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The Gabriel® Feeding Tube with Balloon functions as a conduit to facilitate enteral feeding, and may be used in adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short to moderate term feeding support, such as post-trauma patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exist, or may result, secondary to an underlying disease or condition.

The Gabriel Feeding Tube with Balloon serves as conduit through which enteral feeding solutions are directly infused into patients small bowel. The tube has two distal end openings, one distal end balloon, one proximal end pilot balloon that indicates the status of the inflation of the distal end balloon and a proximal end EnFit connector that replaced our Y shaped catheter tip connector of the predicate device. The tube shaft is lined by a monofilament spiral wire to prevent occlusion from kinking. A braided 7 strands stainless steel stiffening central stylet prevents coiling in the mouth during insertion and provides column strength to facilitate placement into the stomach.The tube patient contacting material is made from DEHP-free PVC. Size 12 Fr tube is 130 cm long.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Gabriel® Feeding Tube with Balloon, and EnFit Connector." This document focuses on demonstrating substantial equivalence to a predicate device (K160787) rather than providing detailed acceptance criteria and study results for a novel AI/software-as-a-medical-device (SaMD) product.

Therefore, the information required to answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI device is not present in the provided text. The document describes a traditional medical device (a feeding tube) and its physical and functional characteristics, along with non-clinical tests for its performance and safety compared to its predicate.

Here's what can be extracted from the document regarding the device and its testing, but it does not fulfill the prompt's request for AI device study details:

Device Description and Purpose:
The Gabriel® Feeding Tube with Balloon, and EnFit Connector is a nasoenteral feeding tube designed to facilitate enteral feeding in adult or elderly patients who cannot orally consume an adequate diet. It's intended for bedside insertion and use in patients requiring short to moderate-term feeding support. Key features include a distal end balloon for peristaltic advancement and airway misplacement detection, a flexible shaft with a spiral wire to prevent kinking, and a central stainless steel stylet for insertion. The primary changes from the predicate device are the replacement of a Y-shaped catheter tip connector with a rigid male EnFit connector to mitigate misconnection risk, a change from MR unsafe to MR conditional, and the addition of certain items to a convenience kit.

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing for Substantial Equivalence):

As this is a physical medical device and not an AI/SaMD, the "acceptance criteria" are implied by successful completion of mechanical, functional, and safety tests to demonstrate equivalence to a predicate device. The reported performance is that the device "passed" these tests.

Information NOT available in the provided text (as it pertains to AI/SaMD studies):

The prompt specifically asks for details related to AI/SaMD acceptance criteria and studies which are not relevant to this 510(k) submission for a non-AI medical device. Therefore, the following points cannot be addressed from the given document:

2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is not an AI device relying on interpreted data.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Clinical Testing:
The document explicitly states: "No clinical testing was performed in association with this submission." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical testing and comparison to an existing predicate device.

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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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The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication, during the time period that gastric decompression is required.

The Next Generation Salem Sump is a dual lumen Naso Gastric tube with a multiport connector/valve to facilitate switching among the various function of the device.

The provided text is a 510(k) summary for the "Next Generation Salem Sump," which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as one might find for a novel, higher-risk device.

Therefore, the information typically requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable or not available in this type of document because the device is a re-engineered version of an existing device and the "studies" are primarily non-clinical comparisons to predicate devices and industry standards.

Here's a breakdown based on the provided text, addressing your points where possible, and indicating where information is not present:

Acceptance Criteria and Device Performance Study for Next Generation Salem Sump (K040388)

This submission is a 510(k) Premarket Notification for a Class II medical device (Gastrointestinal tube and accessories). The device, the "Next Generation Salem Sump," is intended for gastric decompression and fluid delivery. The primary method of demonstrating its suitability for market clearance is by proving substantial equivalence to legally marketed predicate devices, rather than through extensive clinical efficacy trials against pre-defined acceptance criteria for performance. The "study" here refers to non-clinical testing to demonstrate equivalence or adherence to industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified. The document refers to "Nonclinical Testing" which likely involves specific device prototypes or components, but the number of units tested is not detailed in this summary.
• Data Provenance: Not specified, but given it's non-clinical testing performed by the manufacturer (The Kendall Company / Tyco Healthcare Group), it would be proprietary testing. Contextually, such testing is generally performed in a controlled laboratory setting, not with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. For a device like a nasogastric tube undergoing non-clinical testing for substantial equivalence, "ground truth" and "experts" in the context of clinical interpretation (e.g., radiologists interpreting images) are not relevant. The "ground truth" here would be adherence to engineering specifications and performance standards as determined by test methods.

4. Adjudication method for the test set

• Not Applicable. No human interpretation or adjudication in the clinical sense is described. Non-clinical testing follows predefined protocols and acceptance criteria based on engineering and material science principles.

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 physical medical device (nasogastric tube), not an AI/software-as-a-medical-device (SaMD) or imaging device that would involve human readers or AI assistance.

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

• Not Applicable. See point 5.

7. The type of ground truth used

• Not Applicable / Engineering Specifications and Standards. For this type of submission, "ground truth" refers to the established engineering specifications for the device components and performance metrics derived from industry standards (EN1615:2000) or direct comparison to the predicate devices. It is not clinical data like pathology reports, expert consensus of images, or patient outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

• Not Applicable. See point 8.

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