(93 days)
The Air Assisted Sprayer is intended to deliver two nonhomogenous solutions onto a surgical site.
The Air Assisted Sprayer Kit consists of multi-lumen tubing that provides separate channels for the flow of two non-homogeneous solutions and filtered pressurized gas.
The provided 510(k) summary for the KOY 2322 Air Assisted Sprayer does not contain the specific information requested about acceptance criteria or a detailed study proving the device meets those criteria, as it is primarily a substantial equivalence claim based on predicate device comparison.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (MicroMedics Fibrijet Air Assisted Endoscopic Applicator, K042834) rather than presenting a study against a pre-defined set of acceptance criteria for novel device performance. The safety and effectiveness are stated to be demonstrated through biocompatibility and in vitro bench testing, but the details of these tests, including specific acceptance criteria and results, are not provided in the publicly available summary.
Therefore, for almost all of your requested information, the answer will be "Not directly addressed in the provided 510(k) summary."
Below is an attempt to answer your questions based only on the provided text, highlighting where information is absent:
Acceptance Criteria and Device Performance Study for KOY 2322 Air Assisted Sprayer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Not Specified |
| (The 510(k) summary states that "biocompatibility and in vitro bench testing data provided supports Confluent Surgical's belief that the Air Assisted Sprayer is substantially equivalent..." However, no specific acceptance criteria for these tests or their quantitative results are provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided summary.
- Data Provenance: Not specified beyond "biocompatibility and in vitro bench testing data." The origin (e.g., country) or nature (retrospective/prospective) of this data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The summary does not describe a clinical study involving human judgment for "ground truth" establishment. The evaluation mentioned is primarily in vitro bench testing.
4. Adjudication method for the test set
- Not Applicable. No human adjudication of results is described.
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. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic device. The device is a physical sprayer. The in vitro bench testing mentioned would be analogous to a standalone performance evaluation for a physical device, but the specifics are not detailed.
7. The type of ground truth used
- Not explicitly stated in terms of "ground truth" for a performance study. The summary refers to "biocompatibility and in vitro bench testing data." For these types of tests, the "ground truth" would typically be established by established scientific standards, laboratory measurements, or material properties and biological responses, rather than expert consensus or pathology in the context of imaging.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that involves training sets.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device.
§ 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.