(64 days)
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 The Forceps is then withdrawn.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
| Acceptance Criteria (for Substantial Equivalence Determination) | Reported Device Performance (as demonstrated for SE) |
|---|---|
| Intended Use: To insert tracheobronchial stents during ENT procedures. | The device's stated intended use aligns with the predicate device. |
| Technological Characteristics: Basic features, designs, and intended uses are the same as the predicate. Differences raise no new issues of safety and effectiveness. | The device consists of a hand-controlled forceps with a specially designed grasping tip to restrain bronchial limbs of a Y Stent, hold them for insertion, and release them. This functionality is substantially equivalent to the Karl Storz Stent Applicator Forceps. |
| Safety and Effectiveness: Should not raise new questions of safety or effectiveness compared to the predicate. | The submission asserts that "The differences between the Pilling Weck Surgical devices and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices." |
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).
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.