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The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.

Additionally, the 5F Selective Imager II Angiographic Catheters without sideholes can be used for the controlled and selective delivery of the Boston Scientific Interlock™ 35 Detachable Coils into the peripheral vasculature.

The 5F Selective Imager II Angiographic catheters without sideholes are sterile, single use diagnostic intravascular catheters. These catheters are available in a variety of shapes and lengths depending on the catheter model. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Clinically, selective catheters are used to create images of specific areas of interest. The Imager II 5F Selective Catheter without side-holes can also be used to deliver embolic materials.

The provided text describes a 510(k) summary for the Boston Scientific Imager™ II 5F Selective Angiographic Catheter. This is a medical device submission, not a study evaluating an AI device or algorithm. Therefore, many of the requested fields regarding acceptance criteria for AI performance, clinical study details, ground truth, and training data are not applicable.

The submission focuses on establishing substantial equivalence to previously cleared predicate devices through non-clinical design verification testing.

Here's an analysis based on the provided text, highlighting where information is not available due to the nature of the device and submission:

Acceptance Criteria and Reported Device Performance

As this is a traditional medical device (angiographic catheter) and not an AI or algorithm-based device, the "acceptance criteria" and "reported device performance" are primarily focused on physical and functional characteristics, not diagnostic or predictive metrics like sensitivity/specificity. The submission details design verification tests, which implicitly have internal acceptance criteria to demonstrate safety and effectiveness for substantial equivalence.

Study Information (Not Applicable to AI for this Device)

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

   • Not Applicable. This submission is for a physical medical device (angiographic catheter), not an AI algorithm. The "test set" would refer to physical devices tested during non-clinical verification. No data provenance in the context of clinical images or patient data is provided or relevant here.

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

   • Not Applicable. Ground truth, in the context of clinical expert consensus for AI, is not relevant here. The "ground truth" for non-clinical testing would be whether the device physically performs as intended (e.g., coil deploys correctly, catheter doesn't break). This is typically assessed by engineers and technicians against design specifications.

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

   • Not Applicable. This method applies to resolving disagreements among experts for ground truth in clinical evaluations, which is not part of this device submission.

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:

   • No. An MRMC study is explicitly for evaluating the impact of AI on human reader performance. This device is an angiographic catheter, not an AI system. The submission explicitly states: "Summary of Clinical Testing: Clinical Evaluation was not required for these devices."

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

   • Not Applicable. This is not an algorithm or AI device.

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

   • Not Applicable / Engineering Specifications. For non-clinical device testing, the "ground truth" is adherence to predefined engineering specifications and functional performance metrics (e.g., successful deployment of coils, material strength, compatibility with other devices).

7. The sample size for the training set:

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

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

   • Not Applicable. This is not an AI/ML algorithm.

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The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.

The 4F and 5F Imager™ II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90 cm, and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Clinically, flush catheters are used to deliver a bolus of contrast to a patient when obtaining an image of a large area (aorta, leg-run off, etc.). Side-holes are added to disperse the contrast. Selective catheters are used to create images of specific areas of interest.

This 510(k) summary (K120893) describes the Imager™ II Angiographic Catheter, a diagnostic intravascular catheter. The submission focuses on demonstrating substantial equivalence to a predicate device (K050863) regarding its packaging configuration after multiple sterilization, climatic conditioning, and distribution simulation. No clinical studies were conducted for this submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Design verification testing as listed below was performed to verify the performance...is substantially equivalent to the predicate device." It does not provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it lists the types of tests conducted to support the claim of substantial equivalence for the packaging.

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

• Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Design verification testing" but does not detail the number of units tested.
• Data Provenance: The tests are described as "Design verification testing" performed by Boston Scientific Corporation. This implies the data is prospective and generated from internal testing. No country of origin for the data is specified beyond Boston Scientific being based in the US.

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

• Not Applicable. This submission is for a medical device (angiographic catheter) and its packaging. The "ground truth" here relates to the physical and mechanical integrity of the packaging, which is assessed through engineering and quality control tests, not expert interpretation of clinical images or data.

4. Adjudication Method (for the test set)

• Not Applicable. There is no "adjudication" process in the context of package integrity testing like there would be for image interpretation by clinicians. The tests are objective measurements or observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. This was not a clinical or comparative effectiveness study involving human readers.

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

• No. This device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests on packaging, the "ground truth" would be established by engineering specifications, industry standards, and internal quality control criteria for package integrity. For example, a "Pass/Fail" result for dye penetration would be determined by whether dye was observed past a certain barrier, which is an objective measurement based on defined criteria.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

• Not Applicable. As above, no training set was involved.

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The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.

The Imager II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90 cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Clinically, flush catheters are used to deliver a bolus of contrast to a patient when obtaining an image of a large area (aorta, leg-run off, etc.). Side-holes are also added to disperse the contrast. Selective catheters are used to create images of specific areas of interest.

This is a medical device (catheter) and not an AI/ML device. The provided text is a 510(k) summary for a medical device called "Imager II Angiographic Catheters." This document describes the device, its intended use, and its equivalence to previously cleared devices. It does not contain information related to software, algorithms, or any AI/ML components. Therefore, the specific questions regarding acceptance criteria, study details, data provenance, ground truth, expert adjudication, or MRMC studies for AI/ML performance cannot be answered from this document.

The document states:

• Technological Characteristics: "Same as currently marketed Imager II Angiographic Catheter cleared for marketing under K011664 (September 7, 2001) and K022621 (September 4, 2002)."
• Non-Clinical Test Summary: "Same as currently marketed Imager II Angiographic Catheter cleared for marketing under K011664 (September 7, 2001) and K022621 (September 4, 2002)."

This indicates that the device's clearance is based on its substantial equivalence to a predicate device, meaning it has the same technological characteristics and similar non-clinical test performance. There is no study described within this document that "proves the device meets the acceptance criteria" in the context of an AI/ML device's performance. The "acceptance criteria" for this type of medical device would typically relate to physical performance characteristics (e.g., tensile strength, flow rates, biocompatibility, radiopacity, etc.) established through non-clinical bench testing, which are only summarized as being "same as" the predicate.

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The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.

The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.

The provided document is a 510(k) summary for a medical device (Imager II Angiographic Catheter) seeking substantial equivalence to a predicate device. It primarily discusses regulatory compliance and biocompatibility. It does not present a study proving the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would.

Instead, the document states that the device has been tested and compared to a predicate device, and all data gathered demonstrate substantial equivalence. The "acceptance criteria" here are geared towards regulatory approval rather than clinical performance metrics.

Therefore, many of the requested details about statistical studies, sample sizes, ground truth establishment, and expert involvement are not available in this type of regulatory submission.

Here's an analysis based on the information provided, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any specific performance or equivalence testing. The 510(k) process relies on demonstrating equivalence through various engineering, performance, and biocompatibility tests, not typically a large-scale clinical "test set" as understood in AI/ML studies.
• Data Provenance: Not specified. Testing would have been conducted by the manufacturer, Boston Scientific/Medi-Tech, likely under controlled laboratory conditions, possibly involving internal tests and external contract labs for biocompatibility.

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

• Not applicable in the context of this 510(k) submission. The ground truth for biocompatibility is established by ISO 10993 standards and testing protocols. For substantial equivalence, it's a comparison to the known performance and characteristics of the predicate device. There is no mention of human expert-labeled "ground truth" data sets.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of a formal adjudication process for interpreting test results in the way one would for clinical image reviews.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This document describes a 510(k) submission for an angiographic catheter, which is a physical medical device. MRMC studies are typically performed for diagnostic imaging devices or AI-powered algorithms to assess human reader performance with and without assistance. This device does not fall into that category.

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

• No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: Established by international standards (ISO 10993) and the results of specific biological evaluations (e.g., cytotoxicity, sensitization, irritation tests).
• For Substantial Equivalence: Comparison to the known specifications, materials, and intended use of the legally marketed predicate device (NightHawk Angiographic Catheter).

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this type of device and regulatory submission. This is not an AI/ML device.

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

• Not applicable. As above, there is no AI/ML training set. Any internal developmental testing or engineering validation would have relied on established engineering principles, material science, and test methods.

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