Search Results

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is a guide wire with a nominal diameter of 0.012". Like the ACS HI-TORQUE TRA VERSE® Guide Wire, the HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire is constructed from a stainless steel core. The distal segment of the guide wire includes a series of tapers and a flat, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance. The distal tip coil has a radiopaque length of 3 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J".

The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is available in lengths of 190 cm and 300 cm exchange length. The 300 cm exchange length enables the physician ample working length of the guide wire to facilitate catheter exchanges. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal, coiled segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.

The provided text describes a 510(k) summary for a medical device, the HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating. This summary outlines the device's characteristics, intended use, and performance data to establish substantial equivalence to predicate devices.

However, the document does not provide the detailed information requested regarding the acceptance criteria for a study proving the device meets those criteria, as typically seen in an AI/Software as a Medical Device (SaMD) context. This is a physical medical device, and the evaluation relies on bench testing and in vivo animal models, rather than a clinical study with human readers and ground truth established by experts.

Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text.

Here's an attempt to answer based on the available information:

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

The document states that the device "met the acceptance criteria" and "performed similarly to the predicate devices" for the following functional tests:

Note: The specific quantitative acceptance criteria values (e.g., "tensile strength > X N") are not provided in this summary.

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

• Test Set Sample Size: Not specified for the in vitro tests. For the in vivo animal model, the number of animals tested is not specified, only that "two in vivo animal model" studies were conducted.
• Data Provenance: Not specified, but given it's an in vivo animal model, it would be prospective data from an animal study.

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 is a physical device evaluation based on engineering tests and animal models, not a clinical study involving human expert ground truth establishment in the context of diagnostic interpretation.

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

• Not Applicable. See point 3.

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/SaMD product.

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

• Not Applicable. This is a physical device. Performance was assessed through standalone bench tests and in vivo animal performance.

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

• For in vitro tests: Engineering specifications/standards and comparative performance to predicate devices and their established performance characteristics.
• For in vivo animal model: Comparative performance to predicate devices in terms of safety and effectiveness, likely assessed by veterinarians or researchers observing physiological responses and procedural outcomes.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. See point 8.

Ask a specific question about this device

Ask a specific question about this device

The peripheral guiding catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced into the peripheral vasculature. The inner catheter is intended to provide support during the introduction and withdrawal of a guiding catheter.

The VERIPATH™ Peripheral Guiding Catheter is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices, etc. The guiding catheter is a single lumen catheter that allows contrast medium iniections and facilitates the intravascular passage of diagnostic and therapeutic devices into the vascular system. The guiding catheter has a standard working length of 50 cm and a standard overall length of 56 cm, but can be produced in overall lengths from 40 to 80 cm, depending upon physician preference and patient size. The guiding catheter is available in three diameters/French sizes (F), as follows: 6F (0.068" ID, 0.82" OD), 7F (0.078" ID, 0.93" OD), 8F (0.088" ID, 0.105" OD). The guiding catheter is available in varying tip shapes designed for peripheral use. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available. Also included in the VERIPATH™ device package is an inner catheter. The inner catheter is a single lumen catheter with a luer at the proximal end and is recommended for use with the guiding catheter to aid in the introduction and withdrawal of the guiding catheter. The inner catheter has a standard working length of 65 cm and a standard overall length of 67 cm, but can be produced in lengths from 55 to 95 cm depending upon physician preference and patient size. The inner catheter is straight and available in three diameters/French sizes (F), as follows: 6F (0.062" OD), 7F (0.072" OD), and 8F (0.082" OD) and may be sold either with or without a taper at the tip.

The provided text is a 510(k) Summary for the VERIPATH™ Peripheral Guiding Catheter. It indicates that the device's safety and effectiveness were demonstrated through nonclinical bench tests and analyses. However, it does not contain the detailed information necessary to fully answer all aspects of your request.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

The document states: "The safety and effectiveness of the VERIPATH™ Peripheral Guiding Catheter have been demonstrated through data collected from nonclinical bench tests and analyses." However, it does not provide specific acceptance criteria or the reported performance data from these bench tests. This level of detail is typically included in an exhaustive test report, which is not part of this 510(k) summary.

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 "nonclinical bench tests and analyses." This implies that the testing was performed in a lab setting, not on human subjects. Therefore, there is no "test set" in the sense of patient data, nor is there information about data provenance (country, retrospective/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)

Since the testing was nonclinical bench tests, there wouldn't be "experts" establishing ground truth in the context of clinical interpretation or diagnosis. The ground truth for bench tests would be defined by engineering specifications and measurements.

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

Not applicable, as this refers to clinical evaluation and consensus building among human readers, which is not mentioned for this 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 device is a physical medical instrument (a guiding catheter), not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.

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

Not applicable for the same reason as point 5.

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

For nonclinical bench tests, the "ground truth" would be the engineering specifications and performance targets for characteristics like material strength, dimensional accuracy, flow rates, flexibility, and torqueability. The document does not specify these metrics or their targets.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for this device.

In summary, based on the provided 510(k) summary, the VERIPATH™ Peripheral Guiding Catheter demonstrated safety and effectiveness through nonclinical bench tests and analyses. However, the document does not include the detailed performance data, specific acceptance criteria, or information on clinical studies that would be necessary to answer most of your questions. The nature of the device (a physical catheter) means that many of your questions related to AI, clinical imaging, and expert review are not applicable.

Ask a specific question about this device

To facilitate the placement of balloon dilatation catheters during percutancous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

The ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a nominal diameter of 014" and available in: 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 190 cm models are tapcred to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The wire is constructed from a stainless steel core wire. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. A hydrophilic coating is applied to the distal portion of the guide wire and the proximal section is coated with polytetrafluoroethylene.

The provided 510(k) summary describes a medical device, the ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire, and its performance evaluation. The summary is for a traditional medical device, not an AI/ML-powered device, so several of the requested sections regarding AI-specific evaluation criteria (like MRMC studies, ground truth establishment for training sets, and data provenance for AI models) are not applicable.

Here's an analysis of the provided text based on your request, focusing on the information available for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that in vitro bench testing and in vivo performance evaluations were conducted to demonstrate that the new guide wire met acceptance criteria and performed similarly to predicate devices. Specific tests mentioned are:

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

The document mentions "in vitro bench testing and in vivo performance evaluations" but does not specify the sample sizes used for these tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not provided. This type of detail is often found in the full submission, not typically summarized in the 510(k) summary itself.

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

This information is not applicable/provided as this is a physical medical device and not an AI/ML detection or diagnostic device that would require expert-established ground truth for a test set in that context. The "ground truth" here would relate to the physical properties of the guide wire meeting predefined engineering specifications and functional requirements.

4. Adjudication Method for the Test Set:

This information is not applicable/provided for the same reasons as #3. Adjudication methods are typically used for establishing ground truth in image analysis or diagnostic studies.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device.

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

No, a standalone algorithm performance study was not done. This concept applies to AI/ML algorithms, not physical guide wires.

7. The Type of Ground Truth Used:

For this device, the "ground truth" is established through objective engineering specifications and functional performance criteria derived from the intended use and comparison to legally marketed predicate devices. This includes physical properties (tensile strength, torque strength, flexibility) and performance under simulated use conditions (in vitro) and potentially animal or human studies (in vivo, though details are not provided in the summary).

8. The Sample Size for the Training Set:

This information is not applicable/provided. There is no "training set" in the context of an AI/ML algorithm for this physical medical device. The "training" for such a device would be its design and manufacturing process to meet specifications.

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

This information is not applicable/provided for the same reasons as #8.

Ask a specific question about this device

The RX HERCULINK™ 14 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.

RX HERCULINK™ 14 Biliary Stent System is a balloon-expandable stent pre-mounted onto a rapid exchange (RX) delivery catheter designed to be placed perculaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is fabricated from a single piece of 316L medical grade stainless steel tubing. The Stent is pre-mounted onto an RX delivery catheter with an integrated shaft system and an of a single have a look balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated.

The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.

The proximal end of the catheter has a single arm adapter that provides access to the The proximal end of the catherer has a ongro annelly for connection with an inflation device.

The RX HERCULINK™ Biliary Stent System consists of an 18 mm length stent pre-The KA TILICOEINN - Dinary Catheter with balloon diameters of 4.0, 4.5, 5.0, mounted only a 75 cm length don'tory actively Stent System is intended to be delivered and deployed in the biliary tree.

Here's an analysis of the provided text regarding the RX HERCULINK™ 14 Biliary Stent System, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary from 1999 for a medical device (biliary stent), not a diagnostic algorithm or AI system. Therefore, many of the requested categories (like MRMC studies, ground truth for training/test sets, expert adjudication, effect size of human readers with AI assistance) are not applicable to this type of device and submission. The "device" in this context is a physical stent and delivery system.

The "acceptance criteria" for a physical medical device typically revolve around demonstrating substantial equivalence to a predicate device in terms of design, materials, performance, and intended use, rather than meeting specific sensitivity/specificity thresholds. The "study" proving acceptance criteria is often a series of bench tests and analyses to show that the new device performs similarly to the predicate or meets established engineering specifications.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of number of devices tested for the in vitro bench tests. The document only states "data collected from in vitro bench tests and analyses," implying multiple tests were performed.
• Data Provenance: The tests are "in vitro bench tests," meaning they were conducted in a laboratory setting, not on human patients or derived from clinical data. Therefore, there is no country of origin of data or retrospective/prospective classification in the typical sense.

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

• Not Applicable. For a physical device like a stent, "ground truth" isn't established by expert consensus on clinical findings in the same way it would be for an AI diagnostic algorithm. Performance is typically measured against engineering specifications, material properties, and mechanical test standards. The "experts" involved would be engineers, material scientists, and quality assurance personnel performing the bench testing, not clinicians establishing clinical ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers when establishing ground truth for diagnostic studies. This is not relevant for in vitro bench testing of a physical medical 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 a physical medical device (stent), not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Engineering Specifications / Performance Standards: The "ground truth" for this device's performance would be adherence to established engineering specifications, material standards (e.g., for 316L stainless steel), and mechanical performance metrics (e.g., expansion diameter at certain pressures, stent integrity, delivery system functionality). The bench tests verify that the device meets these pre-defined physical and mechanical properties.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

• Not Applicable. As there is no training set for a physical device, this question does not apply.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is described as "in vitro bench tests and analyses." These tests are designed to demonstrate the "safety and effectiveness" of the stent system by verifying its physical, mechanical, and material characteristics against predetermined specifications and in comparison to the predicate device. The ultimate acceptance criterion for a 510(k) summary is "substantial equivalence" to a legally marketed predicate device (in this case, the Cordis J&J PALMAZ™ balloon-expandable Stent, K911581). This substantial equivalence is established by showing that the new device has similar designs, materials, methods of deployment, and intended use as the predicate, which the bench testing would support.

Ask a specific question about this device

The HI-TORQUE IRON MAN™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as atherectomy and compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature.

The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers and flats, which reduce the diameter of the core wire distally, vields the desired tip flexibility. The distal 12 to 15 centimeters proximal to the tip of the ACS HI-TOROUE IRON MAN™ Guide Wire are coated with Microglide® while the remaining portion is coated with polytetrafluoroethylene (PTFE). Both coatings are intended to reduce friction for improved movement of the wire within the catheter. The platinum alloy coils provide the physicians with a radiopaque tip.

The provided document describes a medical device, the ACS HI-TORQUE IRON MAN™ Guide Wire, and its substantial equivalence to predicate devices, rather than a study evaluating its performance against specific acceptance criteria in the context of an AI-powered device. Therefore, a direct response to your prompt with specific acceptance criteria, reported device performance in those terms, and details about training/test sets, ground truth, and human expert involvement is not applicable based on the given text.

The document discusses the following:

• Substantial Equivalence: The primary assertion is that the ACS HI-TORQUE IRON MAN™ Guide Wire is substantially equivalent to existing predicate devices (ACS Hi-Torque Extra S'Port™ Guide Wire and Boston Scientific Corporation .014" Platinum Plus™ Guide Wire) in terms of intended use, materials, and design.
• Testing Data:
  • Biocompatibility: Relies on data from the predicate device as the materials are identical.
  • In vivo Testing: Two animal studies compared the new guide wire's performance to predicate wires when used with specific catheters and stent delivery systems. The conclusion was that it performed "as well as or better than" the predicate wires in most parameters.
  • Bench Testing: Evaluated:
    • Tensile strength of the distal tip (pull test) – "adequate"
    • Torsional strength of the distal tip (turns-to-failure test) – "adequate"
    • Rotational accuracy (correlation between proximal and distal rotation) – "adequate torque response"
    • Tip flexibility – "equivalent to that of the predicate and is acceptable"

Therefore, I cannot populate the table or answer the specific questions about AI/algorithm performance. The document describes a traditional medical device submission focused on demonstrating equivalence through mechanical and animal testing, not an AI/ML device with established acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, accuracy, or human reader improvement.

Ask a specific question about this device

The INDEFLATOR PLUS 30™ Inflation Device is recommended for use during vascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.

The PLUS 30 PRIORITY PACKTM:

INDEFLATOR PLUS 30TM Inflation Device- See description above.

PLUS 30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.)

INDEFLATOR PLUS 30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge.

The PLUS 30 PRIORITY PACK™ is comprised of the INDEFLATOR PLUS 30™ inflation device packaged with accessories used during vascular procedures in conjunction with interventional or diagnostic devices. These accessories include a torque device, a guide wire introducer and a rotating hemostatic valve.

This 510(k) summary is for a medical device (Inflation Device) and does not contain information related to an AI/ML powered device. Therefore, it is not possible to extract the requested information about acceptance criteria, study design, and ground truth as these concepts are not applicable to the provided text.

The document describes the device, its intended use, and claims substantial equivalence to previously cleared devices. It does not present any performance studies or acceptance criteria in the context of an AI/ML algorithm.

Ask a specific question about this device

INDEFLATOR 20/30™ Inflation Device- The INDEFLATOR 20/30™ Inflation Device is recommended for use during cardiovascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.

20/30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during cardiovascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catherectomy devices, stent delivery systems, intravascular ultrasound devices.)

The INDEFLATOR 20/30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge.

The 20/30 PRIORITY PACK™ is comprised of the INDEFLATOR 20/30™ inflation device packaged with accessories used during vascular procedures in conjunction with interventional or diagnostic devices. These accessories include a torque device, a guide wire introducer and a rotating hemostatic valve.

This device submission, K961471, for the INDEFLATOR 20/30™ Inflation Device and 20/30 PRIORITY PACK™ does not contain information typically found in studies designed to establish acceptance criteria for AI/ML-based medical devices.

The document is a 510(k) Summary for a medical device that appears to be a manually operated mechanical inflation device for use in cardiovascular procedures. The submission focuses on demonstrating substantial equivalence to predicate devices (ACS INDEFLATOR 20/20™ and Baxter Inflation Pro™ II) based on similar indications, methods of use, design, and manufacturing processes.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria because the provided text describes a traditional medical device, not an AI/ML system. The concepts of "acceptance criteria" and "study" in the context of AI/ML performance (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets) are not relevant to this type of device submission.

Ask a specific question about this device

The ACS ANCHORTM Exchange Device is used within a guiding catheter to facilitate the exchange of an interventional device while maintaining the position of a guide wire within the vasculature.

The ACS ANCHORTM Exchange Device consists of a proximal control handle and a superelastic core wire within a single lumen hypotube approximately 96 cm. long. The control handle provides the userinterface to control the movement of the hypotube and the core wire. During an exchange procedure, the distal end of the core wire is wrapped around the guide wire to lock its position in the vasculature. The ACS ANCHOR™ Exchange Device is compatible with 0.010" through 0.018" diameter non-hydrophilic-coated guide wires and associated interventional devices (except the ROTOBLATOR® Rotational Angioplasty System) when at least 0.015" free space is available within the guiding catheter.

The provided text describes a medical device, the ACS ANCHOR™ Exchange Device, and its comparison to a predicate device. However, it does not include detailed acceptance criteria or a study designed to prove the device meets specific performance criteria in the way a clinical trial for an AI diagnostic device would.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes tests performed rather than explicit numerical acceptance criteria. The acceptance is broadly stated as "acceptable for its intended use" or "substantially equivalent."

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

The document does not specify exact sample sizes for the "bench" or "in vivo" testing.

• Bench Testing: No specific numbers provided.
• In vivo Testing: "In vivo testing was conducted to substantiate the use..." No specific sample size or details on data provenance (e.g., animal model, human cadaver, specific country of origin) are given.
• Retrospective/Prospective: Not applicable or specified. This device is a mechanical tool, not an AI diagnostic, so these terms don't directly apply in the same way.

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

Not applicable. This is a medical device for facilitating procedures, not an AI diagnostic tool requiring expert interpretation of images or data to establish a "ground truth" in the diagnostic sense. The "ground truth" here is functional performance.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

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

Not applicable. An MRMC study is relevant for evaluating the impact of an AI diagnostic tool on human readers' performance. This device is a procedural accessory, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is primarily engineering specifications and functional performance metrics.

• For biocompatibility: Adherence to ISO standards.
• For mechanical tests (tensile, torsional, locking, fatigue): Measurement against design specifications and comparison to a predicate device.
• For in vivo testing: Successful demonstration of intended function within a living system (though details are sparse).
• For sterility: Achievement of a validated sterility assurance level.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. See point 8.

Summary of what the document does provide:

The document functions as a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device, the Magnet Exchange Device. The "studies" described are focused on:

• Biocompatibility against international standards.
• Bench testing of mechanical properties (tensile, torsional, locking force, fatigue).
• In vivo testing to show compatibility with various interventional devices.
• Sterilization validation.

The "acceptance criteria" are implied by successful completion of these tests and the conclusion that the device is "acceptable for its intended use" and "substantially equivalent" to its predicate. It lacks the detailed, quantitative acceptance criteria and rigorous study design typically expected for an AI-powered diagnostic device clinical validation.

Ask a specific question about this device