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The Karl Storz Imaging (KSI) New Camera Architecture (NCA) Video Imaging System is a color, television camera system intended for use with rigid or flexible endoscopes, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope and the endoscopic image can be displayed on any standard operating room video monitor.

All standard endoscopic light sources may be used with New Camera Architecture (NCA) camera heads. The camera heads will be available in NTSC and PAL configurations.

The Karl Storz Imaging (KSI) New Camera Architecture (NCA) Video Imaging System is a color, television camera system intended for use with rigid or flexible endoscopes.

This is a notification for a Substantial Equivalence Determination. There is no information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

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The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then be displayed on any standard operating room video monitor.

The new autoclavable camera heads are identical to previous single chip and three chip models with the exception that these units are hermetically sealed and use a magnetic switch for operating the integral hand-held camera controls.

The provided text is a 510(k) summary for the Karl Storz Autoclavable Camera Head. It outlines the device's intended use, description, and claims of substantial equivalence to previously reviewed devices. However, it does not contain any information regarding specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria.

The submission focuses primarily on demonstrating substantial equivalence based on the device's design (hermetically sealed, magnetic switch) and sterilization capability, rather than presenting a performance study with detailed metrics.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not provided in the document. The submission focuses on substantial equivalence to predicate devices rather than meeting specific performance metrics.
• Sample size used for the test set and data provenance: Not mentioned. No specific test set or clinical study data is presented.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no test set or ground truth establishment is described.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a camera head, not an AI algorithm.
• The type of ground truth used: Not applicable, as no ground truth is described.
• The sample size for the training set: Not applicable, as no training set for an algorithm is described.
• How the ground truth for the training set was established: Not applicable.

Summary of available information:

The 510(k) summary addresses the regulatory requirements for showing substantial equivalence. It highlights:

• Device Name: Karl Storz Autoclavable Camera Head
• Intended Use: A color, television camera suitable for use with various rigid or flexible endoscopes, coupled to the endoscope, and used with compatible KSI camera control units (CCUs) to display endoscopic images on standard operating room video monitors.
• Device Description: Identical to previous single-chip and three-chip models, but hermetically sealed and uses a magnetic switch for integral handheld camera controls.
• Substantial Equivalence: Claimed to be substantially equivalent to previously reviewed KSI single CCD (K883943) and triple CCD (K950862) camera heads, and in pressurized steam sterilization capability, to M.P. Video's "Autoclaveable Medicam 900 Digicon Camera" (K942358).

The document's purpose is to demonstrate that the new autoclavable camera head is safe and effective because its technological characteristics and intended use are comparable to legally marketed predicate devices, not through a detailed performance study with specific acceptance criteria and outcome data.

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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 Karl Storz Imaging (KSI) Endovision XL System is a color, television camera head designed for use with any flexible or rigid endoscope. The camera head may be attached to any rigid or flexible endoscope, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera is connected to the video processor via a ten foot cable. The endoscopic image can be displayed on any standard operating room video monitor.

The Endovision XL is a state-of-the-art endoscopic camera. The head of the camera is equipped with a V-mount thread, allowing the head to couple to Karl Storz V-mount optical adapters. Three adapters, 15 mm, 20 mm and 25 mm, are available with the system. These couplers allow easy attachment of the XL head to any standard endoscope. Microprocessor controlled automatic exposure adjusts image brightness. The image sensor is a 1/4" CCD-chip. The processor weighs 1.77 pounds and the camera .6 pounds. Dimensions of the processor and camera in width, height and depth are: 8.29 x 2.16 x 6.07 inches and 1.96 x 2.4 x 3.9 inches respectively.

This 510(k) summary (K974391) describes an endoscopic camera system. It does not contain the detailed performance study information typically associated with establishing acceptance criteria and proving a device meets them through clinical or technical studies.

Here's an analysis based on the provided text, highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific reported device performance metrics. The submission focuses on substantial equivalence to previously cleared devices rather than new performance claims that would require specific acceptance criteria and detailed quantitative results.

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

Not applicable. The document does not describe a test set or explicit performance data from a study. The basis for clearance is substantial equivalence to existing devices.

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

Not applicable. No ground truth establishment is described for a test set.

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

Not applicable. No adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done or described in this document. The focus is on the device's physical characteristics being "smaller, lighter, more portable" compared to its predicates.

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

Not applicable. This device is a camera system, not an algorithm. Its performance is inherent in its image capture capabilities, which are established by equivalence.

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

Not applicable. No ground truth is described.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. This is not an AI/algorithm-based device.

Summary of the Study per the Provided Document:

The provided document (a 510(k) summary) does not describe a formal study with acceptance criteria and a detailed performance evaluation. Instead, the "study" (or rather, the justification for marketing) is based on the concept of Substantial Equivalence.

• Substantial Equivalence Claim: Karl Storz Imaging (KSI) states that its "Endovision XL endoscopic camera system is substantially equivalent to several other systems currently on the market including the KSI Tricam Color Endoscopic Television System (K950862) and the KSI Telecam Color Endoscopic Television System (K883943)."
• Basis for Equivalence: The document explicitly states, "The proposed new KSI Endovision XL is unique only in that it is a smaller, lighter, more portable camera system." This implies that its core functional performance (e.g., image quality, illumination, compatibility with endoscopes) is considered comparable or identical to the predicate devices, with the primary difference being size and weight for improved portability.
• FDA Response: The FDA's letter confirms their review and determination that "the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..." This indicates the FDA agreed with the substantial equivalence claim based on the information provided, without requiring a new, specific performance study with acceptance criteria for this particular submission.

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The Karl Storz Imaging (KSI) Direct Coupled (DCC) Camera Head is a color, television camera head designed for attachment to a Karl Storz Tuttlingen (KST) DCC endoscopic visioning system. The KSI DCC camera head is compatible with the currently marketed KSI Telecam SL (Super Luxury) video processor and the KSI Telecam SL with IPM (Image Processing Module) video processor.

The camera head is suitable for attachment to any KST DCC rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the DCC camera head until it locks into place. An optional adapter allows DCC camera head attachment to non-DCC rigid and flexible endoscopes. The endoscopic image can be displayed on any standard operating room video monitor.

The KSI DCC incorporates two programmable function buttons (to select an accessory port(s) and to control the port output) and two focus buttons. The light cable is connected directly to the back of the camera head. The camera is designed to allow the user to directionally rotate the camera head to maintain proper image orientation on the monitor.

The provided document is a 510(k) summary for the Karl Storz Imaging Direct Coupled Camera Head, submitted in 1997. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment.

Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, experts, or ground truth based on this document. The document essentially states that the new device is substantially equivalent to existing ones because it integrates features already present in their earlier models, implying that extensive new performance studies were not deemed necessary for this submission.

Summary of what cannot be provided from the document:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 mentioned. This device is a camera head, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a camera, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
8. The sample size for the training set: Not applicable as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

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The Optronics EPIC System is intended for use as an accessory to a slit lamp biomicroscope, providing enhanced imaging of the eye for opthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need

The Optronics EPIC System consists of a camera and a video processor. The camera consists of a camera head with eyepiece and beamsplitter and an integral cable for electronic transmission of signals and power. The camera head consists of an outer aluminum shell housing the video sensor and optical elements. The cable is permanently attached to the camera head and connects to the processor. The processor consists of a finished aluminum housing containing the power supply, circuit boards, and interconnections necessary to process the video image.

The provided text describes a 510(k) summary for the Optronics EPIC Color Television Camera System. It focuses on the device's description, intended use, and a comparison to predicate devices, particularly regarding video system performance.

However, the document does not contain information typically found in a study designed to demonstrate how a device meets specific acceptance criteria. Specifically, it lacks:

• Explicit Acceptance Criteria: The document does not define specific performance thresholds (e.g., "the device must achieve a resolution of X TV lines"). While it provides performance characteristics like resolution and sensitivity, these are presented as descriptive specifications rather than pass/fail criteria.
• A "Study" Proving Acceptance: There is no mention of a formal study (e.g., a clinical trial, a laboratory validation study) where the device was tested against predefined criteria. The comparison table merely lists the device's specifications alongside those of predicate devices.
• Details about Test Sets, Ground Truth, Experts, or Adjudication: These elements are crucial for any study demonstrating a device's performance, especially for medical imaging where diagnostic accuracy is paramount. This document is a technical summary, not a clinical validation report.
• MRMC or Standalone Performance Data: There's no discussion of multi-reader multi-case studies or standalone algorithm performance, as this device is a camera system and not an AI-powered diagnostic tool.
• Training Set Information: Since no AI algorithm is described, there's no training set or ground truth establishment relevant to AI.

Despite the lack of the requested information, I can extract and present the available performance characteristics in a table format, interpreting them as specifications rather than "acceptance criteria" met by a formal study.

Table of Device Specifications and Predicate Device Performance:

Since the document does not describe a study to prove acceptance criteria, the following points cannot be answered based on the provided text:

2. Sample size used for the test set and the data provenance: Not applicable; no test set described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth or experts described.
4. Adjudication method for the test set: Not applicable; no test set 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: Not applicable; this device is a camera system, not an AI diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is a camera system, not an AI algorithm.
7. The type of ground truth used: Not applicable; no ground truth described.
8. The sample size for the training set: Not applicable; no AI algorithm or training set described.
9. How the ground truth for the training set was established: Not applicable; no AI algorithm or training set described.

In summary, the provided document is a 510(k) summary focusing on device specifications and substantial equivalence, not a detailed study report demonstrating performance against predefined acceptance criteria using clinical or laboratory test sets.

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