(90 days)
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI are intended to be used with a video system center, endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The endoscope consists of three parts: the control section, the insertion section, and the connector section.
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Control section: The UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob on the control section are connected to the tip of the bending section by a series of wires. By operating the angulation control knobs, the bending section at the distal end bends vertically or parallel to guide the distal end for insertion and observation. The observation mode can be selected by focus switching function, "near focus mode" featuring innovative resolving power for close observation or "normal focus mode" for normal observation. To realize the dual focus mechanism, Voice Coil Motor (VCM) is incorporated as an actuator. The endoscope contains a cylinder to attach a suction valve for suction and air/water valve. Depressing the suction valve will allow the physician to use the endoscope to suction any fluids which are obscuring a good view of the tissue. Therapeutic instruments can be passed through the instrument channel for performing endoscopic biopsy and other therapies. Depressing the air/water valve will allow the doctor to feed water through the endoscope for lens washing. It also can be operated to feed air for removing any fluids or debris adhering to the objective lens.
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Insertion section: The insertion section has main parts including the image guide, light guides that bring light from the video system center through the endoscope, and instrument channel where therapeutic tools can be pushed in and out (also the suction channel).
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Connector section: The connector section connects the endoscope with the video system center (CV-1500) through the universal cord.
It appears crucial information regarding the AI or software components' acceptance criteria and the specific study proving the device meets these criteria is missing from the provided FDA 510(k) clearance letter for the Olympus Endoscopes (K250432).
The document details the substantial equivalence of the new endoscopes (CF-EZ1500DL/DI and GIF-EZ1500) to their predicates based on physical characteristics, intended use, and general performance. It mentions extensive non-clinical testing, including:
- Reprocessing validation
- Biocompatibility testing
- Software verification and validation (mentioning FDA guidance for software in medical devices, but not detailing specific performance criteria or tests related to AI/image analysis capabilities)
- Electrical safety and EMC
- Bench testing (performance characteristics like DOF/FOV, Resolution, Noise, etc.)
- Animal study to confirm WLI, NBI, RDI, and TXI performance.
- Risk management
However, the prompt asks for specifics related to an AI/Software component's acceptance criteria and its performance study. The provided text focuses on the endoscope hardware itself and its basic image capture and display functionalities. There is no mention of any AI-driven image analysis, diagnostic augmentation, or automated detection capabilities that would require the kind of clinical performance study details (e.g., sample size, ground truth, expert adjudication, MRMC studies) outlined in the prompt.
The "Indications for Use" for these endoscopes clearly state their purpose is for "endoscopy and endoscopic surgery" for visualization. They are tools for observation and facilitating therapeutic accessories. They are not described as having an AI component for automated analysis or diagnosis.
Therefore, since the provided document does not indicate the presence of an AI or advanced software feature requiring a separate performance study with associated acceptance criteria, I cannot fulfill most of the requested points.
Here's what can be inferred or stated based on the provided document and the information that is explicitly NOT present:
Based on the provided document, there is no evidence of an AI-driven or advanced image analysis software component in the Olympus Endoscopes (CF-EZ1500DL/DI and GIF-EZ1500) that would necessitate the type of acceptance criteria and performance study described in the prompt.
The 510(k) clearance focuses on demonstrating substantial equivalence to predicate endoscopes by comparing physical and operational characteristics, and through general performance testing of the device hardware and its fundamental image capture capabilities.
However, if we were to hypothetically assume there was an AI/Software component (e.g., for polyp detection), and based on common FDA expectations for such devices, here's how the answer would look, highlighting what's missing:
Acceptance Criteria and Study Proving Device Performance (Hypothetical AI Component)
Note: The provided FDA 510(k) clearance letter for K250432 does not detail any specific AI or advanced image analysis software functionality, nor does it contain the performance study metrics for such a component. The following table and points are constructed under the assumption of such a component existing, to illustrate what an ideal response would contain if the information were available in the document.
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical AI Component)
Since no AI/software component is described in the provided document, this table cannot be filled with actual data. Below is a hypothetical example of what such a table would contain if an AI component for, e.g., polyp detection, were present.
| Acceptance Criterion (Hypothetical) | Threshold (Hypothetical) | Reported Device Performance (Hypothetical) | Pass/Fail (Hypothetical) |
|---|---|---|---|
| Sensitivity for Polyp Detection | ≥ 90% | 92.5% | Pass |
| Specificity for Polyp Detection | ≥ 80% | 85.1% | Pass |
| False Positive Rate per Case | ≤ 2.0 per case | 1.8 false positives per case | Pass |
| Latency for AI Annotation | ≤ 100 ms | 50 ms | Pass |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: Not specified (as no AI performance study is detailed). Typical AI/CADe clearances involve hundreds to thousands of cases.
- Data Provenance: Not specified. For AI devices, this would typically include details like:
- Country of Origin (e.g., multi-center, US, Europe, Asia)
- Retrospective or Prospective collection
- Diversity of patient demographics, disease prevalence, equipment used, etc.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified. For AI/CADe devices, often 3 or more independent experts are used.
- Qualifications of Experts: Not specified. Typically, this would involve board-certified gastroenterologists or colorectal surgeons with significant experience (e.g., 5-10+ years) in endoscopic procedures, potentially sub-specialized in screening/surveillance or interventional endoscopy.
4. Adjudication Method for Test Set
- Adjudication Method: Not specified. Common methods for AI medical device clearances include:
- Majority Rule: E.g., 2 out of 3, or 3 out of 5 experts agree.
- Consensus Reading: Experts review and discuss cases to reach a unanimous decision.
- 2+1 or 3+1: Initial reads by 2 or 3 experts, with a senior adjudicator resolving discrepancies.
- Pathology Correlation: Where possible, biopsy/histology results serve as the definitive ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Conducted?: No mention of an MRMC study. The document states "No clinical study was performed to demonstrate substantial equivalence." This implies that any human-in-the-loop performance evaluation of an AI component was not required or not conducted for this 510(k).
- Effect Size of Human Improvement (if applicable): Not applicable as no MRMC study is mentioned. If performed, this would report metrics like the change in reader sensitivity, specificity, or reading time with AI assistance compared to without.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Conducted?: No explicit mention of a standalone algorithm performance study with specific metrics (e.g., AUC, sensitivity, specificity on a defined dataset). The "Software verification and validation" generally refers to software engineering and quality assurance, not necessarily clinical performance of an AI algorithm itself.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified. If an AI component were present for lesion detection, ground truth would typically be established by:
- Expert Consensus: As described in point 3.
- Pathology/Histology: Biopsy results confirming the presence or absence of lesions. This is often considered the gold standard for many gastrointestinal applications.
- Clinical Outcomes Data: Long-term follow-up to confirm diagnoses, though less common for initial device clearance.
8. Sample Size for Training Set
- Sample Size for Training Set: Not specified. This information is typically not included in FDA clearance letters unless directly relevant to a novel AI claim. Training set sizes for medical AI can range from thousands to hundreds of thousands of images/cases.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not specified. It would generally be established through similar methods as the test set (e.g., expert annotations, pathological confirmation), often with additional data augmentation or curation processes.
§ 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.