(266 days)
The SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (consisting of Camera Control Unit and Camera Head) is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process signals transmitted from a fiberoptic endoscope that is connected to the Camera Head.
This product may be used on all patients requiring endoscopic examination using SCHOELLY Laparoscopes and FUJIFILM's light source BL-7000X together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging) and LCI (Linked Color Imaging) are adjunctive tools which can be used to supplement white light endoscopy. BLI and LCI are not intended to replace histopathological sampling as a means of diagnosis.
The SCHOELLY OSI Camera System is further intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in pattents at risk for ischemic states. The prospective clinical value of measurements made with OSI has not been demonstrated in disease states.
The proposed SCHOELLY Oxygen Saturation Imaging (OSI) Camera System is comprised of the SCHOELLY OSI Camera Control Unit (CCU) and the SCHOELLY OSI Camera Head (CH). It is intended for real-time endoscopic imaging and may be used on all patients requiring endoscopic examination.
The proposed device is for use with SCHOELLY Laparoscopes - mounted to the SCHOELLY OSI CH, or a videoscope connected to the SCHOELLY OSI CCU, an endoscopic light source and light guide and optional further light guide accessories. Further optional accessories to complete the endoscopic system include a monitor, an image recorder and further peripheral input devices (keyboard, mouse, foot pedal, etc.).
The proposed SCHOELLY OSI Camera System is suitable for real-time endoscopic visible imaging (white light imaging, WLI) as well as for real-time visualization of tissue oxygen saturation (StO2) levels during minimally invasive surgery (oxygen saturation imaging, OSI).
The document provided does not contain a study proving the device meets specific acceptance criteria based on human-in-the-loop performance, nor does it detail a multi-reader multi-case (MRMC) study or standalone algorithm performance with clearly defined acceptance criteria and adjudicated ground truth as typically found in AI/ML device submissions.
Instead, the document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the SCHOELLY Oxygen Saturation Imaging (OSI) Camera System. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling pre-defined performance acceptance criteria for an AI/ML algorithm.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, and effect sizes in MRMC studies, are not explicitly present in the provided text in the context of an AI/ML performance study.
However, I can extract information related to the device's technical and non-clinical performance and substantial equivalence:
Acceptance Criteria and Reported Device Performance (based on Non-Clinical Performance Testing):
The document details non-clinical performance testing and a comparison to a predicate device. While not presented as a formal "acceptance criteria table" for an AI/ML model, the comparison to the predicate device and the successful completion of specified tests serve as the basis for demonstrating equivalence.
| Acceptance Criteria Category (Implied by Testing) | Reported Device Performance (SCHOELLY OSI Camera System) |
|---|---|
| Reprocessing Validation | - Cleaning: Successfully passed cleaning validations according to instructions in the user manual, compliant with ANSI/AAMI ST98:2022 and ISO 14937:2009. |
- Sterilization: Successfully passed sterilization validations according to instructions in the user manual, compliant with ANSI/AAMI ST98:2022 and ISO 14937:2009. |
| Software Documentation | - Software documentation provided for a Basic Documentation Level per FDA Guidance (June 2023). - Software lifecycle, documentation, and validation managed in accordance with IEC 62304:2006 + A1:2016. |
| Electrical Safety and EMC Testing | - Assessed for conformity and complied with IEC 60601-1:2005+AM1:2012, IEC 60601-1-2:2014, IEC 60601-1-2:2020, and IEC 60601-2-18:2009. |
| Imaging Mode Performance (WLI, BLI, LCI) | - Accurately reproduced reference artifacts for image sharpness, depth of field, signal-to-noise ratio, temporal noise, color reproduction, dynamic range, and distortion. - Produced images with similar intensity, color, and contrast compared to the primary predicate device in in-vivo animal and human oral cavity/hand testing. |
| OSI Performance (Oxygen Saturation Imaging) | - Accuracy: Measurements of oxygen saturation were similar to those produced by the primary predicate device when compared to a reference device (Spectros T-Stat™ 303 Microvascular Tissue Oximeter) on a tissue phantom with controlled oxygen levels. - Effect of Variables: OSI testing included measurements regarding the effect of distance, angle, orientation, temperature, and duration.
- 2D Variation: Measurement of two-dimensional StO2 variation was performed.
- Image Similarity: Produced similar images of tissue oxygenation compared to the primary predicate device in human oral cavity/hand and in-vivo animal (intestines and stomach) testing. |
Regarding the other specific requirements for AI/ML performance studies:
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Sample size used for the test set and the data provenance:
- The document mentions "images of the human oral cavity and hand" and "intestines and stomach images from an in-vivo animal study."
- It does not specify the exact number of images, patients, or animals used for these comparative tests.
- The provenance is implied to be both human (oral cavity and hand) and animal (intestines and stomach), likely from a clinical or laboratory setting for in-vivo testing, but the country of origin is not specified, nor is whether the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish "ground truth" for the imaging comparisons in the sense of independent clinical review. The comparisons are stated as being directly between the SCHOELLY device's output and the predicate device's output, and against reference artifacts/tissue phantoms for quantitative measures.
- For the oxygen saturation accuracy, the "reference device" (Spectros T-Stat™ 303 Microvascular Tissue Oximeter) serves as a quantitative reference for the tissue phantom, but this is a device-to-device comparison, not expert-adjudicated ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no expert adjudication process is described for establishing ground truth for an AI/ML model's output. The performance relies on instrumental comparisons and visual similarity to a predicate.
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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:
- No MRMC study is mentioned. The device's primary function is imaging and visualization, including adjunctive oxygen saturation monitoring, not necessarily an AI-driven diagnostic aid for human readers. Therefore, an MRMC study demonstrating human reader improvement with AI assistance is not described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies a "standalone" technical performance evaluation for the imaging capabilities and oxygen saturation measurements, where the device's output is compared directly to reference standards or the predicate device. However, this is for the device's imaging capabilities (hardware and embedded algorithms for image processing), not an independent AI algorithm producing a standalone diagnostic output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For imaging characteristics (sharpness, color reproduction, etc.), "reference artifacts" were used.
- For oxygen saturation accuracy, a "tissue phantom with controlled oxygen levels" and a "reference device" (Spectros T-Stat™ 303 Microvascular Tissue Oximeter) were used.
- For visual comparisons (intensity, color, contrast, tissue oxygenation), the predicate device's output and in-vivo human/animal images served as the comparison basis, not a an independent "ground truth" established by expert consensus, histology, or outcomes. The substantial equivalence relies on the similarity to the predicate device's output.
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The sample size for the training set:
- Not applicable. This is a 510(k) submission for an imaging system, not explicitly an AI/ML device that requires a distinct "training set" for model development as typically understood in AI/ML validation studies. The "algorithms" mentioned are for image processing (BLI, LCI, OSI modes) and are inherent to the camera system, not necessarily a separate AI/ML model trained on a large dataset.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above. If the device incorporates learned algorithms, the details of their training and validation are not provided in this 510(k) summary, which focuses on demonstrating substantial equivalence rather than detailing AI/ML model development.
In summary: The provided text is a 510(k) summary demonstrating substantial equivalence for an endoscopic camera system. It highlights non-clinical performance testing comparing the device's output to a predicate device and established technical standards, rather than an AI/ML performance study with a distinct test set, ground truth experts, and reader studies.
§ 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.