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The SPIRIT™ Navigable Lead Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The SPIRIT™ Navigable Lead Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen Lead Delivery Sheath with Stylet has a guidewire lumen for introduction of leads. The Modified Acumen Lead Delivery Sheath with Stylet will be packaged with stylets, also referred to as Distal Control Devices (DCDs), to aid in positioning of the device in the vasculature.

The provided 510(k) summary for the Acumen Medical, Inc. SPIRIT™ Navigable Lead Delivery Catheter (K083855) does not contain specific details about acceptance criteria, a study proving device performance against those criteria, or information on AI/ML components.

This document describes a medical device that introduces pacing or defibrillator leads and catheters. It is a traditional medical device submission, primarily focused on establishing substantial equivalence to a predicate device (Acumen Lead Delivery Sheath with Stylet, K070197) based on similar intended use, method of operation, construction, materials, and biocompatibility testing. Performance is generally asserted through "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." without detailing specific performance metrics or study designs.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here's what can be inferred or stated based on the available information:

1. Table of acceptance criteria and the reported device performance

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not specified as no such test set or ground truth establishment is described for performance evaluation.

4. Adjudication method for the test set

• Not applicable/Not specified.

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 a traditional medical device (catheter) and does not involve AI/ML or human readers/interpretation in the way an imaging AI diagnostic device would.

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

• No. This is not an AI/ML algorithm.

7. The type of ground truth used

• Not applicable/Not specified, as performance testing details are very high-level. For a mechanical device like this, "ground truth" would typically refer to engineering specifications and performance capabilities (e.g., tensile strength, bending radius, flow rates) as tested in a lab setting, rather than clinical outcomes or expert labels.

8. The sample size for the training set

• Not applicable/Not specified, as this device does not involve an AI/ML algorithm that requires a training set.

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

• Not applicable/Not specified.

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The Modified Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.

The Modified Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable. The Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 9F. The Modified Acumen Single-Lumen Delivery Sheath is available in straight and multiple curved configurations.

This document describes a 510(k) premarket notification for a medical device and is not a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would. It's a regulatory submission asserting substantial equivalence to existing devices. Therefore, many of the requested data points (like sample size for test sets, number of experts, MRMC studies, standalone algorithm performance, training set details) are not applicable or available within this document.

However, I can extract the relevant information from the provided text based on the 510(k) process.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, "acceptance criteria" and "reported device performance" are primarily framed around substantial equivalence to predicate devices rather than a direct clinical performance study with numerical criteria. The acceptance criteria for the FDA in a 510(k) is whether the new device is "substantially equivalent" to a legally marketed predicate device.

Study Proving Substantial Equivalence:

The "study" in this context is the 510(k) Premarket Notification itself, which argues for substantial equivalence based on a comparison to predicate devices and in-vitro testing.

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

• Sample size for test set: Not applicable (N/A) in the context of a 510(k) summary relying on substantial equivalence and in-vitro testing. The document states "In-vitro testing has been performed," but does not provide the sample size of tested devices.
• Data provenance: N/A. The in-vitro testing was likely conducted by Acumen Medical, Inc. or a contracted lab. The document does not specify country of origin or whether it was retrospective/prospective in a clinical sense.

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

• Number of experts: N/A, as clinical "ground truth" establishment by experts is not described for a test set in this type of submission. The evaluation for substantial equivalence is primarily based on regulatory standards, engineering testing, and comparison to predicate devices by the manufacturer and the FDA.
• Qualifications of experts: N/A.

4. Adjudication method for the test set

• Adjudication method: N/A. This is typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.

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

• MRMC study: No. This device is a physical delivery sheath, not an AI or imaging diagnostic device.
• Effect size: N/A.

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

• Standalone study: No. This is a physical medical device, not a software algorithm.

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

• Type of ground truth: N/A in the clinical sense. For the in-vitro testing, the "ground truth" would be the pre-defined engineering specifications and performance requirements for the device components and full assembly. The primary "ground truth" for the 510(k) submission is the documented characteristics and performance of the predicate devices to which it is being compared.

8. The sample size for the training set

• Sample size for training set: N/A. This term is relevant for machine learning algorithms, not for the development and testing of a physical medical device described here.

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

• Ground truth establishment for training set: N/A.

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The Modified Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.

The Modified Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable. The Modified Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 6F.

This document describes a 510(k) premarket notification for a medical device called the "Modified Acumen Single-Lumen Delivery Sheath". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data as would be found in a PMA.

Therefore, the requested information regarding acceptance criteria and performance data for an AI-powered device, involving sample sizes, expert ground truth, MRMC studies, and standalone performance, is not applicable to this 510(k) submission.

This submission is for a physical medical device (a catheter introducer sheath), not an AI/software as a medical device (SaMD). The "testing" mentioned refers to in-vitro testing of the physical device's components and does not involve AI performance metrics.

Here's a breakdown of why each requested point is not present or applicable:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document states "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not provide a table of these specifications or detailed performance metrics. This is typical for a 510(k) of this nature, where adherence to internal design specifications and equivalence to a predicate device are the primary focus.
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. This refers to physical in-vitro tests, not an AI test set.
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, as there is no AI algorithm being evaluated against expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no AI algorithm and no expert adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, this is a physical medical device, not an AI-assisted diagnostic tool.
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 AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there is no AI algorithm that requires ground truth for its evaluation as per the provided document. The "ground truth" for the device's function would be its ability to physically introduce leads and catheters, assessed through engineering and bench testing.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Summary from the provided documents:

• Device Type: Catheter Introducer Sheath (physical medical device)
• Purpose of Submission: Demonstrate substantial equivalence to a predicate device (Acumen Single-Lumen Delivery Sheath K053400).
• Primary Evidence: In-vitro testing (details not provided beyond "met the required specifications") and comparison of materials, intended use, method of operation, and construction to the predicate device.
• Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

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The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart. The Insight is intended for use in the right heart only.

The Acumen Insight Endocardial Visualization System (Insight) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus. foramen ovale and other venous side cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

The provided text states that "additional device testing was not required" and does not describe any specific studies conducted for this 510(k) submission. Instead, it relies on substantial equivalence to predicate devices (K042381, K062084, K992631). Therefore, information regarding acceptance criteria, study design elements (sample size, ground truth, expert qualifications, adjudication methods), or AI-specific details (MRMC studies, standalone performance, training set) is not available in the given document.

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

No acceptance criteria or reported device performance data are provided in the document from a new study. The submission relies on substantial equivalence to predicate devices based on identical or substantially equivalent intended use, method of operation, construction, and materials.

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. No new device performance study was conducted as stated in the document: "As there is no change in the design of the device, additional device testing was not required."

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. As no new device performance study was conducted.

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

Not applicable. As no new device performance study was conducted.

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 medical catheter for visualization and delivery, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

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

Not applicable. This device is a medical catheter and does not involve an algorithm with standalone performance.

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

Not applicable. As no new device performance study was conducted.

8. The sample size for the training set

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

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

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

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The Acumen Lead Delivery Sheath with Stylet is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Lead Delivery Sheath with Stylet is a single-use percutaneous catheter intended to The Acumen Lead Delivery Birean West villator leads and catheters. The Acumen Lead Delivery Sheath with Stylet has a guidewire lumen and a lumen for introduction of leads. The Acumen Silean with Stylet was a gurdential be packaged with a stylet to aid in positioning of the device in the vasculature.

This document, K070197, describes a 510(k) premarket notification for the "Acumen Lead Delivery Sheath with Stylet." The information provided is a summary of the device's intended use, description, and a statement of substantial equivalence to a predicate device. It does not contain the kind of detailed study data, acceptance criteria, and performance results that would be expected for a typical medical device performance study, especially for AI/ML devices.

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

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

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

• Sample Size for Test Set: Not specified. The document broadly states "Appropriate testing has been performed" without detailing the nature or scope of this testing, including sample sizes for any test sets.
• Data Provenance: Not specified.

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)

• Number of Experts: Not applicable. This device is a medical instrument (lead delivery sheath), not an AI/ML diagnostic or prognostic tool that would typically involve expert-established ground truth from image or other medical data. The testing mentioned would likely involve engineering and biocompatibility tests, not expert reviews of diagnostic interpretations.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. As this is not an AI/ML diagnostic or prognostic device, adjudication methods related to expert consensus on diagnostic interpretations are not relevant.

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

• MRMC Study: No. This is a medical instrument, not an AI-assisted diagnostic or prognostic tool. Therefore, MRMC studies are not relevant.
• Effect Size: Not applicable.

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

• Standalone Study: No. This device is a component used in a medical procedure, not an AI algorithm.

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

• Type of Ground Truth: Not applicable in the context of an AI/ML device. For a physical medical device like this, "ground truth" would refer to established engineering specifications, material properties, and biological compatibility standards. The document only mentions "required specifications for the completed tests."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set" in the machine learning sense.

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

• Ground Truth for Training Set Establishment: Not applicable.

Summary of what is present:

The submission highlights the device's intended use (introduction of pacing/defibrillator leads and catheters) and states its substantial equivalence to a predicate device (Acumen Lead Delivery Sheath, K062145). The substantial equivalence is based on "identical or substantially equivalent" factors in intended use, method of operation, construction, and materials. The document confirms that "appropriate testing has been performed" and that the device "met the required specifications," but it does not provide any details about these tests, the specific specifications, or the results.

This type of 510(k) submission for a non-AI physical medical device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a combination of engineering testing, materials analysis, and comparison of design features. Detailed performance metrics and study designs, as requested in your prompt (which are common for AI/ML devices), are generally not included in this high-level summary for traditional medical devices.

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The Modified Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Lead Delivery Sheath (LDS) is a single-use perculaneous catheter intended (1) introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen LDS has a guidewire lumen and a lumen for introduction of leads.

The provided text contains information about a 510(k) submission for a medical device (Modified Acumen Lead Delivery Sheath). However, it does not include information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or MRMC studies) typically found in a clinical or performance study report.

The document primarily focuses on regulatory aspects, such as:

• Device Description: A single-use percutaneous catheter to introduce pacing/defibrillator leads.
• Intended Use: Introduction of various types of pacing or defibrillator leads and catheters.
• Predicate Device: Acumen Lead Delivery Sheath (K051515).
• Materials: Stated as suitable and used in previously cleared products.
• Testing: "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This statement indicates that testing was done and met specifications, but it does not provide the acceptance criteria or the specific results of those tests.
• Substantial Equivalence: Claimed based on identical or substantially equivalent intended use, method of operation, construction, and materials to the predicate device.

Therefore, I cannot populate the requested table or answer most of the detailed questions about acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• N/A: This information is not explicitly stated in the provided text. The document only mentions "all components, subassemblies, and/or full devices met the required specifications for the completed tests," without detailing what those specifications or results were.

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

• N/A: The document does not describe a clinical test set or details about data provenance. The testing mentioned is likely bench testing for design verification, not a clinical study with human subjects.

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

• N/A: No ground truth establishment is described, as there's no mention of a clinical test set requiring expert interpretation.

4. Adjudication method for the test set

• N/A: Not applicable, as no test set requiring adjudication is described.

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

• N/A: This device is a physical medical instrument (catheter sheath), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• N/A: Not applicable, as this is a physical device, not an algorithm.

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

• N/A: Not applicable, as no ground truth for "testing" in the context of diagnostic performance is described. The "testing" referred to in the document is likely engineering/bench testing (e.g., tensile strength, flexibility, biocompatibility, etc.) that would have defined specifications, but these are not provided.

8. The sample size for the training set

• N/A: Not applicable, as this is a physical device, not an AI model or a device requiring a training set in that context.

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

• N/A: Not applicable, for the same reason as above.

In summary, the provided K062145 document is a regulatory submission for premarket notification (510(k)) asserting substantial equivalence, not a detailed performance study report. It confirms that "appropriate testing has been performed and all components... met the required specifications," but does not disclose those specifications or the detailed results.

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The 7F Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

The 7F Acumen Coronary Sinus Visualization System (CSVS) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

The provided document K062084 for the Acumen Medical, Inc. 7F Acumen Coronary Sinus Visualization System is a 510(k) summary and an FDA clearance letter. It states that appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests to demonstrate substantial equivalence to its predicate device (Acumen Coronary Sinus Visualization System, K042381). However, the document does not provide specific details about the acceptance criteria, study design, or performance metrics.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the details about sample sizes, ground truth establishment, or specific study types. The document explicitly states that the new device is "either identical or substantially equivalent to existing legally marketed predicate product" in terms of its intended use, method of operation, methods of construction, and materials.

To answer your questions based only on the provided text:

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

This information is not explicitly provided in the document. The document states: "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, the specifications themselves are not detailed.

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 provided in the document.

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 provided in the document. The testing mentioned appears to be related to meeting required specifications for a medical device's components and functionality, rather than a clinical study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided in the document. The device is a "Coronary Sinus Visualization System," a physical catheter, not an AI-assisted diagnostic tool for image interpretation.

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

This information is not provided in the document. As mentioned, this is a physical catheter, not an algorithm.

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

This information is not provided in the document. The testing described appears to be engineering/performance testing for a physical device rather than a diagnostic accuracy study.

8. The sample size for the training set:

This information is not provided in the document. This is a physical device, and the concept of a "training set" for an algorithm is not applicable here.

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

This information is not provided in the document.

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The Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable.

This document describes a 510(k) premarket notification for a medical device called the "Acumen Single-Lumen Delivery Sheath". This type of submission is a declaration that a new device is "substantially equivalent" to one or more legally marketed predicate devices, rather than a study proving performance against acceptance criteria in the way one might for a novel AI device.

Therefore, many of the requested categories related to AI device studies (like sample size for test/training sets, expert ground truth adjudication, MRMC studies, or standalone performance of an algorithm) are not applicable to this submission.

Here's a breakdown of the information provided in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is not a clinical trial or AI performance study, but rather a premarket submission demonstrating substantial equivalence to existing devices through a combination of:

• In-vitro testing: Performed to ensure the device components, subassemblies, and the full device meet required specifications.
• Animal testing: Also performed to ensure the device components, subassemblies, and the full device meet required specifications.
• Material compatibility assessment: Confirming that all materials are suitable for medical use and have a history of use in previously cleared products.
• Comparison to Predicate Devices: A detailed comparison of the new device's intended use, method of operation, construction, and materials to those of the predicate devices.

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

• Not Applicable. This is not an AI device study requiring a traditional "test set" from a dataset of images or clinical cases. The testing involved in-vitro and animal studies, which are typically defined by the specific test protocols and models used, rather than a "sample size" of patient data.
• Data Provenance: The document does not specify the country of origin for the in-vitro or animal testing. It also doesn't explicitly state if the testing was retrospective or prospective, though in-vitro and animal studies for device clearance are typically prospective.

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

• Not Applicable. This is not an AI device study involving expert human review for ground truth establishment. The "ground truth" here is compliance with engineering specifications and functional performance in in-vitro and animal models.

4. Adjudication method for the test set

• Not Applicable. No expert adjudication method (like 2+1, 3+1) is mentioned or relevant for this type of device submission.

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 device. No MRMC study was conducted.

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

• Not Applicable. This is not an AI device. No standalone algorithm performance was assessed.

7. The type of ground truth used

• For the in-vitro and animal testing: The ground truth would be engineering specifications, functional performance metrics, and safety outcomes as defined by the test protocols.
• For the substantial equivalence claim: The "ground truth" is the characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI device, so there is no training set mentioned or relevant.

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

• Not Applicable. As no training set exists for an AI model, this question is not relevant.

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The Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Sheath has a guidewire lumen and a lumen for the introduction of various types of I he reading or defibrillator leads and catheters. The sheath is designed to be slittable, thereby allowing its removal from the lead, and a slitter is provided with the device.

The provided text from K051515, a 510(k) premarket notification for the "Modified Acumen Sheath," does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a 510(k) summary and the FDA's clearance letter. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove adherence to specific performance metrics through a clinical trial or detailed performance testing with acceptance criteria.

Here's a breakdown of why this information is missing based on the provided text:

• No Acceptance Criteria or Performance Data: The document explicitly states under "Testing" that "Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not disclose what these "required specifications" were (i.e., the acceptance criteria) or the reported device performance against them.
• Focus on Substantial Equivalence: The "Summary of Substantial Equivalence" section emphasizes that the device is "substantially equivalent to the predicate product" based on "intended use, method of operation, methods of construction and materials used." This reinforces that the primary goal of the 510(k) was to compare it to an existing device, not necessarily to establish new, quantitative performance benchmarks.
• Limited Detail in 510(k) Summary: 510(k) summaries are often high-level and do not typically include detailed test protocols, raw data, or specific acceptance criteria that would be found in the full 510(k) submission.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, ground truth, expert qualifications, or comparative effectiveness studies because this information is not present in the provided text. The document is primarily a regulatory clearance notification and a brief summary of the device's characteristics and its equivalence to a predicate.

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The Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Sheath is a single-use percutaneous catheter indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Sheath has a guidewire lumen for the introduction of various types of pacing or defibrillator leads and catheters. The sheath is designed to be splittable, thereby allowing its removal from the lead, and a slitter is provided with the device.

This document is a 510(k) summary for the Acumen Sheath from Acumen Medical, Inc. It describes the device, its intended use, and states that substantial equivalence to a predicate device has been affirmed.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics, especially those related to AI or algorithm performance.

The document states:

• "Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This is a general statement and does not provide specifics.

Therefore, I cannot fulfill your request for the detailed table and study information because it is not present in the provided text. The device described appears to be a physical medical instrument (an introducer catheter or sheath), not an AI/algorithm-based device, and the 510(k) focuses on substantial equivalence to a predicate device rather than performance metrics of an algorithm.

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