Search Results

Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/), light source, document, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190U/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

CV-190 VIDEO SYSTEM CENTER
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

CLV-190 XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation within the upper and lower digestive tract.

The primary components of the subject system are:

• VIDEO SYSTEM CENTER OLYMPUS CV-190
• XENON LIGHT SOURCE OLYMPUS CLV-190
• ENDOSCOPES
• GASTROINTESTINAL VIDEOSCOPE (GIF-H190,GIF-HQ190, GIF-XP190N)
• COLONOVIDEOSCOPE (CF-HQ190L/I, CF-H190L/I, PCF- PH190L/I, PCF- H190L/I)

The provided document is a 510(k) Summary for the Olympus EVIS EXERA III VIDEO SYSTEM. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining indications for use, rather than presenting a performance study with acceptance criteria for a new and distinct functional claim.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning the following points:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007," but it does not specify what those criteria were or how the device's performance against them was measured or reported.
2. Sample size used for the test set and the data provenance: Not applicable as no specific device performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: This document is for a video system, not an AI-assisted diagnostic device, so this type of study is not relevant here and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states that the purpose of the notification is to "add an additional colonoscopy-related marketing claim" to the existing device and that "There are no new technological features incorporated... No design changes have been made... other than this marketing claim modification." It relies on the substantial equivalence to the predicate device (K112680) and conformity to applicable safety standards (like ISO 14971:2007) and software guidance.

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• Endoscopes (OLYMPUS BF-Q190, OLYMPUS BF-H190, OLYMPUS BF-1TH190 EVIS EXERA BRONCHOVIDEOSCOPE)
  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. This instrument is indicated for use within the airways and tracheobronchial tree.

• OLYMPUS CV-190 EVIS EXERAIII VIDEO SYSTEM CENTER
  This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

• OLYMPUS CLV-190 EVIS EXERATI XENON LIGHT SOURCE
  This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The primary components of the subject system, which are part of this submission, are:

• Video System Center OLYMPUS CV-190
• XENON LIGHT SOURCE OLYMPUS CLV-190
• RENON ENOVIDEOSCOPE OLYMPUS BF-Q190, BF-H190, BF-H190, BF-1TH190

The CV-190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9).

The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation.

In addition, both the CV-190 and CLV-190 can be used with any specified Olymous flexible and rigid including gastroscopes, ultrasound gastroscopes, duodenoscopes, endoscope models, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.

The subject endoscopes are 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.

The provided document, K121959 for the EVIS EXERA III VIDEO SYSTEM, is a 510(k) premarket notification. This type of submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical trials with specific acceptance criteria and performance metrics for new or significantly altered functions.

Therefore, based on the provided text, I can extract information regarding non-clinical testing and general acceptance of safety and effectiveness through substantial equivalence, but I cannot provide a table of acceptance criteria and reported device performance related to a specific study proving those criteria, nor can I provide information on sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not detailed in this type of regulatory submission.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, a detailed table with specific performance metrics against acceptance criteria from a clinical study is not available in this 510(k) summary. The document states that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." However, the specific acceptance criteria and the numerical results of these design verification tests are not provided in the summary.

The primary method for demonstrating safety and effectiveness in this 510(k) is through substantial equivalence to predicate devices. The conclusion states: "When compared to the predicate device, the EVIS EXERA III VIDEO SYSTEM 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."

2. Sample Sizes Used for the Test Set and Data Provenance

This information is not available in the provided document. The submission focuses on non-clinical testing and substantial equivalence, not clinical testing with a "test set" in the context of AI/algorithm performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not available in the provided document. As there is no "test set" described for performance evaluation, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not available in the provided document. The device described is an endoscopic video imaging system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/available as the device is an imaging system, not a standalone algorithm.

7. The Type of Ground Truth Used

Based on the document, the "ground truth" for the device's acceptable performance is primarily established through:

• Compliance with recognized standards: Such as IEC 60601-1, ISO 14971, ASTM E1837-96, ANSI/AAMI/ISO 11135-1, ISO 10993-1, ISO 10993-5, ISO 10993-10.
• Risk analysis: "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007."
• Design verification tests: The design verification tests and their acceptance criteria were identified and performed as a result of the risk analysis assessment.
• Reprocessing validation: "Reprocessing validation was carried out in accordance with 'Labeling Reusable Medical Devices Reprocessing Vallaulton was camose of the FDA Reviewer Guidance - April 1996.'"
• Software validation: "The software validation activities were performed in accordance with the FDA Guidance 'for the Contained of Premarket Submissions for Software Contained in Medical Devices.' The device software is considered a 'Minor Level of Concern.'"
• Substantial Equivalence to Predicate Devices: The overall conclusion of the 510(k) is that the device is substantially equivalent to legally marketed predicate devices, implying its safety and effectiveness are comparable.

8. The Sample Size for the Training Set

This information is not available/applicable. The device is an endoscopic video system, not an AI algorithm that would typically have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not available/applicable for the same reason as point 8.

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Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/l), 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-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190L/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

CV-190 VIDEO SYSTEM CENTER
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

CLV-190 XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The primary components of the subject system, which are part of this submission, are:

• Video System Center OLYMPUS CV-190
• XENON LIGHT SOURCE OLYMPUS CLV-190
• GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190
• COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I

The CV-190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9).

The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation.

In addition, both the CV-190 and CLV-190 can be used with any specified Olympus flexible and rigid including gastroscopes, ultrasound gastroscopes, endoscope models. duodenoscopes. colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.

The subject endoscopes could be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/I). light source, document, monitor. EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment within the upper and lower digestive tract.

The provided text describes the 510(k) summary for the EVIS EXERA III VIDEO SYSTEM ENDOSCOPIC VIDEO IMAGING SYSTEM. This document outlines the device, its intended use, and a summary of non-clinical testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the way typically expected for a new AI/ML-driven medical device, especially regarding performance metrics like sensitivity, specificity, accuracy, or diagnostic improvement.

Instead, this submission focuses on demonstrating substantial equivalence by comparing technological characteristics and indicating that risk analysis and validation activities were performed according to established standards.

Therefore, many of the requested details about acceptance criteria and a study proving device performance (especially for AI/ML) cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

No specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance metrics are provided in the document. The submission focuses on demonstrating substantial equivalence through comparison of technological characteristics and compliance with general safety and performance standards.

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. The document does not describe a clinical performance study with a test set in the context of diagnostic accuracy or similar metrics. The "test set" mentioned in the document refers to design verification tests and software validation, not a clinical data set for assessing diagnostic performance.

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 clinical test set is described.

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

Not applicable. No adjudication method for a clinical test set is described.

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

No such MRMC study is mentioned or referenced. This device is an endoscopic video imaging system, and the submission does not discuss AI assistance for human readers.

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

Not applicable. This device is not described as an algorithm-only device. It's a video system with integrated components for endoscopic imaging.

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

Not applicable. No ground truth in the context of diagnostic assessment is discussed. The "ground truth" for the non-clinical testing would relate to engineering specifications and safety standards.

8. The sample size for the training set

Not applicable. The document does not describe an AI/ML component that would require a "training set" in the sense of machine learning.

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

Not applicable.

Summary based on the provided text:

The document is a 510(k) summary for an endoscopic video imaging system seeking approval based on substantial equivalence to predicate devices. It discusses technological characteristics, risk analysis, reprocessing validation, and software validation according to general regulatory standards. It does not contain information about a clinical performance study with acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or the use of AI/ML algorithms and their associated clinical performance metrics.

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