(74 days)
This instrument has been designed to be used with Olympus gastrointestinal endoscopes and other ancillary equipment for CO2 gas and water feeding.
The Endoscopic Insufflation Unit model XECR-2 is used to distend the gastrointestinal tract to optimize endoscopic observation utilizing carbon dioxide gas. The XECR-2 can be connected to both a CO2 cylinder and the medical facilities gas pipeline facility.
The provided text is a 510(k) summary for the Olympus Endoscopic Insufflation Unit model XECR-2. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It is important to note that a 510(k) submission for a device like an insufflation unit typically relies on bench testing, performance testing to established standards, and a comparison of technological characteristics to a predicate device, rather than clinical studies with human participants that measure diagnostic performance metrics (like accuracy, sensitivity, specificity, etc., which are common for AI/diagnostic software).
Therefore, many of the requested categories related to clinical study design, expert review, and ground truth will not be applicable or present in this type of submission.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative "acceptance criteria" in the format of a table with numerical thresholds for accuracy, sensitivity, or specificity, which are common for diagnostic or AI-driven devices. Instead, the "acceptance criteria" for this device's approval appear to be related to demonstrating substantial equivalence to predicate devices and adherence to safety and performance standards.
The document states:
- "The Endoscopic Insufflation Unit model XECR-2 is basically identical to the predicate devices in intended use, and similar in specifications except for the addition of new functions such as a timer."
- "The clinical literature provided in this submission support the safety and efficacy of the subject device." (Note: this refers to existing literature about insufflation, not necessarily a new study specifically for the XECR-2 establishing new safety/efficacy metrics).
- "When compared to the predicate devices, the XECR-2 insufflation unit does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device."
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Implied) |
|---|---|---|
| Intended Use | Identical to predicate devices | Identical to predicate devices |
| Safety | No significant changes affecting safety compared to predicates; supported by clinical literature | Safe as per predicate devices and general clinical understanding of insufflation |
| Effectiveness | No significant changes affecting effectiveness compared to predicates; supported by clinical literature | Effective as per predicate devices and general clinical understanding of insufflation |
| Specifications | Similar to predicate devices (e.g., CO2 gas delivery, water feeding capability) | Similar to predicate devices, with added functions like a timer |
| Method of Operation | No significant changes compared to predicate devices | Similar to predicate devices |
| Material/Design | No significant changes compared to predicate devices | Similar to predicate devices |
Study Details (Where Applicable)
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Sample size used for the test set and the data provenance:
- Not Applicable in the traditional sense of a clinical test set for AI/diagnostic performance. The approval is based on a comparison to predicate devices and general clinical literature supporting the technology, not a specific clinical study with a "test set" of patients for diagnostic performance evaluation of this specific insufflator.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of diagnostic performance, is not established for this type of device in this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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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 an endoscopic insufflation unit, not a diagnostic AI system or an imaging AI tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device (hardware) for insufflation, not a standalone algorithm. Its function is to facilitate endoscopic procedures, not to provide diagnostic interpretations.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for its approval is its demonstrated technical performance and substantial equivalence to existing (predicate) devices, which are accepted as safe and effective.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable.
§ 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.