Search Results

The Everest 20cc Inflation Device/Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adanter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30 bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a "Survival Kit", the package includes a Y-/ Tri-Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.

The document describes a 510(k) premarket notification for Medtronic's Everest™ Inflation Device and Survival Kits. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing related to packaging and shelf-life, rather than clinical efficacy. Therefore, a traditional "study" proving the device meets acceptance criteria in terms of clinical performance or an AI algorithm's performance isn't applicable here.

Instead, the document details the acceptance criteria for packaging performance and shelf-life, and the tests conducted to show the device meets these criteria. The approval is based on the device being "substantially equivalent" to an existing, legally marketed predicate device, not on demonstrating new clinical efficacy.

Here's the information requested, adapted to the context of this device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device relate to its packaging and shelf-life, ensuring it maintains sterility and integrity. The document states that "No new safety or effectiveness issues were raised during the testing. The test data demonstrated that the modified Medtronic's Everest™ Inflation Devices is as safe and effective as the legally marketed predicate device." This implies that all tested criteria were met.

Due to the nature of the document detailing specific tests rather than numerical performance metrics for each acceptance criterion, a direct table of "performance" for each against a criterion is not provided with exact values. However, the document lists the performed tests, which serve as the acceptance criteria. The "Reported Device Performance" is broadly stated as successful.

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

The document does not explicitly state the numerical "sample size" for the non-clinical packaging and shelf-life tests. This type of information is typically found in the full test reports, which are not included in this summary.

The "data provenance" is internal to Medtronic (manufacturer), based on testing performed on the modified Everest™ Inflation Devices. It is retrospective in the sense that the tests are performed on manufactured devices to confirm design and material changes maintain equivalence.

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

This question is not applicable to this type of device submission. The tests are physical and chemical property tests on packaging and product integrity, not diagnostic or clinical assessments requiring expert human interpretation or "ground truth" establishment in the medical sense. The "ground truth" here is the physical measurement or observation of the packaging and device components against engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. Physical performance tests on a device's parts and packaging do not typically involve adjudication methods like those used for interpreting medical images or clinical outcomes. The results are obtained directly from laboratory measurements and observations.

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 (inflation balloon and accessories) is a mechanical tool used in interventional procedures. It is not an AI-powered diagnostic or assistive tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

Not applicable. This device does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

For the non-clinical tests (packaging and shelf-life), the ground truth is established by engineering specifications, industry standards (e.g., ISO 15223-1 mentioned for symbols), and regulatory requirements for medical device packaging integrity and sterility. The outcome of these tests determines if the device meets these pre-defined physical and performance benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

The inflation device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation catheter.

The inflation device consists of barrel, threaded plunger assemble with a handle, a trigger, pressure gauge, an outer shell assembly that retains the internal components, and a pressure connecting tubing with rotating adapter. Also enclosed is a stopcock to aid in preparation and use of device. The inflation device is 20 mL disposable device capable of producing a maximum pressure of 30 atm.

The inflation device is sterilized by EO.

The provided text describes a 510(k) premarket notification for an "Inflation Device". This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than presenting a clinical study with detailed acceptance criteria for diagnostic performance. Therefore, many of the requested elements are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or a specific clinical outcome. Instead, it refers to compliance with established international standards for medical devices and device specifications.

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

• Sample Size: The document does not specify a "test set" in the context of clinical data. The tests performed are bench tests on the device itself (e.g., for mechanical properties, material testing). The number of units tested per bench test is not detailed.
• Data Provenance: Not applicable as no human data is used. The tests are performed on the manufactured device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. There is no ground truth established by experts in this context as it's a device performance study, not a diagnostic accuracy study relying on human interpretation.

4. Adjudication Method

• Not applicable. No expert review or adjudication process is described as it's not a clinical study involving human assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a 510(k) submission for a physical medical device, not an AI software or diagnostic imaging tool. Therefore, a MRMC comparative effectiveness study is not performed or relevant.

6. Standalone Performance

• Yes, in a way. The "standalone" performance here refers to the device's ability to meet its technical specifications and regulatory standards independently. The non-clinical bench tests assess the device's functional and safety characteristics in a standalone manner.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is compliance with established international standards (ISO) and the manufacturer's own validated specifications. For example, for conical fittings, the ground truth is adherence to ISO 594-1 and ISO 594-2 standards. For biocompatibility, it's the outcome of tests against ISO 10993 standards.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

• Not applicable.

Ask a specific question about this device

The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

The Fluent inflation device consists of a barrel with a plunger, locking button, rotating handle, manometer, and high pressure tube with a rotating luer lock. The manometer is graduated between vacuum and 30 atm.

The provided text is a 510(k) premarket notification for a medical device called the "Fluent Inflation Device." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on bench testing. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving those criteria are met in the format of a clinical or AI-based diagnostic study.

Here's an analysis of what can be extracted and what information is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Missing Specifics: The document states that "results of the verification tests met the specified acceptance criteria," but it does not provide the specific quantitative acceptance criteria (e.g., "pressure retention for X minutes with

Ask a specific question about this device

The Everest 20cc Inflation Device/ Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to be used to inflate/ deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adaptor with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adapter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a “Survival Kit", the package includes a Y-/ Tri- Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.

The provided document is a 510(k) premarket notification for a medical device: Medtronic's Everest™ Inflation Devices. It describes the device's technical characteristics, indications for use, and a summary of performance and biocompatibility testing conducted to demonstrate substantial equivalence to legally marketed predicate devices.

However, this document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss ground truth established by experts for a test set. The device in question is an Angiographic Injector and Syringe, a mechanical device used in interventional procedures.

Therefore, I cannot provide the detailed information requested in the prompt, as the document does not contain:

1. A table of acceptance criteria and reported device performance for an AI/ML study. The performance criteria listed are for mechanical integrity and compatibility (Lubrication break away test, Pressurization test, Rubber Tip and Insert Tensile test, Compatibility with Contrast Media, Saline).
2. Sample size used for an AI/ML test set or data provenance related to AI/ML. The tests mentioned are bench tests.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method for a test set in the context of AI/ML.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about standalone (algorithm only) performance.
7. Type of ground truth used in an AI/ML context.
8. Training set sample size or how ground truth for a training set was established for an AI/ML model.

The document explicitly states under "Summary of Clinical Data": "No clinical investigations have been performed on the modified device." This confirms that there are no human-in-the-loop or AI component studies to discuss in this context.

In summary, the provided text describes the regulatory clearance for a mechanical medical device and does not contain information relevant to AI/Machine Learning device performance criteria or comparative effectiveness studies that involve human readers and AI assistance.

Ask a specific question about this device

The basixTOUCH40 Inflation Syringe is used to inflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

The basixTOUCH40TM Inflation Syringe by Merit Medical is a 30mL disposable device with a threaded plunger assembly, a flexible high pressure extension tube. The basixTOUCH40TM is designed to generate positive and negative pressure, and monitor positive pressures over a range of zero to +40ATM/BAR (zero to 588 PSI).

This document is a 510(k) premarket notification for the basixTOUCH40 Inflation Syringe. It describes the device, its intended use, and its substantial equivalence to a predicate device. The information provided outlines performance testing that was conducted, but it does not contain specific acceptance criteria with reported device performance values in a table, nor does it detail a study that proves the device meets specific acceptance criteria in the format requested.

The document states that "The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device." However, the document does not list those acceptance criteria or the actual performance results of the device against those criteria. It also does not describe a clinical study or a comparative effectiveness study with human readers.

Therefore, for many of the requested points, the information is not present in the provided text.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. The document states that "The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device," but it does not provide the criteria themselves or the specific performance results in detail.

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

This information is not present in the provided document. The document mentions "Performance testing" but does not specify sample sizes for these tests or the data provenance.

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 applicable/present as the device is a medical instrument (inflation syringe), not an AI diagnostic tool that requires expert-established ground truth on a test set. The performance testing would be engineering or bench testing.

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

This information is not applicable/present as the device is a medical instrument and the performance testing described would not involve adjudication of a test set in the way an AI diagnostic tool would.

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 applicable/present as the device is a medical instrument (inflation syringe), not an AI diagnostic tool that would be part of a multi-reader multi-case study.

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

This information is not applicable/present as the device is a medical instrument and not an algorithm. Bench testing was performed for the device's functional attributes.

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

This information is not applicable/present as the device is a medical instrument, not a diagnostic tool requiring such ground truth. The "ground truth" for the performance tests would be defined by engineering specifications and physical measurements.

8. The sample size for the training set

This information is not applicable/present. The device is a physical medical instrument, not an AI model that requires a training set.

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

This information is not applicable/present. The device is a physical medical instrument, not an AI model that requires a training set.

Summary of available information related to performance testing:

• Device: basixTOUCH40 Inflation Syringe
• Purpose: To inflate an angioplasty balloon or other interventional device and to measure the pressure within the balloon.
• Comparison to Predicate: The subject device generates a higher maximum pressure (40 ATM) compared to the predicate (35 ATM). The connection between the gauge and the syringe barrel was modified from a brass-fit to a snap-fit connection.
• Performance Testing Done (Types of tests mentioned):
  • Fluid Functional Use
  • Vertical Gauge Tensile
  • Horizontal Gauge Tensile
  • Vacuum Capability
  • Gauge Accuracy
  • Retainer Cap Bond Torque
  • Tip Adapter Securement and Tip Securement
• Outcome of Testing: "The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device."
• Biocompatibility: Not required due to no patient contact.

Ask a specific question about this device

The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter. The sidearm extension tubing is intended to provide a sterile fluid pathway between two devices.

The Fluent inflation device consists of a barrel with a plunger, locking button, rotating handle, manometer, and high pressure tube with a rotating male luer lock. The manometer is graduated between vacuum and 30 atm. The extension tubing is a plastic tube with plastic luer lock connector hubs (one male and one female) at either end. It is available in 25 cm and 50 cm lengths.

This document describes the Fluent inflation device, intended for use during cardiovascular procedures, and its substantial equivalence to predicate devices. It does not contain information about an AI-powered device or a study involving human readers or AI assistance. Therefore, I cannot provide the requested information regarding acceptance criteria and study details related to AI performance.

However, based on the provided text, I can extract the acceptance criteria and the study that proves the Fluent inflation device meets these criteria. Please note that this is NOT an AI device, and therefore several requested sections of your prompt will be marked as "N/A" (Not Applicable).

Here is the information from the provided text about the Fluent inflation device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria or detailed reported device performance values in a table format. Instead, it states that the design verification tests "met the specified acceptance criteria" and "passed" the biocompatibility tests.

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

The document does not specify the sample size used for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "samples" of the device and extension tubing.

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

N/A. This is a medical device, not an AI model that requires expert annotation for ground truth. The 'ground truth' for device performance is established by meeting predefined engineering and biological specifications through testing.

4. Adjudication method for the test set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers or AI systems to resolve discrepancies in diagnoses or interpretations. This is a physical medical device.

5. If a multi-reader multicase (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

N/A. This document describes a physical medical device, not an AI software.

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

N/A. This document describes a physical medical device, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on predefined engineering specifications, international standards (like ISO 10993-1 for biocompatibility), and regulatory requirements for medical devices of its type. The device's functionality and safety are evaluated against these objective criteria rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set

N/A. This document describes a physical medical device, not an AI model that requires a training set.

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

N/A. This document describes a physical medical device, not an AI model.

Ask a specific question about this device

The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.

The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely. The balloon in-deflation device mainly composes of four parts, injecting system (syringe), pressure gauge and extension tube, 3way stopcock, respectively. The syringe consists of a screw type plunger and a locking lever, by rotating palm grip to control the plunger; the pressure gauge is to measure pressure and the extension tube is to connect catheters. The angle of the pressure gauge can be re-adjusted during the procedure.

Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them:

The document does not detail specific acceptance criteria for each performance characteristic of the Mastro Plus Balloon In-deflation Device. Instead, it asserts substantial equivalence to predicate devices through a comparison of design specifications and non-clinical performance testing. The overarching "acceptance criteria" appear to be that the proposed device must meet all design specifications and perform as safely and effectively as the predicate devices.

1. A table of acceptance criteria and the reported device performance

While explicit acceptance criteria are not presented as numerical targets to be met, the table below infers the performance characteristics evaluated and the proposed device's performance as compared to its predicates. The "Acceptance Criteria" column reflects the general expectation for substantial equivalence (i.e., being comparable to or within acceptable ranges of the predicate's performance).

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 does not specify sample sizes for any of the non-clinical tests (biocompatibility or bench testing). It also does not provide details on the data provenance such as country of origin or whether the data was retrospective or prospective. The tests are described as general performance testing and biocompatibility testing.

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 section is not applicable. The device is a "Balloon In-deflation Device," which is a physical medical instrument used for inflation/deflation of balloons and stents. The "ground truth" here is established through engineering and biological testing against specifications and standards, not through expert clinical consensus on interpretations of medical data.

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

This section is not applicable. As above, the "test set" refers to physical device testing, not clinical data requiring adjudication by experts.

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 section is not applicable. The device is a physical medical instrument for catheter inflation/deflation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This section is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device is established through:

• Design specifications: The device is designed to perform according to a set of pre-defined engineering and functional specifications (e.g., pressure range, volume dispensed per rotation, material composition).
• Recognized industry standards: Compliance with standards like ISO 11135-1:2006 for sterilization validation and ISO 11607-1:2006 for sterilization package performance.
• Biocompatibility testing results: Tests like pyrogen, endotoxin, acute systemic toxicity, irritation, cytotoxicity, skin sensitization, haemolysis, complement activity, and thrombosis tests provide "ground truth" regarding the device's biological safety.
• Bench testing results: Tests for appearance, positive/negative pressure sealing, male luer lock, capacity scale, and gauge accuracy provide "ground truth" for the device's physical and functional performance.

8. The sample size for the training set

This section is not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."

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

This section is not applicable. As stated above, there is no "training set" for this device.

Ask a specific question about this device

The Presto™ Inflation Device is indicated for use with angioplasty balloon dilatation catheters to create and monitor the pressure in the angioplasty balloon dilatation catheter and to deflate the angioplasty balloon dilatation catheter.

The Presto™ Inflation Device is an ultra high pressure, large volume inflation device used to inflate, monitor pressure, and deflate angioplasty balloon dilatation catheters. It is a onepiece, 30 mL disposable inflation device rated for 40 atm with a lever-lock design that controls the piston, a manometer, and a high-pressure connecting tube with a male Luer rotating adapter. Also enclosed is a high-pressure 3-way stopcock to aid in preparation and use of the device. The manometer measures pressures ranging from 0 atm up to 40 atm in 1 atm increments. The accuracy of the manometer has been determined to be within ±1.6 ATM. These products are not made with natural rubber latex.

The provided text describes a 510(k) summary for the Presto Inflation Device, focusing on its substantial equivalence to a predicate device. The information details the device's function, its similarities and differences to the predicate, and various performance tests conducted.

However, the document does not contain the kind of detailed information typically found in a clinical study report that would allow me to fully answer your request regarding acceptance criteria, specific test results, and experimental design (like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies).

The provided text focuses on non-clinical in vitro tests to demonstrate substantial equivalence, rather than clinical efficacy or diagnostic accuracy studies. Therefore, it lacks the specific data points you're asking for in a clinical context.

Here's an attempt to answer based on the available information, noting where data is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The device meets its acceptance criteria through a series of in vitro non-clinical tests as detailed in the "Performance Data" section of the 510(k) summary. These tests were conducted using FDA Guidance Documents, recognized standards (e.g., ASTM F1980-07, ISO 10993-1:2009), and internal Risk Assessment procedures. The document states: "The results from these tests demonstrate that the technological characteristics and performance criteria of the Presto™ Inflation Device is comparable to the predicate devices and that it can perform in a manner equivalent to balloon inflation devices currently on the market with the same intended use."

Information Not Available in the Provided Text:

The following points are primarily relevant for studies involving diagnostic algorithms, AI, or clinical efficacy/safety trials with human subjects. The Presto Inflation Device is a mechanical medical device (angiographic injector), and the provided 510(k) summary focuses on demonstrating substantial equivalence through engineering and physical performance tests, rather than clinical outcomes or diagnostic accuracy. Therefore, the information for points 2-9 is not present in the document.

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. The described tests are in vitro engineering and materials tests, not data-driven test sets in the context of AI or diagnostic algorithms.

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. Ground truth, in this context, would be defined by engineering specifications, recognized standards, and objective measurements, not expert human interpretation.

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

• Not applicable / Not provided. Adjudication relates to resolving disagreements in human interpretation, which is not part of these mechanical device tests.

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 is relevant for AI-assisted diagnostic tools, not for a mechanical inflation device.

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

• Not applicable / Not provided. This device does not involve an algorithm or AI.

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

• Engineering Specifications and Recognized Standards: The "ground truth" for this device's performance would be derived from its design specifications (e.g., 30ml volume, 40 atm rating), adherence to international standards (e.g., ISO, ASTM), and the results of validated physical and chemical tests (e.g., biocompatibility testing).

8. The sample size for the training set

• Not applicable / Not provided. This device does not involve a training set as it is not an AI or machine learning model.

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

• Not applicable / Not provided. As there is no training set, this question is not relevant.

Ask a specific question about this device

The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is intended for use in PTCA or PTA procedures to create and monitor pressure (by connecting the rotating male luer of inflation device with the balloon catheter's female luer) in the balloon and to deflate the balloon. The hemostatic valve is recommended for use during PTCA or PTA procedures in conjunction and/or diagnostic device (e.g. balloon dilatation catheters).Stopcock is used to release and purge any trapped air (if used).

The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is 30ml disposable device capable of producing a maximum pressure of 40ATM. Pressure can be monitored via a pressure gauge. The manually operation of the device is achieved by the manipulation of a large handle to drive a piston housed within the body of the device.

Hemostatic valve is a single Y connector, and may be composed of an insertion tool, and a torquer. The hemostasis valve is designed to provide a port for interventional system. The insertion tool is used to facilitate placement of a guide wire tip through the hemostasis valve. The torque device is designed to hold the guide wire and provide a handle for manipulating.

This FDA 510(k) summary for the Sunmed™ Inflation Device (K133795) describes a device intended for use in PTCA or PTA procedures. However, it does not contain the detailed information required to fill out the user's requested template regarding acceptance criteria and a study proving those criteria are met.

Here's why and what information is available:

The document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove the device meets specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) might require.

Information NOT available in the provided text:

• A table of specific numerical acceptance criteria (e.g., specific thresholds for pressure accuracy, deflation time, etc.) and the reported device performance against those criteria. The document mentions "non-clinical testing" but does not provide results or specific criteria.
• Details about a specific study proving acceptance criteria:
  • Sample size used for the test set.
  • Data provenance (country of origin, retrospective/prospective).
  • Number of experts, qualifications, or adjudication method for ground truth.
  • Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
  • Standalone (algorithm only) performance.
  • Type of ground truth used (expert consensus, pathology, outcomes data).
  • Sample size for the training set (if applicable to an AI/algorithm-based device, which this is not).
  • How ground truth for the training set was established.

What can be extracted and inferred from the document regarding testing:

1. Nature of Testing: The document states "Summary of Non-Clinical Testing" and explicitly says "Clinical Evaluation was not applicable." This indicates that the device's performance was evaluated through bench testing and biocompatibility studies, not human clinical trials against specific performance endpoints.

2. Types of Non-Clinical Tests Performed (as listed in section 7):

   • Biocompatibility Testing:
     • Pyrogen Test
     • Endotoxin Test
     • Acute Systemic Toxicity Test (two kinds of solvent)
     • Intracutaneous Reactivity Test
     • In Vitro Cytotoxicity Test
     • Skin sensitization Test (two kinds of solvent)
     • In Vitro Hemolysis Study
     • Complement Activity Test (C3a, SC5b-9)
     • In Vivo Thrombogenicity
   • Package Penetrate Testing
   • Asepsis Testing
   • Aging Testing
   • EtO and ECH Residue Testing
   • Bench Testing

3. Lack of Reported Performance Data: While these tests were performed, the document does not report the results of these tests or the specific acceptance criteria (e.g., "Pyrogen test result must be

Ask a specific question about this device

The Encore 26 Advantage Kit is a kit of sterile disposable devices intended of ruse as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
Encore™ 26 Inflation Device: indicated for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
Gateway™ Plus Y-Adaptor: used for providing hemostasis around balloon dilatation catheters, guidewires and other therapeutic devices during general intravascular procedures.
Torque Device: used for guidewire manipulation during general intravascular procedures.
Insertion Tool: used to facilitate the introduction of a quidewire during general intravascular procedures.

The Encore™ 26 Advantage Kit is a Kit of sterile disposable devices intended for use as accessories and percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.

This is a 510(k) premarket notification for a medical device (Encore™ 26 Advantage Kit), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with acceptance criteria and performance metrics in the way one might for a novel AI algorithm or diagnostic tool.

Therefore, many of the requested sections are not applicable to the provided document. I will fill in the information that is present or directly inferable from the document.

1. A table of acceptance criteria and the reported device performance

The submission states, "Design Verification and Design Validation Testing was performed to verify that the performance and usability of the modified Insertion Tool remains substantially equivalent to the predicate device via K140673. In addition Sterilization, Packaging and Biocompatibility testing verifies the overall substantial equivalence to the kit predicate."

While specific numerical acceptance criteria and performance values for each test are not listed in this summary document, the overall acceptance criterion is substantial equivalence to the predicate device(s). The reported performance is that the device met this criterion.

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 in the summary. The document refers to "Design Verification and Design Validation Testing" but does not detail the specific sample sizes used for these engineering/performance tests. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for this type of device submission.

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 is not applicable to a device like a balloon inflation kit. Ground truth, in the context of diagnostic algorithms, involves expert labeling of data. For a hardware medical device, "ground truth" would relate to engineering specifications and performance benchmarks, not expert consensus on medical images or diagnoses.

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

Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, not for performance testing of a mechanical device.

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 not an AI-assisted diagnostic device, and no MRMC study was conducted or mentioned.

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

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

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

For this type of device, the "ground truth" for performance testing would be established by:

• Engineering specifications and standards: Performance parameters (e.g., pressure capabilities, sealing integrity, material strength, dimensional accuracy) are measured against predefined engineering requirements and industry standards.
• Predicate device performance: The performance of the predicate device serves as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that uses a "training set."

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

Not applicable.

Ask a specific question about this device