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The AutoDetect Syringe is intended for use with an epidural needle for the verification of needle tip placement in the epidural space.

The AutoDetect Syringe is a spring loaded, loss of resistance syringe used during epidural anesthetic procedures. The device is intended for single-use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AutoDetect Syringe.

It's important to note that the provided 510(k) summary is very brief regarding detailed study results. The information available points to a pre-market notification for a Class II device, which often relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy trials involving human readers or ground truth establishment in the same way an AI-powered diagnostic device would.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not specified. The document only mentions "in-vitro and in-vivo simulation testing" for loss of resistance. It does not provide specific numbers for patients or an in-vitro experimental setup.
   • Data Provenance: Not specified. Given the nature of the device (a mechanical syringe) and the context of a 510(k) for a Class II device, the "in-vivo simulation" would likely refer to animal models or cadaver studies, though this is not explicitly stated. It is not clear if human data was used for testing.

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

   • Not Applicable. This device is a mechanical syringe, not an AI/diagnostic imaging device where expert ground truth establishment for a test set in the traditional sense would be required. The "ground truth" for its performance would be its ability to consistently demonstrate a "loss of resistance" in a controlled environment or simulation, as evaluated by engineers or medical professionals operating the device in the test.

3. Adjudication Method for the Test Set:

   • Not Applicable. As this is a mechanical device, there is no "adjudication method" for interpreting results in the way there would be for an AI diagnostic output. Performance would be assessed against engineering specifications and functional testing.

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. An MRMC study is not relevant for this type of mechanical device. This device is a physical tool, not an AI to assist human "readers." The "convenience" offered by the spring-loaded plunger is stated to allow one-handed use, which is a qualitative benefit to the user experience, not an improvement in diagnostic accuracy for a "reader."

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

   • No. This is a mechanical device, not an algorithm. There is no AI component.

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

   • The "ground truth" relates to the device's functional performance:
     • Biocompatibility: Conformance to ISO 10993-1 standards (chemical/material testing).
     • Syringe Performance: Conformance to ISO 7886-1 standards (mechanical and functional testing of the syringe).
     • Loss of Resistance: Reliable detection of the "loss of resistance" phenomenon in simulated environments (in-vitro/in-vivo). The "ground truth" here is the physical phenomenon itself, not an expert medical interpretation.

7. The Sample Size for the Training Set:

   • Not Applicable. As a mechanical device without an AI component, there is no "training set."

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. There is no "training set" for this mechanical device.

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