(47 days)
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is indicated for use transorally or transnasally within the upper digestive tract (including the esophagus, stomach, and duodenum).
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE, GIF-XP190N is an additional component of the EVIS EXERA III VIDEO SYSTEM.
The subject endoscope could be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment within the upper digestive tract.
The provided document is a 510(k) summary for the EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested for AI/device performance studies.
Instead, it refers to:
- Risk analysis carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007.
- Design verification tests and their acceptance criteria identified and performed as a result of this risk analysis assessment.
- Software validation activities performed in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Application of standards like IEC 60601-2-18, IEC 60601-1-2, and ISO 14971.
This type of submission primarily focuses on establishing "substantial equivalence" to a predicate device based on technological characteristics and safety standards, rather than providing a performance study with detailed acceptance criteria of the kind typically found for diagnostic AI algorithms (e.g., sensitivity, specificity, AUC).
Therefore, I cannot populate the table and answer all the questions directly from the provided text about how the device meets acceptance criteria in a diagnostic performance study context. The document states that the device was found to be "substantially equivalent" to its predicate based on the non-clinical testing performed, implying the acceptance criteria for those engineering and safety tests were met.
Here's what I can extract and infer based on the request and the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from document) | Reported Device Performance (Inferred from document) |
|---|---|---|
| Safety and Effectiveness (Overall) | Device does not incorporate any significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness compared to the predicate. | "Substantially Equivalent": The FDA determined the device is substantially equivalent to the predicate, implying it meets the necessary safety and effectiveness thresholds for its intended use as defined by regulatory standards (e.g., no significant changes that would impact safety/effectiveness compared to the K100584 predicate). |
| Risk Management | Risks are identified, evaluated, controlled, and their acceptability is determined in accordance with ISO 14971:2007. | Risk analysis was carried out and design verification tests and their acceptance criteria were identified and performed, indicating risks were managed to an acceptable level. |
| Software Validation | Software validation activities performed according to FDA Guidance for Software Contained in Medical Devices (Device classified as "Minor Level of Concern"). | Software validation activities were successfully performed, demonstrating compliance with FDA guidance. |
| Electrical Safety & EMC | Compliance with relevant medical electrical equipment standards (e.g., IEC 60601-2-18, IEC 60601-1-2). | The device applies IEC 60601-2-18 and IEC 60601-1-2, implying it passed tests demonstrating compliance with these standards for safety and electromagnetic compatibility. |
| Biocompatibility/Material Safety (Implied) | Materials used are safe for patient contact and do not elicit adverse biological responses. | While not explicitly stated as "acceptance criteria met," the substantial equivalence determination and risk analysis process would have covered material safety. The document states "no significant changes in... material or design that could affect the safety or effectiveness." |
| Functional Performance (Implied from changes) | Features like new integrated scope connector, new nozzle, and compatibility with High-Frequency Electrocautery perform as intended without compromising overall device functionality or safety. | These new features are incorporated, and the device is deemed substantially equivalent, indicating they function correctly and safely. |
Regarding the other points:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not provide details on sample sizes for specific performance tests in the context of a diagnostic dataset (e.g., image sets for an AI algorithm). The non-clinical testing refers to engineering, safety, and software validation tests, not a performance evaluation on clinical data.
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)
- Not applicable or not provided. This information is typically relevant for studies validating diagnostic AI where expert consensus or pathological confirmation establishes ground truth for image data. This submission is for a medical device (endoscope), not a diagnostic AI algorithm that interprets images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable or not provided. See explanation for 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 a diagnostic AI device requiring an MRMC study to compare human performance with and without AI assistance. It is a gastrointestinal videoscope.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an endoscope, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's validation revolves around engineering specifications, safety standards, and functional performance criteria. For example, ground truth for electrical safety is defined by IEC standards, for material safety by biocompatibility tests, and for mechanical integrity by durability tests. It's not clinical "ground truth" derived from patient diagnostic labels.
8. The sample size for the training set
- Not applicable or not provided. This is not an AI/machine learning device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable or not provided. See explanation for point 8.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device (an endoscope) through compliance with engineering, safety, and software standards, rather than a clinical performance study of a diagnostic AI algorithm. Therefore, many of the specific questions about AI study methodology cannot be answered from this text.
§ 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.