for pediatric thoracoscopic surgery. Instruments that are needed for the surgical procedures are cannula, lung retractor, clip appliers, grasping forceps with ratchets, scissors, hooks, and clamps. These instruments have specific overtures and dimensions suited for this surgical procedure.

The provided document is a summary of safety and efficacy for a medical device (Burke Congenital Thoracoscopy Instruments) from 1996. It describes the device, its intended use, indications, and contraindications. It does not contain any information about acceptance criteria, performance studies, or clinical trial data.

Therefore, I cannot answer your request for the specified information as it is not present in the provided text.

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