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The FlexiScope 50MH / 50MHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.

The Schoelly FlexiScope 50MH / 50MHC system is comprised of a camera handpiece and a combination light source / video processor; the system is intended for use with currently marketed endoscopes. The light source utilizes visible light to provide illumination of the area under endoscopic examination. The compact camera system component attaches to the proximal eyepiece of the user-supplied flexible or rigid endoscope. Images are optically captured via the endoscope. The image is transferred to the camera's CCD (charge coupled device) sensor through the scope objective lens, where it is converted to an electrical signal and amplified for output to accessories such as a monitor, printer, etc.

The provided 510(k) summary for the Schoelly FlexiScope 50MH / 50MHC does not contain information related to acceptance criteria, device performance metrics, or a study proving the device meets specific performance criteria in the way a diagnostic AI device would.

This device is a light source and video camera system for endoscopy, not a diagnostic AI or image analysis tool. Its approval is based on establishing substantial equivalence to predicate devices through comparisons of labeling, physical, and performance design characteristics, and compliance with electrical safety and electromagnetic compatibility standards.

Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary. I will address the relevant points and indicate when information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). The "acceptance criteria" for this type of device are primarily related to safety, electrical performance, and functional equivalence to predicate devices. The document states:

2. Sample size used for the test set and the data provenance

Not applicable. This device is not a diagnostic tool that relies on a "test set" of patient data for performance evaluation in the conventional sense of AI. Its "testing" involved electrical and electromagnetic compatibility standards and functional verification, not analysis of clinical images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for AI validation (e.g., expert consensus on clinical findings, pathology results) is not relevant for the regulatory approval of an endoscopic light source and camera system.

4. Adjudication method for the test set

Not applicable for the same reasons as points 2 and 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

No. This is a medical device for visualization, not an AI-powered diagnostic system. MRMC studies demonstrating human reader improvement with AI assistance are not relevant to this 510(k) submission.

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

Not applicable. The device itself is a "standalone" hardware component, in the sense that it functions to provide light and video. It does not employ an algorithm for independent diagnostic performance.

7. The type of ground truth used

For the safety and performance claims, the "ground truth" used would be the compliance with recognized electrical and electromagnetic standards (IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18) and the functional equivalence to its predicate devices. This is ascertained through engineering tests and direct comparison, not clinical pathology or outcomes data in the way an AI diagnostic would be evaluated.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable for the same reason as point 8.

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The Karl Storz Imaging (KSI) Direct Coupled Interface (DCI 5) Camera System combines a color, television camera head with an integrated light source cable and camera control unit (CCU). These units are designed for attachment to any Karl Storz Tuttlingen (KST) DCI compatible rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The DCI 5 camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the camera head until it locks into place. An optional adapter allows DCI 5 camera head attachment to non-DCI rigid and flexible endoscopes. The endoscopic image can be displayed on any standard operating room video monitor. All commonly available endoscopic light sources may be used with the DCI 5 System.

The KSI DCI 5 incorporates two programmable function buttons (to select an accessory port(s) and to control the port output), a focus knob and a zoom in/zoom out control bar. The camera head also has an integrated light cable. The camera is designed to allow the user to axially rotate the camera head while maintaining proper image orientation on the monitor.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Karl Storz Imaging Direct Coupled Interface Camera Head and primarily focuses on:

• Device Description and Intended Use: Explaining what the DCI 5 Camera System is and how it's used with various endoscopes.
• Substantial Equivalence: Demonstrating that the DCI 5 is substantially equivalent to previously cleared Karl Storz Imaging devices by combining features from them.
• FDA Clearance Letter: Official notification from the FDA granting clearance for the device to be marketed.

The text does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes or data provenance for a test set.
• Information on expert ground truth establishment for a test set.
• Adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study.
• Details about standalone algorithm performance if an AI component were present.
• The type of ground truth used.
• Training set sample size or how its ground truth was established.

This is a predicate device submission, meaning it compares the new device to existing, legally marketed devices to demonstrate that it is largely similar in terms of technology, safety, and effectiveness, without necessarily providing comprehensive new performance studies against predefined acceptance criteria in the way a novel AI device might.

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The EC 1000-7 Digital Endoscopy Video Camera is a device used for monitoring and recording during endoscopic procedures.

EC 1000-7 Digital Endoscopy Video Camera (Models EC 1000-7P (PAL) & EC 1000-7 (NTSC))

The provided text is a 510(k) clearance letter from the FDA for the EC 1000-7 Digital Endoscopy Video Camera. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The text is a regulatory clearance and not a scientific or clinical study report.

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The 1 CCD Endocam 5502 and 3 CCD Endocam 5507 are designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions.

The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current. This permits its use for cardiac visualization procedures when used in conjuction with the proper instrumentation for entry into the cardiac system.

The endoscopic video camera systems include a camera controller and a small camera head which is connected by a camera cable to the controller. Endoscopic procedures are displayed with the objective lenses attached to the camera head and the video monitors connected to the camera controller.

The camera heads are CF Equipment (cardiac floating) according to UL2601-1 / IEC601-1.

This document is a 510(k) summary for the Richard Wolf Medical Instruments Corp. 1 CCD Endocam 5502 and 3 CCD Endocam 5507. It declares substantial equivalence and does not detail a study proving specific acceptance criteria in the manner you've requested for a medical device's performance metrics. Instead, it focuses on general safety and effectiveness through compliance with regulatory standards and comparison to predicate devices.

Therefore, many of the requested fields cannot be directly populated from the provided text. I will explain why each field cannot be filled if the information is missing.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance:

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

The document does not detail specific "test sets" for performance evaluation in the way requested for a clinical or AI-based device study. Instead, it refers to regulatory compliance testing performed by "Independent laboratories." Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The document describes compliance testing against standards, not a study involving expert-established ground truth for a test set.

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

This information is not applicable and not provided. The document refers to engineering and safety standard compliance testing, not a clinical study with image interpretation requiring adjudication.

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 information is not applicable and not provided. The device is an endoscopic video camera 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 and not provided. The device is hardware (camera system), not an algorithm.

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

The "ground truth" for the device's acceptance is based on adherence to specified international and national electrical and medical device safety standards (e.g., IEC601-1, UL2601-1) and the Medical Device Directive 93/42/EEC, rather than clinical outcomes or expert consensus on diagnostic performance.

8. The sample size for the training set:

This information is not applicable and not provided. The device is a physical camera system, not a machine learning algorithm that requires a training set.

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

This information is not applicable and not provided. As above, no training set for an algorithm is mentioned.

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The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.

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The provided text is a 510(k) clearance letter from the FDA for a device called "VES 3001-M Complete Video Endoscopic System". This letter primarily addresses the regulatory clearance of the device and does not contain detailed information about acceptance criteria or performance studies as typically requested for AI/ML-driven devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document. The document confirms that the device is "substantially equivalent" to predicate devices, but does not provide specific performance metrics or the studies that would demonstrate them.

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The VES 1501-m use is indicated whenever video display from an endoscope is required for more convenient viewing.

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The provided text is a 510(k) clearance letter from the FDA for a device called "VES 1501-M Video Endoscopic System." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing details of new clinical efficacy or performance studies with acceptance criteria for the new device itself.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: The letter states the device is substantially equivalent to a predicate, not that it met specific performance criteria from a new study.
2. Sample size used for the test set and the data provenance: No new test set data is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. The letter does not mention such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a video endoscopic system, not an AI algorithm.
7. The type of ground truth used: Not applicable as no new study data is presented.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and no new training data is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The FDA 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and intended use. It does not typically involve the presentation of new efficacy studies with defined acceptance criteria in the same way a Premarket Approval (PMA) application might.

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The VES-1CAM use is indicated when ever there is a need for the use of video in endoscopic procedure.

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This document is a 510(k) clearance letter from the FDA for the Angiolaz VES-1Cam device, dated August 4, 1998. It primarily confirms the device's substantial equivalence to a legally marketed predicate device and grants permission to market it.

Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter focuses on regulatory approval and states the device's intended use: "The VES-1CAM use is indicated whenever there is a need for the use of video in endoscopic procedure."

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study that proves the device meets them from the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

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