(255 days)
The endoscope system is used to examine body cavities, hollow organs and canals, specifically the lower GI tract (colon) only, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The endoscope system includes the endoscope with control head, a disposable assembly, an imaging system, and a fluid and air system. The endoscope system features: 1) a smooth control head containing a minimal number of outside angles and joint crevices, 2) a single use disposable system encompassing all of the inner passage channels that start at the manifold, continue through the endoscope cavity, and seal onto the outside of the rigid distal tip, 3) a pneumatically driven air and fluid system eliminating the need for mechanical valves in the contamination path, and 4) a lavage function that provides a bolus of water through the working channel to loosen and flush debris from the field of view as the insertion tube advances through the colon.
The provided text is a 510(k) premarket notification for an endoscope system. It details the device's description, indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
The document states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, rather than proof of meeting specific performance acceptance criteria through independent studies.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated based on the given information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific device performance metrics in the way that would typically be seen in a clinical study. Instead, it compares the physical and functional specifications of the akos endoscope system to several predicate devices.
| Feature | Predicate Range (Based on provided data from Olympus, Pentax, Vision Sciences, Fujinon, Welch Allyn) | akos biomedical, inc. (TBD) |
|---|---|---|
| Viewing Direction | Forward | Forward |
| Optical Field of View | 100-140 degrees | 125-135 degrees |
| Optical Depth of Field | 3-120mm | 5-100mm |
| Rigid Tip Diameter | 11.4-15.4mm | 13.7-14.2mm |
| Bending Tip Deflection | Up/Down (180-210 degrees), Right/Left (90-180 degrees) | Up/Down (180 degrees), Right/Left (160-180 degrees) |
| Bending OD | 11.2-14.3mm | 13.4-14mm |
| Insertion Tube Dia. | 11.4-14.0mm | 13.2-13.9mm |
| Insert. Working Length | 620-1770mm (note: some are given in cm) | 700-1750mm |
| Biopsy Channel ID | 2.8-4.3mm | 3.2-3.8mm |
| Total Length | 920-2100mm (incomplete data for some predicates) | 1020-2070mm |
| Op. Env. Amb. Temp | 10-40 deg C | 12-35 deg C |
| Op. Env. R Humidity | 15-85 % | 15-85 % |
| Atmospheric Pressure | 70-106 kPa (700-1060 mbar) | 70-106 kPa |
| Disposable Channels | Yes/No | Yes |
Note: The "acceptance criteria" here are inferred from the comparison to predicate devices, implying that performance within the range of existing, legally marketed devices for similar specifications is deemed acceptable for substantial equivalence. No specific quantitative performance targets (e.g., image resolution, diagnostic accuracy) are provided in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information available. The document does not describe a test set or clinical study with a specified sample size or data provenance. The clearance is based on substantial equivalence to predicate devices, not on a new clinical performance study.
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)
- No information available. There is no mention of a test set or ground truth established by experts within this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information available. There is no mention of a test set or adjudication method.
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 information available. This document is for a medical device (endoscope), not an AI-powered diagnostic system, and it predates widespread AI application in this context (1997). No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an endoscope system, which is a tool used by a human operator for examination and procedures. It is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- No ground truth discussed. The 510(k) submission primarily focuses on engineering specifications and intended use comparison to predicate devices for substantial equivalence, not on establishing a ground truth for diagnostic accuracy.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth for it is relevant to this device's submission.
§ 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.