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This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopic diagnosis and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral anal insertion.

Indications for Use of the Components are as follows:

SIF-Q180 (SMALL INTESTINAL VIDEOSCOPE)

This instrument has been designed to be used with an Olympus video system center, light source, single use splinting tube, balloon control unit, documentation equipment, video monitor, endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract (including the esophagus, stomach, duodenum, colon, and small intestine) by either oral and anal insertion.

OBCU (BALLOON CONTROL UNIT)

This balloon control unit has been designed for inflating and deflating the balloon attached to the distal end of a single use splinting tube in order to assist the insertion of an Olympus -designated small intestinal endoscope.

The subject device, Small Intestinal Videoscope system, is designed for endoscopy and endoscopic surgery within the small intestine. This system is composed of Small Intestinal Videoscope, Single Use Splinting Tube, and Balloon Control Unit and its accessories. The subject system is compatible with NBI observation which utilizes narrow-band spectrum to enhance contrast of the surface structure and fine capillary patterns of the mucous membranes. Also, the subject system utilizes a balloon attached to the splinting tube to facilitate advancement of the endoscope well within the small intestine.

This 510(k) summary for the Olympus Small Intestinal Videoscope System (K071254) does not contain the information requested about acceptance criteria, device performance, statistical studies, or ground truth establishment.

The document is a premarket notification for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device. It addresses:

• General Information: Applicant, manufacturer, official correspondent.
• Device Identification: Trade name, common name, regulation number, regulation name, regulatory class, product code.
• Predicate Device Information: Details of the device it's being compared against.
• Device Description: A brief overview of the system components and their function.
• Indications for Use: The medical conditions and procedures for which the device is intended.
• Comparison of Technological Characteristics: How the new device is similar to and different from the predicate device, highlighting features like NBI observation and balloon technology.
• Conclusion: A statement that the device does not incorporate significant changes that would affect safety and effectiveness compared to the predicate.
• FDA Correspondence: The official letter from the FDA determining substantial equivalence, including regulatory compliance reminders.

The document does NOT provide:

1. Acceptance criteria or reported device performance data: There is no table detailing specific performance metrics (e.g., image resolution, depth of field, illumination, insertion success rates, diagnostic accuracy) or acceptance thresholds for these metrics.
2. Details of any study: No information is given about sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set details. This is typical for a 510(k) submission where substantial equivalence is demonstrated through technological comparison rather than efficacy or performance studies against specific criteria.
3. Type of ground truth used: Since no study is described, no ground truth information is available.

Summary of missing information:

• Acceptance Criteria & Device Performance: Not reported.
• Sample Size (Test Set) & Data Provenance: Not reported, as no study is detailed.
• Number & Qualifications of Experts: Not reported.
• Adjudication Method: Not reported.
• MRMC Comparative Effectiveness Study: Not reported.
• Standalone Performance Study: Not reported.
• Type of Ground Truth: Not reported.
• Sample Size (Training Set): Not reported.
• Ground Truth for Training Set: Not reported.

In essence, this document establishes market clearance based on substantial equivalence to a previously cleared device, focusing on its intended use, design, and technological characteristics, rather than new clinical performance data or specific acceptance criteria.

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This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.

The subject device, Small I surgery within the small intrisune. The subject device utilizes senuential geolovment of two bailouns, one attached to an gastrointestinal . ment of the endoscope well within the small intestine. The suppor over can access inrough the small intestine via either oral or anal introduction.

The provided 510(k) summary (K051551) for the "SMALL INTESTINAL VIDEOSCOPE SYSTEM" does not include a detailed study with acceptance criteria and reported device performance in the way a modern AI/ML device submission would. This document is from 2005, and the device in question is a medical endoscope system, not an AI-powered diagnostic tool. Therefore, the traditional acceptance criteria and study design elements typically associated with AI/ML device evaluations (like sensitivity, specificity, AUC, sample sizes for training/test sets, ground truth establishment by experts, MRMC studies, etc.) are not present in this submission.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, intended use, and materials.

Here's an attempt to answer the questions based on the available information, noting where no direct information is provided due to the nature of the device and submission type:

1. A table of acceptance criteria and the reported device performance

No explicit "acceptance criteria" or "reported device performance" in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy) are presented in this 510(k) summary. The acceptance criteria for this type of device and submission are implicitly met by demonstrating substantial equivalence to predicate devices, meaning the device performs as safely and effectively as a legally marketed predicate device. The performance is summarized by comparing physical specifications and material commonalities.

• Field of View: 140° (same as predicates)
• Depth of Field: 3~100 mm (same as predicates)
• Direction of View: 0° Forward Viewing (same as predicates)
• Outer Diameter of Distal End: φ 9.2 mm (smaller than predicates)
• Outer Diameter of Insertion Tube: φ 9.2 mm (smaller than predicates)
• Working Length: 2000 mm (different, but within typical variations for endoscopes)
• Inner Diameter of Instrument Channel: φ 2.8 mm (smaller than XSIF-1TQ140A, larger than PCF-160AL/I)
  XSIF-160DB vs. K040048 (EN-450P5/20):
• Field of View: 140° (larger than predicate's 120°)
• Depth of Field: 3100 mm (predicate 5100 mm)
• Direction of View: 0° Forward Viewing (same as predicate)
• Outer Diameter of Distal End: φ 9.2 mm (larger than predicate's φ 8.5 mm)
• Outer Diameter of Insertion Tube: φ 9.2 mm (larger than predicate's φ 8.5 mm)
• Inner Diameter of Instrument Channel: φ 2.8 mm (larger than predicate's φ 2.2 mm) |
  | Intended Use | Identical or highly similar to predicate devices. | "Designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion." (Essentially identical to general endoscope intended uses). |
  | Materials | Patient contact materials are identical to those in legally marketed predicate Olympus devices. | "All the patient contact materials used in the SMALL INTESTINAL VIDEOSCOPE SYSTEM are identical to those used in the legally marketed Olympus devices." |
  | Safety and Effectiveness | No new questions of safety or effectiveness are raised compared to predicate devices. Non-clinical tests support this. | "When compared to the predicate devices, SMALL INTESTINAL VIDEOSCOPE SYSTEM do not the safety and offectiveness, In intended use, method of operation, material, or design that could affect the safety and effectiveness. In addition, the provided of operation, or design that could and efficacy of the subject system." (This statement is slightly garbled in the scan but suggests no new safety/effectiveness concerns). |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) for a physical medical device (endoscope), not a software/AI device that requires a test set of data for performance evaluation. The "study" here is a comparison of specifications and intended use against existing predicate devices.

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. No ground truth establishment by experts for a test set is part of this type of submission for a physical endoscope.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication method is relevant for this device.

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 an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There is no ground truth concept in the context of this 510(k) submission as it's not evaluating diagnostic or interpretation performance.

8. The sample size for the training set

Not applicable. This is not a software/AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set or associated ground truth.

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