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510(k) Data Aggregation
(29 days)
TECHDEVICE CORPORATION
The Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This guidewire is not intended for use in the coronary arteries or neurovasculature.
The Guidewire is constructed of a stainless steel core wire and a platinum coil welded/brazed in place over the core wire. The coil may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum Tungsten marker bands may be placed under the coil to aid in visualization.
The provided text describes a 510(k) Premarket Notification for a vascular guidewire and does not contain information about a study involving an AI-powered device or software. The document pertains to a physical medical device (guidewire) and its substantial equivalence to predicate devices based on physical and performance characteristics.
Therefore, many of the requested categories for AI/software-related studies cannot be filled as they are not applicable to the provided document.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent or irrelevant:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Safety and Performance" as a section and describes how substantial equivalence was based on a comparison to predicate devices and "comparative bench testing." The specific tests performed are listed, but no explicit numerical acceptance criteria or performance metrics are provided for these tests within the given text.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength A | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Torque Strength B | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Torqueability C | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Tip Flexibility D | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Coating Integrity E | (Not explicitly stated, but deemed substantially equivalent to predicate) |
| Corrosion Testing F | (Not explicitly stated, but deemed substantially equivalent to predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "comparative bench testing" and "Physical testing has been conducted to confirm the proposed products performance characteristics." However, it does not specify the sample size, data provenance, or whether the tests were 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)
Not applicable. This document describes the testing of a physical medical device (guidewire) against predicate devices, not an AI or software algorithm requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this is not a study involving expert adjudication for a test set in the context of AI/software performance. The evaluation is based on bench testing of physical properties.
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 document describes the premarket notification for a physical guidewire, not an AI-assisted device or software that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm described in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical bench testing, the "ground truth" would be the direct measurements obtained from the various tests (Tensile Strength, Torque Strength, etc.) which are then compared to established specifications for such devices or to the predicate device's performance. It is not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.
8. The sample size for the training set
Not applicable. This document does not describe the development or testing of an AI or software device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI/software device is described.
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(107 days)
TECHDEVICE CORPORATION
The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This device is not indicated for neuro, or cardiac use.
The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coil may cover the entire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.
The provided text is a 510(k) Premarket Notification for a vascular guidewire, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies or extensive performance testing with acceptance criteria.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets them in the context of typical AI/software device evaluation.
Here's a breakdown of why the specific questions cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on comparison to predicate devices and bench testing results, not predefined acceptance criteria for a novel performance metric.
- Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the sense of clinical data or image data for an AI algorithm. The testing described is bench testing in a lab.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI/diagnostic device.
- Adjudication method for the test set: Not applicable.
- 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 (guidewire), not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance (from the document):
The device's safety and performance were established through:
- Comparison of labeling, physical, and performance design characteristics to predicate devices.
- Results of comparative bench testing, which included:
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Coating Integrity
The document concludes that "Based on the indications for use, technological characteristics, and comparison to predicate devices, the TechDevice Guidewire has been shown to be safe and effective for its intended use." This statement is based on the substantial equivalence argument and the bench test results against the predicate, not a defined set of quantitative acceptance criteria for clinical performance that would typically be associated with an AI study.
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(296 days)
TECHDEVICE CORPORATION
The TechDevice Percutaneous Occlusion Balloon Catheter is for temporary vessel occlusion, where the stoppage of blood flow is desirable. This device is not indicated for neuro, or cardiac use.
The occlusion balloon catheter consists of a latex balloon (outside diameter 11mm, 15mm, 18mm or 27mm) mounted on the distal end of a 5 French catheter shaft ( 45cm -- 100cm in length). The dual-lumen catheter shaft terminates in a proximal molded bifurcation attached to luer connectors. The hub labeled "Distal" connects to the distal lumen which passes completely through the catheter and can be used for catheter placement over a guidewire, or fluid infusion into the vessel. The second hub, labeled "Balloon", terminates under the balloon via an opening skived into the extrusion. This is used for balloon inflation.
The provided text describes a 510(k) submission for a medical device, the "TechDevice Percutaneous Occlusion Balloon Catheter." This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than performance against specific acceptance criteria for a diagnostic or AI-driven decision-making system.
Therefore, many of the requested fields are not applicable or cannot be extracted from this type of regulatory submission. The submission details physical and performance design characteristics and bench testing, but not clinical study data for AI or diagnostic performance.
Here's an attempt to address the request based on the provided text, highlighting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Not explicitly stated as "acceptance criteria" for a study. | Tensile Strength (balloon-to-shaft and hub/lube-to-shaft): No specific values reported, but comparative testing was performed and deemed equivalent. |
| Balloon Burst Testing: No specific values reported, but comparative testing was performed and deemed equivalent. | |
| Balloon Multiple Inflation Testing: No specific values reported, but comparative testing was performed and deemed equivalent. | |
| Substantial equivalence to predicate device (K021721). | The device has been shown to be safe and effective for its intended use based on comparison to predicate and results of comparative bench testing. |
2. Sample size used for the test set and data provenance
- Sample Size for Test Set: Not applicable. The submission refers to "comparative bench testing" rather than a clinical trial with a test set of patient data. The sample sizes for the bench tests (e.g., number of catheters tested for burst strength) are not provided.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this was bench testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- Not applicable. Ground truth is not established by experts for bench testing of device physical properties. The "ground truth" here would be the physical properties of the predicate device.
4. Adjudication method for the test set
- Not applicable. There is no adjudication method described for bench testing results against a "ground truth" in the context of expert consensus.
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 not an AI/diagnostic device. An MRMC study was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/diagnostic device. A standalone algorithm performance was not done.
7. The type of ground truth used
- For the bench testing, the "ground truth" would be the established performance characteristics of the predicate device (Equalizer Balloon Catheter K021721). The TechDevice catheter's performance was compared to these.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI or diagnostic device based on machine learning.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" and therefore no ground truth established for it.
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(96 days)
TECHDEVICE CORPORATION
The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the alimentary tract. This device is not indicated for neuro or cardiac use.
The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coll may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum iridium marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.
This 510(k) summary describes a medical device called the TechDevice Guidewire. The device is intended to facilitate the placement and exchange of catheters and other instruments in the alimentary tract, but not for neuro or cardiac use. The submission states that substantial equivalence was based on a comparison of labeling, physical and performance design characteristics to predicate devices, as well as the results of comparative bench testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Tensile Strength A | Comparative bench testing performed |
| Torque Strength B | Comparative bench testing performed |
| Torqueability C | Comparative bench testing performed |
| Tip Flexibility D | Comparative bench testing performed |
| Coating Integrity E | Comparative bench testing performed |
2. Sample Size and Data Provenance
The document does not specify the sample sizes used for the comparative bench testing (test set sizes). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. It only states "comparative bench testing."
3. Number of Experts and Qualifications
This information is not provided in the document. Bench testing typically does not involve human expert review in the same way clinical studies do.
4. Adjudication Method
This information is not provided in the document. Adjudication methods are typically associated with clinical studies involving human interpretation, not bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. The document describes bench testing of physical and performance characteristics, not a clinical study involving human readers or AI.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical guidewire, not an algorithm or software. The performance described is for the physical device itself.
7. Type of Ground Truth Used
The ground truth for the performance tests would be the established engineering standards or specifications for each of the measured characteristics (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Integrity). The document implies that the "ground truth" was the performance of the predicate devices. The phrase "comparative bench testing" suggests that the TechDevice Guidewire's performance was compared directly against the predicate devices for these characteristics.
8. Sample Size for the Training Set
Not applicable. This device is a physical guidewire, not an AI or software device that uses a training set. The "training" in the context of device development would refer to the design and engineering process, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The design and manufacturing process would be guided by engineering principles and comparison to predicate devices, rather than a data-driven ground truth.
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