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The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Lower GI Models are accessories intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract Lower GI Models are indicated for use in the large intestine with any standard endoscope as follows:

The GripTract-GI™ Endoscopic Tissue Manipulator (GripTract) Lower GI Models are disposable, non-sterile accessories intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment. There are four (4) different GripTract Lower GI Models (GT-CL170, GT-CL130, GT-CM170, and GT-CM130) which are indicated for use in the large intestine with standard endoscopes that have specific tip outer diameters and working lengths.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

Here's a breakdown of the acceptance criteria and study information based on the provided document, addressing each of your points:

Important Note: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator Lower GI Models). This type of document focuses on demonstrating substantial equivalence to an existing predicate device rather than proving clinical efficacy or diagnostic accuracy for an AI/software device. Therefore, many of your questions, particularly those related to AI-specific studies (MRMC, standalone AI performance, ground truth establishment for training AI, etc.), are not applicable to this device and information. The device described is not an AI/software device.

The document primarily details non-clinical performance data to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with numerical performance targets against which the device was measured like typical AI/diagnostic studies. Instead, it lists various non-clinical tests performed and states whether the device "passed" or exhibited "equivalent force transmission" or "exceeded reported maximum pull forces."

Here's a summary derived from the "Summary of non-clinical performance testing" table and the subsequent paragraphs:

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

As this is a physical medical device (endoscopic tissue manipulator) and not an AI/software, the concept of a "test set" in the context of diagnostic data doesn't apply directly.

• Sample Size: The document does not specify particular "sample sizes" for the non-clinical tests in terms of number of devices tested. It refers to "worst-case simulated use," "repeated worst-case torsional load," and testing "at the dimensional extremes of the product line" for Torque Comparison. For Biocompatibility, it states "Final, finished devices tested."
• Data Provenance: Not applicable in the context of retrospective/prospective patient data or country of origin for such data. The data provenance is from bench performance testing conducted by the manufacturer, Actuated Medical, Inc.

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

Not applicable. "Ground truth" in the context of expert consensus on medical images or diagnostic outcomes is not relevant for this device's non-clinical performance testing. The "ground truth" for these tests would be the measured physical properties and performance characteristics against established engineering specifications and regulations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies among expert readers in diagnostic AI studies. This is a non-clinical, bench testing document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

Not applicable. This device is a physical medical instrument, not an AI or software that assists human readers in diagnostic interpretation. An MRMC study would not be performed for this type of device.

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

Not applicable. This is not an algorithm or software. It is a physical device operated by a clinician.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by:

• Engineering specifications and design requirements.
• Industry standards (e.g., ISO 10993-1 for biocompatibility).
• Quantitative measurements derived from bench testing (e.g., force measurements, dimensional checks, fatigue cycles).
• Simulated worst-case scenarios and interactions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no training set of data in that sense.

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

Not applicable. As there is no AI training set, there's no ground truth establishment process for it.

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The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and working length of 168 - 170 cm.

GripTract is a single-use, non-sterile, endoscope accessory intended to ensure complete positioning of an endoscope and assist with optical visualization, diagnosis, and endoscopic treatment. It is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and a working length of 168 - 170 cm.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

The provided text describes the regulatory clearance for the GripTract-GI Endoscopic Tissue Manipulator (K231254). It outlines the device's intended use and provides non-clinical performance data to demonstrate its safety and effectiveness.

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

Key Takeaway: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific numerical performance acceptance criteria typical of AI/ML device studies. Therefore, many of the requested criteria (e.g., specific quantitative metrics, sample sizes for training/test sets for AI, expert numbers for ground truth, MRMC studies) are not directly applicable or explicitly stated in this type of regulatory submission for a mechanical device.

However, I can extract the information related to the device's performance and the studies conducted to show its safety and effectiveness.

Acceptance Criteria and Device Performance (based on provided text)

The acceptance criteria for this device are primarily related to its functional performance, safety, and compatibility, demonstrated through various non-clinical tests. The "performance" is reported as "Pass" for each test, indicating that the device met the pre-defined criteria for that specific test.

Study Details (based on provided text)

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

   • Usability Testing: "A total of 15 Users" for both "Set-Up" and "Use" usability tests.
   • Porcine Testing: Number of animals or procedures is not specified, but it's an "in vivo porcine testing" in "worst-case procedure."
   • Other Bench Tests: Sample sizes are not explicitly stated for product specification verifications, distribution, shelf-life, reliability, or bench safety (other than the endoscope viewing area comparison).
   • Data Provenance: The studies are non-clinical, primarily bench and animal (porcine) testing. No explicit mention of country of origin for the data or whether it's retrospective/prospective (these terms are more relevant for human clinical studies).

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

   • This information is not provided. For non-AI mechanical devices, the "ground truth" is typically established by engineering specifications, validated test methods, and potentially expert interpretation for things like tissue damage in animal studies. The "users" in usability testing are relevant, but their "qualification" is broadly "intended user population" (medical specialists).

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

   • Not applicable/mentioned for this type of non-clinical device testing.

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:

   • Not applicable. This device is a mechanical accessory, not an AI-powered diagnostic tool requiring human reader comparison studies.

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. Bench tests evaluate the device's standalone performance.

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

   • Bench Performance: Engineering specifications and ASTM/ISO standards.
   • Usability: Defined user tasks and absence of serious use errors, likely determined by observation and user feedback against pre-defined criteria.
   • Biocompatibility: ISO 10993 standards and their associated pass/fail criteria (e.g., lack of cytotoxicity, sensitization).
   • Porcine Testing: Visual and histological mucosal damage assessment compared to a control (endoscope-only procedures), suggesting pathology as a component of ground truth for tissue effects.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable.

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The IO Needle Safety Sheath (IOSS) is intended to assist in the safe removal of intraosseous needles.
IOSS is Indicated for Use with 25mm EZ-IO Vascular Access Needles and BD Luer-Lok 10mL Syringes.

The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, antineedlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is placed around the syringe and IO needle prior to removal from the patient. It irreversibly captures the IO needle within the device upon removal from the patient; helping to prevent accidental needle sticks to the patient or user. There is tactile confirmation of capture, and the clear body of IOSS allows for visual confirmation that the IO needle is in Safe Mode.

This is a 510(k) premarket notification for the "IO Needle Safety Sheath (IOSS)", a device intended to assist in the safe removal of intraosseous needles. The information provided heavily focuses on proving substantial equivalence to a predicate device (EZ-IO Intraosseous Vascular Access System) and includes non-clinical performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Usability Testing:

  • Sample Size: 500 uses by thirty (30) users.
  • Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, human factors validation testing typically involves prospective studies with enrolled participants.

• Other tests (Biocompatibility, Product Specifications, Distribution, Accelerated Shelf Life): These involve device units, not human subjects, so "test set" and "data provenance" as typically applied to clinical studies are not directly applicable. These are conducted in a laboratory setting. The "final, finished devices" were tested.

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

• Usability Testing: The document refers to "thirty (30) Users" to assess usability. It does not specify if these were "experts" in the sense of establishing ground truth for the device's functional performance, but rather participants for evaluating user experience and safety.

  • Ground Truth: The "ground truth" for usability testing is whether these users encountered needle sticks, serious use errors, or problems. This is established by direct observation and feedback from the users themselves, evaluated against predefined safety and effectiveness criteria.
  • Qualifications: The qualifications of these 30 users are not detailed beyond "intended user population." They likely represent healthcare professionals who would typically use such a device. There is no mention of "experts" specifically establishing a ground truth for the test set.

• Other tests: Ground truth for these bench tests is established by industry standards (e.g., ISO 10993, ISTA 3A) and internal product specifications, which are typically developed by engineers and quality assurance personnel. No external experts are mentioned for validating these specific test outcomes.

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1 or 3+1 consensus) is mentioned for any of the tests.
• For Usability Testing, the results would typically be analyzed by human factors engineers against predefined pass/fail criteria for safety and effectiveness (e.g., zero needle sticks, minimal serious use errors). This is more of a data analysis and evaluation process than an adjudication by multiple, independent experts as seen in, for example, image interpretation studies.
• For Bench Performance Testing, results are typically compared directly to quantitative specifications and pass/fail criteria.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is a physical accessory (safety sheath) for an existing medical needle. The studies focus on its physical performance, safety features (preventing needle sticks), and usability, rather than diagnostic interpretation effectiveness that would necessitate an MRMC study.
• Therefore, there is no effect size of human readers improving with AI vs. without AI assistance, as AI is not a component of this device.

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

• No, a standalone algorithm-only study was not applicable or performed.
• This device is a mechanical accessory; it does not involve algorithms or AI. Its core function is to be used with a human operator and an existing IO needle.

7. The Type of Ground Truth Used

• Biocompatibility: Ground truth is established by adherence to recognized international standards (ISO 10993 series) and specific laboratory test parameters designed to detect cytotoxic, sensitization, irritation, acute systemic toxicity, and pyrogenicity responses.
• Verification of Product Specifications, Distribution, Accelerated Shelf Life, Shelf Life: Ground truth is established by the device meeting its predefined engineering and product specifications and demonstrating performance in accordance with recognized industry standards (e.g., ISTA 3A).
• Usability: Ground truth is established by direct observation of user interaction, user feedback, and analysis of adverse events (e.g., needle sticks) or serious use errors during simulated use scenarios, evaluated against predefined safety and effectiveness criteria.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical safety accessory, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The device itself is designed, manufactured, and tested, not "trained."

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

• Not applicable, as there is no training set for an AI/ML algorithm.

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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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