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The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias. The catheter is designed for use in the coronary sinus.

The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The catheters have a high-torque shaft with a braided uni-directional deflectable tip section containing an array of ten platinum electrodes that includes a 2 mm tip dome, which can be used for stimulation and recording. The catheters are 6 French with a usable length of 115 cm. The braided tip is controlled by a proximal hand piece that features a thumb operated sliding piston, and is offered in various curve types. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The provided text describes a 510(k) premarket notification for Reprocessed Electrophysiology Diagnostic Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a novel device meets specific performance criteria in a typical clinical study involving AI or diagnostic accuracy.

Therefore, many of the requested points related to AI, clinical studies, ground truth, expert consensus, and sample sizes for training/test sets are not applicable to this type of regulatory submission. The "acceptance criteria" here are primarily about demonstrating that the reprocessed device performs as intended and is as safe and effective as the original, rather than meeting specific diagnostic accuracy thresholds.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where it doesn't apply:

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

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

• The document mentions "Representative samples of reprocessed EP diagnostic catheters were tested." It does not specify the exact sample size for the various non-clinical and functional tests.
• "Data provenance" is not directly applicable in the sense of patient data. The tests are laboratory-based and simulated use, conducted by the manufacturer (Sterilmed, Inc., from Plymouth, Minnesota, USA).

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 is not applicable. This submission is for a reprocessed medical device, not a diagnostic AI device requiring expert ground truth for image or data interpretation. The "ground truth" for the reprocessed device is its ability to meet performance specifications, safety standards, and functional equivalence to the original device, which is evaluated through engineering and laboratory testing.

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

• This is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations in diagnostic studies, which is not the nature of this device's evaluation.

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. This is not an AI-assisted diagnostic device, and no MRMC study was performed.

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

• This is not applicable. This device does not involve an algorithm.

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

• The "ground truth" for this submission is established through objective engineering performance specifications, industry standards (ISO, ASTM, USP), and validated testing protocols. The desired outcome (e.g., sterility, biocompatibility, functional performance like the original device) is the "truth" that the tests aim to confirm.

8. The sample size for the training set

• This is not applicable. This is not an AI device, so there is no "training set."

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

• This is not applicable for the same reason as above.

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The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The catheters have a high-torque shaft with a braided bi-directional deflectable tip section containing an array of ten platinum electrodes that includes a 2 mm tip dome, which can be used for stimulation and recording. The catheters are 7 french with a usable length of 115 cm. The rocker lever located on the hand piece is used to deflect the tip section. A friction control knob is located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve and rocker lever in place. The high-torque shaft allows the plane of the curved tip to rotate, enabling accurate positioning of the catheter tip.

The provided text describes the 510(k) summary for Sterilmed, Inc.'s Reprocessed Electrophysiology Diagnostic Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria for a new AI or diagnostic device.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document, as it outlines the regulatory pathway for a reprocessed medical device.

However, I can extract information related to the functional and safety testing performed, which serves a similar purpose of demonstrating the device's acceptable performance.

Acceptance Criteria and Study for Reprocessed Electrophysiology Diagnostic Catheters (K121158)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a tabular format as would be typical for a new diagnostic device. Instead, the "acceptance criteria" are implied by demonstrating that the reprocessed device performs "as originally intended" and is "substantially equivalent" to the predicate device.

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

• Sample Size for Test Set: The document states that "Representative samples of reprocessed EP diagnostic catheters were tested." It also mentions "100% of products reprocessed" undergo visual and validated functional testing as part of the manufacturing process. However, specific numbers for the "representative samples" used in the validation studies (cleaning, sterilization, biocompatibility, etc.) are not provided.
• Data Provenance: The studies were conducted by Sterilmed, Inc. and are related to their reprocessing procedures. This would be considered prospective testing and validation of their reprocessed devices. The country of origin of the data is implicitly the United States, where Sterilmed, Inc. is located.

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

This type of information is not applicable to this 510(k) submission. Ground truth established by experts is typically relevant for diagnostic devices that analyze medical images or data requiring clinical interpretation. This submission is for a reprocessed electrophysiology diagnostic catheter, where the "truth" is its functional performance, safety, and sterility, verified through engineering and laboratory testing rather than expert clinical consensus.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. The safety and performance of a reprocessed medical device are determined by standardized physical, chemical, and biological testing methods.

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. This submission is for a reprocessed medical device, not an AI or imaging diagnostic device. No human-in-the-loop diagnostic performance studies are mentioned or relevant for this type of product.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Reference to predicate device specifications and intended performance.
• Validated engineering and laboratory testing (e.g., functional bench testing, cleaning validation, sterilization validation, biocompatibility studies, packaging integrity tests, shelf-life tests) against recognized industry standards (ISO, ASTM, USP).
• Visual inspection and functional testing of 100% of reprocessed products.

8. The Sample Size for the Training Set

This is not applicable. This is not a machine learning or AI device 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 this device.

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The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

SterilMed Reprocessed Irvine Biomedical EP diagnostic catheters consist of a shaft with a handle at the proximal end and some models are considered to be steerable. These catheters have a varying outer diameter (French size) and length. These catheters also feature a number of platinum, radiopaque electrodes with a variety of inter-electrode spacing configurations and curve styles at the distal tip. The distal tip may be steerable and cables connect to the handle and interface between the catheter and an external stimulator and /or an electrophysiological recorder. Note: Only the catheter is the subject of this submission, the external stimulator and /or electrophysiological recorder and any other related equipment are not included in the scope of this submission.

This document is a 510(k) premarket notification for SterilMed, Inc.'s Reprocessed Electrophysiology Diagnostic Catheters. The purpose of the submission is to demonstrate substantial equivalence to predicate devices, not necessarily to prove effectiveness against clinical endpoints. Therefore, many of the typical acceptance criteria and study data points that might be found for a novel AI device are not present here.

Here's an breakdown of the available information regarding 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 present a table of acceptance criteria with corresponding reported device performance values in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the scope of the non-clinical tests performed, aiming to demonstrate that the reprocessed devices perform equivalently to new, un-reprocessed predicate devices.

The "acceptance criteria" can be inferred as successful completion of the specified validation tests, demonstrating that the reprocessed catheters maintain their functional characteristics, sterility, and biocompatibility. The "reported device performance" is the conclusion that the devices met these criteria.

The conclusion states: "The reprocessed EP diagnostic catheters are substantially equivalent to the Irvine Biomedical, Inc. electrophysiology diagnostic catheters. This conclusion is based upon the devices' similarities in functional design (principle of operation), materials, indications for use and methods of construction." This implies that all non-clinical acceptance criteria were met to support this claim of substantial equivalence.

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

The document mentions "Representative samples of reprocessed EP diagnostic catheters were tested" for functional characteristics. However, specific sample sizes for each test (e.g., number of catheters tested for electrical leakage) are not provided. The provenance of the data is internal to SterilMed, Inc., as these are tests performed on their reprocessed devices. The tests are "non-clinical" and "bench testing," meaning they were conducted in a lab environment on physical devices, not on human patients, so there is no patient data provenance (country of origin, retrospective/prospective).

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

This is not applicable as the submission pertains to a reprocessed medical device, not an AI/algorithm-based diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for the reprocessed catheters is their adherence to specified engineering and performance standards, which are objectively measurable.

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

Not applicable for a reprocessed medical device. No human adjudication is mentioned or implied for the performance testing of the catheters.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a submission for a reprocessed physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device is based on objective engineering and performance standards for medical devices (e.g., electrical leakage measurements, tensile strength, sterility through biological indicator testing, biocompatibility testing via ISO standards). The reprocessed catheters are compared to these established standards and to the performance of the original, un-reprocessed devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. There is no training set for a physical medical device.

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The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

SterilMed Reprocessed Reflexion EP diagnostic catheters consist of a shaft with a handle at the proximal end, and are considered to be steerable. These catheters have an outer diameter of either 6 or 7F and are either 99 or 105cm in length, with 2 - 20 platinum, radiopaque tip electrodes and a variety of inter-electrode spacing's and curve styles at the distal tip. The distal tip is steerable and cables connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiological recorder.

Note: Only the catheter is the subject of this submission, the external stimulator and/or electrophysiological recorder and any other related equipment are not included in the scope of this submission.

The provided text is related to a 510(k) submission for reprocessed electrophysiology diagnostic catheters, demonstrating substantial equivalence to a predicate device. It focuses on the safety and functional testing of the reprocessed device, rather than the performance of a software algorithm or AI.

Therefore, the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria in the context of AI/software performance (e.g., sample size for test set, ground truth experts, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.

The document describes the functional and safety testing performed on the reprocessed catheters to demonstrate appropriate functional characteristics and validate cleaning and sterilization procedures. However, it does not provide specific acceptance criteria or detailed results in a structured table or outline a study comparing algorithmic performance to established metrics for AI/software devices.

Here's the relevant information that can be extracted, framed within the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a table format for reprocessed catheter performance that would be directly comparable to a software algorithm's output. Instead, it broadly states:

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

• Sample Size: "Representative samples of reprocessed EP diagnostic catheters were tested." The exact number of samples is not specified in the provided text.
• Data Provenance: The testing was "performed to validate the cleaning and sterilization procedures as well as device packaging" and includes "visual and validated functional testing of all products produced" by SterilMed, Inc. This implies the data is prospective and generated internally during the reprocessing and manufacturing process. The country of origin of the data is implicitly the USA given the submission to the FDA.

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

• Not Applicable. This document concerns physical device reprocessing and testing, not AI/software performance requiring expert-established ground truth.

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

• Not Applicable. Adjudication methods are typically for subjective expert review in AI/software performance studies. The testing described is objective functional and validation testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI or imaging device, so no MRMC study or AI assistance comparison was conducted.

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

• Not Applicable. There is no algorithm described in this document.

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

• For the functional and safety testing, the "ground truth" would be established by engineering specifications, validated test protocols, and performance standards for electrophysiology diagnostic catheters, ensuring they meet pre-defined criteria for safety and efficacy after reprocessing. This is inherent in process and design validation, not typically referred to as "ground truth" in the same way as in AI studies.

8. The sample size for the training set:

• Not Applicable. There is no "training set" for an AI model described.

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

• Not Applicable. There is no "training set" for an AI model described.

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The Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.

The device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and may or may not be steerable. These catheters have an outer diameter of 4F to 8F, a length ranging from 60 to 160 cm, with 2-20 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip generally is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as, connector cables, external stimulators, or electrophysiologic recorders.

This is not an AI/ML device, and therefore the criteria listed in parts 1-9 do not apply. This is a reprocessed medical device (electrophysiology diagnostic catheters) that functions identically to original manufacturer devices. The 510(k) summary focuses on demonstrating that the reprocessed device is substantially equivalent to predicate devices in terms of functional design, materials, indications for use, and construction.

Here's an analysis of the provided text, addressing the requested information where applicable for a non-AI/ML device:

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

For this reprocessed device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the original, predicate devices. The performance is measured against these established characteristics rather than novel AI/ML metrics.

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 a "test set" in the context of an AI/ML model. Instead, it refers to "Representative samples of reprocessed electrophysiology diagnostic catheters" used for design testing. The sample size is not quantified.

• Sample Size: Not specified beyond "Representative samples."
• Data Provenance: Not explicitly stated, however, the testing would be conducted internally by SterilMed, Inc. (Minneapolis, MN, USA) on their reprocessed devices. This would be prospective for the reprocessed devices.

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 is not applicable to this type of device. "Ground truth" in the context of this device would refer to the established performance characteristics and safety profiles of the original predicate devices, as well as the successful validation of reprocessing steps (cleaning, sterilization). These are typically established through engineering standards, clinical trials of the original devices, and scientific validation methods, not expert consensus on interpretations like in AI/ML.

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

Not applicable. Adjudication is a term relevant to resolving discrepancies in expert interpretations, typically in AI/ML or clinical trial settings where subjective assessment is involved. The testing described for this device (functional and safety) involves objective measurements and validation protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, and therefore MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this reprocessed device is established by:

• Predicate Device Specifications: The known functional, material, and performance specifications of the original, legally marketed electrophysiology diagnostic catheters.
• Engineering Standards & Bench Testing: Objective measurements and tests (e.g., electrical conductivity, mechanical integrity, sterility assays) to ensure the reprocessed device meets these predefined specifications.
• Process Validation: Scientific evidence that the cleaning, sterilization, and packaging processes consistently achieve their intended outcomes without degrading the device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this device.

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