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The Blue Eye is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device.

Blue Eye, submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointestinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.

This is a 510(k) premarket notification for a medical device called "Blue Eye" (model TS-910), a submucosal injection agent used in gastrointestinal endoscopic procedures. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, "Blue Eye" (model TS-905) (K220434), manufactured by the same company.

The provided document describes physical and performance characteristics, but does not include any clinical study data or acceptance criteria relating to device performance for diagnostic accuracy or clinical effectiveness.

The document states that the substantial equivalence determination is based on an assessment of non-clinical performance data. Therefore, the information requested regarding acceptance criteria and a study proving device meets these criteria in a clinical context cannot be fully provided from the given text.

However, I can extract the relevant information from the provided text regarding the non-clinical performance studies conducted:

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

The document does not explicitly state specific numerical acceptance criteria for each non-clinical test, nor does it provide detailed quantitative performance results. It generally states that "The tests were performed on the subject device using the same method as the predicate device, and acceptance criteria," and that based on the results, the device is "as safe and effective and performs as well as the legally marketed predicate device."

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 non-clinical performance tests. There is no information about data provenance because these are non-clinical (laboratory/engineering) tests, not involving human subjects or real-world data collection in a clinical setting.

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

This question is not applicable. The studies described are non-clinical engineering and laboratory tests, not clinical studies requiring expert consensus for ground truth establishment.

4. Adjudication method for the test set

This question is not applicable for the same reason as above.

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 conducted. This device is a submucosal injection agent, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.

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

This question is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements outlined in the referenced ISO and ASTM standards (e.g., sterilization effectiveness, packaging integrity, syringe function). The tests simply confirm whether the device meets these established engineering and safety standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this device is not a machine learning model.

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

This is not applicable as there is no training set.

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The Blue Eye (TS-905) is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions with a snare or endoscopic device.

The Blue Eye (TS-905), submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointenstinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.

This is not an AI/ML SaMD product. The provided text is a 510(k) summary for a medical device called "Blue Eye (TS-905)," which is a submucosal injection agent used in gastrointestinal endoscopic procedures. The information pertains to traditional medical device clearance, not an AI/ML-driven software device.

Therefore, the specific information requested about acceptance criteria, study details for AI/ML performance, sample sizes for test and training sets, expert qualifications, and adjudication methods for AI/ML ground truth cannot be extracted from this document because it is not applicable to this type of device.

The study described is a non-clinical performance test comparing the device to a predicate device, focusing on sterilization, shelf-life, biocompatibility, and physical characteristics. There is no mention of an algorithm or AI/ML components.

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The gel is an injection agent for endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD).

Not Found

The provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for a device called "LiftUp" (a gel for endoscopic mucosal resection and/or endoscopic submucosal dissection). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for the manufacturer.

To answer your request, I would need a different document that details the performance study and acceptance criteria for the "LiftUp" device.

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Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early state cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. Under the surveillance of endoscope, in conjunction with endoscopic injection needles with a diameter equal to or greater than 23G are recommended), inject the product beneath the lesion until enough submucosal lift. It is supplied in a 5 mL, 10ml syringe. The contents of the syringe are sterile and nonpyrogenic. The proposed devices are moist heat sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 2 years.

The provided document describes the Micro-Tech (Nanjing) Co., Ltd. Blue Beacon™ Submucosal Injectable Solution (K200071) and its substantial equivalence to a predicate device. This document is a 510(k) summary, which focuses on demonstrating equivalence rather than providing detailed acceptance criteria and a comprehensive study report with statistically significant outcomes against specific acceptance thresholds for a diagnostic AI device.

Therefore, the requested information, which is typical for a diagnostic AI device requiring performance against quantitative acceptance criteria, is largely not present in this type of submission. The device described is a medical injectable solution, not an AI or diagnostic device.

However, I can extract the available information which pertains to device performance and testing, and explain why other requested details are not applicable or provided in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a non-AI injectable solution, there are no "acceptance criteria" in the sense of accuracy, sensitivity, or specificity metrics typical for AI or diagnostic devices. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Eleview™ Submucosal Injection Composition, K150852) and meeting general medical device standards.

The "acceptance criteria" are implicitly meeting the performance characteristics of the predicate device and relevant international standards.

Note on Differences: The differences in sterilization method, composition, and packaging are addressed by performance testing (bench tests, syringe tests, biocompatibility, sterilization validation) to demonstrate that these differences do not raise new questions of safety or effectiveness. The conclusion is that despite these differences, the devices are "substantially equivalent."

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

• Sample Size for Test Set: Not explicitly stated numerically for "bench performance tests" (Appearance, Content, pH, etc.) or for the pre-filled syringe tests. The document mentions "a series of bench performance tests" and "a series tests were conducted" which implies multiple samples were tested under each category.
• Data Provenance: The studies were conducted by Micro-Tech (Nanjing) Co., Ltd. in China, as indicated by the company's address and the origin of the submission. The studies are retrospective in the sense that they are conducted on manufactured devices and evaluated against established standards and the predicate device's characteristics.

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 and not provided as the device is an injectable solution, not a diagnostic device requiring expert interpretation of results or images. The "ground truth" for the performance tests would be objective measurements against specified physical/chemical properties or validated standards.

4. Adjudication Method for the Test Set

This information is not applicable as the device is not a diagnostic device requiring adjudication of human reader interpretations.

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 device is not an AI diagnostic tool and therefore no MRMC studies involving human readers and AI assistance would be performed.

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 not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics of this device is based on:

• Objective measurements of physical and chemical properties (e.g., pH, viscosity, content, colorant concentration).
• Compliance with international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization, ASTM F1980 for accelerated aging).
• Comparison to the established characteristics of the legally marketed predicate device (K150852) to demonstrate substantial equivalence.
• Animal testing for safety and effectiveness, conducted under GLP Regulations (21 CFR §58), is also cited as "ground truth" for in-vivo performance.

8. The Sample Size for the Training Set

This information is not applicable as the device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable as the device does not involve a "training set."

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EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.

The GI Supply EverLift™ Submucosal Lifting Agent (10mL) is a prefilled plastic syringe with attached plunger rod containing 10mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available endoscopic injection needle.

EverLift™ Submucosal Lifting Agent is an injectable liguid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD), and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers, and other pathological lesions by EMR, ESD, or polypectomy.

EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD, or polypectomy).

This document focuses on the EverLift™ Submucosal Lifting Agent (10mL) and its substantial equivalence to a predicate device, the EverLift™ Submucosal Lifting Agent (5mL). This is a medical device, not an AI/ML algorithm, therefore most of the requested information regarding AI/ML studies (such as MRMC studies, standalone performance, training set details, or ground truth establishment methods for AI) is not applicable.

The acceptance criteria and device performance are established through a series of non-clinical performance tests designed to show that the 10mL device is as safe and effective as the previously cleared 5mL predicate device.

Here's the relevant information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical performance tests. For each test, the conclusion is that the subject device (10mL) performed equivalently or met the acceptance criteria used for the predicate device (5mL). The specific numerical acceptance criteria for each test are not explicitly detailed in quantifiable values, but rather referred to as "the same method and acceptance criteria as the predicate device" or conforming to specific ISO/USP standards.

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

The document does not explicitly state the sample sizes used for each individual non-clinical performance test. It refers to "the subject device" and "the predicate device" implying that samples of each were tested.

The data provenance is from non-clinical performance testing conducted by the manufacturer, GI Supply. This is typically laboratory or bench testing. There is no mention of human subject data, retrospective, or prospective studies in a clinical setting.

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

This question is not applicable as this is a medical device performance study, not a study evaluating an AI/ML algorithm requiring expert ground truth for interpretation of images or other data. The "ground truth" for these tests is defined by the technical specifications of the device and relevant international standards (e.g., ISO, USP, ASTM).

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML study requiring adjudication of expert interpretations. The evaluation is based on objective measurements against predefined technical specifications and standards.

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

No. An MRMC comparative effectiveness study is not mentioned 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 device is a submucosal lifting agent, a physical medical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" (or basis for acceptance) for these non-clinical performance tests consists of:

• Technical specifications of the device (implying equivalence to the predicate device).
• International standards such as ISO 7886-1:2017, ISO 17665-1, USP , USP , ASTM D7386-16, and ASTM F1980-16.
• The performance of the legally marketed predicate device (K191923) as a benchmark for equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or medical "ground truth" established in this context.

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EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.

The GI Supply EverLift™ Submucosal Lifting Agent is a prefilled plastic syringe with attached plunger rod containing 5mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available, endoscopic injection needle.

The EverLift™ Submucosal Lifting Agent is an injectable liquid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy.

EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal laver, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).

The provided document is a 510(k) premarket notification for the EverLift Submucosal Lifting Agent, describing its substantial equivalence to a predicate device. It details non-clinical performance testing but does not include information about AI/ML device performance or clinical studies involving human readers or AI assistance. Therefore, I cannot fulfill all parts of your request related to AI/ML device acceptance criteria and studies.

Based on the provided text, here's what can be extracted and what cannot:

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

The document speaks to "functional and performance requirements" and various "functional performance tests" but does not explicitly list quantified acceptance criteria with corresponding performance metrics in a clear table format that would be typical for an AI/ML device. Instead, it states that tests were conducted to "demonstrate substantial equivalence."

Acceptance Criteria and Reported Device Performance (as inferred and specified in the document):

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 mentions "a series of functional performance tests, animal studies, biocompatibility tests, and sterility tests" but does not provide specific sample sizes (e.g., number of devices tested, number of animals in the preclinical study).
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a non-AI/ML device based on physical/chemical properties and animal studies, "retrospective/prospective" in the context of clinical data isn't directly applicable here.

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 applicable and not provided as this is a medical device for submucosal lifting, not an AI/ML diagnostic or image analysis device requiring expert ground truth for image interpretation. The ground truth for this device's performance is based on physical/chemical measurements and in-vivo effects in animal models.

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

This information is not applicable and not provided as this relates to expert review and consensus for imaging or diagnostic studies, which is not relevant to this device's 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

This information is not applicable and not provided. The device is not an AI/ML algorithm that assists human readers. It is a physical agent used in endoscopic procedures.

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

This information is not applicable and not provided. The device is not an AI algorithm.

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

The "ground truth" for this device's performance is established through:

• Direct physical and chemical measurements (e.g., pH, viscosity, osmolality, density, flow rate).
• Direct observation of physical effects and safety in an in vitro (container integrity) and ex vivo / in vivo (porcine model for lift duration and performance) setting.
• Results from standardized biocompatibility, sterility, and aging tests.
  This is not based on expert consensus, pathology, or outcomes data in the typical sense of AI/ML diagnostic evaluation.

8. The sample size for the training set

This information is not applicable and not provided as this is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided as this is not an AI/ML device that requires a training set.

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EndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

EndoClot® Submucosal Injection Agent is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a plastic bottle and a spiral plunger syringe. AMP® particles are dissolved with sterile 0.9% saline to make the agent prior to use. The syringe has a Luer lock fitting to ensure a secure connection to a standard, commercially available endoscopic injection needle. The agent can be injected by rotating the plunger.

This document does not contain the information required to fully answer the request. The document describes a medical device, the EndoClot Submucosal Injection Agent, and its substantial equivalence to predicate devices, but it does not provide detailed acceptance criteria and the results of a specific study proving the device meets these criteria in the format requested.

However, I can extract what is available regarding performance and testing:

Key Takeaways (Missing Data for Comprehensive Answer):

• No explicit "acceptance criteria" table with corresponding "reported device performance" values are provided. The document states that performance tests were conducted and that the device meets design specifications, but it doesn't quantify those specifications or the results in a comparative table.
• The document describes device verification rather than a clinical study for demonstrating "AI vs. human" comparative effectiveness. The device is a physical submucosal injection agent, not an AI or imaging diagnostic tool that would typically involve such a study.
• No information is provided about training sets, expert qualifications, adjudication methods, or specific sample sizes for establishing ground truth, as these are typically relevant for AI/diagnostic device studies.

Extracted Information Regarding Device Performance and Testing:

Here's an attempt to structure the available information, noting where requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (for Animal Study): Not specified. The document states "Animal studies have also been conducted," but does not give the number of animals.
• Data Provenance: "porcine model" (animal study).
• Retrospective/Prospective: Not specified, but animal studies are typically prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This information is typically relevant for diagnostic devices that require expert review (e.g., radiologists interpreting images). The EndoClot device is a physical injection agent, and its performance (e.g., lift, duration, safety) is assessed directly through physical and biological tests, not by expert interpretation of data.

4. Adjudication Method for the Test Set

• Not Applicable. As above, adjudication methods are usually for resolving discrepancies in expert interpretations, which is not relevant for this type of device testing.

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

• No. An MRMC study is not relevant for this device. This type of study would compare human readers' performance with and without an AI diagnostic aid. The EndoClot device is a physical medical device (submucosal injection agent), not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This question is also focused on AI/algorithmic performance, which does not apply to a physical medical device like the EndoClot Submucosal Injection Agent.

7. The Type of Ground Truth Used

• For Biocompatibility and Sterility: Established by adherence to recognized international standards and guidance documents (e.g., ISO, OECD, ASTM, USP).
• For Material Properties (pH, density, viscosity, osmolality): Likely established through laboratory measurements and comparison to predicate device specifications.
• For "Cushion-forming duration": Likely established through laboratory or in-vivo testing to measure duration of submucosal lift.
• For Efficacy/Safety: Established through observed outcomes in the porcine model following EMR/ESD procedures, likely including visual assessment of lift and histological examination for safety.

8. The Sample Size for the Training Set

• Not Applicable. This question relates to machine learning models. The EndoClot device is a physical product and does not involve a "training set" in this context.

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

• Not Applicable. As above, this relates to machine learning.

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This device is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers, or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.

The ORISE™ Gel device is a viscous dyed solution which is pre-filled into a standard luer lock syringe for use in submucosal injection to lift gastrointestinal mucosa during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, such as the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy. The Injection is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope.

The ORISE™ Gel is a submucosal injection agent used in gastrointestinal endoscopic procedures to lift lesions prior to excision. The provided text outlines the performance data for the device, including acceptance criteria derived from comparative testing against a predicate device and safety/efficacy studies.

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

• Bench Testing: Not specified for individual tests, but comparative testing was conducted against the predicate device.
• Ex-Vivo Testing: Not specified, but direct comparison was made to the predicate (Eleview) and dyed saline.
• Preclinical Testing (Porcine Study):
  • Test set for efficacy and safety:
    • EMR procedures: 12 performed with ORISE™ Gel (Test Article) and 12 with dyed saline (Control Article). Total n=24.
    • ESD procedures: 11 performed with ORISE™ Gel (Test Article) and 11 with dyed saline (Control Article). Total n=22.
    • Overall total n=46 procedures.
  • Data Provenance: The study was conducted in a porcine model, meaning it used animal subjects. This is a prospective study design, as procedures were performed specifically to evaluate the device. The country of origin of the data is not specified.

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

This information is not provided in the given text. For a device like this, "ground truth" might refer to expert assessment of the quality of submucosal lift, ease of use, or adverse events. The text only states that a preclinical study was conducted, implying observational data collection rather than expert adjudication of a fixed dataset.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated in the provided text. In a porcine study, the assessment of efficacy (e.g., quality and duration of lift) and safety (e.g., signs of tissue damage) would typically be performed by trained veterinary or medical personnel involved in the study. It's unclear if multiple independent observers were used or if a consensus method was employed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The studies described are bench tests, ex-vivo tests, and a preclinical animal study. These types of studies do not involve human readers assessing cases. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. This device is a medical product (a gel), not an AI-powered diagnostic or assistive technology.

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

This question is not applicable as the device is a medical product (submucosal injection gel), not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

• Bench Testing: Engineering specifications and direct measurements (e.g., viscosity, pH, osmolality, injection force, physical integrity tests). Comparison to predicate device performance served as a benchmark for equivalence.
• Ex-Vivo Testing: Direct measurement of tissue lift height and duration, likely against predetermined success criteria or direct comparison to the predicate and saline.
• Preclinical Testing (Porcine Study):
  • Efficacy: Directly observed and measured submucosal lift, determined by the operative team and potentially recorded measurements (e.g., lift height, duration). The "ground truth" for efficacy was whether the gel produced a lift comparable to the control (dyed saline) that facilitated EMR/ESD.
  • Safety: Direct observation of adverse events, tissue response, and macroscopic/microscopic examination of the treated areas in the porcine model. The "ground truth" for safety was the absence of significant adverse effects or comparability to the control.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (a gel), not an AI model that requires a training set. The descriptions relate to product development and validation studies, not machine learning.

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

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

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The SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.

SIC 8000 is an injectable liquid composition in the form of an oil-in-water (o/w) emulsion for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, such as the esophagus, the small intestine, the colon, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy. SIC 8000 is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The emulsion, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).

The provided document is a 510(k) summary for the SIC 8000 device, which is an injectable liquid composition for submucosal lift during gastrointestinal endoscopic procedures. While it states that "A series of performance tests and animal studies were conducted which demonstrated the quantitative mechanical performance, tolerance and usability of SIC 8000 in endoscopic procedures," the document does not provide specific details on the acceptance criteria, the study design, sample sizes, expert qualifications, adjudication methods, or whether MRMC or standalone studies were performed.

Therefore, I cannot fully answer your request based solely on the provided text. The requested information regarding acceptance criteria and the study that proves the device meets them, along with specific details about the study design, is not present in this 510(k) summary.

Based on the available information, here's what can be deduced, with significant gaps:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not detailed in the document. The summary only generally states that "A series of performance tests and animal studies were conducted which demonstrated the quantitative mechanical performance, tolerance and usability of SIC 8000 in endoscopic procedures."

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

• Sample Size for Test Set: Not specified.
• Data Provenance: The document mentions "animal studies," implying the data originated from animal models, but it does not specify the country of origin or whether the studies were retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Not specified.

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 device is described as an "injectable liquid composition" for submucosal lift, not an AI software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device. The document does not mention any AI components.

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

• Again, as this is an injectable substance and not an AI algorithm, the concept of a standalone algorithm performance study is not applicable. The document does not mention an algorithm.

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

• Given it's an injectable composition for medical procedures, the ground truth would likely involve direct observation during endoscopic procedures, histological analysis (pathology) of resected tissues, and potentially short-term outcomes data to assess the efficacy of the lift and success of the resection. However, the document does not explicitly state how ground truth was established for the "performance tests and animal studies."

8. The sample size for the training set:

• Not applicable as this is not an AI device that typically relies on a training set in the conventional sense for machine learning. The term "training set" is usually associated with AI/ML model development.

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

• Not applicable for the same reason as point 8.

In summary:

The provided 510(k) summary is a high-level overview intended to demonstrate substantial equivalence to a predicate device. It does not contain the detailed study protocols, results, acceptance criteria, or statistical analysis that would be present in a comprehensive clinical or performance study report. To obtain the requested information, one would typically need access to the full 510(k) submission, which includes the detailed performance data.

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