(84 days)
Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has has been previously established.
The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal procedures. The system consists of a hand-held cutting device and device cleaner. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.
The provided text describes the Laurimed PolypVac Microdebrider and its substantial equivalence to a predicate device. However, it does not present acceptance criteria in a quantitative table or the specific details of a study designed to prove the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc. for a diagnostic or AI-driven medical device.
The studies mentioned are non-clinical (bench-top and cadaver) and aim to demonstrate substantial equivalence to a predicate device, focusing on mechanical performance and safety, rather than diagnostic accuracy.
Here's an analysis of the information provided based on your request, highlighting the absence of certain details relevant to evaluating an AI/diagnostic device:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given text in the format of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) and corresponding reported performance.
The non-clinical studies aimed to demonstrate "non-inferiority" in specific mechanical and functional aspects compared to the predicate device. If we interpret "acceptance criteria" loosely as the demonstration of non-inferiority in these performance characteristics, then we can summarize the findings as follows:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-inferiority in resection rates (Bench-top Performance) | Demonstrated non-inferiority based on resection rates in two sample simulated polyp tissue models. The device "trended in favor of the PolypVac Microdebrider" for clogging (clogged less frequently than the predicate). |
| Non-inferiority in complete polyp removal (Cadaver Comparison) | Demonstrated non-inferiority based on the degree of complete polyp removal (measured by grams of unresected tissue). Post-resection images were graded similarly for both devices (PolypVac: 1.08 average; Predicate: 1.00 average, by a blinded reviewer). The text implies 1.08 and 1.00 are scores for the "degree of complete polyp removal." |
| Meeting established specifications for materials, manufacturing, design, and consistent performance (Overall Non-Clinical Data) | Results of non-clinical testing demonstrate that the materials chosen, manufacturing process, and design meet established specifications necessary for consistent performance and that the device is substantially equivalent to the named predicate in terms of safety and effectiveness. |
2. Sample size used for the test set and the data provenance
- Bench-top Performance Testing: "two sample tissue models" were used. The number of tests or runs performed on these models is not specified. Data provenance is implied to be laboratory-generated.
- Cadaver Predicate Comparison Testing: A "cadaver model" was used. The number of polyps excised or the number of simulated polypectomy procedures is not specified. Data provenance is implied to be laboratory-generated using a cadaver.
- Type of Study: Both are non-clinical, in-vitro (bench-top) or ex-vivo (cadaver) studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Bench-top Performance Testing: No explicit "experts" were used to establish ground truth in the sense of clinical interpretation. The evaluation was based on measurable resection rates.
- Cadaver Predicate Comparison Testing:
- Operators: Three (3) independent board-certified ENT surgeons performed the excisions.
- Reviewer for Post-resection images: A "blinded reviewer" graded the post-resection images. Qualifications beyond "blinded reviewer" are not specified (e.g., specialty, years of experience).
4. Adjudication method for the test set
- Bench-top Performance Testing: Not applicable. Performance was measured quantitatively (resection rates, clogging frequency).
- Cadaver Predicate Comparison Testing: One "blinded reviewer" graded post-resection images. This is a single-reviewer assessment, not a consensus-based adjudication method like 2+1 or 3+1.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the Laurimed PolypVac Microdebrider is. The study involved human operators (surgeons) using the device, but it wasn't an evaluation of AI assistance to human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this device is a surgical instrument, not an algorithm. Therefore, this concept is not applicable. The device relies on human operation.
7. The type of ground truth used
- Bench-top Performance Testing: The "ground truth" was the physical measurement of resected simulated polyp tissue and observation of clogging.
- Cadaver Predicate Comparison Testing: The "ground truth" was based on:
- "grams of unresected tissue" (objective measurement after surgeon's attempt).
- Grades from a "blinded reviewer" on post-resection images (subjective assessment, but based on physical evidence).
8. The sample size for the training set
- Not applicable. This device is a mechanical surgical instrument, not an AI/machine learning model. There is no concept of a "training set" for its development as described in the provided text.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of a traditional medical device (a microdebrider) through non-clinical performance and safety testing. It does not provide the kind of acceptance criteria or study design details typically associated with AI-powered diagnostic devices, which involve performance metrics like sensitivity, specificity, and human reader studies. The "acceptance criteria" here are implicitly achieving non-inferiority to a predicate device in functional and mechanical performance.
§ 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.