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The Esperance 3+ Aspiration Catheter with the Wallaby Aspiration Tubing set and a compatible aspiration pump is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has a tapered shaft with tapered inner diameter (ID) from 0.054'' (proximal) to 0.041'' (distal) and tapered outer diameter (OD) from 0.066'' (proximal) to 0.050'' (distal). It has five different working lengths: 120 cm, 133 cm, 145 cm, 153 cm, and 160 cm. The device is supplied as a kit with the Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The Esperance 3+ Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the neurovasculature.

The document provided is a 510(k) premarket notification decision letter from the FDA for a medical device called the "Esperance 3+ Aspiration Catheter System." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and biocompatibility).

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

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

The document lists various performance tests and their outcomes, all indicating that the device met the acceptance criteria. The specific numerical acceptance criteria themselves are not detailed in this public FDA letter, but the conclusion for each test is consistently "All samples met the acceptance criteria" or similar.

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 dedicates a section to "PERFORMANCE TESTING - BENCH" and concludes most tests with "All samples met the acceptance criteria." However, it does not specify the sample size used for each of these non-clinical tests.

The data provenance is through non-clinical bench testing performed by the manufacturer, Wallaby Medical. There's no information about the country of origin of the data within the document, beyond the sterilization facility being in "Suzhou) Ltd., Jiangsu, China." The nature of the tests (bench testing, biocompatibility, sterilization, shelf life) indicates these are prospective tests performed specifically for this submission, rather than retrospective analysis of existing 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)

This section is not applicable as the document describes non-clinical bench performance testing, not a clinical study involving human or image-based data that would require expert ground truth labeling. The "ground truth" for these tests is based on objective measurements and established engineering standards (e.g., ISO, ASTM).

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

This is not applicable as the document describes non-clinical bench performance testing where adjudication methods typical for clinical or image-based studies 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

No MRMC comparative effectiveness study was done or reported. The device is a medical catheter and not an AI/imaging algorithm that would typically involve human readers.

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

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

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

For the non-clinical tests described, the "ground truth" is based on:

• Engineering specifications and standards: Adherence to ISO standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 10555-1 and 80369 for bench tests) and relevant FDA guidance documents.
• Objective measurements: Dimensional verification, force measurements, flow rates, visual inspections for defects, etc.
• Comparison to predicate/reference device: Many tests involved comparing the subject device's performance (e.g., navigability, clot removal, lubricity, particulate generation) to the predicate or reference device to establish similarity and ensure similar safety and effectiveness profiles.

8. The sample size for the training set

This is not applicable. The document describes the testing of a physical medical device, not an AI or machine learning model that would require a training set.

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

This is not applicable for the same reason as point 8.

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The Esperance Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The Esperance® Distal Access Catheter is a single-use, single lumen, variable stiffness, composite catheter. The device includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, and 131 cm. The device is supplied with a peelable introducer and shaping mandrel. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The Esperance® Distal Access Catheter is a non-active, surgically invasive device intended for short term use within the vasculature.

The provided document is a 510(k) Substantial Equivalence Determination letter from the FDA for a medical device called the "Esperance Distal Access Catheter." It details non-clinical performance testing but does not include information about a study proving device performance against acceptance criteria in the context of an AI/ML-driven device or human-in-the-loop performance.

Specifically, the document states:

• "Animal data were not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."
• "A clinical study was not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."

Therefore, I cannot extract the requested information points related to a study proving the device meets acceptance criteria for an AI/ML device, as such a study was not performed or detailed in this submission. The tests listed are primarily engineering bench tests for a physical catheter, not AI model validation.

However, I can extract the acceptance criteria for the physical device's performance from the "NON-CLINICAL PERFORMANCE DATA" section.

Here's what I can provide based on the document:

1. A table of acceptance criteria and the reported device performance (for non-clinical bench tests):

For the remaining points, the document explicitly states that clinical or animal studies were not deemed necessary beyond the non-clinical bench testing for this specific device (a physical catheter). Therefore, the following information cannot be provided from the given text:

2. Sample sized used for the test set and the data provenance: Not applicable for an AI/ML context, as no such test set was described. Bench tests were performed on physical units, but specific sample sizes for each test are not listed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is not relevant to this physical device's non-clinical bench testing. "Physician Validation" was mentioned, but no details on the number or qualifications of physicians, nor their role in establishing a ground truth for an AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI/ML system. Ground truth in this context would refer to the reference standards for the physical tests (e.g., precise measurements, material specifications, functional performance during simulated use).
8. The sample size for the training set: Not applicable, as there is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set.

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The Paragon 8F Balloon Guide Catheter is in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

The Paragon™ 8F Balloon Guide Catheter (BGC) is a multi-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. Balloon inflation can be facilitated through the side port of the bifurcated luer hub. The 10 mm long balloon can be inflated up to a maximum volume of 0.6 mL. At this volume, the balloon diameter is 10 mm. The through-lumen extends from the center port of the bifurcated luer hub to the distal tip. The external distal segment of the catheter shaft has hydrophilic coating to reduce friction during use. The coating starts from the proximal balloon bond and extends proximally for 19 cm in length. There are two Paragon 8F BGC configurations which have working lengths of 85 cm. The difference in device length resides in the proximal shaft segment only. The 16 cm distal flexible segment and the balloon are identical for both configurations.

The Paragon 8F Balloon Guide Catheter is compatible with minimum 0.110 inch inner diameter (ID) introducer sheaths, guidewires up to 0.038 inch outer diameter (OD), and 6F catheters up to 0.085 inch OD. The Paragon 8F Balloon Guide Catheter is sterile, non-pyrogenic, and intended for single use only.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the Wallaby Medical Paragon 8F Balloon Guide Catheter (K232437). However, it focuses on the physical and biological performance of the catheter, not on an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to this submission.

Here's a breakdown of the available information based on the provided text, adapted to the context of a physical medical device.

Acceptance Criteria and Device Performance (for a Physical Medical Device)

Since this is for a physical medical device (catheter) and not an AI/ML software, the following sections are either not applicable ("N/A") or cannot be extracted from the provided text, as they pertain specifically to AI/ML software validation.

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

• Sample Size for Test Set: The exact number of samples for each bench test is not explicitly stated in the summary, other than "all samples" met the criteria. For biocompatibility, it refers to standard GLP (Good Laboratory Practice) animal and in vitro studies, which have their own sample size guidelines.
• Data Provenance: N/A. This applies to clinical data for AI/ML. The "data" here is the physical performance and biocompatibility of the device, typically conducted in a laboratory setting.
• Retrospective or Prospective: N/A. (Applies to AI/ML clinical data).

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

• N/A. Ground truth in this context refers to established standards (e.g., ISO, ASTM), specified design requirements, and GLP guidelines for testing. Expert interpretation of images or other data to establish a "truth" is not relevant here.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• N/A. This is relevant for AI/ML where multiple human readers interpret data. For physical device testing, results are objective measurements against predefined criteria.

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 is a physical device, not an AI/ML algorithm.

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

• N/A. This is a physical device, not an AI/ML algorithm.

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

• For bench testing: Pre-defined engineering specifications, industry standards (ISO, ASTM), and design requirements.
• For biocompatibility: Standardized biological evaluation methods and acceptance criteria defined in ISO 10993 series. Animal studies (e.g., guinea pig, rabbit) are the "ground truth" for assessing biological responses.

8. The Sample Size for the Training Set:

• N/A. This applies to AI/ML software. This device does not have a "training set."

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

• N/A. This applies to AI/ML software.

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The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials such as contrast media as well as delivery of embolic coils.

The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device is a microcatheter with an inner diameter (ID) of 0.017", designed with a working length of 150 cm. The device has three different tip configurations: straight (0°), 45°, 90°, and is steam shapeable by the user. The device is supplied as a kit with an introducer sheath, shaping mandrel, and mandrel card provided with a single catheter. The distal tip of the Wallaby 017 Micro Catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each microcatheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous vasculature.

The Wallaby 017 Micro Catheter is a non-active, surgically invasive device intended for limited duration use within the vasculature.

Here's a summary of the acceptance criteria and the study details for the Wallaby 017 Micro Catheter, based on the provided document.

It's important to note that the document describes a medical device rather than an AI/ML powered device. Therefore, many of the typical questions for AI studies (like sample size for test/training sets, ground truth methodology with experts, adjudication, or MRMC studies) are not applicable here. The "performance" being evaluated is the physical and functional performance of the catheter itself, not the performance of an algorithm.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on passing various bench tests and biocompatibility evaluations. The full "acceptance criteria" are implied by "met all pre-defined acceptance criteria" for each test. Specific numerical thresholds for each criterion are not provided in this summary but would have been defined in detailed test protocols.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Applicable for a medical device cleared via 510(k))

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

   • The document does not specify exact sample sizes (N-values) for each bench test. For example, "The device was evaluated..." doesn't indicate if this was one unit or multiple units.
   • The data provenance is from non-clinical bench testing performed by Wallaby Medical for regulatory submission in the United States (as indicated by the FDA 510(k) process). It is prospective in the sense that the testing was conducted specifically to support this regulatory submission.
   • No human-collected test sets (like medical images) are involved, so country of origin of data in that sense is not applicable.

2. 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 this is a physical medical device, not an AI/ML algorithm. "Ground truth" for physical device performance is established through standardized engineering and biological tests against predefined specifications and industry standards (e.g., ISO standards).
   • For the "Physician Validation (Usability)" test, it states "The device was evaluated in a simulated anatomy model by physicians." The number and qualifications of these physicians are not detailed in this summary.

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

   • Not applicable. This concept pertains to expert review for AI/ML algorithm performance. For physical device testing, results are typically objective measurements or observations against predefined pass/fail criteria.

4. 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 non-AI medical device without human "readers" in the context of an AI study.

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

   • Not applicable. The device itself is standalone in the sense that it is a physical product, but the concept of "standalone algorithm performance" does not apply.

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

   • "Ground truth" for this device's performance is established by engineering specifications, industry standards (e.g., ISO 10555-1, ISO 594-1, ISO 11135:2014, ISO 10993 series, USP ), and comparison to legally marketed predicate devices. The results of the bench tests and biocompatibility evaluations, when conforming to these standards and specifications, are the "ground truth" for proving the device's safety and effectiveness.

7. The sample size for the training set:

   • Not applicable. There is no AI/ML model for which to define a training set.

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

   • Not applicable. There is no AI/ML model or training set.

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The 6F Wallaby Long Sheath is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has an inner diameter (ID) of 0.088 inch and outer diameter (OD) of 0.105 inch designed with three different working lengths (80 cm, 90 cm, and 100 cm) and two different tip configurations (straight and multipurpose curve). The distal tip of the 6F Wallaby Long Sheath is visible under fluoroscopy and the distal shaft of the catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of the catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. The 6F Wallaby Long Sheath has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The 6F Wallaby Long Sheath is a non-active, surgically invasive device intended for short term use within the vasculature.

The provided text describes the non-clinical testing performed on the "6F Wallaby Long Sheath" to demonstrate substantial equivalence to a predicate device, the "Neuron MAX System." This document does not describe the evaluation of an AI/ML powered medical device. Therefore, the information requested in the prompt related to AI/ML device evaluations (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or available in this document.

However, I can extract the acceptance criteria and reported device performance from the Design Verification Testing - Bench and Biocompatibility sections as they relate to a medical device in general.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document often states that the device "met all pre-defined acceptance criteria" or "demonstrated similar results to the predicate," rather than providing specific numerical acceptance thresholds. Where quantitative results are provided, they are included.

For the following points, the information is not applicable to this document as it details the clearance of a non-active, surgically invasive device (a vascular catheter), not an AI/ML powered device.

2. Sample size used for the test set and the data provenance: Not applicable. Data provenance is not relevant for bench and biological testing of this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Physician Validation" involved physicians but their exact number or role in "ground truth" establishment (which is an AI/ML concept) is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth as typically defined for AI/ML evaluations is not relevant here. The ground truth for device performance is based on established engineering principles, ISO standards, and comparison to a legally marketed predicate device.
8. The sample size for the training set: Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.

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The Esperance Aspiration Catheter with the Medela Dominant Flex Surgical Suction Pump and Wallaby Aspiration Tubing set is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral - Ml and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Esperance Aspiration Catheter System is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device system includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, 125 cm, and 131 cm. The device is supplied as a kit with Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy. The Esperance Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the vasculature.

The document describes the acceptance criteria and supporting studies for the Esperance Aspiration Catheter System.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a single format. Instead, it lists various tests with outcomes indicating that the device "met all pre-defined acceptance criteria" or "performs as intended and met all pre-defined acceptance criteria." For some tests, there's also a comparison to a predicate device, noting the subject device "demonstrates equivalency" or its results "were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent."

Below is a summary derived from the "Design Verification Testing - Bench" and "Biocompatibility" sections, which outlines the tests performed and the general performance statements provided. Since specific numerical acceptance criteria are not detailed in the provided text, the performance is reported as meeting these (unspecified) criteria or being comparable to the predicate device.

Table of Acceptance Criteria (Inferred) and Reported Device Performance:

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

• Test Set Sample Size: The document does not provide specific numerical sample sizes for most bench tests (e.g., how many catheters were visually inspected or how many were subjected to tensile testing). For the animal study, it mentions a "porcine model" but doesn't specify the number of animals used.
• Data Provenance: The studies were non-clinical bench, animal, and biological compatibility testing, indicating laboratory-generated data (bench tests, biocompatibility assays) and animal study data (porcine model). The country of origin is not explicitly stated, but the submission is to the U.S. FDA. The studies are prospective in the sense that they were conducted for this submission, rather than retrospective analysis of existing data.

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

• Bench Testing (Physician Validation): The "Physician Validation" test mentioned that the device was "evaluated in a simulated anatomy model by physicians." The exact number of physicians is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience").
• Animal Study: For the animal study, an "interventionalist assessed the safety and usability of the subject and predicate devices." Again, the specific number and detailed qualifications of this interventionalist are not provided.
• For other tests, ground truth was based on established engineering standards or biological assay protocols, not expert consensus in the same way.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, especially for the "physician validation" or "interventionalist assessment." The general phrasing "met all pre-defined acceptance criteria" suggests that results were compared against predetermined thresholds or qualitative expectations.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies focused on technical performance, safety, and equivalence to a predicate device via non-clinical means (bench and animal testing). The comparison involved subjective assessment by physicians/interventionalists in simulated or animal settings, but not in a formal MRMC design to measure human reader improvement with AI assistance. This device is not an AI-powered diagnostic tool, but a medical intervention device.

6. Standalone (Algorithm Only) Performance Study

This question is not applicable. The Esperance Aspiration Catheter System is a physical medical device, not an algorithm or AI software. Therefore, there is no "standalone (algorithm only)" performance to evaluate.

7. Type of Ground Truth Used

• Bench Testing: Ground truth was primarily based on:
  • Engineering Specifications: Pre-defined dimensional requirements, tensile strength, burst pressure, flow rates, etc.
  • Performance Metrics: Qualitative and quantitative assessments against intended function (e.g., "kink resistance," "lubricity," "clot removal").
  • Predicate Device Comparison: Establishing equivalence to the performance of a legally marketed predicate device.
• Biocompatibility Testing: Ground truth was based on:
  • Standardized Assay Results: Outcomes of well-established biological tests (e.g., cytotoxicity, irritation, sensitization) conforming to ISO 10993 standards, with defined thresholds for acceptance.
  • Control Device Comparison: Comparison to a control or predicate to establish similar biological interaction.
• Animal Study: Ground truth for safety and usability stemmed from:
  • Interventionalist Assessment: Expert observation and qualitative evaluation of device handling and performance.
  • Pathology/Histopathology: Gross necropsy and microscopic examination of tissues for adverse effects.

8. Sample Size for the Training Set

This question is not applicable. The Esperance Aspiration Catheter System is a physical medical device, not an algorithm that requires a "training set" in the context of machine learning. The term "training set" is usually associated with AI/ML model development.

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

This question is not applicable for the same reason as point 8.

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The Wallaby Avenir Coil System is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Wallaby Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.

The Wallaby Avenir Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are mechanically detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided text describes a medical device, the Wallaby Avenir Coil System, and its substantial equivalence to a predicate device. It includes a table of technical characteristics and a summary of performance data from various tests. However, it does not include the specific information requested about acceptance criteria for device performance, particularly related to AI/algorithm performance. It is a submission for a neurovascular embolization device, which is a physical medical device, not an AI/algorithm-driven one.

Therefore, most of the requested information regarding AI/algorithm performance, such as:

• Acceptance criteria related to AI/algorithm performance.
• Study proving device meets acceptance criteria specifically for AI/algorithm performance.
• Sample size and data provenance for AI test set.
• Number of experts and qualifications for AI ground truth.
• Adjudication method for AI test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth for AI.
• Sample size for AI training set.
• How AI training set ground truth was established.

...is not available in the provided document, as it pertains to a physical medical device.

The document states that "All necessary testing has been performed for the Wallaby Avenir Coil System to assure substantial equivalence to the predicate device and demonstrate the device performs as intended." The "Performance Data" table lists various tests conducted, and for each, it states "All devices performed as intended" or similar positive outcomes. These are the "reported device performance" and the "study that proves the device meets the acceptance criteria" in a general sense for a physical device.

Here's the relevant information that can be extracted, largely focusing on the physical device performance rather than AI:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria for each test in a clear table format, except by implying that the device successfully met the "established criteria" or "performed as intended." The "acceptance criteria" are generally derived from relevant standards (e.g., ASTM, ISO, USP) and the intended function of the device to be substantially equivalent to the predicate. The reported performance is consistently positive.

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

• Sample Size: Not explicitly stated for most tests (e.g., "All devices performed as intended"). For the GLP Survival Animal Study, it refers to a "chronic canine model" but doesn't specify the number of animals. For particulate testing, it's implied that a statistically relevant sample was tested per USP 788.
• Data Provenance: The animal study was a "GLP Survival Animal Study," implying a controlled laboratory setting. Other tests were "performed on test units representative of finished devices" in a laboratory environment, likely at the manufacturer's facility or a certified contract lab. Country of origin not specified, but the applicant is Wallaby Medical, Inc. in California, USA. The studies are prospective in the sense that they are specifically designed to test the device before market submission.

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

• Not applicable as this is a physical medical device, not an AI/algorithm.
• For the "Physician Simulated Use Validation," it mentions "physician users" but does not specify the number or their qualifications.

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

• Not applicable for a physical medical device. The tests are typically objective measurements or observations against established standards.

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-assisted device. Therefore, no MRMC study as described was performed. The "Physician Simulated Use Validation" might be seen as a form of human interaction but not in the context of improving human reading with AI.

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

• No, this is a physical medical device.

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

• For physical performance characteristics, the "ground truth" is defined by engineering specifications, material science standards (ASTM, ISO), biological safety standards (ISO 10993), and regulatory requirements for medical devices. For the animal study, histopathology results likely served as a form of ground truth regarding biological response.

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.

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

• Not applicable.

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