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The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The IntellaMap Orion™ High Resolution Mapping Catheter (Orion catheter) is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bidirectional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.

This 510(k) summary states that no performance data was applicable for changes proposed in this special 510(k). This is because the new device is substantially equivalent to a previously cleared device, the IntellaMap Orion High-Resolution Mapping Catheter (K192360). The proposed changes were limited to labeling modifications and updated contraindications. Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

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The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve of an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System.

The provided text describes the regulatory clearance of a reprocessed medical device, the Reprocessed IntellaMap Orion High Resolution Mapping Catheter, and lists the types of functional and safety testing conducted to demonstrate its performance. However, it does not provide specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I detail a study that proves the device meets specific acceptance criteria based on the information given. The document focuses on regulatory equivalence to a predicate device rather than presenting a performance study with detailed metrics against defined acceptance criteria.

Based on the provided text, here's what can be inferred regarding the request:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly indicates that the reprocessed device's performance (safety and effectiveness) needs to be demonstrated and that its purpose, design, materials, function, and intended use are "identical to the predicate device."
   • Reported Device Performance: No specific numerical performance metrics are reported in this document. The document lists the types of tests performed (e.g., Biocompatibility, Cleaning Validation, Functional testing, Electrical Safety Testing, Packaging Validation), but not their outcomes or criteria for success.

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. The document mentions "Bench and laboratory testing" but does not specify sample sizes or data provenance for these tests.

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. The testing described is primarily laboratory and bench testing, not clinical studies requiring expert ground truth establishment in the context of diagnostic interpretation.

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

   • This information is not applicable and not provided, as the testing described does not involve expert adjudication of a diagnostic output.

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 is mentioned. This device is a physical medical instrument (catheter), not an AI diagnostic tool, so this type of study is not relevant to its clearance.

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

   • This is not applicable as the device is a physical medical instrument, not an algorithm.

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

   • For the functional and safety testing, "ground truth" would be established through engineering specifications, material standards, and validated testing methodologies (e.g., sterilization validation based on established microbial inactivation levels, biocompatibility based on ISO standards, electrical safety based on IEC standards). No expert consensus, pathology, or outcomes data is mentioned as a "ground truth" for these tests in this document.

8. The sample size for the training set:

   • This is not applicable. The device is a reprocessed physical instrument, not an AI model, so there is no "training set."

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

   • This is not applicable for the reasons stated above.

In summary, the provided document is a regulatory clearance letter focused on substantial equivalence based on a comparison to a predicate device and a list of performed functional and safety tests. It does not contain the detailed performance data, acceptance criteria, or study specifics that would be expected for an AI/diagnostic software clearance, or a clinical study on a novel device.

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The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The IntellaMap Orion High Resolution Mapping Catheter is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.

The provided text describes a medical device, the IntellaMap Orion™ High Resolution Mapping Catheter, and its clearance process with the FDA. It does not contain information about the acceptance criteria or a study that specifically proves the device meets those criteria, as typically found in a clinical trial report or a performance study for AI/software devices. The document focuses on establishing substantial equivalence to a predicate device through design verification and biocompatibility testing.

However, I can extract the information that is present and indicate what is not available based on your request.

Here's the breakdown of the available and unavailable information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Electrical Testing: Pass
• Reliability Testing: Pass
• Catheter Joint Strength: Pass
• Tip Buckle: Pass
• Visual Inspections and Dimensions: Pass
• Simulated Use: Pass
  Biocompatibility Testing:
• Cytotoxicity: Pass
• Hemolysis Direct Contact and Extract Methods: Pass
• Sensitization Maximization: Pass
• Intracutaneous Irritation: Pass
• Acute Systemic Toxicity: Pass
• Materials Mediated Rabbit Pyrogen: Pass
• Partial Thromboplastin Time: Pass
• In Vitro Hemocompatibility: Pass
• Complement Activation: Pass
• USP Physicochemical Test: Pass
• Latex Assay: Pass |

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

• Sample Size for Test Set: Not applicable in the context of electrical, reliability, mechanical, simulated use, and biocompatibility bench testing as described. There are no "test sets" of patient data in the sense of a clinical or image-based AI study.
• Data Provenance: The data comes from internal Boston Scientific Corporation design verification and biocompatibility testing. The country of origin for this data is not specified but is implicitly internal to the manufacturer's testing processes. This is retrospective in the sense of being an assessment of the manufactured device's characteristics rather than a prospective clinical trial.

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

• Not applicable. Ground truth, in this context, refers to established engineering standards, material science properties, biological responses, and simulated use protocols rather than expert clinical consensus on patient data.

4. Adjudication method for the test set:

• Not applicable. The "Pass" results indicate that the device met pre-defined internal specifications and regulatory requirements for each test, which serves as the "adjudication."

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. This device is a mapping catheter, a hardware device, not an AI software intended to assist human readers with diagnostic interpretation.

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

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

7. The type of ground truth used:

• The "ground truth" for the performance claims comes from established engineering specifications, material science testing standards (e.g., ISO 10993-1 for biocompatibility), and simulated use protocols.

8. The sample size for the training set:

• Not applicable. There is no AI component requiring a "training set."

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

• Not applicable. There is no AI component requiring a "training set."

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The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The IntellaMap Orion™ High Resolution Mapping Catheter is intended for multiple electrode electrophysiology mapping of the heart and is intended for recording of electrograms and stimulation of cardiac tissue. The IntellaMap Orion™ High Resolution Mapping Catheter is a 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter. The catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only. The IntellaMap Orion™ High Resolution Mapping Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment.

The provided document is a 510(k) summary for the IntellaMap Orion High Resolution Mapping Catheter. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing of a handle design modification. This type of regulatory submission does not typically include the detailed clinical study information requested in your prompt (e.g., acceptance criteria for diagnostic performance, human reader studies, ground truth establishment, sample sizes for training/test sets for AI devices).

This device is an "Electrode Recording Catheter," which is a medical instrument used for electrophysiological mapping of cardiac structures. It captures electrograms and can stimulate cardiac tissue. It is not an AI-powered diagnostic device in the sense of analyzing images or data to provide a diagnosis or improve human reader performance. Therefore, many of your requested points relate to AI/diagnostic device performance studies, which are not applicable to the information presented in this 510(k) summary.

However, I can extract the relevant information regarding the non-clinical performance described in the document.

Here's the information that can be extracted relevant to the performance criteria and study from the provided document:

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

Note: The document states "The verification testing confirmed that the new handle design met the product performance requirements of the predicate device." It does not specify the numerical or qualitative requirements themselves, only that they were met.

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. The document refers to "bench top testing," which implies laboratory-based tests rather than data from human subjects.

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 applicable/provided. The testing described is benchtop testing for a handle modification, not a diagnostic or AI performance study requiring expert ground truth establishment in a clinical context.

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

This information is not applicable/provided. Adjudication methods are typically for clinical studies involving interpretation, not for benchtop engineering verification.

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 applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned. The device is a physical catheter for electrophysiological mapping.

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

This information is not applicable. This is not an algorithm-only device. It's a medical instrument used by clinicians.

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

This information is not provided. For benchtop testing of a handle, ground truth would relate to engineering specifications and measurements, which are not detailed here.

8. The sample size for the training set

This information is not applicable/provided. "Training set" refers to data used for machine learning or AI model development, which is not relevant to this device's description.

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

This information is not applicable/provided. As above, "ground truth for training set" is for AI models, not a physical medical device like this catheter.

Summary of what is clear from the document:

• Device Type: IntellaMap Orion High Resolution Mapping Catheter (a physical medical instrument).
• Purpose: Electrophysiological mapping (recording or stimulating) of cardiac structures.
• Regulatory Submission Reason: Modification to the handle design of an already cleared device.
• Performance Study Type: Non-clinical benchtop testing.
• Key Finding: The new handle design met the product performance requirements of the predicate device.
• Conclusion: The modified device is considered substantially equivalent to its predicate.

The document does not describe the specific performance metrics or acceptance criteria for the electrophysiological mapping overall, nor does it delve into the clinical accuracy of the mapping capability, as the focus of this particular 510(k) was on a modification to a previously cleared device's handle.

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