(199 days)
This device is used to enter human gastrointestinal tract (stomach or duodenum) via endoscope to collect cells.
The main component of the proposed device is Brush Head, Outer Sheath, Sliding Handle, Thumb ring, Catheter and Steel Wire. The device is expected to use via endoscope to obtain cellular material from the human body. The main operation is move the Finger Ring back and forth to achieve the movement of Brush Head, and then the Brush Head can collect cells from the target site.
The proposed device has twenty-one (21) specifications, the main differences of these specifications are Diameter of Brush Head, Brush Length, Outer Sheath OD and Effective Length.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The provided document is a 510(k) premarket notification letter and summary for a medical device called "Single Use Cytology Brush." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials.
As such, the document does not describe a study proving the device meets acceptance criteria in the manner requested by your prompt (i.e., for an AI/ML-based medical device with performance metrics, ground truth, expert adjudication, etc.). Instead, it focuses on bench testing and an assessment of substantial equivalence.
Therefore, I cannot extract the information to fill your requested categories for acceptance criteria and a study that proves the device meets them in the context of an AI/ML device. However, I can explain what is presented in the document regarding the acceptance of this specific device.
Based on the provided text, here's what can be inferred about the acceptance process for the Single Use Cytology Brush:
The "acceptance criteria" here are fundamentally about demonstrating substantial equivalence to a predicate device (K172663). This is a regulatory pathway, not a performance study of an AI model.
No study proving device meets acceptance criteria in the AI/ML context was performed or described. Instead, the manufacturer performed bench tests to ensure the physical and operational characteristics of the device were comparable to the predicate.
Here's a breakdown of the information from the document related to "acceptance" of this device:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria for device performance with specific numerical targets like sensitivity/specificity for an AI model. Instead, it refers to regulatory and bench testing requirements.
| Acceptance Criterion (Type) | Reported Device Performance |
|---|---|
| Regulatory Compliance | Meets requirements of ISO 10993 (Biological Evaluation), ISO 11135-1 (EO Sterilization Development, Validation, Control), ISO 10993-7 (EO Sterilization Residuals). |
| Physical/Operational Functionality | The following bench tests were performed and all results were passing: |
- Appearance
- Dimension
- Operational performance |
| Substantial Equivalence | Demonstrated to be "Substantially Equivalent (SE)" to the currently cleared predicate device (K172663) based on indications for use, technological characteristics (materials, design, configuration, packaging, fundamental technology, sterilization process), and safety and performance testing. |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the bench tests. It refers to general passing results without providing the number of units tested. This is not a data provenance in the sense of patient data; it's product testing.
- No mention of a "test set" in the context of patient data for an AI model.
- Sample size: Not specified for bench tests.
- Data provenance: Not applicable in the context of clinical data. The tests are performed on the device itself by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical instrument (cyto brush), not an AI algorithm. Ground truth (e.g., disease presence) is not established by experts for its performance in the way it would be for a diagnostic AI. Its "performance" refers to its physical capabilities and safety.
4. Adjudication method for the test set
Not applicable. There is no "adjudication" necessary for the physical properties and functional tests of a cytology brush.
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-assisted device.
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 (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's acceptance is its ability to meet engineering specifications, adhere to ISO standards, and be substantially equivalent to a predicate physical device. There are no clinical "ground truth" labels like pathology for its clearance.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set or clinical ground truth in the context of this 510(k) submission for a physical device.
Summary relevant to the document:
The provided 510(k) submission for the "Single Use Cytology Brush" demonstrates that the device is substantially equivalent to a predicate device (K172663). This equivalence is based on:
- Similar intended use (collecting cells from the GI tract via endoscope).
- Similar technological characteristics (materials, design, configuration, packaging, sterilization).
- Successful completion of non-clinical bench testing for appearance, dimension, and operational performance, which all yielded "passing" results.
- Compliance with relevant ISO standards for biological evaluation and sterilization.
- Crucially, Section 9 states: "Clinical Test is not applicable for the proposed device. No clinical study is included in this submission." This confirms that no human clinical performance study was conducted or required for this 510(k) clearance, and therefore, no data related to AI/ML performance on patient data, expert ground truth, or MRMC studies would be present.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.