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The ClearPath Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain.

The ClearPath™ Disposable Introducer is a sterile, single-use, neurological endoscope Introducer, consisting of a Sheath and a Dilator.

A locking mechanism design allows the Dilator to lock into the Sheath and prevent "push back" during insertion into the brain. The Dilator tip is designed to be atraumatic during insertion. The Sheath is graduated in centimeters to assist the surgeon in determining the Introducer insertion depth. The Sheath's transparency is useful for full endoscopic visualization during insertion.

The proximal end of the Sheath is labeled 20F, indicating the inner diameter of the Sheath.

The provided text is a 510(k) summary for the ClearPath™ Disposable Introducer. It focuses on demonstrating substantial equivalence to a predicate device (MINOP® Disposable Introducer 26F, K142315) rather than providing extensive details about acceptance criteria and a specific study proving device performance against those criteria in the context of an AI/ML device.

Therefore, many of the requested details, such as AI-specific acceptance criteria, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established, are not available in this document as it pertains to a mechanical medical device, not an AI/ML device.

However, I can extract the available information related to performance and testing from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify a "test set" in the context of data for an algorithmic device. The testing described (biocompatibility, bench testing, transit testing, shelf life) refers to physical device testing, not data-driven performance evaluation. Therefore, sample sizes for data-driven testing and data provenance are not applicable or 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 the device is a physical medical instrument, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth from a test set of data.

4. Adjudication method for the test set:

• This information is not applicable for the same reasons as point 3.

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:

• This information is not applicable as the ClearPath™ Disposable Introducer is a physical medical device, not an AI-assisted device.

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

• This information is not applicable as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

• For the performance aspects mentioned (biocompatibility, bench testing, transit testing, shelf life), the "ground truth" would be established by pre-defined engineering specifications, international standards (ISO 10993, ASTM D4169), and validated laboratory testing procedures. There is no "expert consensus" or "pathology" in the context of data for this type of device.

8. The sample size for the training set:

• This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

• This information is not applicable for the same reasons as point 8.

In summary, the provided FDA 510(k) document is for a conventional medical device (an introducer) and thus does not contain the detailed AI/ML specific information requested in many of the questions. It uses standard engineering and biocompatibility testing to demonstrate safety and effectiveness and substantial equivalence to a predicate device.

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The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner positions teeth by way of continuous gentle force.

The ClearPath clear aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription.

The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to ClearPath. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked.

The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

The provided text describes the ClearPath Aligner, a series of clear plastic appliances for correcting dental malocclusion. The submission (K202857) seeks substantial equivalence to a predicate device (K162609). The key difference is the new device's use of software (Ortho Analyzer, 3Shape A/S, K180941) for treatment planning and 3D printing of models.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative (e.g., minimum accuracy, sensitivity, specificity) acceptance criteria for the device from a clinical performance standpoint for the software's functionality. Instead, the focus is on the manufacturing process and materials.

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

The document explicitly states that "Bench testing was performed to validate the manufacturing process: to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan."

• Sample Size for Test Set: The exact sample size for this bench testing is not specified in the provided text.
• Data Provenance: The nature of the bench testing suggests it would be prospective data generated specifically for this validation. The country of origin of the data is not specified, but the applicant's address is Lahore-Pakistan.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the bench testing. Given the type of testing (accuracy of thermoformed aligner vs. digital scan), ground truth would likely be established through precise metrological measurements, not expert clinical assessment in this context.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method, as the testing described is bench testing for manufacturing accuracy, not a clinical study involving human interpretation or consensus.

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

No, an MRMC comparative effectiveness study was not done or reported. The submission focuses on the substantial equivalence of the device, primarily through material and manufacturing process validation, and not on the comparative effectiveness of human readers with or without AI assistance. This device is not an AI diagnostic tool that assists human readers.

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

The document mentions that the software system (Ortho Analyzer) is used for "management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models."

However, a standalone performance study specifically for the algorithm's accuracy in these tasks, independent of the human-in-the-loop manufacturing process, is not explicitly described or quantified in terms of specific metrics (e.g., accuracy of tooth movement simulation). The bench testing described validates the manufacturing process based on the digital plan, rather than the intrinsic diagnostic or planning accuracy of the software itself in a standalone context.

7. The Type of Ground Truth Used

For the bench testing, the ground truth was the initial digital scan used as the reference against which the final thermoformed physical aligner was compared for accuracy. This implies a precise, measurable digital model.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The device is an orthodontic aligner and the new part of the submission relates to the use of existing software in its manufacturing process. There's no indication that a new algorithm or AI model was developed by ClearPath Orthodontics that required a separate training set. The "Ortho Analyzer" software itself would have had its own development and validation, but that information is not part of this 510(k) submission for the ClearPath Aligner.

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

As no training set is discussed for the ClearPath Aligner device itself (other than potentially for the pre-existing Ortho Analyzer software), this information is not provided in the document.

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The AHMED® ClearPath glaucoma drainage device is indicated for the management of refractory glaucoma where previous surgical treatment has failed or is not expected to provide satisfactory results. Such refractory glaucoma may include but is not limited to: neovascular glaucoma, congenital or infantile glaucoma, and refractory glaucoma resulting from aphakia or uveitis.

The AHMED® ClearPath Glaucoma Drainage Device is a non-valved drainage device designed to shunt aqueous in eyes suffering from refractory glaucoma. Two models CP250 are available covering surface areas of approximately 250mm². The implant consists of a medical grade silicone tube secured to a medical grade silicone episcleral plate near the anterior suture points. The anterior suture points are located on the anterior side of the plate, flanking each side of the tubing track. The silicone plate is barium impregnated to increase ultrasound resolution and identification with CT scan, MRI and plain skull films. The plate conforms to the shape of the globe at its equator and provides a surface from which fluid can be dispersed. Each AHMED® ClearPath is supplied with a 23-gauge hypodermic needle and a 2-inch polypropylene ripcord (pre-loaded in the lumen of the tube) in a sterile, sealed double- pouch. The supplied needle and ripcord are for optional use and are available to be incorporated into the implantation procedure per the surgeon's usual routine. The device is for single use only.

The provided document is a 510(k) summary for a medical device (AHMED® ClearPath Glaucoma Drainage Device), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific acceptance criteria as would be done for an AI/ML medical device.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable (N/A) because this is a submission for a physical medical device (an aqueous shunt) and not a software/AI medical device. The "acceptance criteria" here refers to the device meeting its design specifications and demonstrating equivalence to a predicate, not performance metrics like sensitivity/specificity for an AI model.

However, I can extract and present the relevant information provided in the document:

Acceptance Criteria and Study for AHMED® ClearPath Glaucoma Drainage Device

This 510(k) submission demonstrates substantial equivalence of the AHMED® ClearPath Glaucoma Drainage Device to a legally marketed predicate device (Baerveldt Glaucoma Implant), rather than proving the device meets specific acceptance criteria through a clinical performance study as would be typical for an AI/ML device. The "acceptance criteria" for this device are its ability to meet design specifications and perform comparably to the predicate device in bench testing, and its biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Bench Testing Sample Size): Not explicitly stated how many devices or samples were tested for each bench test. The document refers to "the AHMED® ClearPath glaucoma drainage device was evaluated" and "results establish that the AHMED® ClearPath glaucoma drainage device meets the defined specifications." These are laboratory tests, not clinical studies with patients.
• Data Provenance: The bench testing was conducted internally or by validated labs as part of the device development process.
• Retrospective/Prospective: N/A (Bench testing, not clinical data)

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

• Number of Experts: N/A (Ground truth established by standardized test methods and comparisons to a physical predicate device, not by expert consensus on clinical images/data).
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: N/A (No human interpretation requiring adjudication for bench tests).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: N/A (This is a physical medical device, not an AI/ML software).
• Effect Size of Human Reader Improvement: N/A

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

• Standalone Performance: N/A (This is a physical medical device, not an algorithm).

7. The type of Ground Truth Used

• Ground Truth:
  • Bench Testing: Engineering specifications, functional requirements, and direct comparison to the physical predicate device (Baerveldt Glaucoma Implant) for "pressure/flow characterization and effectiveness of tube occlusion utilizing a ripcord." Standards such as ANSI Z80.27 and ISO 11137-1/2, ISO 10993-1 were used as references for test methodologies and acceptance criteria.
  • Clinical Efficacy/Safety: Substantial equivalence is supported by reference to published clinical literature on the predicate device (Budenz et al. 2015, 2016) and other relevant literature for specific design features (Kahook et al. 2006 for placement, Sherwood & Smith 1993, An et al. 2018 for ripcord use). The device itself did not undergo a de novo clinical trial.

8. The Sample Size for the Training Set

• Training Set Sample Size: N/A (This is a physical medical device. No "training set" in the AI/ML sense).

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

• Ground Truth Establishment for Training Set: N/A (No training set for this type of device).

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The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner is intended to position teeth by way of continuous gentle force.

ClearPath Orthodontics uses clear, thin, thermoformed plastic material for the manufacture of its ClearPath Aligner. The aligners are provided non-sterile and are customized for each patient according to the molds provided by the treating dentist or orthodontist. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each aligner is 14 days and it is to be worn except during meals.

This document is a 510(k) premarket notification for the ClearPath Aligner. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria, especially concerning artificial intelligence (AI) or an algorithm's performance. The document explicitly states:

• No in vitro or animal testing were required for this product.
• The reason for this 510(k) was to expand the indication from "minor anterior tooth movement" to "realignment of all permanent teeth."
• Clinical case reports were submitted to demonstrate that the aligners can effectively realign all permanent teeth as indicated. These are not described as a formal clinical study with acceptance criteria, sample sizes, or ground truth establishment in the way one would evaluate an AI/algorithm's performance. They appear to be observational case reports supporting the broader indication by showing positive outcomes.
• The focus of the submission is on substantial equivalence to an existing predicate device based on "the same intended use, the same design, identical materials, identical methods used for fabricating the aligners, and submission of clinical reports that demonstrate the device performs as intended."

Therefore, it is not possible to provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or an MRMC study for AI performance, as this document does not describe such a study. The device itself (ClearPath Aligner) is a physical, thermoformed plastic appliance, not an AI or algorithm.

The request details are relevant to the evaluation of AI/ML-driven medical devices, but the provided text describes a traditional medical device submission.

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The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner is intended for minor anterior tooth movement by way of continuous gentle force.

ClearPath Orthodontics uses clear, thin, thermoformed plastic material for the manufacture of its ClearPath Aligner. The aligners are provided non-sterile and are customized for each patient according to the molds provided by the treating dentist or orthodontist. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each aligner is 14 days and it is to be worn except during meals.

The provided text describes the ClearPath Aligner, a device for correcting dental malocclusion. However, it explicitly states that no performance testing was warranted for this product. Therefore, there is no study described that proves the device meets specific acceptance criteria.

The submission relies on a comparison to predicate devices and asserts substantial equivalence based on similarities in intended use, design, material composition, and mechanism of action.

Given this, I cannot provide a table of acceptance criteria and reported device performance or other details of a study that does not exist for this device.

Here's the information that can be extracted or inferred based on the provided text, along with clarifications for items that are not applicable:

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

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

• Not applicable. No test set was used as no performance testing was conducted.

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)

• Not applicable. No test set was used and therefore no ground truth was established by experts for a test set.

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

• Not applicable. No test set was used.

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. This product is a physical dental aligner, not an AI-assisted diagnostic tool.

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)

• Not applicable. No ground truth was established for a performance study. The submission relies on the established safety and efficacy of predicate devices (K073121 - NuBrace Invisible Removable Orthodontics and K981095 - Align System) and scientific literature for the materials used.

8. The sample size for the training set

• Not applicable. No training set was used as no algorithm was developed or tested.

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

• Not applicable. No training set was used.

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The ClearPath DS-120® Lens Fluorescence Biomicroscope is indicated for use to detect autofluorescence of the crystalline lens.

The major functional components of the ClearPath DS-120® Lens Fluorescence Biomicroscope are an optics unit and a laptop personal computer. The only components that contact the patient are a manually adjustable headrest (in/out) and a motorized adjustable chin rest (up/down). The adjustable optics window does not contact the patient.

Acceptance Criteria and Study Details for ClearPath DS-120® Lens Fluorescence Biomicroscope

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a clinical precision study designed to evaluate the repeatability and reproducibility of the ClearPath DS-120® Lens Fluorescence Biomicroscope. The study's purpose was to characterize the variability of measurements, not to establish diagnostic or prognostic utility, and thus does not explicitly state acceptance criteria in terms of diagnostic performance metrics like sensitivity, specificity, or accuracy.

Instead, the acceptance criteria implicitly relate to the variability of measurements (repeatability and reproducibility), which indicates the device's consistency and reliability as a measurement tool. The "fitness for purpose as a measurement tool" suggests that the variability should be within an acceptable range for clinical use in detecting lens autofluorescence.

Based on the "RESULTS" and "SUDY CONCLUSION" sections, the device is deemed to meet its purpose if its repeatability and reproducibility (expressed as standard deviation (SD) and Coefficient of Variation (%CV)) are within acceptable limits for a clinical measurement tool. The study did not define specific numerical thresholds for these values as "acceptance criteria" but rather presented them as characterizations of the device's performance.

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

• Sample Size (Test Set): 27 participants.
• Data Provenance: Prospective, single-site study in humans. The country of origin of the data is not explicitly stated, but the submission is to the FDA (USA), implying the study was likely conducted in the USA.

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

The study was a precision study evaluating the repeatability and reproducibility of the device's measurements of lens autofluorescence. It was not designed to establish diagnostic or prognostic utility, and therefore, it did not use expert-established ground truth in the typical sense (e.g., for disease diagnosis). The "ground truth" for this study was the measurement itself as performed by the device under different conditions, which was then analyzed for variability.

4. Adjudication Method for the Test Set

Not applicable. As this was a precision study evaluating direct measurements from the device, rather than diagnostic classifications requiring expert interpretation and adjudication, no adjudication method was used. The study involved multiple operators and devices taking measurements, and the variability across these measurements was analyzed.

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

No, an MRMC comparative effectiveness study was not explicitly stated or performed. The study described is a precision study focused on the device's measurement consistency. It investigated inter-operator and inter-device variability but did not compare human reader performance with and without AI assistance, nor did it measure an effect size for human improvement with AI.

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

The ClearPath DS-120® is a measurement device that computes the ratio of lens autofluorescence to scattered light. The "summary of protocol" describes operators taking measurements, implying human interaction is part of its intended use. The study evaluates the device's performance as used by operators, rather than a standalone algorithm performance without any human interaction. The device performs automatic tracking and computation, but human operators position the patient and initiate scans. Therefore, a purely standalone algorithm evaluation was not the focus.

7. The Type of Ground Truth Used

The "ground truth" for this precision study was the repeated measurements of lens autofluorescence and scattering response in human crystalline lenses themselves. The study aimed to characterize the natural variability of these measurements taken under controlled conditions, not to correlate them with an independent "true" clinical state (like the presence or absence of a disease).

8. The Sample Size for the Training Set

The document describes a clinical precision study rather than a study involving machine learning model training. Therefore, there is no mention of a training set in the context of an algorithm or model development. The data collected was for evaluating the device's precision, not for training it.

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

Not applicable, as there was no training set mentioned for machine learning model development.

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The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Lower GI, ClearPath Upper GI, and ClearPath Irrigator).

The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Upper GI, ClearPath Lower GI, and ClearPath Irrigator). The ClearPath Tubing is single use, disposable.

The ClearPath irrigation system is designed to improve procedure reliability by improving visualization during endoscopic procedures by performing a colon or stomach wash.

The ClearPath Tubing is used to connect the irrigation fluid source (i.e. water bottle), via the peristaltic pump, to the cleaning device of the ClearPath product family (ClearPath Lower GI, K091305 and K113050, ClearPath Upper GI, K093779 and K113166, and ClearPath Irrigator, K 101094). Note that only the ClearPath accessories are to be used with the ClearPath Tubine.

Here's a breakdown of the acceptance criteria and study information for the ClearPath Tubing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on establishing substantial equivalence to predicate devices for the ClearPath Tubing, which is an irrigation tube for gastrointestinal endoscopic procedures. As such, the "acceptance criteria" are more related to functional performance and safety demonstration rather than specific quantitative metrics often seen with diagnostic devices.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a clinical study with a defined sample size of patients or cases. The performance testing appears to be primarily engineering or bench testing focused on the physical integrity and function of the tubing itself. This type of testing typically involves a number of manufactured units but not a patient-centric test set.

• Sample Size: Not specified in terms of patient/case count. The testing focused on manufactured tubing units.
• Data Provenance: Not applicable in the context of patient data. The tests are likely internal laboratory tests.

3. Number of Experts and Qualifications

This information is not applicable. The device is an irrigation tube, and its performance testing as described focuses on physical properties (leakage, degradation) rather than diagnostic performance requiring expert interpretation.

4. Adjudication Method

This information is not applicable. There's no mention of a human-in-the-loop diagnostic study or a need for expert adjudication.

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

No MRMC comparative effectiveness study was mentioned or conducted. This type of study is more common for diagnostic devices where AI assistance could impact human interpretation.

6. Standalone (Algorithm Only) Performance

Not applicable. The ClearPath Tubing is a physical medical device (irrigation tube), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance acceptance is based on the satisfactory results of engineering tests (leak detection, material integrity, visible degradation) rather than clinical outcomes, pathology, or expert consensus on a diagnosis. The primary "ground truth" for regulatory approval is demonstrating substantial equivalence to predicate devices through functional and design similarities.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML-based system that requires a training set.

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

Not applicable. As noted, there is no training set for this type of device.

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The ClearPath Lower GI is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The proposed modified ClearPath Lower Gl is one component of the predicate ClearPath (K091305) which included a number of components: Controller, Tubing Set, Irrigation set (now referred to as the ClearPath Lower GI). We are proposing to only modify the ClearPath Lower GI which attaches to a conventional endoscope. The ClearPath Lower GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Lower GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the colon during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.

The provided text describes a 510(k) premarket notification for a medical device called "ClearPath Lower GI," an irrigation/evacuation system for colonoscopies. However, the document focuses on demonstrating substantial equivalence to predicate devices through a performance testing summary, rather than presenting a detailed study with specific acceptance criteria and outcome metrics that would typically be found in a clinical trial report.

The performance testing listed aims to verify that the modified device performs as expected and is equivalent to the predicate, but it does not define quantitative acceptance criteria or provide specific numerical results of a study designed to meet those criteria.

Here's an attempt to answer your questions based on the available information, noting where information is not explicitly provided:

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

The document does not explicitly state quantitative acceptance criteria in the format you requested (e.g., a specific success rate, a defined threshold for dislodgement, etc.). Instead, it mentions that "All testing demonstrated that the modified ClearPath Lower GI disposable performed to its specifications and / or was equivalent to the predicate."

Here's a summary of the performance testing categories and the general "reported performance," which is a claim of equivalence/specification compliance rather than specific numerical outcomes:

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: The document does not specify the sample size for the bench or animal testing. For animal testing, it likely refers to a number of individual animals, but this is not quantified.
• Data Provenance: Not explicitly stated. The applicant is "EasyGlide Ltd." from Israel, but whether the testing was conducted in Israel or elsewhere is not mentioned.
• Retrospective or Prospective: Not explicitly stated. Animal testing, by nature, is prospective. Bench testing is also inherently prospective for verifying specific design elements.

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)

This information is not provided in the document. The testing involved "trained medical personnel" for the animal studies, but their specific number or qualifications are not detailed.

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

This information is not provided in the document. It's unclear if any formal adjudication method was used for evaluating the animal testing outcomes.

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

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not conducted. This device is an irrigation/evacuation system, not an AI-powered diagnostic tool, so such a study would not be relevant.
• Effect Size: Not applicable, as no MRMC study or AI component is involved.

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

No, a standalone (algorithm-only) performance was not done. This device is a physical medical instrument requiring human operation in conjunction with an endoscope, not a standalone algorithm.

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

For the animal study, the "ground truth" would be the direct observation and assessment of the device's performance characteristics by trained personnel during the simulated procedure. This would implicitly involve expert judgment on aspects like "ease of maneuverability," "quality of visibility," and "quality of evacuation." There is no mention of pathology or broader outcomes data for these specific tests.

8. The sample size for the training set

This is not applicable as this device is a physical instrument, not a machine learning model, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this device.

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The ClearPath Upper Gl is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The ClearPath Upper GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Upper GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the upper gastrointenstinal tract during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.

The provided document describes a 510(k) premarket notification for the ClearPath Upper GI device, which is an irrigation/evacuation system for endoscopic procedures. The submission is for a modified design of a previously cleared device (K093779).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it describes performance testing in qualitative terms and asserts equivalence to the predicate device.

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

• Test Set Sample Size: The document does not specify a numerical sample size for either the bench or animal testing. It refers to "animal testing," implying more than one animal, but no specific count is given.
• Data Provenance: The testing appears to be conducted by the manufacturer, EasyGlide Ltd., which is based in Kfar Truman, Israel. The study type is prospective as it involves new testing performed for this 510(k) submission, referencing "We have performed bench and animal testing to verify..."

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., for diagnostic accuracy). The testing performed seems to be primarily engineering validation (bench tests) and observational assessment by presumably trained personnel during animal studies. No specific number or qualifications of experts for ground truthing are provided.

4. Adjudication Method for the Test Set

Not applicable. The reported studies are primarily performance verification against specifications and observational assessments during animal trials, not diagnostic accuracy studies requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an irrigation/evacuation system, not a diagnostic imaging device typically requiring MRMC studies to assess human reader performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently through bench and animal testing against its specifications and the performance of the predicate device. This is not "algorithm only" performance as the device is a physical medical device. The testing aimed to confirm that the modified device itself, when used as intended, meets its design and functional requirements.

7. Type of Ground Truth Used

The "ground truth" in this context is based on:

• Pre-defined specifications for dimensional, strength, functional, and mechanical testing.
• Observational assessment during animal testing for factors like dislodgement, maneuverability, visibility, irrigation quality, and evacuation effectiveness. This observational assessment likely relies on the expertise of veterinary or medical personnel conducting the animal procedures.
• Equivalence to the predicate device (K093779), meaning the performance of the modified device was compared to the expected performance of the predicate.

8. Sample Size for the Training Set

Not applicable. This device is a physical, mechanical system, not an AI/ML algorithm that requires a "training set" of data.

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

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

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The ClearPath-UGI System is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The ClearPath UGI's main purpose is to improve procedure reliability by improving procedural visualization during endoscopic procedures. The ClearPath UGI utilizes a suction / irrigation head for the purpose of irrigating or cleaning the upper digestive tract. The ClearPath UGI is composed of two major units: . The disposable Irrigator and . the reusable Control cabinet. The disposable Irrigator is attached to a standard endoscope by means of silicone bands and does not hinder the endoscope's functionality nor affects the procedure sequence in any way. The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.

The provided text describes the ClearPath UGI device and its 510(k) submission for substantial equivalence. However, it does not contain information about a study that proves the device meets acceptance criteria in terms of clinical performance, efficacy, or specific performance metrics beyond simple engineering specifications.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on:

• Identical indications for use.
• Identical technology.
• Identical patient-contact materials.
• Identical environment of use.
• Identical performance specifications (Air/Water pressure, Flow rate, Suction specifications).

Therefore, I cannot populate the table and answer several of your questions as the requested information (related to a clinical study, reader performance, ground truth, and training data) is not present in the provided text.

Here's the information that can be extracted or inferred based on the provided document:

1. Table of acceptance criteria and the reported device performance:

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

Not applicable. The document describes engineering specification comparisons, not a clinical test set.

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):

Not applicable. Ground truth for clinical performance was not established in the provided context. The "ground truth" here is the published specifications of the predicate device.

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

Not applicable. No clinical test set or adjudication is 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:

Not applicable. This device is not an AI diagnostic tool and no MRMC study is mentioned.

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

Not applicable. This is not an AI algorithm; it's a physical medical device accessory.

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

For the purpose of substantial equivalence, the "ground truth" used are the engineering specifications and performance characteristics of the predicate device (K091305 – Easy Glide – ClearPath). The new device's performance was compared against these established specifications.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of the Study (as described in the document):

The "study" described in the 510(k) summary is a benchtop comparison against a predicate device (K091305 – Easy Glide – ClearPath). The purpose was to demonstrate substantial equivalence for the modified ClearPath UGI device, which has a shorter disposable tubing set and a redesigned irrigation tip, but no modifications to the controller or software.

The study involved confirming that the key performance specifications of the proposed device (Air/Water pressure, Flow rate, Suction specifications) are identical to those of the predicate device. This was presented as "testing to demonstrate that the operating performance of the ClearPath UGI is equivalent to the predicate for flow rate, irrigation and vacuum pressures."

The acceptance criteria were simply that the new device's engineering performance for these specific parameters should match those of the legally marketed predicate device. The document states, "Performance specifications - Irrigation pressures, flow rate and suction pressures are identical to the predicate -. K091305 EasyGlide ClearPath."

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