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TubeClear Clearing Stem Model GJ-1422 is indicated for use ONLY and SOLELY in clearing occlusions/clogs in adults that have the following Tube type and size (French and length).

• GJ-1422, for G-Jet®, MIC®, and MIC-KEY® Gastro-jejunostomy tubes that are size 14-22 Fr and have a jejunal length of 15-45 cm (6-18 in).

The TubeClear System is comprised of a reusable Control Box and a single use Clearing Stem. Control Box Model 101 is used to actuate all Clearing Stem models. The Clearing Stem for the predicate device is TubeClear Clearing Stem Model TC-0608 (TC-0608). The Clearing Stem for the subject device is TubeClear Clearing Stem Model GJ-1422 (GJ-1422). GJ-1422 is connected to the Control Box. The Operator then coats GJ-1422 with Coconut Oil and manually inserts it into the gastro-jejunostomy (GJ) tube (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. Sixteen (16) Clearing Stem Models are currently marketed to accommodate different types, sizes, and materials of feeding tubes. This submission adds a seventeenth (17th) Clearing Stem model (GJ-1422) for use in a specific set of gastro-jejunostomy (GJ) tubes. Use of TubeClear Clearing Stem Model GJ-1422 requires coating the Clearing Stem with Coconut Oil prior to introduction into a patient's feeding tube.

The provided text describes the submission for a new model of the TubeClear System, GJ-1422, which is essentially an updated version of the previously cleared TC-0608. The document focuses on demonstrating substantial equivalence rather than presenting an entirely new study with rigorous acceptance criteria and standalone performance for a novel AI device. Therefore, some of the requested information, particularly regarding AI-specific studies (e.g., MRMC, training set details, ground truth for training), is not applicable or not present in this regulatory submission.

However, based on the non-clinical performance data provided, we can infer and construct a table of acceptance criteria and reported performance for the mechanical device (TubeClear System), not an AI algorithm.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance (Non-Clinical Benchtop Testing for Mechanical Device)

The document specifies that the acceptance criteria for the new GJ-1422 model were "the same as that used for the legally marketed TC-0608 model". It also states that both models "passed their respective a priori acceptance criteria for each test, which reflects clinically acceptable success rates." While specific numerical values for the acceptance criteria are not explicitly stated, the text indicates that the device met these criteria.

Study Details:

This document is a 510(k) Premarket Notification, not a detailed research study publication. Therefore, some granular details typically found in a scientific paper's methodology section are not fully elaborated.

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

   • Test Set Sample Size: Not explicitly stated as a single number. The tests involved "series of indicated Tubes" for Benchtop Efficacy, "artificially created clogged Tube" for Removal Forces, and "different geometry and materials used in indicated Tubes" (GJ tubes) with ex vivo porcine tissue for Tube Integrity. Flow Rate testing involved "feeding tube of the smallest French size and maximal length." The specific number of tubes tested for each scenario is not quantified.
   • Data Provenance: This is
     • Benchtop/Laboratory Data: The tests were performed in a controlled laboratory setting (benchtop efficacy, removal forces, tube integrity, flow rate).
     • Ex Vivo Data: Feeding Tube Integrity test used "ex vivo porcine tissue model."
     • Literature Review: Toxicity assessment relied on a "literature review found eight (8) clinical trials exploring the effects of consuming coconut oil."
     • Geographic Source: Not specified, but generally, regulatory submissions for US markets involve testing conducted in the US or in compliance with US standards.

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

   • This is a mechanical device performance submission, not an AI diagnostic device. Therefore, no "ground truth" in the diagnostic sense (e.g., radiology interpretation) was established by human experts for a test set. The "ground truth" for these tests comes from objective measurements (e.g., cleared tube patency, measured forces, visual inspection for damage, flow rates, chemical analysis).

3. Adjudication method for the test set:

   • Not applicable as this is not a subjective interpretation task (like image reading) requiring adjudication. The outcomes were direct measurements or observations based on predefined objective criteria.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. This device is a mechanical tool for clearing occlusions, not an AI-assisted diagnostic device where human reader performance is compared with and without AI.

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

   • Not applicable. This is a mechanical device, not an algorithm. The "performance" described is the ability of the physical device to clear clogs and its safety.

6. The type of ground truth used:

   • Objective Benchtop Measurements: Patency (clearing of artificial clogs), force measurements, visual microscopic inspection for damage, flow rate measurements.
   • Chemical Analysis: USP monograph testing for Coconut Oil.
   • Literature-based Evidence: For toxicological risk assessment of Coconut Oil.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The engineering design and testing are based on traditional medical device development.

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

   • Not applicable. (See #7).

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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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TubeClear Clearing Stem Model TC-1018 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type and size (French and length).

· 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).

TubeClear Clearing Stem Model TC-0812 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.

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

TubeClear Clearing Stem Model TC-0608 is indicated for use ONLY and SOLELY in clearing occlusion / cloas in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.

• 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).

The Proposed Device, the TubeClear Control Box and Clearing Stem, is comprised of Control Box Model 101 and Clearing Stem Models TC-0608, TC-0812, and TC-1018. The Control Box is reusable and the Clearing Stems are single use. The Operator manually inserts the Clearing Stem into the feeding and/or decompression tube (i.e., Tube), while the Tube remains in the Patient, and directs the Clearing Stem's progression along the inside of the Tube. The Control Box Motor via electromechanical actuation creates a linear reciprocating motion. The linear reciprocating motion is transferred to the proximal end of the Clearing Stem which contains a Wire that also reciprocates. Because the Wire is continuous throughout the Clearing Stem, the reciprocating motion is further transferred to the distal Tip of the Wire. The motion at the Wire Tip mechanically acts on the occlusion and restores Tube patency.

Three (3) new Clearing Stem Models are proposed. The additional Clearing Stem Models expand the specific indications for use.

This document describes the TubeClear Control Box and Clearing Stem (referred to as the "Proposed Device") and its substantial equivalence to a previously marketed device, also called TubeClear (referred to as the "Predicate Device"). This is a summary from a 510(k) premarket notification to the FDA. The information provided focuses on the non-clinical performance data to demonstrate substantial equivalence, as no clinical data was collected.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table with numerical acceptance criteria and reported device performance. Instead, it uses qualitative statements about conformance and substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set:
  • Technical Testing: Not explicitly stated for each test, but implied to be sufficient for verification and adherence to product specifications (e.g., "Verification confirmed that the Clearing Stem Models met product specifications").
  • Efficacy Testing (Human Factors Validation & Device Effectiveness): The number of participants for human factors validation is not specified, but they are described as "certified and licensed healthcare practitioners." The number of simulated uses or cases for device effectiveness testing is also not explicitly stated.
  • Safety Testing: Not explicitly stated for each test (e.g., number of tubes tested for integrity, heating, or movement).
  • Animal Testing: Not explicitly stated, but performed "on porcine jejunum tissue."
• Data Provenance: The document does not specify the country of origin of the data. It indicates the testing was "in-house" for much of the technical, efficacy, and safety testing, with some safety tests conducted by a "third-party organization (Intertek Group (Boxborough, MA))" in the US.
• Retrospective or Prospective: All testing described appears to be prospective as it's designed to evaluate the new device for market clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Human Factors Validation: "Certified or Licensed Healthcare Practitioners" were involved. The specific number or their detailed qualifications (e.g., years of experience, specific specialty) are not provided. They were the "users" in this context, and their performance likely contributed to the "ground truth" of usability.
• Other Testing: For the bench and animal testing, the "ground truth" was established by objective measurements and assessments against predefined criteria, rather than expert consensus on interpretation. For instance, "Verification confirmed that the Clearing Stem Models met product specifications," implies internal testing against engineering specifications forming the ground truth.

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

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in the context of expert review, as the testing primarily involves objective performance metrics and human factors validation rather than interpretive tasks.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is a mechanical tool for clearing clogs, not an AI-assisted diagnostic or interpretive system. The "Human Factors Validation and comparison of device effectiveness testing" focused on the performance of the device itself and user interaction, not on improving human "reading" or diagnostic skills with AI.

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

This question is not applicable to the TubeClear system, as it is a mechanical device that inherently requires "human-in-the-loop" operation (an operator manually inserts and directs the clearing stem). There is no "algorithm only" component.

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

The ground truth used for evaluating the TubeClear device was primarily based on:

• Engineering Specifications/Objective Measurements: For technical aspects like product specifications, wire tip flexibility, forces, shelf life, and packaging.
• Simulated Use Performance: For efficacy, where the ability to clear occlusions in simulated tubes was measured.
• Direct Observation/Measurement of Physical Effects: For safety, assessing tube integrity, heating, and movement directly.
• Controlled Animal Study: For assessing the risk of puncture in worst-case scenarios.
• Conformance to Consensus Standards: For basic safety, usability engineering, risk management, and electromagnetic compatibility.

8. The sample size for the training set

This question is not applicable as the TubeClear device is a mechanical device and does not involve AI or machine learning models that require a "training set."

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

This question is not applicable for the same reason as point 8.

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TubeClear is indicated for use ONLY and SOLELY in clearing occlusions / clogs in Feeding and Decompression Tubes in adult patients that have a Tube of size 10 to 18 Fr.

The Clearing Stem Models are indicated for use as follows:

• 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).
• G-1014, for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 36 cm (14 in).

The Proposed Device, TubeClear, is comprised of Control Box Model 101 and Clearing Stem Models NE-1036, NE-1042, NE-1043, NE-1045, NE-1048, NE-1050, NE-1055, G-1008, G-1009, G-1010, G-1012, and G-1014. The Control Box is reusable and the Clearing Stems are single use. The Operator manually inserts the Clearing Stem into the feeding and/or decompression tube (i.e., Tube) and directs the Clearing Stem's progression along the inside of the Tube. The Control Box Motor via electromechanical actuation creates a linear reciprocating motion. The linear reciprocating motion is transferred to the proximal end of the Clearing Stem which contains a Wire that also reciprocates. Because the Wire is continuous throughout the Clearing Stem, the reciprocating motion is further transferred to the distal Tip of the Mire. The motion at the Wire Tip mechanically acts on the occlusion and restores Tube patency.

The provided document details the 510(k) summary for the TubeClear device, specifically focusing on the new Clearing Stem Models. The submission claims substantial equivalence to its predicate device, also named TubeClear. The core of the device is to clear occlusions in feeding and decompression tubes using a reciprocating wire.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format for each individual criterion. Instead, it describes various tests and states whether they were "successfully completed," "passed acceptance criteria," or found to be "equivalent" to the predicate device.

Below is a synthesized table based on the descriptions provided:

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

The document does not specify the exact sample sizes used for the test sets in any of the described tests (Technical, Efficacy, Safety). It mentions "Clearing Stem Models" in plural, implying multiple units were tested, but no concrete numbers.

The data provenance is from bench testing performed by the manufacturer (Actuated Medical, Inc.) and a third-party lab (Intertek Group for electrical safety). All testing appears to be retrospective in the sense that it's performed on manufactured devices for regulatory submission. There is no mention of country of origin for the data; however, the testing entity (Intertek Group, Boxborough, MA) suggests the testing itself occurred in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For the "Usability testing," it states "Usability testing by licensed healthcare practitioners was successfully completed." However, it does not specify the number of these practitioners or their specific qualifications (e.g., years of experience, specialty). Therefore, the number and qualifications of experts for establishing ground truth are not provided.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1, none) for the test results. The assessment of equivalence and success appears to be based on direct measurement and comparison to the predicate device or established standards, rather than expert consensus on individual cases that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted or reported. This submission primarily focuses on the technical and safety equivalence of the device itself through bench testing, not on the improvement of human readers' performance with or without the device. The device is a tool used by practitioners, not an AI diagnostic aid for human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The device described, "TubeClear," is a physical medical device that requires direct human operation to insert and advance the clearing stem. It is not an algorithm or AI system that can perform without human-in-the-loop. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed. The "Control Box" provides electromechanical actuation, but the device's function is inherently human-assisted.

7. The Type of Ground Truth Used

The ground truth for the efficacy and safety tests appears to be based on:

• Product Specifications: For technical verification.
• Simulated Use Conditions: For efficacy testing, where successful clearing of occlusions in simulated tubes would be the "ground truth."
• Measurement and Observation: For safety tests like tube damage, heating, and movement, where direct measurement of these parameters against acceptable ranges or predicate device performance constitutes the "ground truth."
• Licensed Healthcare Practitioner Evaluation: For usability, where their feedback on the device's ease of use and performance in a simulated environment serves as the "ground truth."

There is no mention of pathology, biological outcomes data, or patient outcomes data being used as ground truth for this submission, as it explicitly states "No clinical data was collected."

8. The Sample Size for the Training Set

Since "No clinical data was collected" and the device is a mechanical tool rather than an AI/ML algorithm, there is no concept of a "training set" in the context of this 510(k) submission.

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

As there is no training set for an AI/ML algorithm, the question of how its ground truth was established is not applicable.

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TubeClear™ is indicated for use only and solely in clearing occlusions / clogs in nasogastric (NG) tubes (i.e., tubes that are placed through the nose and reside in the stomach) of adult patients. Clearing Stem Model NG-1036 is indicated for use in nasogastric tubes that are of size 10 - 14 French and have a length of 36 - 42 inches (91 - 108 cm). Clearing Stem Model NG-1043 is indicated for use in nasogastric tubes that are of size 10 - 18 French and have a length of 43 - 50 inches (109 - 127 cm).

The Proposed Device is TubeClear. TubeClear is composed of a reusable Control Box and single use Clearing Stem. One Control Box model. Model 101 is used to actuate all Clearing Stem models. TubeClear has two Clearing Stem models, Models NG-1036 and NG-1043.

The Operator manually inserts the Clearing Stem into the feeding or decompression tube (i.e., Tube) and directs the Clearing Stem's advancement along the inside of the Tube. The Control Box Motor via electromechanical actuation creates a linear reciprocating motion. The linear reciprocating motion is transferred to the proximal end of the Clearing Stem which contains a Wire that also reciprocates. Because the Wire is continuous throughout the Clearing Stem, the reciprocating motion is further transferred to the distal Tip of the Wire. The motion at the Wire Tip mechanically acts on the occlusion, breaks up the occlusion and restores Tube patency.

Because the Control Box remains outside of the patient and it functions only to provide actuation to the Clearing Stem when the two are attached, the Clearing Stem is considered to be the primary element of TubeClear.

Here’s a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document mentions "Usability and Retainability testing by end users" but does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth of Test Set

The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The testing described is "Usability and Retainability testing by end users," implying a user-centric evaluation rather than expert ground truthing in a diagnostic context.

4. Adjudication Method for Test Set

The document does not describe an adjudication method for the test set. Given the nature of the testing (usability and retainability), a formal adjudication process as seen in diagnostic studies would likely not be relevant.

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

The document does not indicate that an MRMC comparative effectiveness study was done, nor does it mention any effect size for human readers improving with or without AI assistance. This device is a mechanical medical device (TubeClear™), not an AI-powered diagnostic tool, so such a study would not be applicable.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study. This device is a mechanical clearing system, not an algorithm, so a "standalone" or "algorithm only" performance study is not applicable.

7. Type of Ground Truth Used

The ground truth for the usability and retainability testing was based on "acceptance criteria" being met by "end users." This implies a subjective or objective assessment of the device's functionality and user interaction rather than a diagnostic accuracy ground truth like pathology or outcomes data.

8. Sample Size for Training Set

The document does not mention a training set as this device is a mechanical medical device and does not involve machine learning or AI models that require training data.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no training set for this type of medical device.

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TubeClear™ is indicated for use only and solely in clearing occlusions / clogs in nasogastric (NG) tubes (i.e., tubes that are placed through the nose and reside in the stomach) of adult patients. Clearing Stem Model NG-1036 is indicated for use in nasogastric tubes that are of size 10 - 14 French and have a length of 36 - 42 inches (91 - 108 cm). Clearing Stem Model NG-1043 is indicated for use in nasogastric tubes that are of size 10 - 18 French and have a length of 43 - 50 inches (109 - 127 cm).

The Proposed Device, TubeClear™ is composed of a reusable Control Box and single use Clearing Stem. One Control Box Model, 101, is used to actuate all Clearing Stem models. Two Clearing Stem Models, NG-1036 and NG-1043, are available to accommodate different sizes of Tubes. The Operator manually inserts the Clearing Stem into the feeding or decompression tube (i.e., Tube) and directs the Clearing Stem's progression along the inside of the Tube. The Control Box Motor via electromechanical actuation creates a linear reciprocating motion. The linear reciprocating motion is transferred to the proximal end of the Clearing Stem which contains a Wire that also reciprocates. Because the Wire is continuous throughout the Clearing Stem, the reciprocating motion is further transferred to the distal Tip of the Wire. The motion at the Wire Tip mechanically acts on the occlusion and restores Tube patency.

The provided text describes the acceptance criteria and the study that proves the TubeClear™ device meets these criteria. Since this is a 510(k) summary for a medical device, the studies are non-clinical (bench testing).

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a single table, but are woven throughout the "NON-CLINICAL PERFORMANCE DATA" section, particularly under Technical, Efficacy, and Safety Testing. The "Reported Device Performance" refers to the results of these tests for TubeClear™. The predicate device, The DeClogger®, is used for comparison in many cases to establish substantial equivalence.

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

The document does not specify a "test set" in the context of patient data, as no clinical data was collected. Instead, the "tests" refer to non-clinical bench testing.

• Sample Size for Test Set: Not specified in terms of number of particular items tested for each bench test. For example, for "Tube Damage," it implies multiple tubes were tested, but the exact number isn't quantified. For "Control Box Reliability," it passed "testing equivalent to one year of operation," suggesting a duration-based test rather than a sample size of distinct control boxes.
• Data Provenance: The data is entirely non-clinical bench testing.
  • Country of Origin: Testing was performed by Intertek Group, Inc. (Boxborough, MA) for Electromagnetic Compatibility (EMC) and Electrical Safety Tests. The location of other technical, efficacy, and safety tests is not explicitly stated, but given the company's address (Bellefonte, PA), it is likely conducted within the USA or through US-based labs.
  • Retrospective or Prospective: These are prospective tests designed and conducted specifically to validate the device's performance against predefined criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the studies are entirely non-clinical (bench testing). There is no "ground truth" established by human experts in the way clinical studies requiring diagnosis or evaluation by medical professionals would. The "ground truth" for these tests is based on objective performance metrics and engineering standards (e.g., passing electrical safety standards, negligible heating, equivalent efficacy in simulated use).

4. Adjudication Method for the Test Set

Not applicable. Since the performance assessment is based on objective bench testing measurements and adherence to engineering specifications, there is no need for expert adjudication in the traditional clinical sense (e.g., 2+1 review for discordant readings).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was collected; therefore, no clinical data is presented in this submission." The effectiveness comparison was performed through "Efficacy testing" in a simulated environment, comparing TubeClear™ with the predicate device, the DeClogger®. This was not a human-in-the-loop study with multiple readers and cases.

• Effect size of human readers improve with AI vs without AI assistance: Not applicable, as no human-in-the-loop clinical studies were conducted, and the device is not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

While the device's function is automated (linear reciprocating motion from a control box), it is not an "algorithm only" device in the sense of software for image analysis or diagnosis. Its performance (efficacy, safety) was evaluated in standalone bench tests without direct human-in-the-loop clinical scenarios. For example, the "efficacy during simulated use" and "safety testing in terms of Tube damage" represent standalone performance evaluations.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the bench testing was based on:

• Engineering Specifications: For technical tests like product specifications, reliability, vibration, and firmware validation.
• Objective Measurements: For safety tests like heating, tube movement, and magnetic field strength (measured by equipment).
• Simulated Performance: For efficacy and tube damage, where performance was observed and compared to the predicate device in a controlled, non-clinical setting.
• Industry Standards: For electrical safety and EMC testing (e.g., UL, CSA, IEC, ISO standards).

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical/electromechanical medical device, not a machine learning or AI-based system that requires a "training set" of data.

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

Not applicable. As stated above, there is no "training set" for this type of device.

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