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TubeClear System Clearing Stem Models are indicated for use ONLY and SOLELY in clearing occlusions/clogs in Feeding and Decompression Tubes in adult patients that have the following Tube type and size (French and length):

· TC-0608: for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 6 - 8 Fr and have a length of 38 - 140 cm (15 - 55 in);

· TC-0812: for Nasoenteral and Nasogastric Tubes composed of Polyviny1 Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in);

· TC-1018: for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 91 - 140 cm (36 - 55 in); and Gastrostomy and Jejunostomy Tubes that are size 10 - 18 Fr and have a length of 20 - 36 cm (8 - 14 in);

• · NE-1036: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 91 cm (36 in);
• NE-1042: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 107 cm (42 in);
• NE-1043: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 109 cm (43 in);
• NE-1045: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 114 cm (45 in);
• · NE-1048: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 122 cm (48 in);
• NE-1050: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 127 cm (50 in);
• NE-1055: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 140 cm (55 in);
• · G-1008: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 20 cm (8 in);
• · G-1009: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 23 cm (9 in);
• · G-1010: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 25 cm (10 in);
• · G-1011: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 28 cm (11 in);
• · G-1012: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 30 cm (12 in); and
• · G-1014: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 36 cm (14 in).

The TubeClear System is comprised of a reusable Control Box and a single use Clearing Stem. The Clearing Stem is connected to the Control Box. The Operator then manually inserts the Clearing Stem into the Feeding and Decompression Tube (i.e., Tube) and directs the progression of the Clearing Stem inside the Tube. The Control Box actuates the Clearing Stem Wire. The Clearing Stem Wire Tip mechanically clears the occlusion to restore Tube patency. Control Box Model 101 is used to actuate all Clearing Stem models. Sixteen (16) Clearing Stem Models are proposed to accommodate the different types, sizes, and materials of Tubes.

The provided text describes the Actuated Medical, Inc. TubeClear System (K172556), a device intended for clearing occlusions in feeding and decompression tubes.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions "Performance bench testing used to support substantial equivalence was water ingress testing of the o-ring." This suggests that the testing was likely conducted in a lab environment.

3. Number of Experts and Qualifications for Ground Truth
Not applicable. The study described is bench testing (water ingress), not a clinical study involving human assessment or expert review for ground truth.

4. Adjudication Method for the Test Set
Not applicable. This was a bench test, not a study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. The submission focuses on bench testing for a material change, not a comparative study of human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance
Not applicable. The TubeClear System is a physical medical device, not an AI algorithm. The performance evaluation was for the physical properties of a component (o-ring).

7. Type of Ground Truth Used
The ground truth for the performance testing was based on direct physical measurements: "water ingress testing of the o-ring." This is a measure of the o-ring's ability to prevent water from entering the control box.

8. Sample Size for the Training Set
Not applicable. This device is not an AI/algorithm-based device and therefore does not have a "training set" in the context of machine learning. The "training" for this device would refer to its design, engineering, and manufacturing processes.

9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI algorithm.

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