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

Reprocessed Electrophysiology (EP) Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

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.

The provided text is a 510(k) summary for the Alliance Medical Corporation's Reprocessed Electrophysiology (EP) Catheters. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it broadly claims that the reprocessed devices "perform as originally intended" and are "safe, effective and substantially equivalent to the predicate devices."

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

The document does not specify the sample size for the test set used in the performance studies (biocompatibility, reprocessing validation, sterilization validation, function tests).

The data provenance is implied to be prospective bench and laboratory testing conducted by Alliance Medical Corporation. There is no mention of country of origin for the data in this summary.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. The nature of the tests (biocompatibility, sterilization, function) suggests objective laboratory measurements rather than expert human interpretation in a clinical setting.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned (biocompatibility, reprocessing, sterilization, function) are objective laboratory or bench tests, not requiring an adjudication method among experts.

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 510(k) submission for a reprocessed medical device (catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

Not applicable. This is a medical device, not an algorithm. The testing focuses on the physical and functional properties of the reprocessed catheter.

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

The "ground truth" for the performance tests would be based on:

• Established standards and protocols: for biocompatibility and sterilization.
• Predetermined functional specifications: for the function tests, likely defined by the original manufacturer's specifications for new devices.
• Validated reprocessing procedures: for reprocessing validation.

8. The Sample Size for the Training Set

Not applicable. This is a medical device approval, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a machine learning model.

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Reprocessed diagnostic 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. EP catheter designs all incorporate a connector, a handpiece, a flexible polymeric shaft, and a distal tip containing two or more electrodes. The distal tips of steerable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.

This looks like a 510(k) clearance letter for reprocessed diagnostic electrophysiology (EP) catheters, noting the FDA's acceptance of supplemental validation data. Unfortunately, the provided document does not contain the detailed acceptance criteria or the specific study results that confirm the device meets these criteria. The letter primarily states that the reprocessed devices are found to be substantially equivalent to legally marketed predicate devices, and lists the specific models cleared.

The letter explicitly mentions "supplemental validation data as required for reprocessed single-use devices," but it does not describe the methodologies or the outcomes of this validation.

Therefore, I cannot provide the requested information based solely on the text provided. The document you've given is a regulatory clearance letter, not a detailed study report.

To provide the requested details, I would need access to the actual "supplemental validation data" mentioned in the letter, which would typically be included in the 510(k) submission itself (a much larger document).

However, I can extract what is implied or stated generally about the device and its intended use:

• Device Name: Electrophysiology (EP) Catheter (reprocessed)
• Intended Use/Indications for Use: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
• Technological Features Comparison: The document states, "Since reprocessing does not significantly change any of these parameters, the reprocessed catheters are the same as the original devices." This implies that the performance characteristics (e.g., integrity, electrical properties, mechanical properties) after reprocessing are expected to be equivalent to new devices.

Without the actual validation study report, I must state that the following information is NOT available in the provided text:

1. Table of acceptance criteria and reported device performance: Not provided.
2. Sample size used for the test set and data provenance: Not provided.
3. Number of experts used to establish ground truth and their qualifications: Not provided.
4. Adjudication method for the test set: Not provided.
5. Multi-reader multi-case (MRMC) comparative effectiveness study effect size: This type of study is more common for diagnostic imaging AI devices, not typically for reprocessed catheters. The document does not mention it.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not provided. For reprocessed catheters, the "ground truth" would likely involve comparison to original device specifications and performance rather than a clinical ground truth like pathology for a diagnostic imaging device.
8. Sample size for the training set: Not applicable; this is not an AI/ML device that requires a training set.
9. How ground truth for the training set was established: Not applicable.

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