(111 days)
The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of the following endoscopic sinus procedures: ethmoidectomy, maxillary antrostomy, polypectomy, turbinectomy / turbinate reduction, sphenoidotomy, and frontal recess dissection.
The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of endoscopic sinus procedures. The system consists of a hand-held cutting device, tissue filter, and stylet. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.
This document describes a 510(k) premarket notification for the PolypVac Microdebrider. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, specifically the PolypVac Microdebrider (K161101) and the Medtronic Xomed XPS 3000 (K041413).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical "acceptance criteria" in the format of a table with thresholds and corresponding performance values for the new PolypVac Microdebrider. Instead, it relies on demonstrating that the device functions as intended, meets design specifications, and is substantially equivalent to predicate devices based on various non-clinical tests.
The "Testing Type" and "Results Supporting Substantial Equivalence" columns in Table 2 serve as a proxy for acceptance criteria and reported performance:
| Testing Type | Test Description | Reported Device Performance and Support for Substantial Equivalence |
|---|---|---|
| Bench Testing | - Durability/Functionality Testing – Motor and Shaft |
- Dimensional Testing
- Pull Force Testing - Bond Strength
- Predicate Comparison - Resection Rate | "The subject PolypVac Microdebrider passed all functional testing and met all product specification requirements, thereby demonstrating equivalence to the predicate PolypVac device and suitability to the expanded indications for use."
The comparison of technological characteristics in Table 1 (pages 4-5) implicitly provides performance comparisons (e.g., "Same" for mechanism of action, compatibility, human factors, materials/biocompatibility, and sterility; "Blades of similar diameter are offered" for design features like blade diameter). In particular, the "Predicate Comparison - Resection Rate" implies that the new device's resection rate performance was comparable to the predicate. |
| Validation Testing | "Cadaver Simulated Use Testing" | "Simulated use testing was completed successfully, no adverse events were observed. This testing demonstrates that the subject PolypVac Microdebrider is capable of safely performing the following procedures: turbinate reduction / turbinectomy, uncinectomy / maxillary antrostomy, ethmoidectomy, frontal recess dissection, and sphenoidotomy." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the bench testing or the cadaver simulated use testing. For the cadaver study, it implies a sufficient number of cadavers/procedures were used to successfully complete the testing without adverse events across a range of procedures.
- Data Provenance: Not explicitly stated, but the testing would typically be conducted at the manufacturer's R&D facilities or a contract research organization. Given it's a premarket notification to the US FDA, the data is intended for the US market. The testing is non-clinical bench and cadaver testing, not human subject data. It's prospective in the sense that the studies were designed and conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts establishing a "ground truth" for the non-clinical bench or cadaver testing in the same way as, for example, a clinical study interpreting images. The "ground truth" for these tests would be the established engineering specifications and the successful completion of the simulated surgical procedures.
- In the cadaver study, the success was based on the device's capability of safely performing the procedures and the absence of adverse events, which would be assessed by the surgical operators (likely qualified surgeons or trained personnel) conducting the simulations. However, the exact number and qualifications of these individuals are not provided.
4. Adjudication Method for the Test Set
Not applicable in the context of this non-clinical testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., imaging reads). Here, the tests evaluate mechanical performance, functionality, and simulated surgical outcomes, which would be objectively assessed against design specifications and technical success criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed nor necessary in support of this premarket notification." Therefore, there is no effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The PolypVac Microdebrider is a mechanical surgical device, not an AI algorithm. Its performance is inherent to its design and function, not based on an algorithm that operates independently or with human input.
7. The Type of Ground Truth Used
For the non-clinical testing:
- Bench Testing: The "ground truth" is defined by the device's technical specifications and engineering requirements (e.g., specified dimensions, bond strengths, motor functionality, resection rates comparable to predicate devices).
- Cadaver Simulated Use Testing: The "ground truth" is the successful and safe execution of the listed surgical procedures on cadaveric tissue, with the absence of adverse events. This implies functional performance equivalent to established surgical practice.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI or machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used or required.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.