Search Results

The Reprocessed Achieve Catheter Connecting Cable is designed for use only with the Achieve family of mapping catheters. It is intended to provide connection of the catheter to a standard ECG interface box.

The Reprocessed Achieve Catheter Connecting Cable provides conduction from the proximal end of the mapping catheter to standard shielded ECG pins that connect standard EP recording and pacing equipment. The cable is designed for use with the Achieve family of mapping catheters.

The provided text is a 510(k) summary for the Innovative Health LLC's Reprocessed Achieve Catheter Connecting Cable. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report of a device's performance against specific acceptance criteria in a clinical or AI-related context.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or not explicitly detailed in this type of FDA submission. This is because the device being described is a reprocessed cable, and the 510(k) emphasizes functional and safety testing to show equivalence to a predicate device, not necessarily a clinical outcomes study with AI components.

However, I can extract information related to the bench and laboratory testing that was conducted.

Here's a breakdown of the available information based on your request:

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

The document does not explicitly present a table of quantitative acceptance criteria with reported numerical device performance as would be found in a detailed study report. Instead, it lists the types of functional and safety testing performed to ensure the reprocessed device is "as safe and effective as the predicate device."

Types of Testing Performed:

• Cleaning Validation
• Sterilization Validation
• Functional Testing
  • Visual Inspection
  • Dimensional Verification
  • Electrical Continuity Testing
  • High Potential (HiPOT) Testing
• Packaging Validation

The "performance" implied is that the device passed these validations and tests, demonstrating its equivalence. Specific quantitative performance metrics or acceptance thresholds are not provided in this summary. For example, instead of stating "Electrical Continuity: Resistance < 1 Ohm (acceptance criteria: < 5 Ohm)," it simply states "Electrical Continuity Testing."

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

• Sample Size: Not specified. The document states "Bench and laboratory testing was conducted," but does not provide details on the number of units tested for each validation or test.
• Data Provenance: Not specified, but implied to be internal testing conducted by Innovative Health, LLC.
• Retrospective or Prospective: Not applicable in the context of device reprocessing testing. The tests are performed on reprocessed devices, which are then cleared for use.

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)

• Not Applicable. This device is a connecting cable, not an interpretive diagnostic device. No "ground truth" established by experts in a clinical interpretation sense is mentioned or relevant to the tests described. The "ground truth" here is the performance of the predicate device, against which the reprocessed device is compared through engineering and functional tests.

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

• Not Applicable. As per point 3, there is no clinical interpretation or "ground truth" requiring adjudication by multiple experts. The tests are objective engineering and validation procedures.

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 document is for a medical device (reprocessed cable), not an AI-enabled diagnostic device. No MRMC study or AI component is mentioned.

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

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

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

• The "ground truth" for this reprocessing device is implicitly the performance specifications and safety profile of the original, new predicate device. The tests performed (Cleaning Validation, Sterilization Validation, Visual Inspection, Dimensional Verification, Electrical Continuity Testing, HiPOT Testing, Packaging Validation) are designed to confirm that the reprocessed device meets these established engineering and safety standards, making it equivalent to the new device. There is no clinical outcomes data or expert consensus on clinical cases involved.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As per point 8.

Ask a specific question about this device