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The SIREN SGT™ is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, and to assist in gastric sleeve formation by decompressing and stabilizing the stomach, and by serving as a sizing guide.

The Tools for Surgery™ SIREN SGT™ gastric tube is a clean, non-sterile, single patient use device, comprising a 36 Fr insertion tube portion 109 cm long, a hub containing a suction regulating valve, an extension tube, pinch clamp, and connector. Tubular portions including the hub are flexible polyvinylchloride (PVC). There are multiple apertures in proximity to a rounded distal tip. Line and numeric markings are provided to indicate depth of insertion. The suction regulating valve limits negative pressure applied to the stomach to less than 175 mmHg, and produces an audible signal when the suction pressure in the stomach exceeds ≈160 mmHg.

The document describes the Siren SGT™, a gastric tube used in bariatric and gastric surgical procedures. The provided content is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission usually focuses on demonstrating equivalence through comparison of technical characteristics and performance testing rather than establishing clinical efficacy or a specific "acceptance criteria" measured using clinical outcomes.

Based on the provided information, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to the predicate device (Boehringer Laboratories Gastric Sizing Tube, ViSiGi 3D®, K130483). The performance testing described is intended to show that despite some differences in design, the Siren SGT™ performs comparably and safely for its intended use.

Here's an attempt to extract and organize the information according to your request, acknowledging that a typical "acceptance criteria" table with performance metrics as you might see for a diagnostic AI device isn't explicitly laid out in this type of submission.

Table of Implicit Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence)

Since this is a 510(k) submission for a physical medical device, the "acceptance criteria" are not framed in terms of precision, sensitivity, or specificity as they would be for an AI/diagnostic tool. Instead, the criteria revolve around demonstrating equivalent performance to a predicate device. The "reported device performance" refers to the results of the non-clinical tests that show the Siren SGT™ functions as intended and comparably to the predicate.

Regarding the other requested information:

1. Sample sizes used for the test set and the data provenance:

   • The document describes non-clinical bench testing. It does not mention "test sets" in the context of patient data or typical AI validation; rather, it refers to a series of physical tests performed on the device itself.
   • Sample Size: The document does not specify the number of devices or components tested for each specific non-clinical test. This information is typically detailed in the individual test reports, which are "submitted, referred to, and relied on" but not elaborated upon in this summary.
   • Data Provenance: Not applicable in the context of patient data. These are laboratory/bench tests on manufactured devices.

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

   • Not applicable. This is a physical device, and "ground truth" for patient data interpretations (e.g., radiology images) is not relevant here. The "ground truth" for device performance is established by engineering specifications, validated test methods, and comparison to the predicate device's known characteristics. The tests themselves, and their interpretation, would be performed by qualified engineers and technicians.

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

   • Not applicable. This is not a study involving human interpretation of data where adjudication is needed. Device performance is measured against predefined engineering and functional specifications.

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, a TRADITIONAL MRMC study was not done. This is a non-AI physical medical device. The study design is focused on demonstrating substantial equivalence through engineering testing, not clinical effectiveness studies with human readers.

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

   • Not applicable. This is a physical device, not an algorithm. The "standalone" performance refers to the device's functional integrity as measured in the described bench tests.

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

   • For this type of device, the "ground truth" is defined by engineering specifications, established industry standards (e.g., ISO standards for biocompatibility), and the known functional characteristics of the predicate device. The purpose of the tests is to verify that the manufactured device meets these predefined functional and safety parameters.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI model.

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