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The DICOM Theater device is Intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

The DICOM Theater device is a digital image display system. The DICOM Theater consists of components to provide high resolution visualization of digital images.

The provided text is a 510(k) summary for the Barco NV DICOM Theater device, a digital image display system. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device (Coronis 1MP Medical Flat Panel Display System, K023340).

The document does not contain information regarding specific acceptance criteria, a study that proves the device meets those criteria, or details regarding ground truth establishment, sample sizes, or expert qualifications for a performance study. It merely states the device's intended use and technological characteristics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the information provided. The document outlines the regulatory process and approval of the device, but not the technical performance study details that would be required to answer your questions.

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The device is intended for use to identify by standard radiologic mark or techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.

The TumorLocalizer MRI is a standard needle and hookwire device used for the localization of non-palpable lesions.

The provided document is a 510(k) summary for the "TumorLocalizer MRI" device, a surgical needle and hookwire device for localizing non-palpable lesions. It primarily addresses the regulatory approval process and states substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific performance criteria.

Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory compliance and not on detailed performance studies or statistical data.

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The PunctureNeedle device is intended for use in puncturing precise anatomical locations (including but not limited to cysts, lesions, fluid spaces, etc.) and aspirating or injecting various fluids or contents. The device may be utilized under MRI guidance.

The PunctureNeedle is a standard needle to puncture precise anatomical locations and inject or aspirate various fluids or contents. The proposed device is different than many needles in that the PunctureNeedle device has components manufactured of titanium alloy, which yields less artifact than stainless steel when utilized under magnetic resonance conditions.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study, or any of the other specific details requested in your prompt regarding a study that proves a device meets acceptance criteria.

The documents are a 510(k) summary for the "PunctureNeedle" device and the FDA's clearance letter for it. They describe the device, its intended use, technological characteristics, and its substantial equivalence to predicate devices, particularly highlighting its titanium alloy components for reduced MRI artifact. However, there is no mention of a clinical or technical study proving specific performance metrics against defined acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information.

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Embla is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where patients require documentation of various sleep or other physiological disorders.

The device is an EEG and physiological signs recorder. Embla is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to EEG and other physicians. The device will be used in hospitals, institutions, sleep centers used in hospitals, institutions, environments where of various or clinics, of ocure documentation patients require doodaologic disorders. The Embla device is a totally digital recorder utilizing 16 channels of input Gata. The device is available in ambulatory as well as desktop configurations.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study details that would allow me to populate the requested table and answer the specific questions about a device study.

The document is a 510(k) summary for a device called "Embla," which is an electroencephalograph (EEG) and physiological signs recorder. It details the device's classification, proprietary name, substantial equivalence to predicate devices, description, intended use, and technological characteristics. It also includes the FDA's letter of substantial equivalence.

There is no mention of:

• Acceptance criteria for the device's performance.
• Any specific study conducted to prove the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.

Therefore, I cannot fulfill your request with the given input.

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The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

The device is an assortment of various sizes and configurations of stainless steel bone screws.

The provided text is related to a 510(k) submission for an "Orthopedic Screw System." It describes the device, its intended use, and substantial equivalence to predicate devices, along with the FDA's decision. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment that would be typically found in a clinical study report or a summary of safety and effectiveness data.

Therefore, I cannot extract the requested information from the provided input. The document is primarily a regulatory clearance letter, not a performance study report.

If you have a document that details the performance study, please provide it, and I will do my best to answer your questions.

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The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

The device is an assortment of various sizes and configurations of stainless steel bone plates.

I am sorry, but the provided text only contains a 510(k) summary and FDA clearance letter for an "Orthopedic Plate System." This document primarily focuses on establishing "substantial equivalence" to previously marketed devices rather than detailing specific performance acceptance criteria or a dedicated study proving performance against such criteria.

Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies from the given text.

The document states:

• The device is an assortment of various sizes and configurations of stainless steel bone plates.
• The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.
• The Orthopedic Plate System is a standardly used device.
• The FDA determined the device is "substantially equivalent" to predicate devices, implying it meets the same general safety and effectiveness standards as those products.

To provide the requested information, a different type of document, such as a clinical study report, a scientific publication, or a more detailed technical file, would be needed.

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TarqoBeam is an aiming device intended to be used to verify and control correct angulation of interventional -----devices such as needles used in CT- or MRI-quided punctures, biopsies, and related procedures.

The TargoBeam is an aiming device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle.

Here's an analysis of the provided text regarding the TargoBeam device's acceptance criteria and study information.

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter from 1997. These documents are primarily focused on demonstrating substantial equivalence to pre-existing devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way modern device submissions often do.

Based on the provided text, the specific details regarding acceptance criteria and a structured study proving device performance are not explicitly available in the format requested. The documents emphasize substantial equivalence to predicate devices rather than meeting a pre-defined performance threshold through a dedicated study.

However, I can extract the available information and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: There are no quantitative acceptance criteria (e.g., accuracy +/- X degrees, success rate > Y%) or quantified performance metrics (e.g., "The device achieved an average angular deviation of 0.5 degrees, meeting the acceptance criterion of < 1 degree"). The assessment is qualitative and comparative.

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

• Sample Size for Test Set: Not specified. The document does not describe a formal "test set" in the context of a clinical performance study.
• Data Provenance: Not specified. There is no mention of a study involving patient data, either retrospective or prospective, or country of origin. The submission relies on a comparison to predicate devices and a description of the device's technical characteristics and intended use.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  As no formal test set or ground truth establishment process is described for performance, experts for this purpose are not mentioned. The "experts" involved would likely be the FDA reviewers assessing the substantial equivalence.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication for ground truth is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or implied in the provided documents. The focus is on device features and comparison to predicates.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable. The TargoBeam is a physical aiming device, not an AI-assisted diagnostic or interventional tool for image interpretation.

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

• Standalone Performance Study: Not applicable. The TargoBeam is an aiming device that inherently requires human interaction for its use in guiding interventional procedures. It is not an "algorithm only" device.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly defined or used in the context of a performance study in these documents. The "ground truth" for the submission is primarily the established performance and safety of the predicate devices and the technical specifications of the TargoBeam itself.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As the TargoBeam is a physical device and not an AI/machine learning model, there is no "training set" in the conventional sense.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Summary of what's provided vs. requested:

The provided documents are a regulatory submission for substantial equivalence for a physical medical device from 1997. The requirements for such submissions at that time, and for this type of device, differ significantly from the detailed clinical performance studies, AI model validation, and specific quantitative acceptance criteria that are often expected for newer, more complex devices, especially those incorporating AI or novel clinical pathways.

The "study" that proves the device meets the acceptance criteria in this context is the 510(k) submission itself, which argues that the TargoBeam is functionally equivalent, equally safe, and equally effective to legally marketed predicate devices, and therefore acceptable for market. No specific standalone clinical trial data with defined acceptance criteria and performance results are presented in these particular documents.

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This device is indicated for use in the fixation of subtrochanteric fractures.

The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian Fractures is an implantable device be used in orthopedic trauma to procedures.

This appears to be a 510(k) premarket notification for a medical device called the "Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian Fractures." This documentation focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria based on detailed performance metrics.

Therefore, the provided text does not contain the information requested to describe acceptance criteria and a study that proves the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details about a specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC studies or standalone algorithm performance.
• Information on training set sample size or how its ground truth was established.

This document is a regulatory submission demonstrating substantial equivalence, not a clinical or performance study report.

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This device is indicated for use in the fixation of unstable femoral neck fractures.

The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures is an implantable device to be used in orthopedic trauma procedures. The D.S.S. System For Osteosynthesis of Unstable Femoral Neck Fractures is a hip screw mechanism that allows a natural, weight-bearing compression. The D.S.S. screws can be utilized alone, or in combination with a mini-plate, allowing most flexibility in configurations of osteosynthesis in unstable femoral neck fractures.

This document is a 510(k) summary for the Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures. As such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth establishment is not available in this document. The 510(k) process primarily relies on non-clinical data (e.g., mechanical testing, materials characterization) and comparison to legally marketed predicate devices to establish safety and effectiveness.

Here's a breakdown of why this information isn't present in this type of submission:

• Acceptance Criteria & Performance Data: 510(k) submissions typically do not include detailed performance tables from clinical trials with specific acceptance criteria like sensitivity, specificity, or AI-assisted improvement. Instead, they focus on showing that the new device performs as intended and is as safe and effective as a predicate device.
• Clinical Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone): These are elements of a clinical trial designed to assess device performance in human subjects. A 510(k) summary usually relies on bench testing and comparisons to predicate devices, especially for devices like orthopedic implants, where clinical studies may not be required for market clearance if substantial equivalence can be established otherwise.
• Ground Truth: The concept of "ground truth" (e.g., expert consensus, pathology) for clinical performance is not typically a primary focus of a 510(k) submission for orthopedic implants unless a specific clinical study was conducted (which isn't detailed here).
• Training Set Information: This is relevant for AI/ML devices. The Fixano DSS system is a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic device. Thus, there is no AI training set.

Summary of available information related to performance/equivalence from the document:

• Intended Use: Fixation and osteosynthesis of unstable femoral neck fractures.
• Technological Characteristics: Hip screw mechanism allowing natural, weight-bearing compression. Can be used alone or with a mini-plate for flexibility in osteosynthesis configurations.
• Substantial Equivalence: Claims substantial equivalence to various existing hip screw systems, including Synthes Sliding Screws (K954757), Dynamic Hip Screw (DHS) (K791619), and Howmedica Plus Compression Hip Screw System Omega (K955306). This implies that the device performs similarly in its intended function to these predicate devices, which are already on the market.

In conclusion, this 510(k) summary does not contain the detailed clinical study information requested because it is a premarket notification for an orthopedic implant seeking clearance based on substantial equivalence, rather than a clinical trial report for an AI-enabled device or a device requiring new clinical performance data.

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Osteosynthesis of Per-Trochanterian Fractures is intended for use in the fixation and osteosynthesis of per-trochanterian fractures.
This device is indicated for use in the fixation of pertrochanteric fractures.

The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Per-Trochanterian Fractures is an implantable orthopedic trauma device to be used in procedures.

The provided text is a 510(k) summary for the Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanterian Fractures. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study evaluating specific acceptance criteria and device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided text.

The document describes the device, its intended use, and technological characteristics, and then directly compares it to pre-existing, legally marketed devices to establish substantial equivalence for regulatory approval. It does not contain information about:

1. Acceptance criteria and reported device performance: This document does not specify quantitative acceptance criteria or provide performance data for the Fixano D.S.S. system.
2. Sample size and data provenance for a test set: No information regarding a specific test set, its size, or origin is present.
3. Number and qualifications of experts for ground truth: There is no mention of experts establishing ground truth.
4. Adjudication method for the test set: No test set means no adjudication method is described.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is not mentioned.
6. Standalone (algorithm-only) performance: As this is a physical medical device (hip screw system), an algorithm-only performance assessment is not applicable.
7. Type of ground truth used: No ground truth is described.
8. Training set sample size: No training set is mentioned.
9. How ground truth for the training set was established: Not applicable, as no training set is described.

The 510(k) summary format is designed for regulatory submission to demonstrate that a new device is as safe and effective as devices already on the market, usually by comparing features and materials, not typically by presenting detailed performance study results against predefined acceptance criteria for a new clinical study.

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