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Reprocessed Diagnostic Electrophysiology (EP) Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. The reprocessed IBI AFocus 100 Steerable and the Inquiry TM Optima™ catheters are to be used to map the atrial regions of the heart. The reprocessed Inquiry™ fixed curve and steerable catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

The Reprocessed Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece. Specific to the Inquiry™ Optima™, Optima™ Plus steerable electrophysiology catheters: The catheter incorporates both a deflectable shaft steering mechanism and a distal end with a variable loop diameter, which allows selection of diameters within a specific range. The distal shaft may be deflected by pushing and pulling the thumb control and the distal loop diameter may be expanded or contracted by turning the rotating knob. Specific to the AFocus™ steerable and the Inquiry™ fixed curve and steerable electrophysiology catheters: The catheters are flexible and insulated catheters constructed of noble metal electrodes and thermoplastic elastomer material. The control mechanism located in the handle at the proximal end of the catheter manipulates the tip of the steerable catheters. The distal tip on the AFocus™ catheter has been designed to expedite the collection of electrogram recordings of a circumferential area.

The provided text describes a 510(k) summary for "Reprocessed Electrophysiology Catheters" by Stryker Sustainability Solutions. It details the device, its intended use, and the performance data submitted to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly list quantitative acceptance criteria in a numerical table format for device performance. Instead, it states that "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended." This implies that the acceptance criterion is that the reprocessed devices function equivalently to the original, new devices. The reported performance is that this equivalence has been demonstrated through various tests.

The performance data listed includes:

• Biocompatibility
• Validation of reprocessing
• Sterilization Validation
• Function test(s)
• Packaging Validation

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 does not specify the sample size used for the test set for any of the performance tests (Biocompatibility, Reprocessing Validation, Sterilization Validation, Function Tests, Packaging Validation). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. The type of device (reprocessed catheters) and the nature of the tests (biocompatibility, sterilization, function) suggest that ground truth would likely be established through standardized laboratory methods and measurements, rather than human expert interpretation of images or clinical outcomes.

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

This information is not applicable and is not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or subjective endpoints. The tests described are primarily objective bench and laboratory tests.

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 is not applicable to the device described. The device is a reprocessed electrophysiology catheter, and the studies mentioned are bench and laboratory tests. There is no AI component, no human readers involved in interpreting results in the way an MRMC study would assess, and therefore no effect size relating to AI assistance.

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 reprocessed medical instrument, not an algorithm or AI system.

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

For the performance tests mentioned (Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation), the ground truth would be established by:

• Biocompatibility: Adherence to ISO standards (e.g., ISO 10993) and established toxicological profiles.
• Validation of reprocessing: Verification that the reprocessing steps (cleaning, disinfection, inspection) meet predefined criteria to render the device clinically safe and functional. This would involve testing for residual soil, microbial load, and material integrity.
• Sterilization Validation: Demonstrating a specified sterility assurance level (SAL), typically 10^-6, through established sterilization methodologies (e.g., ethylene oxide or steam sterilization validation protocols).
• Function test(s): Comparison of critical performance parameters (e.g., electrical conductivity, steerability, mechanical integrity, electrode adhesion) of the reprocessed device against predetermined specifications (often based on the original new device's specifications).
• Packaging Validation: Ensuring package integrity and maintenance of sterility through simulated shipping and environmental challenges (e.g., according to ISO 11607).

These forms of ground truth are based on objective, measurable criteria and established scientific standards, rather than expert consensus on subjective findings, pathology, or long-term outcomes data.

8. The sample size for the training set:

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

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

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

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Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the LASSO® 2515 Variable Circular Mapping Catheter and the Reflexion Spiral 140 Variable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.

Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

The provided text describes the 510(k) summary for Ascent Healthcare Solutions' Reprocessed Electrophysiology Catheters (K090323). This submission focuses on demonstrating substantial equivalence to predicate devices through various performance tests, but it does not include a study design or acceptance criteria related to a diagnostic algorithm or AI performance.

Therefore, I cannot provide information on acceptance criteria for a diagnostic device's performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not discussed in the provided regulatory document.

However, I can extract the information regarding the performance data presented in the 510(k) summary, which focuses on the safety and effectiveness of the reprocessing procedure and the reprocessed physical device, rather than the diagnostic accuracy of an algorithm.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (as pertaining to reprocessed physical device, not AI/diagnostic algorithm performance):

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

• Sample Size: Not specified in the provided text. The document mentions "Bench and laboratory testing," implying physical testing of reprocessed devices, but does not quantify the number of units tested.
• Data Provenance: Not specified. The testing was conducted by Ascent Healthcare Solutions. There is no mention of country of origin or whether it was retrospective or prospective, as these terms are typically used for clinical data rather than bench testing.

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

• Not Applicable. This submission concerns the reprocessing of a physical medical device, not a diagnostic algorithm that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this submission would be defined by engineering specifications and industry standards for medical device performance and reprocessing.

4. Adjudication method for the test set:

• Not Applicable. As explained above, this is not a study assessing diagnostic accuracy requiring expert 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. This type of study is completely unrelated to the content of this 510(k) submission. No AI component is mentioned or evaluated.

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

• No. There is no algorithm or AI component in this device.

7. The type of ground truth used:

• The "ground truth" for the performance tests (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation) would be based on established engineering specifications, industry standards, and regulatory requirements for medical devices and their reprocessing. For example, sterilization validation would have standards for sterility assurance levels, and function tests would have specified electrical and mechanical performance criteria that the reprocessed catheters must meet to perform "as originally intended," mirroring the predicate device.

8. The sample size for the training set:

• Not Applicable. There is no training set mentioned or implied as this is not an AI or diagnostic algorithm submission.

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

• Not Applicable. There is no training set.

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Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.

Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text, a 510(k) summary for Reprocessed Electrophysiology Catheters, does not explicitly define quantitative acceptance criteria for device performance in a table format. Instead, it broadly states that "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended."

The closest approximations to "acceptance criteria" are the types of tests performed. Since specific numerical targets for these tests are not provided, I will present the tests as the criteria implied to demonstrate safety and effectiveness.

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

The document does not provide specific sample sizes for the test sets used in biocompatibility, reprocessing validation, sterilization validation, function tests, or packaging validation. It only states that "Bench and laboratory testing was conducted." The data provenance is also not specified beyond being "bench and laboratory testing," implying it was conducted by Ascent Healthcare Solutions, likely in a controlled, prospective manner to demonstrate equivalence. There is no mention of country of origin of the data.

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

This information is not provided in the document. The study described is a series of bench and laboratory tests to demonstrate device performance and equivalence to predicate devices, not a clinical study involving diagnosis or interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is focused on bench and laboratory testing of the reprocessed device itself, not on human interpretation or diagnostic accuracy where adjudication would be 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

An MRMC comparative effectiveness study was not conducted. The device is a reprocessed medical catheter, not an AI-assisted diagnostic or interpretative system.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone performance" in the context of AI does not apply.

7. The Type of Ground Truth Used

For the performance testing (biocompatibility, reprocessing, sterilization, function, packaging), the ground truth was established through validated laboratory methods and engineering specifications designed to ensure the reprocessed device meets the original design requirements and safety standards of the new predicate devices. For demonstrating equivalence, the ground truth was the specifications and performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This document describes the re-processing of medical devices, not the development or training of an AI algorithm.

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

This information is not applicable as there is no training set mentioned or implied in the context of this device.

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Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece. Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

The provided document is a 510(k) Summary for a reprocessed medical device, specifically Electrophysiology Catheters. This type of submission focuses on proving "substantial equivalence" to existing legally marketed devices (predicates) rather than establishing new performance claims or conducting clinical efficacy studies.

Therefore, the acceptance criteria and study information requested, which are typically associated with demonstrating novel performance or clinical superiority of a device, are not directly applicable in the context of this 510(k) submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or detailed device performance metrics in the way one would see for a new device's clinical trial or performance study. Instead, the performance demonstration focuses on showing that the reprocessed devices function identically to their predicate devices and meet safety standards after reprocessing.

The "Performance data" section states:

• "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Electrophysiology Catheters."
• This included:
  • Biocompatibility
  • Validation of reprocessing
  • Sterilization Validation
  • Function test(s)
  • Packaging Validation
• "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended."

Since there are no specific numeric acceptance criteria or quantitative performance results provided in the summary, a table cannot be populated as requested. The "acceptance criteria" here are implied to be adherence to the original device specifications and established reprocessing standards. The "reported device performance" is a general statement that they "perform as originally intended."

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

The document does not specify the sample size used for the bench and laboratory testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests. This information is typically found in the detailed test protocols and reports, which are not part of this summary.

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

This is not applicable to the type of testing described (bench and laboratory). Bench testing for medical devices typically relies on engineering specifications and measurement against those specifications, not expert consensus on interpretations of qualitative data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or experts when establishing ground truth, typically in image interpretation or diagnostic studies. The tests mentioned (biocompatibility, sterilization, function, packaging) are objective, quantitative, or qualitative assessments against predefined standards, not subjective interpretations requiring 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

This is not applicable. The device described is a reprocessed electrophysiology catheter, which is a physical medical device, not an AI or software algorithm. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

This is not applicable as the device is not an algorithm or AI.

7. The Type of Ground Truth Used

For the bench and laboratory testing:

• Biocompatibility: Ground truth would be adherence to established biocompatibility standards (e.g., ISO 10993).
• Validation of reprocessing: Ground truth would be the successful removal of soil, decontamination, and functionality post-reprocessing, verified by established protocols and measurable criteria.
• Sterilization Validation: Ground truth would be a Sterility Assurance Level (SAL) meeting an accepted standard (e.g., 10^-6), confirmed by established sterilization validation methods.
• Function test(s): Ground truth would be that the reprocessed catheter performs according to the original manufacturer's specifications for function (e.g., electrical conductivity, deflection, structural integrity).
• Packaging Validation: Ground truth would be that the packaging maintains sterility and integrity, confirmed by established packaging validation methods.

8. The Sample Size for the Training Set

This is not applicable. The device is a reprocessed physical medical device, not a machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a physical reprocessed device.

In Summary:

The provided document describes a 510(k) submission for a reprocessed electrophysiology catheter. The "acceptance criteria" and "study" described are fundamental safety and performance validations for a reprocessed medical device, ensuring it remains equivalent to the original, legally marketed device. It does not involve AI, clinical trials, or expert consensus studies for diagnostic interpretation. The focus is on demonstrating that the reprocessing does not compromise the device's original intended use, safety, or effectiveness.

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Reprocessed Electrophysiology Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

Here's a breakdown of the acceptance criteria and study information for Alliance Medical Corporation's Reprocessed Electrophysiology Catheters (K061045) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided 510(k) summary is a high-level overview. It lists the types of tests conducted but does not provide specific acceptance values or detailed results for each test. The conclusion section broadly states that the device passes.

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

• Sample Size: Not explicitly stated in the provided text. The document mentions "Bench and laboratory testing" but doesn't quantify the number of reprocessed catheters or tests performed during the performance evaluation.
• Data Provenance: The studies were retrospective in the sense that they were conducted on already reprocessed devices, comparing their performance to the "originally intended" performance of the new predicate devices. The country of origin for the data is implicitly the United States, where Alliance Medical Corporation is based and where the testing would have been overseen for FDA submission.

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

• This information is not provided in the document. The studies described are bench and laboratory tests, not clinical studies involving human observers forming a ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1) are relevant for studies where multiple human readers interpret data to establish a ground truth. Since the studies described are bench and laboratory tests, an adjudication method for a test set is not applicable or mentioned.

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

• No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study typically involves human readers using a device (often an AI) to evaluate cases. The studies here are bench tests on the reprocessed physical device.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a reprocessed physical medical device (catheter), not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate. The performance noted is that of the reprocessed physical product.

7. Type of Ground Truth Used

• The ground truth for the bench and laboratory tests would have been established by engineering and performance specifications of the original, new predicate devices. For example, a function test for electrical conductivity would compare the reprocessed catheter's performance against the expected conductivity of a new catheter. The "ground truth" is adherence to established engineering parameters and predicate device performance.

8. Sample Size for the Training Set

• Not applicable. This device is a reprocessed physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As stated above, there is no training set for this device.

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Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape. Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.

This document describes the Reprocessed Electrophysiology (EP) Catheters by Alliance Medical Corporation.
Here's a breakdown of the requested information:

Acceptance Criteria and Device Performance

The provided document does not specify quantitative acceptance criteria with numerical targets (e.g., "sensitivity > 90%"). Instead, the acceptance criteria are implicitly defined by the demonstration that the reprocessed catheters perform "as originally intended" and are "safe, effective and substantially equivalent to the predicate devices."

The reported device performance is a categorical assertion of meeting these implied criteria through various tests.

Study Details

The provided information pertains to a 510(k) premarket notification for a reprocessed medical device. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than conducting large-scale clinical trials measuring performance against specific endpoints in a patient population.

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 a numerical sample size for the "test set" in the traditional sense of a clinical study. The performance data is based on "Bench and laboratory testing." This would typically involve a sample of reprocessed catheters undergoing the listed tests. The exact number of catheters tested is not provided, which is common for 510(k) submissions focusing on substantial equivalence through engineering and laboratory testing rather than clinical performance data.
   • Data Provenance: The testing was conducted by Alliance Medical Corporation, located in Phoenix, Arizona, USA. The data is retrospective in the sense that it evaluates the performance of the reprocessed devices under controlled lab conditions.

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

   • Not applicable in this context. The "ground truth" for this type of submission is not established by human experts interpreting clinical data. Instead, the "ground truth" is adherence to engineering specifications, validated reprocessing procedures, and performance metrics (e.g., electrical conductivity, mechanical integrity, sterility) derived from the original device's specifications and regulatory requirements for reprocessed devices. The expertise involved would be in engineering, microbiology, and quality assurance, rather than clinical specialists establishing a "diagnosis."

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials where multiple human readers interpret medical images or patient data to establish a consensus ground truth. This submission relies on objective, measurable laboratory and bench tests, where the results are typically quantitative or pass/fail based on predefined criteria, not subjective interpretation requiring adjudication.

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. This is a submission for a reprocessed medical device (electrophysiology catheters), not an AI diagnostic or assistance tool. Therefore, an MRMC study and effects on human reader performance are not relevant.

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

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

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

   • The "ground truth" for this submission is based on objective engineering specifications, validated reprocessing parameters, and standardized laboratory tests (e.g., sterility tests, mechanical integrity tests, electrical function tests). It is essentially conformance to established benchmarks for the original device and regulatory standards for reprocessed devices.

7. The sample size for the training set:

   • Not applicable in the typical sense of machine learning. This is a reprocessed physical device. There isn't a "training set" to develop an algorithm. However, the development of the reprocessing procedures themselves would involve extensive internal testing and refinement, which could be seen as an iterative "training" process for the reprocessing protocol, but not a data set in the AI context.

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

   • Not applicable. As noted above, there isn't a "training set" for an algorithm. The "ground truth" for developing the reprocessing procedure would be successful validation that the reprocessed device consistently meets the performance and safety characteristics of a new equivalent device. This involves engineering design, material science, and regulatory compliance expertise.

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