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The indication for use for all the product variants is grouped into three different sections:

(a) Uncuffed, oral/nasal and Cuffed, oral /nasal:
The intended use of this device is to be intubated into a patient's trachea via the nose or mouth for airway management.

(b) Uncuffed, nasal only and Cuffed, nasal only:
The intended use of this device is to be intubated into a patient's trachea via the nose for airway management, specifically for use in surgical procedures involving the head, neck and face.

(c) Uncuffed, oral only and Cuffed, oral only:
The intended use of this device is to be intubated into a patient's trachea via the mouth for airway management, specifically for use in surgical procedures involving the head, neck and face.

Tiger Medical Products Ltd's Endotracheal tube is available in 90 different variants distributed among 6 main configurations and different sizes, as detailed below. It is marketed as sterile, single use, for airway management.

It consists of a clear tracheal tube with radiopaque blue stripe running its entire length, and it is graduated with multiple centimeter markings to allow easy detemination of intubated length, and is terminated with a 15mm standard connector.

It conforms to ISO 5261: 1999 and ASTM F1242: 1996 with one minor exception in the tube marking.

The six categories (or confiqurations) are listed below:

• (a) CATEGORY 1: uncuffed, oral/nasal:
  It is provided as uncuffed, murphy, oral/nasal, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes

• (b) CATEGORY 2: uncuffed, nasal only:
  It is provided as uncuffed, murphy, preformed nasal- 2 eyes, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes

• (c) CATEGORY 3: uncuffed, oral only:
  It is provided as uncuffed, murphy, preformed oral- 2 eyes, and it is provided as anones from sizes 2.0 to 10.0 inclusive, totalling 17 sizes

• (d) CATEGORY 4: cuffed, oral/nasal:
  lt is provided as cuffed, murphy, oral/nasal, and in 0.5mm ID it is provided as sizes 4.0 to 10.0 inclusive, totalling 13 sizes

• (e) CATEGORY 5: cuffed, nasal only:
  It is provided as cuffed, murphy, preformed nasal, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes

• (f) CATEGORY 6: cuffed, oral only:
  lt is provided as cuffed, murphy, preformed oral, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes

The provided text describes a 510(k) summary for Tiger Endotracheal tubes, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested sections about acceptance criteria and study details cannot be directly extracted or inferred from this document. The document argues for substantial equivalence based on similarity in design, materials, performance, and other characteristics, rather than by presenting new performance data against numerical thresholds.

Here's a breakdown of what can be gathered and what is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary does not outline specific numerical acceptance criteria (e.g., tensile strength minimums, cuff pressure retention rates) or present a study showing the Tiger Endotracheal tubes met such criteria with quantified performance metrics. Instead, it relies on a qualitative comparison of "TECHNOLOGICAL CHARACTERISTICS" to predicate devices, stating conclusions like "Identical" or "Similar."

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

This information is not provided. The document makes no mention of a "test set" in the context of a performance study, nor does it refer to sample sizes used for testing. The primary focus is on comparing the technological characteristics of the new device to existing predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/not provided. There is no mention of a performance study requiring expert review or ground truth establishment for a test set.

4. Adjudication Method

This information is not applicable/not provided. As no expert-reviewed test set is mentioned, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable/not provided. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance. This device is a physical medical device (endotracheal tube), not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable/not provided. This is a physical device, not an algorithm, so a standalone performance study in that context is not relevant. The information provided is for regulatory clearance based on substantial equivalence.

7. Type of Ground Truth Used

This information is not applicable/not provided. Since no performance study generating new data for assessing ground truth is described, this detail is not relevant to the document's content. The document relies on the established safety and effectiveness of predicate devices as a basis for its claims.

8. Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable/not provided. As there is no training set mentioned, there is no ground truth establishment process described for it.

In summary: The provided document is a 510(k) summary for a medical device (endotracheal tubes), which aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. This regulatory pathway typically involves comparing the new device's design, materials, intended use, and technological characteristics to the predicate, rather than conducting new clinical trials or extensive performance studies with quantitative acceptance criteria and ground truth establishment in the manner that would be expected for a novel diagnostic or AI-powered device. The document explicitly states: "This device is safe and effective as the predicate device cited above."

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