(266 days)
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.
Intended patient population: Adults
The Disposable Cytology Brush is a sterile, single-use device as a kind of accessories for bronchial endoscopy. The Disposable Cytology Brush is intended to be used in conjunction with a bronchoscope to collect cells from the bronchi.
The Disposable Cytology Brush is designed to insert through suitable endoscope's accessory channel to collect cells from the bronchi.
The Disposable Cytology Brush mainly consists of brush head part and handle part. The brush head is composed of bullet, bristles, brush core, brush sheath, connecting tube and steel wire. The handle part is composed of hand grip and push/ pull rod.
The Disposable Cytology Brush has two different models depending on different design of the brush head. The WB series is a cytology brush with straight type of brush head and the XA series is a cytology brush with oval type of brush head. Each model has different specifications depending on different working length.
The provided text is a 510(k) summary for a medical device (Disposable Cytology Brush) and primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic product. The document describes a traditional medical device (a cytology brush), not an AI/software device.
Therefore, many of the requested categories for AI/algorithm performance (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.
However, I can extract information related to non-clinical testing performed to demonstrate the device's performance and safety, which serves a similar purpose to meeting acceptance criteria for a physical device.
Here's the breakdown based on the provided text:
Device: Disposable Cytology Brush (AF series)
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the way one would for an AI diagnostic. Instead, it lists performance tests conducted to verify the device meets design specifications and is substantially equivalent to a predicate. The "acceptance criteria" are implied to be "met all design specifications" and "demonstrated safety and essential performance" based on applicable standards. The "reported device performance" is summarized as the tests being successfully performed and demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility in accordance with ISO 10993 standards | All specified biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity, Pyrogen) were performed and validated. |
| Sterilization validation (EO sterilization) per ISO 11135 | EO sterilization validated according to ISO 11135, ISO 11737-2, ISO 10993-7, USP . |
| Shelf Life and Sterile Barrier System validation | Validated per ASTM F1980, ISO11607-1, ISO11607-2, ASTM F 1929, ASTM D 3078, DIN 58593-6, ASTM F88/F88M-15, ASTM D4169-16. |
| Mechanical performance/design specifications | All specified performance tests (Appearance, Size and Dimension, Bronchoscope Compatibility, Brush Bond Strength, Tensile Strength, Push ability and Actuation, Tissue Sampling Performance) were performed on both subject and predicate devices, demonstrating substantial equivalence. |
| Safety and effectiveness (Substantial Equivalence to Predicate) | Non-clinical testing demonstrated that differences did not adversely affect performance and the device is substantially equivalent to the legally marketed predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of devices/samples used for each non-clinical test (e.g., how many brushes were tested for tensile strength).
- Data Provenance: The tests are described as "Non-clinical testing for Disposable Cytology Brush." The document's origin (Alton (Shanghai) Medical Instruments Co. Ltd in China) suggests the testing likely occurred there or was managed by them. The studies are bench (laboratory) tests and do not involve patient data in the typical sense of a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical medical device. Ground truth, in the AI/diagnostic sense, is not established by human experts for these mechanical/biocompatibility tests. The "ground truth" here is compliance with engineering specifications and recognized international standards.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
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. This is not an AI/imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
- For biocompatibility: Adherence to ISO 10993 standards (e.g., no cytotoxicity, no irritation).
- For sterilization: Adherence to ISO 11135 standards (e.g., Sterility Assurance Level of 10-6).
- For shelf life/sterile barrier: Adherence to ASTM and ISO 11607 standards (e.g., package integrity, product performance after aging).
- For mechanical performance: Meeting internal design specifications and demonstrating performance comparable to the predicate device through side-by-side bench testing.
8. The sample size for the training set:
- Not Applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary, this 510(k) pertains to a traditional medical device (a cytology brush) and not an AI or software-driven diagnostic tool. Therefore, the information provided in the document focuses on demonstrating substantial equivalence through non-clinical bench testing, biocompatibility, and sterilization validation, rather than the types of studies typically conducted for AI-powered diagnostic devices.
§ 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.