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The Lumendi DiLumen C1 and EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen C1 and EZ1 consists of a sleeve with an inflatable balloon at the distal end that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The DiLumen C1 includes an attached flexible tool channel to allow endoscopic tools to be inserted through it and used in conjunction with the endoscope. The DiLumen EZ1 does not have the tool channel. The C1 and EZ1 are provided non-sterile and do not require disinfection or sterilization prior to use. The devices are intended only for single patient use.

To stabilize the system during clinical use, the C1 is used with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channel to a surgical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling. As the EZ1 does not have a tool channel, the Tool Mount is not used to perform its intended functions.

The provided text is a 510(k) summary for the Lumendi DiLumen C1, EZ1, and Tool Mount device. It outlines the product, its intended use, and its substantial equivalence to a predicate device (Lumendi DiLumen C2 and Tool Mount). However, it does not contain the specific information required to answer your questions about acceptance criteria, study details, human reader performance, or ground truth establishment for AI-related studies.

This document describes a medical device clearance process based on substantial equivalence to an already cleared predicate device, not on the performance of a novel AI algorithm tested against specific ground truth data with human readers. The performance data section refers to bench testing for mechanical integrity and usability of the physical device, not an AI model's diagnostic accuracy or its impact on human performance.

Therefore, I cannot provide the requested information from the given text. The text does not describe:

1. A table of acceptance criteria and reported device performance related to an AI model. The acceptance criteria here are about physical device specifications (e.g., balloon integrity, insertion force), not AI metrics like sensitivity or specificity.
2. Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication methods for an AI study. The "test set" mentioned refers to physical units undergoing bench tests.
3. MRMC comparative effectiveness study, effect size of human reader improvement with AI assistance, or standalone AI performance. This is a hardware device, not an AI diagnostic tool.
4. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI model.
5. Sample size for a training set or how ground truth for a training set was established for an AI model.

The "Performance Data" section lists several bench tests:

• Instrument Insertion Force Test
• Tool Channel Separation Force
• Balloon Leak Force/Bond Leak Testing
• Colon Grip Test
• Fatigue/Cycling and System Leakage Test
• Balloon Scope Centering Test
• User Verification Test (Device Usability)

The conclusion states: "In all instances, the device functioned as intended and the results observed were as expected." This indicates that the device met its pre-defined specifications for these physical and mechanical tests, which serves as the "acceptance criteria" for this type of device and submission. However, these are not the kind of "acceptance criteria" typically associated with AI/ML medical devices.

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The Lumendi DiLumen C² is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen C2 consists of a sleeve including two inflatable balloons that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The C2 is provided non-sterile and does not require disinfection or sterilization prior to use. The device is intended only for single patient use.

To stabilize the system during clinical use, the C2 is provided with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channels to a surqical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling.

The provided text is a 510(k) summary for a medical device (DiLumen C2 and Tool Mount) and thus focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study description of how acceptance criteria were met for a novel AI/software device. Consequently, many of the requested details about acceptance criteria, study design for AI models, ground truth, and expert involvement are not applicable or available in this document.

However, I can extract the general "performance data" that was provided to support the device's substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests but does not explicitly state quantitative acceptance criteria for each. Instead, it generally states that the device "meets specifications" and "functioned as intended."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not applicable as this is a physical medical device, not an AI/software device generating data. The testing would have been conducted on physical units of the device.

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

• Not applicable. This is a physical device submission; ground truth in the context of expert consensus for AI models is not relevant here. "User Verification Testing" implies evaluation by users/clinicians, but specific numbers or qualifications are not provided.

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

• Not applicable. This is a physical device.

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:

• Not applicable. This is a physical device, not an AI or software product that assists human readers.

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

• Not applicable. This is a physical device.

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

• Not applicable in the context of AI/software ground truth. For a physical device, "ground truth" would refer to established engineering and performance specifications and industry standards for safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/software product requiring a training set.

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

• Not applicable. This is a physical device.

Study that proves the device meets the acceptance criteria:

The document states: "Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate device. As the DiLumen C2 shares many of the same components as the predicate and reference devices, bench testing primarily targeted verification of the balloon integrity and operation of the DiLumen C2 with an endoscope."

The specific studies performed were:

1. Biocompatibility (cytotoxicity, sensitization, systemic toxicity, material mediated pyrogenicity)
2. Fore and Aft Balloon Diameter
3. Therapeutic Zone Creation
4. Balloon/Endoscope Centering
5. Endoscope Insertion Force
6. Instrument Insertion and Removal Force
7. Tool Channel Deflection
8. User Verification Testing

The conclusion is that "In all instances, the device functioned as intended and the results observed were as expected," supporting its substantial equivalence to the predicate device. The details of these "bench tests" are not provided in this summary.

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The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment.

The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope. The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope and DiLumen are navigated to the target zone with the balloons deflated. At the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, is inflated until it contacts the tissue near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the intestine tissue, and in combination with the Aft Balloon, creates an isolated diagnostic / therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate them (independently) with ambient air as they assist in stabilizing the endoscope and the therapeutic area. The Suture Loops attached to the Fore Balloon of the DiLumen allow clinicians to manipulate tissue when used with an endoscopic clip. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflation, etc.) are unaffected by the presence of the DiLumen is designed to permit the usage of any standard tool through the endoscope working channel.

The provided text is a 510(k) summary for the DiLumen Endolumenal Interventional Platform, detailing modifications to a previously cleared device. It primarily focuses on demonstrating substantial equivalence to the predicate device rather than presenting a full de novo clearance study with extensive clinical performance data against specific acceptance criteria.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria (like a large human reader study, detailed ground truth establishment for a test set, etc.) are not present in this document. The document states that the changes "do not raise different questions of safety or effectiveness," and therefore, "the bench testing to support this 510(k) notice is limited."

However, I can extract the information that is present and indicate where the requested information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) typical for a new AI/diagnostic device. Instead, the "acceptance criteria" are implied by the nature of a 510(k) for a modified device – demonstrating that the modifications do not negatively impact the device's original performance and that it remains substantially equivalent to its predicate. The "performance" is largely demonstrated through bench testing and verification studies.

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

This document primarily describes bench and user validation testing for design changes, not a clinical trial with a "test set" in the sense of patient images or data for an AI algorithm. Therefore:

• Sample size for test set: Not applicable in the context of an AI/diagnostic algorithm testing on patient data. The "test set" would be the modified device itself, subjected to various physical and functional tests. Specific sample sizes for bench tests (e.g., number of devices tested for pull force) are not detailed.
• Data Provenance: Not applicable in terms of patient data. The "data" comes from engineering bench tests and potentially user feedback on the device.

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

• Number of experts: Not applicable. Ground truth for an AI/diagnostic algorithm using expert reads is not relevant here. The "experts" would likely be the engineers, quality assurance personnel, and potentially clinical users (e.g., endoscopists) involved in the design verification, validation, and user testing. Their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. This concept applies to consensus reading for ground truth in diagnostic studies, which is not the nature of the tests described here.

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

• MRMC study: No, an MRMC comparative effectiveness study was not done. The document states that the changes "do not raise different questions of safety or effectiveness," implying that extensive clinical re-evaluation of diagnostic accuracy or comparative effectiveness was not deemed necessary for this 510(k) Special submission. The study is focused on the device's technical and physical performance after minor modifications.

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

• Standalone performance: Not applicable. This device is a mechanical accessory to an endoscope, not a software algorithm, so the concept of standalone performance does not apply.

7. The Type of Ground Truth Used

• Type of ground truth: For mechanical and functional performance, the "ground truth" would be established engineering specifications, design parameters, and relevant ISO/USP standards (e.g., ISO 10993 for biocompatibility, predetermined values for pull/push force). For user validation, the "ground truth" would be the subjective and objective feedback from clinical users regarding the ease of use and functionality of the modified device compared to the predicate.

8. The Sample Size for the Training Set

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

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

• Ground truth for training set: Not applicable.

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The DiLumen Endolumenal Interventional Knife ("DiLumen |ç") is a disposable monopolar electrosurgical device intended to be used for marking, cutting, and cauterizing tissue within the digestive tract during endoscopic procedures. This device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization.

The DiLumen Ix is a sterile, single patient use, disposable electrosurgical instrument. The DiLumen ly utilizes a pistol style handle, flexible shaft with an articulating section at its distal end, and a stainless-steel knife tip that can be extended and retracted. The handle incorporates controls that allow the clinician to rotate the shaft, extend or retract the knife tip, articulate the distal end of the shaft in a specific plane, and lock the articulation in a fixed position. The DiLumen Ik has a plug at the bottom of the handle that is used to connect the device to an electrosurgical unit. When connected to the generator, and used in combination with grounding pads, high-frequency current can be applied through the knife tip to mark, cut or cauterize tissue at the lesion site. There is also a female luer lock connector on the handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing the knife tip or to inject saline into the submucosa to lift lesions.

This document is a 510(k) summary for the DiLumen Endolumenal Interventional Knife (DiLumen IK™), a medical device. It does not describe a study involving algorithms, AI assistance, or human readers. Therefore, I cannot provide information on acceptance criteria or studies related to AI performance metrics (like sensitivity, specificity, or MRMC studies) for this particular device based on the provided text.

The document focuses on demonstrating the substantial equivalence of the DiLumen IK to a predicate device (DiLumen Endolumenal Interventional Scissors) and a reference device (Olympus Single Use Electrosurgical Knife) through non-clinical performance testing.

Here's what can be extracted about the device's validation:

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

The document lists performance tests but does not provide specific quantitative acceptance criteria or the numerical results of these tests. It generally states, "In all instances, the device functioned as intended and the results observed were as expected."

2. Sample sized used for the test set and the data provenance:

The document does not specify sample sizes for any of the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found in the full 510(k) submission, not the summary.

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

Not applicable, as this is for a physical medical device, not an AI, so "ground truth" in the context of expert review of images is not relevant here. The "ground truth" for this device would be established by physical testing and adherence to engineering specifications and safety standards.

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

Not applicable for a physical device's performance testing.

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:

Not applicable. This device is a manual surgical tool, not an AI or imaging diagnostic aid.

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

Not applicable. This is a physical device used by a clinician.

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

The "ground truth" for this device's performance is based on direct physical and electrical testing against pre-defined specifications and industry standards for electrosurgical devices and biocompatibility. For example, electrical safety is tested against relevant standards, and biocompatibility is tested according to ISO standards.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable.

Ask a specific question about this device

The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 - 14.3 mm. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment.

The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope. The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope and DiLumen are navigated to the target zone with the balloons deflated. At the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, is inflated until it contacts the intestinal wall near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate them (independently) with ambient air as they assist in stabilizing the endoscope and the therapeutic area. This 510(k) notice encompasses a minor revision to the device's indications statement to specify that it can be used for tissue manipulation, as well as addition of suture loops to the Fore Balloon skirt to facilitate that functionality. The DiLumen is designed to permit the usage of any standard endoscopic tool through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) are unaffected by the presence of the DiLumen, including the sleeve, balloons, and suture loops.

Here's an analysis of the provided text regarding the DiLumen Endolumenal Interventional Platform, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device (DiLumen Endolumenal Interventional Platform). 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting entirely new, rigorous clinical trials for effectiveness. Therefore, the information related to studies proving new performance claims is limited, and much of the "proof" is based on the substantial equivalence argument, relying on prior clearances and bench testing. Questions related to AI algorithm performance (e.g., MRMC studies, training set details) are not applicable as this is a mechanical accessory, not an AI device.

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the format of specific quantitative benchmarks (e.g., "Device must maintain position for X minutes" or "Force required to reposition must be Y"). Instead, the performance is demonstrated through its substantial equivalence to predicate devices and confirmation of its mechanical and functional specifications via bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

• Ability to securely fit over a standard endoscope (12.5 - 14.3 mm distal tip OD).
• Balloons can be inflated and deflated independently.
• Capable of positioning and stabilizing the endoscope within the large intestine.
• Creates an isolated diagnostic/therapeutic zone.
• Permits usage of standard endoscopic tools through the endoscope working channel.
• Endoscope flexibility, maneuverability, and functionalities (visualization, suction, insufflation) are unaffected.
• Facilitates tissue manipulation. | Relied upon testing from prior 510(k) (K162428).
  Confirmed through bench testing (for suture loops and overall functionality).
  "Performs to its pre-defined specifications." Note: No specific numerical performance metrics are provided in this summary. |
  | Mechanical Performance:
• Structural integrity of components (sleeve, balloons, push rods, inflation handle, suture loops).
• Durability for single-use. | Relied upon testing from prior 510(k) (K162428).
  Confirmed through bench testing (for suture loops and overall functionality). |
  | Safety: Device presents no new safety concerns compared to predicates. | Demonstrated through substantial equivalence argument and performance data (bench testing, biocompatibility). |

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

• The document states: "The testing submitted in that 510(k) notice [K162428] is relied upon to establish the device's biocompatibility and functional and mechanical performance."
• "In addition, the company has conducted bench testing to assess the performance and impact of the suture loops added to the Fore Balloon."
• Sample Size: Not explicitly stated for any of the bench tests. 510(k) summaries often do not detail the exact number of units tested.
• Data Provenance: The testing was conducted by or for Lumendi LLC. The location (country) of the testing is not specified. All testing described is retrospective (i.e., conducted before the 510(k) submission). No mention of prospective clinical studies.

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

• This device is a mechanical accessory, not an AI or diagnostic device that requires expert adjudication of images or outputs.
• "Ground truth" in this context would relate to the mechanical and functional performance specifications. These are established through engineering design, regulatory standards, and bench testing, not expert consensus on diagnostic interpretations.
• Therefore, this question is not applicable.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

• Not applicable, as this is not a diagnostic device requiring adjudication of human readings or algorithm outputs.

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

• Not applicable. This is a mechanical accessory, not an AI-powered device or a diagnostic aid that would involve human readers interpreting images.

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

• Not applicable. This is a mechanical accessory, not an algorithm.

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

• For this device, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device. For the new features (suture loops), the "ground truth" would be the successful demonstration via bench testing that they perform as intended and do not compromise safety or functionality. This is primarily engineering specifications and bench test results.

8. The sample size for the training set

• Not applicable. This is a mechanical accessory, not an AI device that requires a training set.

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

• Not applicable.

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The DiLumen Endolumenal Interventional Scissors ("DiLumen Is™") is a disposable monopolar electrosurgical device intended to be used for cutting, and cauterizing tissue within the digestive tract during endoscopic procedures.

The DiLumen I , is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. This allows the clinician maximum flexibility to cut, dissect and cauterize tissue during endoscopic interventions in the digestive tract. The clinician can insert the DiLumen Is into any endoscopic tool channel with a diameter of at least 6mm. With the DiLumen Is under direct visualization, the clinician can position the scissor blades as appropriate for the particular procedure using blade rotation, blade articulation, and shaft rotation as necessary. The clinician can then cut gastrointestinal tissue either with or without energizing the blades, depending on the specific need during the procedure.

In addition, the DiLumen Is has a plug at the bottom of the handle. If desired by the clinician, this plug can be used to connect the device to an electrosurgical generator via a dedicated cord in order to apply monopolar electrical current through the blades to the target site in the gastrointestinal tract. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically.

The DiLumen I , can also be used in conjunction with other endoscopic devices such as graspers, knives, etc. to perform endolumenal interventions.

The provided text describes the 510(k) premarket notification for the DiLumen Endolumenal Interventional Scissors (DiLumen Is™). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance criteria through a study involving AI performance or human reader improvement, as typically found in AI/ML medical device submissions.

Therefore, many of the requested details about acceptance criteria, study design for AI models (sample size, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training sets), and adjudication methods cannot be extracted from the provided text.

The document details performance testing that demonstrates the device meets specifications and is as safe and effective as the predicate. These tests are primarily engineering and mechanical evaluations, rather than clinical efficacy studies in the context of AI diagnostic or assistive devices.

Here's what can be extracted based on the provided text:

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

The document lists performance tests but does not provide specific acceptance criteria or quantitative results for these tests. It states qualitatively that "In all instances, the device functioned as intended and the results observed were as expected."

Regarding the other points, the information is not available in the provided text:

• 2. Sample sized used for the test set and the data provenance: Not mentioned. The "performance data" refers to engineering and bench testing, not clinical data for an AI model.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. "Ground truth" in this context would refer to device specifications and performance metrics, not expert interpretations of medical images for AI.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
• 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: No, an MRMC study was not done as this is not an AI/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in terms of common AI model ground truth. The "ground truth" for this device's performance would be engineering specifications and functional requirements.
• 8. The sample size for the training set: Not applicable/not mentioned. This device does not have a "training set" in the context of AI/ML.
• 9. How the ground truth for the training set was established: Not applicable/not mentioned.

In summary, the provided document describes a traditional medical device submission (510(k)) that focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance testing against engineering specifications, rather than clinical studies involving AI or machine learning.

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The Lumendi DiLumen C2 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen C² consists of a sleeve including two inflatable balloons that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The C2 comes into limited (

The provided text describes a medical device called the DiLumen C2 and its accessory, the Tool Mount, and generally states their performance and equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and the results of a specific clinical study in the format requested.

The document is a 510(k) Premarket Notification summary from the FDA, aiming to demonstrate substantial equivalence to a legally marketed predicate device (DiLumen Endolumenal Interventional Platform, K162428). This typically relies on comparing technological characteristics and demonstrating that any differences do not raise new questions of safety or effectiveness, often through bench testing rather than extensive clinical trials with specific performance metrics against pre-defined acceptance criteria.

The "Performance Data" section lists various tests performed (e.g., Biocompatibility, Balloon Diameter, Inflation/Deflation and Leakage Test, User Validation), but it does not provide quantitative acceptance criteria or the specific performance results from these tests. It merely states, "In all instances, the device functioned as intended and the results observed were as expected." It also explicitly states, "No animal or clinical testing was required to demonstrate substantial equivalence to the predicate."

Therefore, I cannot fill in the requested table and answer many of the specific questions about clinical study details (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set) because this information is not present in the provided document.

Here's what I can extract and state based on the provided text, and where I must indicate information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document indicates "No animal or clinical testing was required," implying that the performance data primarily comes from bench testing, for which sample sizes are not detailed in this summary.
• Data Provenance: Not applicable for a clinical study, as the document states no clinical testing was required. For bench testing, provenance details like country of origin or whether data was retrospective/prospective are not provided.

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

• This information is not applicable as no clinical study or expert-adjudicated ground truth for a test set is described.

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

• This information is not applicable as no clinical study with a test set requiring adjudication is described.

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

• No MRMC comparative effectiveness study was done. The device (DiLumen C2 and Tool Mount) is an endoscope accessory, not an AI diagnostic or assistive imaging tool that involves "human readers" in the context of an MRMC study.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Ground truth in the traditional sense of clinical studies (e.g., pathology, outcomes) is not mentioned as "No animal or clinical testing was required." For the enumerated performance tests, the "ground truth" would be the engineering specifications and functional requirements of the device.

8. The sample size for the training set

• Not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable.

Summary of what the document does provide regarding performance:
The document states that "Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate." The listed tests (Biocompatibility, Balloon Diameter, etc.) are bench tests. The conclusion is that the device is "substantially equivalent" to its predicate based on these tests and similar technological characteristics, not based on a clinical trial with acceptance criteria for specific performance metrics against clinical outcomes.

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The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope. The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope, the endoscope and DiLumen are navigated to the target zone with the balloons deflated. Once the clinician is at the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate the two balloons with ambient air. The balloons assist in stabilizing the endoscope and the therapeutic area and are inflated or deflated independently. The balloons and sleeve are designed to permit the usage of any standard endoscopic tool (such as biopsy forceps, snare, needle, etc.) through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, insufflations, etc.) are unaffected by the presence of the DiLumen.

The provided text describes the 510(k) summary for the DiLumen Endolumenal Interventional Platform, a medical device. However, it does not contain the specific details about the acceptance criteria or a dedicated study that rigorously proves the device meets specific performance criteria with quantitative metrics like sensitivity, specificity, or reader improvement. The document focuses on demonstrating substantial equivalence to predicate devices through various performance tests, but these tests are not presented as a formal study with detailed acceptance criteria and reported numerical performance.

Therefore, I cannot generate the exact table or detailed information requested without that specific data.

However, I can extract the types of performance tests conducted, which imply underlying acceptance criteria, and some general statements about the studies.

General Information Extracted:

• Device Name: DiLumen Endolumenal Interventional Platform
• Intended Use: Accessory to an endoscope, intended for use with standard endoscopes with specific distal tip outer diameter and working length. Indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
• Predicate Devices: Fujinon EC-450B15 Double Balloon Enteroscopy System (K090116), Smart Medical Systems NaviAID™ BGE (K060923), and Smart Medical Systems NaviAID™ BGC (K102616).
• Performance Data Provided: The document lists 18 performance tests conducted to support the premarket notification.

Here's how I can answer the prompt based on the available information, noting the absence of specific quantitative acceptance criteria and results:

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

Based on the provided text, specific numerical acceptance criteria (e.g., "burst pressure must be > X psi") and reported quantitative performance values are not detailed. The document lists the types of performance tests conducted and generally states that the device "meets specifications" and "has substantially equivalent performance to the predicates."

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for any of the listed "Performance Data" tests. It also does not mention an explicit "test set" in the context of clinical data or patient images for algorithm evaluation. The tests listed are primarily bench tests and engineering validations. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for these types of tests.

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

Not applicable. The listed performance data are mainly physical/mechanical bench tests. "User Validation" implies involvement of users, likely medical professionals, but their number and specific qualifications for establishing a "ground truth" (in the diagnostic sense) are not provided.

4. Adjudication method for the test set

Not applicable. The listed performance data are mainly physical/mechanical bench tests.

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

No such study is mentioned or provided in the document. The device itself is an accessory for an endoscope, not an AI diagnostic tool.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

For the bench tests, the "ground truth" is typically established by engineering specifications, physical measurements, and functional requirements of the device. For example, a burst pressure test would compare actual burst pressure to a pre-defined minimum specification. For "User Validation," the ground truth would be user feedback and ability to complete tasks effectively with the device.

8. The sample size for the training set

Not applicable. This is not an algorithm-based device requiring a training set.

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

Not applicable. This is not an algorithm-based device.

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