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Delivery of Epidural anesthesia for the epidural kits and delivery of combined spinal/epidural anesthesia for the combined kits.

The Epidural kit includes an epidural needle (Eldor combined spinal/epidural), epidural catheter, Touhy-Borst Adapter, Loss of resistance syringe, and Epidural. The epidural/spinal combined Kit includes the same components and adds a pencil point spinal needle.

The Alexander Medical Epidural Kit and Combined Spinal/Epidural Kit did not undergo a study with acceptance criteria in the traditional sense, as it was cleared through the 510(k) pathway by demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance metrics through a clinical trial.

Instead, the "acceptance criteria" can be inferred as demonstration of equivalence in key characteristics to legally marketed predicate devices. The study proving this "acceptance" is the 510(k) Notification submission itself, which presents a detailed comparison of the new device's characteristics to those of established predicate devices.

Here's the breakdown of how the provided information addresses your request, interpreted in the context of a 510(k) submission:

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are the characteristics of the predicate devices. The "reported device performance" is the comparison of Alexander Medical's device to these predicates.

Conclusion from 510(k) Submission: "All components are legally marketed, and other devices with the same or similar components and same intended use are legally on the market. The kits are substantially equivalent."

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

• Sample Size: Not applicable. This was not a study involving patient data or a test set of samples. The submission relies on a comparison of device specifications and components to legally marketed predicate devices.
• Data Provenance: Not applicable. No clinical or performance data was generated for the Alexandar Medical device to establish its effectiveness or safety independently. The data provenance refers to the regulatory clearances of the individual components and predicate devices (e.g., K935255 for the Eldor needle, K920076 for Becton Dickinson's Durasafe). This is essentially retrospective data in the sense that it relies on previously established clearances.

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

• Not applicable. There was no "ground truth" to establish for a test set in the context of a clinical study. Substantial equivalence is determined by regulatory review of similarities to predicate devices. The "experts" involved are the FDA reviewers who assess the submission based on their knowledge of medical device regulations and relevant clinical standards.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication was used. The regulatory review process for 510(k) involves an assessment by FDA personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is irrelevant for a device like an epidural kit cleared via substantial equivalence.

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

• No, a standalone (algorithm only) performance study was not done. This device is a physical medical kit, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the established safety and effectiveness of the identified predicate devices and the individual legally marketed components as demonstrated through their prior FDA clearances. The Alexander Medical device is considered "substantially equivalent" if it does not raise new questions of safety or effectiveness compared to these predicates.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the machine learning sense. The "training" for the submission comes from the prior regulatory clearances of numerous similar devices and components already on the market.

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

• Not applicable. As there is no training set as understood in AI/ML, there is no ground truth established for it. The "ground truth" for the overall submission's argument of substantial equivalence relies on existing regulatory approvals and industry standards for similar devices and components. These standards and approvals were established through various means, including pre-amendment status, previous 510(k) clearances, and potentially clinical data for those predicate devices or components (though not part of this specific 510(k) submission).

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