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Acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures.

The Surgery Image Recorder (SIR) is an acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures. The SIR is designed to provide surgeons the ability to capture still images and streaming video from standard video outputs typically associated with imaging devices used during endoscopic surgery. To allow for the entry of patient demographic information and to provide a user interface the SIR will have and VO for a USB type keyboard and mouse, and will also provide I/O's for a USB compatible color printer, video outputs, serial outputs and network connectivity. Additionally, the SIR will be able to store data to its internal hard disk drive and to removable storage media (e.g., DVD, CD-R).

The provided 510(k) summary for the Camtronics Surgery Image Recorder (SIR) states that performance data is "Not required for determination of substantial equivalence for this class of device." It also states, "Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device."

Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for device performance evaluation is present in the document. The device was deemed substantially equivalent to a predicate device based on comparison of technological characteristics and intended use, not on specific performance metrics or clinical study outcomes.

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VERICIS Physiolog monitors, measures, and/or records physiologic data and patient images from a patient undergoing a cardiac catheterization procedure. VERICIS Physiolog is intended for use in hospital cardiac catheterization laboratories.

VERICIS Physiolog monitors, measures, and/or records physiologic data and patient images from a patient undergoing a cardiac catheterization procedure. VERICIS Physiolog is intended for use in hospital cardiac catheterization laboratories.

Here's an analysis of the acceptance criteria and study information for the VERICIS Physiolog device, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or a direct comparison of its performance against those criteria in a table format. Instead, it describes a functional validation process. The "Predicate device specifications comparison" table, while comparing features, does not represent acceptance criteria met by the device under test.

However, based on the performance data section, we can infer the implicit acceptance criteria were that the device functioned appropriately for the specific tests performed.

Study Details:

1. Sample Size Used for Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing involved "various types of ECG aberrations," "multiple pressures," "multiple oxygen saturations," "multiple erroneous and/or incongruous entries," and "multiple cases." This suggests a varied test suite but no specific count of simulated data points or cases.
   • Data Provenance: The data was generated using physiologic simulators. This indicates that the data was synthetic/simulated, not derived from human patients. The country of origin is not applicable as it was simulated data. It was retrospective in the sense that the simulated scenarios were pre-defined for testing.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable. The ground truth for the simulated data points (e.g., correct R-wave detection for a given simulated ECG, correct pressure calculation for a given simulated pressure waveform) would be inherent in the design of the physiologic simulators and the expected output of the device. There's no mention of human experts establishing ground truth for these simulated scenarios.

3. Adjudication Method for the Test Set:

   • Not applicable. Since the ground truth was based on simulator output and expected device behavior, human adjudication of results against a separate expert consensus was not performed or mentioned.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. This type of study assesses human reader performance, often with and without AI assistance. The testing described for VERICIS Physiolog exclusively focuses on the device's standalone functional performance with simulated data and does not involve human readers or clinical efficacy studies.

5. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

   • Yes. The described "Performance data" section details testing of the VERICIS Physiolog software and system in a standalone capacity using physiologic simulators. The device's "appropriate response" to various simulated conditions was assessed as purely algorithmic and system function.

6. Type of Ground Truth Used:

   • Simulated data ground truth / Expected algorithmic output: The ground truth for the performance tests was based on the known, expected output of a properly functioning physiologic data recording system given the inputs from the physiologic simulators. This is not expert consensus, pathology, or outcomes data.

7. Sample Size for the Training Set:

   • Not applicable. The document does not describe the use of machine learning or AI models that would require a distinct training set. The device appears to be a rule-based system for monitoring, measuring, and recording physiologic data.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as no training set for a machine learning model is mentioned.

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Video Plus is a digital imaging acquisition and review system for the cardiac video Fras is a cigation findedigital fluoroscopy, digital fluoroscopy, digital cine, real time cannoterization no. To icatalor meterssing, image processing, quantitative coronary processing digital subtraction angiography, digital video input, linked biplane acquisition, auto injection, and histogram equalization.

This is a software upgrade for the existing Video Plus System cleared under K954159. This release encompasses some general enhancements and more integrated support for certain vendors.

This document is a 510(k) Summary for a software upgrade (Video Plus software upgrade) for an existing digital image acquisition unit, Camtronics Video Plus, cleared under K954159. The submission compares the upgraded device to a predicate device, GE Medical Systems "Advantx DLX" (K945459, K926258).

The document explicitly states:
"Performance data: Not required for determination of substantial equivalence for this class of device."
"Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device."

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be provided from this document as no such data was required or presented for this 510(k) submission. The FDA clearance was based on substantial equivalence to a predicate device, not on specific performance data against acceptance criteria.

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The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.

A digital image capture, storage, and review system for echocardiography.

The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.

Here's a breakdown of the acceptance criteria and study information for the Camtronics Echocardiography System (K992259), based on the provided document:

This 510(k) submission states that performance data and conclusions from clinical/non-clinical test data were "Not required for determination of substantial equivalence for this class of device." This means that a specific study to prove the device meets acceptance criteria, as a primary submission requirement, was not conducted or submitted. The FDA's determination of substantial equivalence was based on a comparison to a predicate device, not on specific performance testing against pre-defined acceptance criteria.

However, based on the principle of substantial equivalence, the implicit acceptance criteria for the Camtronics Echocardiography System are its ability to function comparably to its predicate device, the MPACS "EchoLINK" (K980060), for the intended use of digital image transport and archival in echocardiography.

Below is a table summarizing the implicit "acceptance criteria" (based on predicate device specifications) and the reported performance of the Camtronics device, as well as the information directly asked for regarding a study, even if it wasn't explicitly required for this submission.

Acceptance Criteria and Reported Device Performance

Study Information (Based on K992259 Document)

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

   • Sample Size: Not applicable. The document explicitly states: "Performance data: Not required for determination of substantial equivalence for this class of device." Therefore, no specific test set was used for a performance study.
   • Data Provenance: Not applicable. No test data was required or provided.

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

   • Not applicable. No test set was used, and thus no ground truth was established by experts for a performance study.

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

   • Not applicable. No test set was used.

4. 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 comparative effectiveness study was done. This device is an image transport and archive system, not an AI-assisted diagnostic tool.

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

   • No standalone performance study was done.

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

   • Not applicable. As no performance study was conducted, no ground truth was established.

7. The sample size for the training set:

   • Not applicable. This device is an image management system and does not rely on machine learning or require a training set in the conventional sense.

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

   • Not applicable. No training set was used.

Summary regarding performance studies for K992259:

The FDA determined that for the Camtronics Echocardiography System, "Performance data: Not required for determination of substantial equivalence for this class of device." The clearance was based on substantial equivalence to a legally marketed predicate device (MPACS "EchoLINK" K980060) due to comparable intended use and technological characteristics, features, specifications, materials, and modes of operation. No new safety or effectiveness issues were raised. Therefore, the information typically requested about a study to prove acceptance criteria, including test sets, ground truth, experts, and adjudication, is not applicable to this particular 510(k) submission.

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This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.

This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.

The provided document is a 510(k) summary for the Camtronics CCD Camera, K990066. It claims substantial equivalence to a predicate device, K953974 MediCal Imaging Ltd. "Camvision 1000".

However, the 510(k) summary explicitly states two crucial points:

• "Performance data: Not required for determination of substantial equivalence for this class of device."
• "Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device."

Therefore, based on the provided text, there is no acceptance criteria or study data presented that proves the device meets specific acceptance criteria in terms of performance metrics. The submission relies solely on demonstrating substantial equivalence to a predicate device through a comparison of specifications.

Given this, I cannot provide the requested information in the format requested. The document does not contain:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are reported.
2. Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned as performance data was not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring ground truth was presented.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is a device submission, not an AI/ML algorithm submission in the modern sense.
9. How the ground truth for the training set was established: Not applicable.

Instead, the submission focuses on a direct comparison of technical specifications between the proposed device and the predicate device, as shown in the table below:

Predicate Device Specifications Comparison (as presented in the 510(k) Summary)

The conclusion of the 510(k) summary is that the Camtronics CCD Camera is "substantially equivalent to a legally marketed predicate device" and that "No new safety or effectiveness issues are raised." This determination is based on the "substantially equivalent technological characteristics, features, specifications, materials, modes of operation, and intended uses."

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This product is intended primarily for on-line or remote viewing of cardiac catheterization angiography studies communicated by network, or transported by CD-R interchage media. The CD-R media may also be used as a full resolution digital image archive of complete cath lab studies, to replace cine film. The ARS2 can optionally be used with other digital imaging modalities, such as R/F, nuclear and ultrasound. The ARS2 provides the capability to write and read CD-R optical discs which are produced in accordance with the ACC/NEMA DICOM standard.

Digital image recording and display system for use in cardiac catheterization, radiography/fluoroscopy, ultrasound, or other digital imaging modalities.

This 510(k) summary for the Camtronics Analytical Review Station (ARS2) does not contain the information needed to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.

Here's a breakdown of why based on the provided text:

• No Acceptance Criteria or Performance Study: The document explicitly states:
  • "Performance data: Not required for determination of substantial equivalence for this class of device."
  • "Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device."

This means that for the purpose of this 510(k) submission, the FDA did not require the manufacturer to provide specific performance acceptance criteria or a study demonstrating the device met such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices based on specifications and intended use, not on a detailed performance evaluation with acceptance metrics.

Therefore, I cannot populate the table or provide information on sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established from the provided text.

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• Image Acquisition .
• . Display Control/Image Processing
• Input /Output Control .
• . Patient Data Management

Digital image recording and display system fo use in a cardiac catheterization laboratory or radiography/fluoroscopy suite.

The provided text is a 510(k) summary for the Camtronics Digital Imaging System, submitted in 1995. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a clinical study for device performance against specific metrics. Therefore, much of the requested information cannot be extracted directly from this document.

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

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

This information is not provided in the document. The 510(k) summary is comparing the features and specifications of the new device to predicate devices to argue for substantial equivalence, not against pre-defined acceptance criteria for performance.

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

This information is not provided. The document explicitly states: "Performance data: Not required for determination of substantial equivalence for this class of device." This indicates that a formal study with a test set and associated data provenance was not conducted or submitted for this specific regulatory pathway.

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):

This information is not provided. Since performance data and a test set are stated as "not required," there would be no ground truth establishment by experts for such a study.

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

This information is not provided. As no test set performance data was required or provided, there would be no adjudication method.

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 provided. The device described is a "Digital Imaging System," a Picture Archiving and Communications Device, intended for image acquisition, display control/image processing, input/output control, and patient data management. It predates the widespread concept of AI assistance in medical imaging and its primary function is not to interpret images or assist human readers in that capacity. Therefore, an MRMC study on reader improvement with AI assistance would not be applicable to this device or its regulatory submission context in 1995.

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

This information is not provided. Given the device's function as an imaging system, not an interpretive algorithm, a standalone performance study in the modern sense of AI algorithms would not have been relevant or conducted for this submission.

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

This information is not provided. As no performance study with a test set was required or presented, there is no mention of ground truth types.

8. The sample size for the training set:

This information is not provided. As this is a digital imaging system and not a machine learning algorithm in the modern sense, the concept of a "training set" as it relates to AI/ML would not apply. The device's functionality is based on established engineering principles for image acquisition, processing, and display.

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

This information is not provided. Similar to point 8, the concept of a training set and its associated ground truth establishment is not applicable to this type of device and its regulatory submission in 1995.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of the Camtronics Digital Imaging System to existing predicate devices based on feature comparison. It explicitly states that "Performance data: Not required for determination of substantial equivalence for this class of device." Therefore, the document does not contain information about acceptance criteria, performance studies, test/training sets, or ground truth establishment that would typically be found in submissions for devices requiring such data (e.g., AI/ML-driven diagnostic devices).

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