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The Dale® ACE* Connector (*Access Controller for Enteral) is indicated for controlling fluid flow into and out of medical tubes while providing for the delivery of enteral formula, syringe irrigation, and liquid medication, without breaking the fluid delivery lines for up to 30 days. This closed system protects the healthcare worker from accidental exposure to the patient's gastric fluids.

The Dale® ACE* Connector is a device that is inserted between the enteral tube and the fluid administration tubing or drain receptacle. It is designed to reduce the need for repeated and regular disconnection of the enteral tube from the associated tubing.

Here's an analysis of the provided text regarding the Dale® ACE* Connector, focusing on acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document (K082241) is a 510(k) summary for a medical device. In this context, "acceptance criteria" for performance refer to the specifications the device must meet to demonstrate substantial equivalence to a predicate device and ensure safety and effectiveness. The document states:

"Testing of the Dale® ACE* Connector demonstrates that the device meets design and performance specifications."

However, the specific quantitative acceptance criteria (e.g., maximum leak rate, force required for connection/disconnection, number of cycles) are not explicitly detailed in this summary document. Similarly, the reported numerical performance values are also not provided. The summary confirms that testing was done and that the device met these unstated specifications.

For a 510(k) submission, the "study" referred to is the performance testing conducted to show substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Note: The exact quantitative criteria and performance data would typically be found in the full 510(k) submission, which is not fully provided here, but are summarized as having been met.

Study Details Pertaining to Device Performance

Based on the provided K082241 510(k) summary, here's what can be inferred or explicitly stated:

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

   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified in the provided summary (e.g., country of origin, retrospective/prospective). However, such testing is generally conducted by the manufacturer (Dale® Medical Products, Inc.) or a contracted lab to support the 510(k) submission.

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 connector. Performance testing for such devices typically involves engineering and functional tests (e.g., leak tests, flow rate, durability) rather than human expert categorization of complex data where "ground truth" is established by medical experts for diagnostic purposes. The ground truth would be based on objective physical measurements against engineering standards.

3. Adjudication Method for the Test Set:

   • Not Applicable. As mentioned above, this type of device undergoes functional and engineering performance testing, not studies requiring adjudication of human-interpreted data.

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 kind of study is specific to diagnostic aids, often involving AI or imaging interpretation, where human readers evaluate cases.

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

   • Not Applicable. This is a mechanical device, not a software algorithm. Performance is inherent to its physical design and function.

6. The Type of Ground Truth Used:

   • Engineering Standards and Objective Measurements. For a mechanical device like the Dale® ACE* Connector, the "ground truth" for performance testing (e.g., fluid flow, leak prevention, durability, connection integrity) is established by adherence to predefined engineering specifications, industry standards, and reproducible physical measurements using calibrated equipment. This is distinct from ground truth derived from pathology, expert consensus on medical images, or patient outcomes data.

7. The Sample Size for the Training Set:

   • Not Applicable. This is a hardware device; it does not involve machine learning or AI models that require a "training set" of data.

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

   • Not Applicable. As there is no training set for this type of device, this question is not relevant.

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