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The Tracer Implantation Kit is indicated for use to radiographically and radioactively mark soft tissue for future therapeutic procedures.
The Tracer is indicated for permanent implantation in the prostate.
The Tracer is intended to be used in conjunction with the RealEye system as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator.
The IndeX Implantation Kit is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The IndeX is intended to be used as a radiographic fiducial marker for visualization using x-ray, CT, or Cone Beam CT.

The Tracer is a Platinum/Iridium radioactive soft tissue fiducial for implantation in the prostate, in or near the treatment target for radiotherapy treatments. The Tracer emits photons that enable its localization by the Navotek RealEye system that is designed to track localized gamma-emitting radioactive sources.
The implantation of the Tracer is performed using an Implantation Device, which is supplied with the Tracer pre-loaded within it. Therefore, the Tracer is supplied as a 'Tracer Implantation Kit' which includes the Tracer and the Implantation Device. The Tracer lmplantation Kit is provided in a single package, sterile (by gamma radiation) and ready for use. It is intended for single use only.
The IndeX is identical to the Tracer in all respects except that it is not radioactive. It is intended for use to radiographically mark soft tissue and to be visible in x-ray, CT, and Cone Beam CT images.

{"1. A table of acceptance criteria and the reported device performance": "The document describes performance testing that demonstrated the Tracer Implantation Device performs "according to specifications and function as intended." It also states that "differences in technology compared to the predicate device do not impact safety or effectiveness." However, specific quantifiable acceptance criteria (e.g., minimum accuracy rates, success rates, or ranges of performance metrics) are not explicitly provided in the document. Therefore, a table comparing acceptance criteria to reported performance cannot be fully constructed.", "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 mentions "clinical testing" but does not specify the sample size used for this testing. It also does not provide information on the country of origin of the data or whether the study was retrospective or prospective.", "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)": "The document does not provide information regarding the number of experts used to establish ground truth or their qualifications.", "4. Adjudication method (e.g., 2+1, 3+1, none) for the test set": "The document does not specify any adjudication method for the test set.", "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": "A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned. The device is a fiducial marker, not an AI-assisted diagnostic tool for human readers.", "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "This is a physical medical device (fiducial marker and implantation kit), not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.", "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The document mentions "bench, animal, and clinical testing" as part of the performance evaluation. For a fiducial marker, ground truth would likely involve direct physical measurements (for bench testing), imaging verification (for animal and clinical testing), and potentially long-term follow-up for outcomes related to marker stability and efficacy in therapy. However, the document does not explicitly state the type of "ground truth" used for each test.", "8. The sample size for the training set": "This is a physical medical device. The concept of a "training set" as used in AI/ML is not applicable here.", "9. How the ground truth for the training set was established": "This question is not applicable as the device is not an AI/ML algorithm that requires a training set."}

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The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and The Tracer Metro Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wilson-Cook's Tracer Metro Smart Wire Guide is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.

The proposed Tracer Metro Smart Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cock. The Tracer Metro Smart Wire Guide is .035" in diameter and is compatible with a full range of Wilson-Cook accessories.

I apologize, but the provided text does not contain the specific information required to complete a table of acceptance criteria and reported device performance, nor details about a comprehensive study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria and results.

Here's what I can infer from the text and why I cannot fully answer your request:

What the document does provide:

• Device Name: TRACER METRO SMART WIRE GUIDE
• Intended Use: "The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and pancreatic ducts and to aid in bridging difficult strictures during ERCP."
• Predicate Device: Wilson-Cook Wire Guide (k9910497)
• Basis for Clearance: Substantial equivalence to the predicate device.
• Statement on Performance Data: "We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics tested and biocompatibility."

What the document does not provide (and is needed for your request):

1. A specific table of acceptance criteria and reported device performance: The document states that the device is "substantially equivalent...in terms of performance characteristics tested and biocompatibility" but does not detail what these characteristics are, what the acceptance criteria for them were, or what the measured performance results were. This is common in 510(k) summaries where the focus is on equivalence, not necessarily on presenting a comprehensive performance study like a PMA submission might.

2. Details of "the study that proves the device meets the acceptance criteria": Since the acceptance criteria are not detailed, neither are the specifics of a study proving they were met. The document implies that some performance characteristics were tested to demonstrate substantial equivalence, but it doesn't describe the study design (sample size, data provenance, ground truth establishment, etc.).

Due to the limitations of the provided text, I cannot generate the detailed response you requested. If you have a document that specifically outlines performance studies with acceptance criteria and results, I would be happy to analyze it for you.

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TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin to provide radiopacity for imaging purposes.

TRACERS® Ta Bone Cement Opacifier is an additive to be used with Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of the implant material. The TRACERS® Ta Bone Cement Opacifier is added to the Secour polymer (powder) prior to mixing with the Secour monomer (liquid). TRACERS Bone Cement Opacifier is comprised of USP Barium Sulfate and unalloyed Tantalum disks.

The provided text describes a 510(k) summary for the TRACERS® Ta Bone Cement Opacifier, focusing on its substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, many of the requested details are not available in the given document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on specific performance acceptance criteria for a new clinical or technical study.

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

This information is not available. The document does not describe a performance study with a test set.

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

This information is not available. The document does not describe a performance study that involved expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not available. The document does not describe a performance study involving adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned. The device's purpose is as an additive to provide radiopacity, not typically requiring this type of study for a 510(k) submission of this nature.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the described device. The TRACERS® Ta Bone Cement Opacifier is a physical additive to a medical cement to enhance radiopacity for imaging purposes. It is not an algorithm or a software-based device that would have standalone performance (algorithm only) testing.

7. The Type of Ground Truth Used

This information is not available. The 510(k) submission is based on substantial equivalence, not on the performance against a defined ground truth from a study. The "ground truth" for this device would inherently be its physical properties and chemical composition, which are confirmed through validation of its manufacturing and material specifications, and its ability to become radiopaque as intended. The document states its intended use is "to provide radiopacity for imaging purposes," which implies that its performance would be assessed by its visibility under imaging. However, a specific study establishing "ground truth" in the context of clinical outcomes or expert consensus is not described.

8. The Sample Size for the Training Set

This information is not applicable and not available. The TRACERS® Ta Bone Cement Opacifier is a medical device (an additive), not a machine learning or artificial intelligence system that would require a training set.

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

This information is not applicable and not available, as there is no training set for this type of device.

Summary of the Document's Content:

The K033230 submission for TRACERS® Ta Bone Cement Opacifier is a 510(k) premarket notification. Its primary argument for market clearance is substantial equivalence to an already legally marketed predicate device, TRACERS® Bone Cement Opacifier (K023445).

• Intended Use: To be used as an additive to Secour Acrylic Resin to provide radiopacity for imaging purposes.
• Product Description: Comprised of USP Barium Sulfate and unalloyed Tantalum disks, mixed with the Secour polymer (powder) before liquid monomer is added.
• The document explicitly states: "Based on the information provided in this notification, the subject device is substantially equivalent to the currently marketed predicate device with regard to intended use, technological characteristics, and design."

The FDA's response letter (DEC 12 2003) confirms a finding of substantial equivalence, allowing the device to be marketed. This type of submission does not typically involve extensive clinical performance studies with acceptance criteria, ground truth establishment, or human reader effectiveness studies as would be required for novel, higher-risk devices or AI/software-as-a-medical-device products. Instead, the focus is on demonstrating that the new device is as safe and effective as the predicate device based on its materials, design, and intended use.

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TRACERS® Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin or Codman Cranioplastic™ (Type I -- Slow Set) to provide radiopacity for imaging purposes.

TRACERS Bone Cement Opacifier is an additive to be used with Codman Cranioplastic (K8736989) or Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of material. The TRACERS Bone Cement Opacifier is added to the Cranioplastic or Secour monomer (powder) prior to mixing with the Cranioplastic or Secour polymer (liquid). The end product (Cranioplastic or Secour and Tracer particles) is substantially equivalent to Cranioplastic and Secour alone.

This 510(k) summary does not contain information regarding acceptance criteria or studies proving device performance in the typical sense of a diagnostic or AI-driven device.

The device, TRACERS Bone Cement Opacifier, is an additive to provide radiopacity to bone cements for imaging purposes. Its 510(k) submission is primarily focused on demonstrating substantial equivalence to a predicate device (TRACERS Bone Cement Opacifier, K991893) based on its intended use, design, and technological characteristics, rather than detailed performance metrics from a clinical study for diagnostic accuracy.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not provided in this document for the following reasons:

• Device Type: This is a material additive, not a diagnostic imaging device or an AI algorithm that generates predictions or diagnoses.
• Regulatory Pathway: The 510(k) process for this type of device typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing of material properties or direct comparison of formulation, rather than large-scale clinical trials measuring diagnostic performance.
• Lack of Performance Metrics: The document does not describe any quantifiable performance metrics like sensitivity, specificity, or accuracy that would require acceptance criteria or a "study that proves the device meets the acceptance criteria" in the context of diagnostic performance. The radiopacity, which is its primary function, is likely assessed through physical or radiographic comparison to the predicate or standard materials, but no specific study details are shared here.

Summary of available and non-applicable information:

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

   • Not applicable / Not provided. The document does not specify quantitative acceptance criteria or detailed performance results typically associated with diagnostic or AI devices (e.g., sensitivity, specificity thresholds). The performance implicitly refers to its ability to provide radiopacity when added to bone cement, making it visible in imaging for placement and visualization. This is assessed via substantial equivalence to a predicate.

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 / Not provided. No test set for evaluating diagnostic performance or AI algorithm output is mentioned.

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 / Not provided. No "ground truth" establishment by experts is described as this is not a diagnostic device requiring such validation for accuracy.

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

   • Not applicable / Not provided.

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 / Not provided. This device is an additive for bone cement, not an AI or diagnostic tool that assists human readers.

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

   • Not applicable / Not provided. This is not an algorithm.

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

   • Not applicable / Not provided.

8. The sample size for the training set:

   • Not applicable / Not provided. No training set for an algorithm is mentioned.

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

   • Not applicable / Not provided.

In conclusion, this 510(k) submission focuses on demonstrating substantial equivalence for a material additive rather than providing detailed performance metrics from clinical studies that would require the information requested for AI or diagnostic devices.

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The Tracer diagnostic mapping device is intended for use in cardiac multations For Ose. This catheter can be used to temporarily record epicardial electrical signals from the coronary sinus. The Tracer catheter can be used to temporarily pace during the mapping procedure.

The Cardima Tracer Over-the-Wire Mapping Microcatheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials as measured from within the venous system of the heart. The Tracer catheter can also be utilized for temporary epicardial pacing during the mapping procedure. The catheter is designed to accommodate a 0.010" guide wire and is available in five configurations with either 4, 8, or 16 electrodes. Both the 4 and 8 electrode catheters come with either regular spaced electrodes of 5mm or electrode pair spacing of 2-5-2 mm. The 16 electrode catheter is available only with 2-5-2mm pair spacing. The outer diameter of the catheter is 3.2F - 3.3F and will be available with working lengths of 145cm. The outer surface is treated with a hydrophilic coating to enhance lubriciousness. The Tracer is not indicated for ablation.

The provided text describes the regulatory clearance of the Cardima Tracer Over-the-Wire Mapping Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device and outlines safety and effectiveness testing, but it does not include a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in a way that aligns with a typical AI/software device evaluation.

The information provided is for a physical medical device, not an AI/software product, which typically has quantitative performance metrics for acceptance criteria. As such, I will interpret "acceptance criteria" based on the described safety and effectiveness evaluations for this type of device.

Here's an attempt to answer the request based on the provided text, highlighting where information is not available due to the nature of the device and the provided document:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The Cardima Tracer Over-the-Wire Mapping Microcatheter received clearance based on demonstrating substantial equivalence to a predicate device (Cardima 2.5F Pathfinder electrode recording catheter, K955802) and through safety and effectiveness evaluations. The "acceptance criteria" for this type of device primarily revolve around material compatibility, mechanical/electrical integrity, and biological safety and performance in a relevant physiological environment.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Animal Studies: The animal study for maneuverability, signal quality, and pacing involved an unspecified number of animals/instances, but pacing was conducted on "twelve occasions". The provenance is not explicitly stated but implies a controlled laboratory setting (likely within the USA). The study appears to be prospective in nature, as it describes the conduct and results of specific tests.
• Bench Testing: Sample sizes for reliability and mechanical/electrical property testing are not specified, nor is the provenance, but it would have been conducted in a laboratory setting.
• Biocompatibility: The biocompatibility testing was conducted on the Pathfinder predicate device and deemed applicable to the Tracer. The sample size for this original testing is not provided.

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

Not applicable in the context of this physical device evaluation. The "ground truth" was established through objective measurements (e.g., signal recording, pacing threshold measurements, post-mortem examination) and established regulatory standards (e.g., ISO 10993-1, Electrode Recording Catheter Preliminary Guidance).

4. Adjudication method for the test set

Not applicable. The evaluation methods described (bench testing, animal studies, biocompatibility) rely on objective measurements and established protocols rather than expert adjudication of subjective assessments.

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 is a physical medical device, not an AI/software algorithm. No human reader studies or AI assistance were part of this evaluation.

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

Not applicable. This refers to a physical medical device, not an algorithm.

7. The type of ground truth used

• Bench Testing: Physical and electrical measurements.
• Biocompatibility: Results against ISO 10993-1 standards for biological response.
• Animal Studies: Direct observations during catheter placement, recorded electrical signals, measured pacing thresholds, and macroscopic/microscopic examination of tissues post-mortem. This could be considered outcomes data or pathology in the animal model.

8. The sample size for the training set

Not applicable. This is a physical medical device clearance, not an AI/ML model that requires a training set. The "development" of the device involves engineering and design, validated through the described testing.

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

Not applicable (as above).

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For patient’s who may be experiencing cardiac events symptomatic pulse rate abnormalities.

TRACER

The provided text is a 510(k) premarket notification approval letter from the FDA for a device named "TRACER." It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the requested table and study description based on the provided text.

The document primarily focuses on:

• The FDA's decision that the TRACER device is substantially equivalent to legally marketed predicate devices.
• Regulatory classification (Class II, product code MJW).
• General controls and potential additional controls (Special Controls or Premarket Approval) applicable to the device.
• Contact information for various FDA offices.
• A brief mention of "Indications For Use" on the enclosure, which is not fully visible, but hints at cardiac events and symptomatic pulse rate abnormalities.

To provide the requested information, a document specifically detailing the pre-market studies and their results would be needed.

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