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The 0.035" and 0.025" Hytek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.

The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for the purpose of directing the catheter through a blood vessel.

The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to help facilitate smoother passage.

The HyTek Guidewire is available in diameters of .014" to .035, and in lengths from 80 cm to 300 cm.

The provided text is a 510(k) summary for the HyTek Guidewire. It discusses the device's substantial equivalency to predicate devices based on non-clinical tests. However, it does not contain information about acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically required for AI/ML-based medical devices.

Instead, this document describes a traditional medical device (a guidewire) and its regulatory clearance process, which relies on demonstrating substantial equivalence to already approved predicate devices through bench testing.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

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

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

2. Sample sized 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 "tests" mentioned are non-clinical bench tests. Sample sizes for these types of engineering tests are rarely specified in 510(k) summaries as they are not human subject studies. Data provenance (country, retrospective/prospective) is irrelevant for bench testing of a physical device.

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 the context of AI/ML usually refers to human expert annotations or clinical outcomes. For physical device bench testing, the "ground truth" is typically established by engineering specifications and direct measurement, not human experts in the clinical sense.

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

• Not applicable / Not provided. Adjudication is a concept for resolving discrepancies in human expert opinions for ground truth establishment. This is not relevant for bench testing a physical 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 / Not provided. MRMC studies are for evaluating the impact of AI on clinical reader performance. This device is a physical guidewire, not an AI algorithm.

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

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

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

• Not applicable / Not provided. The "ground truth" for the bench tests would be the physical properties and performance measured against engineering specifications, which are implicitly derived from the predicate device's characteristics and industry standards.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not an AI/ML device.

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

• Not applicable / Not provided. There is no "training set."

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The study consisted of non-clinical tests designed to demonstrate that the HyTek Guidewire's functionality and performance characteristics are comparable to the currently marketed predicate device (K943390 and K991194).

These tests specifically included:

• Torque
• Flexibility
• Coating adherence

The document states that "The results of these tests demonstrated the functionality and performance characteristics of the guidewire are comparable to the currently marketed device." This statement, along with the detailed comparisons to predicate devices in the full 510(k) submission (which is summarized here), was sufficient for the FDA to determine substantial equivalence and clear the device for market. The specific methodology, detailed results, and quantitative acceptance thresholds for these bench tests are not provided in this summary but would have been part of the full 510(k) submission.

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The 0.025" HyTek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.

The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for directing the catheter through a blood vessel.

The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to facilitate smoother passage.

The HyTek Guidewire is available in diameters of .014" to .025, and in lengths from 80 cm to 300 cm.

This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI-powered medical device. Instead, it is a 510(k) summary for a traditional medical device (guidewire) seeking substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table or answer the questions related to AI device performance evaluation as the provided text pertains to a conventional medical device submission. The focus of this document is on the physical characteristics and intended use of the HyTek Guidewire and its comparability to an existing device, not on the performance of a software algorithm.

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The Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and subacute thrombus within dialysis fistulae.

The Amplatz Thrombectomy Device (ATD) is a percutaneous, thrombectomy device consisting of a catheter, a small diameter impeller encased in a distal housing, and a driveshaft. The driveshaft is the connection between the impeller and a disposable, high speed, air driven motor. An infusion line with luer connector, attached to the proximal motor housing, allows infusion of saline. A foot pedal/regulator assembly is required to operate the air motor.

Here's an analysis of the provided text regarding the Amplatz Thrombectomy Device's acceptance criteria and study information, specifically noting the absence of certain data as this is a 510(k) summary and approval letter, not a detailed clinical study report:

This 510(k) submission for the Amplatz Thrombectomy Device focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria for device performance as one might see for a diagnostic AI device. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, etc., which are typical for AI/diagnostic device evaluations) is not present in this type of regulatory document.

However, based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The document refers to "functional and safety testing" rather than a clinical human-subject test set as understood for AI performance.
• Data Provenance: Not specified. The testing likely occurred in a laboratory setting or on simulated models for functional and safety aspects.

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

• Not applicable to this type of submission. This document describes the acceptance of a medical device based on engineering and safety tests, and equivalence to a predicate, not performance against an established ground truth in a diagnostic context.

4. Adjudication method for the test set

• Not applicable. (See answer to 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 device, and no MRMC study is mentioned.

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

• Not applicable. This is a thrombectomy device, not an algorithm or AI. The device operates mechanically.

7. The type of ground truth used

• For the functional and safety testing: Engineering specifications, material standards, and possibly performance benchmarks against the predicate device.
• For the overall regulatory decision: Substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. (See answer to point 8).

Summary of what the document IS:

This is a 510(k) premarket notification for the Amplatz Thrombectomy Device. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed "predicate device." This usually involves comparing the new device's technological characteristics, indications for use, safety, and effectiveness to the predicate. Clinical studies with detailed performance metrics and ground truth establishment (as described in your questions) are more common for novel devices or those seeking PMA approval, or for AI/diagnostic devices where performance metrics are critical for regulatory acceptance.

In this case, the "study" is the submission demonstrating substantial equivalence, supported by functional and safety testing, rather than a clinical trial directly measuring treatment efficacy against an outcome "ground truth" or diagnostic accuracy.

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The Amplatz "GOOSE NECK" Microsnare is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system and hollow viscus. This includes intravascular foreign objects such as coils, balloons, portions of catheter and/or guidewires misplaced during interventional radiological procedures within the peripheral, neuro and cardiovasculature.

The Amplatz Goose Neck MicroSnare (NEUROSnare) is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the cornary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

The Amplatz "GOOSE NECK" Microsnare is a percutaneous retrieval and manipulation device with a uniquely shaped retriever loop. The "GOOSE NECK" Microsnare component consists of a core wire, with the "beak-like" retriever loop mounted at a right angle to the axis of shaft at its distal tip. The device is primarily comprised of a nickel-titanium alloy allowing virtual kink-resistant performance during navigation and retrieval of a foreign object.

The provided text describes a 510(k) summary for the Amplatz "GOOSE NECK" Microsnare, intended for retrieving foreign bodies from the cardiovascular system and hollow viscus. However, the document does not contain details about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth methodologies typically found in a clinical study report for proving device performance.

The text states:

• "The Amplatz "GOOSE NECK" Microsnare has successfully passed all functional and safety testing requirements."
• "The Amplatz "GOOSE NECK" Microsnare is deemed substantially equivalent to commercially available MICROVENA and Target Therapeutics Retrieval devices based on functional testing and published clinical experiences."

This indicates that the device's performance was evaluated, but the specifics of how it met acceptance criteria for a study are not provided. The 510(k) summary is generally a high-level overview for regulatory submission, not a detailed clinical study report.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer based on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document refers to "functional and safety testing requirements" and "published clinical experiences" but does not provide a sample size for any specific clinical or non-clinical test set.
• Data Provenance: Not specified. The data provenance (e.g., country of origin, retrospective/prospective) for the "functional and safety testing" or "published clinical experiences" is not mentioned.

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

• This information is not provided in the document. The filing refers to "functional testing and published clinical experiences," but details on expert involvement in establishing ground truth are absent.

4. Adjudication method for the test set

• This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. An MRMC comparative effectiveness study is not mentioned. The regulatory submission is based on "functional testing and published clinical experiences" and establishing substantial equivalence to predicate devices, not on a direct comparison of human readers with and without AI assistance (which is not applicable here as it's a device, not an AI).

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

• This question is not applicable as the Amplatz "GOOSE NECK" Microsnare is a physical medical device, not an algorithm or AI. Its performance is inherent to the device's mechanical function, not an algorithm. The term "standalone" in this context typically refers to the performance of an AI model independently.

7. The type of ground truth used

• The document implies that the ground truth for performance was established through:
  • Functional and Safety Testing: Likely determined by successful completion of engineering specifications, mechanical tests (e.g., kink resistance, retrieval force), and biocompatibility assessments, rather than clinical 'ground truth' in the sense of pathology or expert consensus on clinical findings.
  • Published Clinical Experiences: This suggests that existing literature or previous clinical use of similar devices informed the understanding of desired performance, but specific ground truth definition for a study is not given.

8. The sample size for the training set

• Not applicable/Not provided. As a physical medical device, there isn't a "training set" in the context of machine learning or AI. If "training set" refers to pre-market testing (e.g., bench testing, animal studies), the sample size for such activities is not detailed in this summary.

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

• Not applicable/Not provided. As there's no training set in the AI sense, this question doesn't apply. For the general device development, ground truth would be established through engineering specifications, successful mechanical performance benchmarks, and compliance with safety standards. Details of these are not provided.

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The Amplatz Goose Neck Snare is a Class II device intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.

The Amplatz Goose Neck Snare consists of a braided nitinol loop attached to a solid core nitinol guidewire. The plane of the loop is perpendicular to the host wire. The loop is covered with a gold-plated tungsten coil to enhance radiopaque. The shaft of the snare consists of a solid continuous Nitinol core wire shaft. The loop snare is delivered in a multi-purpose catheter. The catheter has a radiopaque marker band at its distal tip. The package configuration consists of a compact spiral configuration, using hoops to contain the snare and catheter. These spiral hoops are then double pouched in Tyvek/mylar pouches.

The provided 510(k) summary for the Amplatz Goose Neck Snare (K972511) does not contain a detailed study report that includes acceptance criteria and performance data in the format requested.

The document states: "The Amplatz Goose Neck Snare received clearance for market based on functional and safety testing detailed in the original premarket notification K901502." This means the detailed study information regarding acceptance criteria and performance would be found in the K901502 submission, which is not provided in this document.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the information given. The current document is a summary of the 510(k) application for a new version of the device, referencing the original clearance for the testing.

The document focuses on establishing substantial equivalence to a predicate device (MICROVENA Amplatz Goose Neck Snare, K901502) based on design and intended use, rather than presenting new performance data from a specific study for K972511.

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The modified Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and sub-acute thrombus within dialysis fistulae.

The Amplatz Thrombectomy Device (ATD) is a percutaneous, rotational thrombectomy device consisting of a polyurethane catheter. Inside the catheter, a distal rotor housing contains a small diameter, recessed impeller, attached to a drive shaft. The shaft is connected to a disposable, high speed, air driven motor. An infusion line with luer connector, attached to the proximal motor assembly, allows for infusion of saline through the catheter. A foot pedal/regulator assembly is required to operate the air motor.

The provided document is a 510(k) summary for the Amplatz Thrombectomy Device (ATD). It describes the device, its intended use, and states that it has undergone functional and safety testing to demonstrate substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria for device performance or the details of a study proving those criteria were met in the way that would typically be described for clinical performance of a diagnostic device or a AI/ML-based system.

The document primarily focuses on functional and safety testing of modified design features, not clinical outcomes or performance against a specific metric. Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and performance study specifics.

Here's a breakdown of what can be inferred or what is explicitly missing based on your requested points:

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

• Missing. The document states: "The modified Amplatz Thrombectomy Device (ATD) device has successfully undergone functional and safety testing of new design features, including joint strengths, flow rate tests, burst tests, flexibility tests, device life tests, maceration capability tests, and material biocompatibility tests." It does not provide specific acceptance criteria values (e.g., "joint strength must exceed X N") or the quantitative results achieved for these tests. It concludes that the device "successfully underwent" these tests, implying compliance without detailing the metrics.

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

• Not applicable / Missing. This refers to a clinical performance study, which is not detailed in this 510(k) summary. The testing mentioned (functional/safety) would involve engineering samples, not patient data.

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 / Missing. This would be relevant for a clinical or diagnostic performance study, which is not described.

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

• Not applicable / Missing. Same as above.

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 / Missing. This is for AI/ML-based systems, and the ATD is a mechanical thrombectomy device.

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

• Not applicable / Missing. This is for AI/ML-based systems.

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

• Not applicable / Missing. For the functional and safety testing, the "ground truth" would be engineering specifications and standards (e.g., material properties, physical dimensions, burst pressure ratings), not clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

• Not applicable / Missing. This is for AI/ML-based systems, and the ATD is a mechanical thrombectomy device.

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

• Not applicable / Missing. This is for AI/ML-based systems.

In summary: The provided 510(k) summary is for a mechanical thrombectomy device and focuses on establishing substantial equivalence through functional and safety testing of its design features. It does not include the type of clinical performance study details, expert ground truth establishment, or AI/ML-specific information requested in your prompt.

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The HyTek Guidewire is intended for general intravascular use to aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.

The shaft of the HyTek Guidewire is constructed of Nitinol (nickel titanium alloy). The Nitinol core is a continuous piece of wire extending from the distal tip to the proximal shaft. The distal tip is tapered to provide flexibility and softness. The distal tip is composed of gold plated tungsten wire. The guidewire is coated with a hydrophilic coating to enhance lubricity.

I am sorry, but there is not enough information in the provided text to describe the acceptance criteria and the study that proves the device meets those criteria, as detailed in your request.

The text is a 510(k) summary for a medical device called "The 'HyTek' Hydrophilic Guidewire." While it mentions "Functional/Safety Testing" and states that "The HyTek Guidewire successfully underwent all functional and safety testing," it does not provide:

• Specific acceptance criteria: It doesn't list defined thresholds or benchmarks that the device needed to meet (e.g., "tensile strength must be >X Newtons").
• Reported device performance: It doesn't provide the actual measured results of these tests (e.g., "tensile strength was Y Newtons").
• Details about the study design: It lacks information on sample sizes, data provenance, ground truth establishment, expert involvement, or any comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence to predicate devices based on the successful completion of functional testing, rather than detailing the specific performance metrics and methodologies used in those tests.

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The Amplatz Thrombectomy Device is intended for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. This device is not intended to be used for the removal of atheroma and is contraindicated in coronary, cerebral, and pulmonary vessels.

The Amplatz Thrombectomy Device is a polyurethane catheter that contains a distal rotor housing in which a small diameter, recessed impeller is attached to a drive shaft. The shaft is connected to a disposable, high-speed air-driven motor. An infusion line with luer connector, attached to the proximal casing, allows infusion of saline, contrast medium, or thrombolytic medications.

This document, K954205, is a 510(k) summary for the Amplatz Thrombectomy Device. It describes the device's intended use and provides a summary of its comparative analysis. However, it does not contain the detailed acceptance criteria or the specific study details needed to fully answer your request.

The 510(k) summary states: "It has been demonstrated (through clinical studies) that the ATD is as safe and effective as surgery for the removal of acute and subacute thrombus within dialysis fistulae." and "The Amplatz Thrombectomy Device has successfully undergone design validation, animal, and clinical testing."

To provide the information you requested, I would need access to the actual clinical study report that was submitted to the FDA, which is not available in this summary.

Based on the provided text, I can extract the following limited information, but please note that most of your requested details are not present in this 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The actual quantitative acceptance criteria (e.g., specific success rates, complication rates, freedom from re-thrombosis rates) are not provided in this summary. The summary only broadly states "as safe and effective as surgery."

Regarding the rest of your questions, the information is not available in this 510(k) summary.

Here's why and what's missing:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The summary mentions "clinical studies" but does not provide sample sizes, study design (retrospective/prospective), or data provenance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
• 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 device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance is not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's a mechanical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): While it mentions demonstrating safety and effectiveness compared to surgery, the exact "ground truth" used for effectiveness (e.g., angiographic clearance, patency rates, clinical success defined by specific metrics) is not detailed.
• 8. The sample size for the training set: Not applicable for a traditional medical device like this in the context of AI/algorithms. If "training set" refers to early development or pilot studies, that information is not provided.
• 9. How the ground truth for the training set was established: Not applicable.

To obtain the specific details of the clinical studies and their outcomes, you would need to refer to the full 510(k) submission or any published literature related to the Amplatz Thrombectomy Device from that period.

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The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires (revised February 13, 1996)

The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires (revised February 13, 1996)

This document is a 510(k) summary for a medical device called the "CRICKET™ Multipurpose Steering Device and Tip Shaper." It is a premarket notification to the FDA to demonstrate that the device is as safe and effective as a legally marketed predicate device.

The provided text does not contain the acceptance criteria or the details of a study that proves the device meets acceptance criteria in the format requested.

Here's why and what information is available:

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

• Not present. The document states "All current MICROVENA guidewires were successfully shaped with the CRICKET™ and the guidewires successfully passed visual, functional and tensile strength tests." However, it does not define specific quantitative acceptance criteria for "successfully shaped," "visual," "functional," or "tensile strength tests." For example, it doesn't say "tensile strength must be > X Newtons" or "no visible damage greater than Y mm."

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

• Not present. The document mentions "All current MICROVENA guidewires" but does not specify the number or type of guidewires tested. There is no information on 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):

• Not applicable/Not present. This device is a mechanical tool (a steering device and tip shaper for guidewires), not an AI or diagnostic imaging device that requires expert ground truth for interpretation. The "ground truth" would be objective physical measurements and functional performance, not expert consensus on images.

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

• Not applicable/Not present. Adjudication methods are typically used in studies involving subjective interpretation, like reading medical images. This is a mechanical device test.

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.

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 concensus, pathology, outcomes data, etc):

• Implied objective testing. The ground truth would be based on "visual, functional and tensile strength tests" of the guidewires after shaping. These are objective measures rather than subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable/Not present. This device is not an AI model, so there is no "training set."

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

• Not applicable. There is no training set for this type of device.

What the document does tell us about the "study":

The document describes "Functional/Safety Testing" where:

• Device Tested: CRICKET™ Multipurpose Steering Device and Tip Shaper.
• Purpose: To demonstrate that the device successfully shapes guidewires and that the shaped guidewires maintain their integrity.
• Method: "All current MICROVENA guidewires were successfully shaped with the CRICKET™."
• Evaluations: The shaped guidewires "successfully passed visual, functional and tensile strength tests."
• Conclusion: The testing led to the conclusion that the CRICKET™ is "substantially equivalent to the predicate devices based on intended use and the results of functional testing." This implies the performance was at least as good as the predicate devices, though no specific benchmarks are given.

In summary, the provided 510(k) summary is for a physical medical device and therefore does not contain the information typically associated with studies for AI/diagnostic devices as requested in your prompt. It focuses on functional and safety testing to establish substantial equivalence, without detailing specific quantitative acceptance criteria or study design elements like sample sizes or ground truth establishment relevant to AI/diagnostic performance.

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