(104 days)
The DEFENDO Disposable Suction Valve is intended to be used to control the suction function of a compatible bronchoscope during a pulmonary procedure.
The subject device is a sterile, single use, disposable medical device. It is designed to be attached to the suction port of a bronchoscope during a pulmonary procedure to help the user engage in the suction function of the bronchoscope by depressing/activating the valve. The activation of the suction valve allows the user to control the suction flow of fluids from the patient to a suction pump/waste canister.
The provided text describes a 510(k) premarket notification for the DEFENDO Disposable Suction Valve. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a comparative effectiveness study with AI.
Therefore, many of the requested details, such as those related to AI performance, sample sizes for test/training sets for an algorithm, ground truth establishment, or human reader performance with/without AI assistance, are not applicable or not present in this type of regulatory submission.
However, I can extract the relevant information from the document regarding the non-clinical performance data used to support substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of precise numerical acceptance criteria and reported performance values in the way you might expect for an AI algorithm. Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The implied "acceptance criterion" for these tests is that the new device performs similarly or equivalently to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Equivalent Valve Connection | Passed "Valve Connection Test" |
| Equivalent Valve Depression Force | Passed "Valve Depression Force Test" |
| Equivalent Suction Flow | Passed "Suction Flow Test" |
| Maintained Functionality over Shelf-life | Passed "Functional Testing" over shelf-life |
| Integrity of Sterile Barrier | Passed "Dye Penetration Testing", "Peel Strength Testing", "Visual Seal Inspection" |
| Effective Sterilization | Passed "Sterilization Validation" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The 510(k) summary only generically states that "Medivators has conducted the following testing." It does not detail specific sample sizes for these non-clinical mechanical and functional tests. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of non-clinical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as this is not a study involving human interpretation of data where ground truth needs to be established by experts. The tests are focused on the mechanical and functional properties of the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reasons as above.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a disposable suction valve for bronchoscopes, not an AI-powered diagnostic tool. Therefore, there's no "human readers improve with AI vs without AI assistance" to report.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical tests would be defined by the engineering specifications and performance characteristics necessary for a functional and safe suction valve. This is typically established through established engineering standards, predicate device performance, and internal design requirements. It's not "expert consensus, pathology, or outcomes data" in the medical sense, but rather adherence to functional and safety benchmarks.
8. The sample size for the training set:
This information is not applicable as this device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as above.
Summary of the study conducted (Non-Clinical Performance Data):
The study conducted was a series of non-clinical design verification tests and validation tests to demonstrate that the DEFENDO Disposable Suction Valve is substantially equivalent to its predicate devices (Olympus Disposable Suction Valve (K920025) and Defendo Disposable Suction Valve (K102581)).
The specific tests performed include:
- Design Verification Comparison Tests to Predicate Device:
- Valve Connection Test
- Valve Depression Force Test
- Suction Flow Test
- Shelf-life validation:
- Functional Testing
- Dye Penetration Testing
- Peel Strength Testing
- Visual Seal Inspection
- Sterilization validation
The purpose of these tests was to show that the new device performs safely and effectively in a manner comparable to the legally marketed predicate devices, thereby supporting the claim of substantial equivalence for regulatory clearance. The document concludes that "The information and performance data provided indicates that the subject device is as safe and as effective as its predicate devices for its intended use when used in accordance with the device labeling."
§ 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.