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EndoClot® PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.

EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS) is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a PE bellow and an EndoClot® Applicator (K162197). The device contains no human or animal components. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch.

The provided text describes the 510(k) premarket notification for the EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS), seeking substantial equivalence to predicate devices, primarily Hemospray®. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) study. The performance data presented are for the medical device itself, demonstrating its physical and biological equivalence to the predicate, rather than the performance of an algorithm or human readers.

Therefore, many of the requested criteria related to AI/ML device performance, expert ground truth establishment, adjudication methods, and MRMC studies, cannot be extracted from this document.

However, I can provide information based on the device's performance tests and studies, framed as acceptance criteria and proof of meeting them:

Acceptance Criteria and Device Performance for EndoClot® PHS

The EndoClot® PHS is a medical device intended for hemostasis of nonvariceal gastrointestinal bleeding. The studies presented aim to demonstrate that the proposed device is substantially equivalent to its predicate devices (Hemospray® and EndoClot® Applicator) by meeting specific performance, biocompatibility, and safety criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the properties of EndoClot® PHS were evaluated and compared to the predicate device Hemospray®. The acceptance criteria were implicitly set as being "similar to or better than" the predicate device.

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

The document does not explicitly state the sample sizes for the performance tests (e.g., number of units tested for spray pattern, pressure). For the in vivo animal study, it specifies a "swine model" but does not give the number of animals used. The provenance of the data is from testing conducted by the manufacturer (EndoClot Plus Co., Ltd. and their correspondent Med-wheat Shanghai) to support their 510(k) submission. The type of study is prospective testing of the device's physical, chemical, biological, and functional properties. The country of origin for the submitter is China (Shanghai).

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

This information is not applicable to the type of device and studies described. The "ground truth" here is objective physical, chemical, and biological measurements, and observed hemostatic performance in an animal model, rather than expert interpretation of medical images or patient outcomes for an AI algorithm.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are device performance tests and animal studies, not interpretative studies requiring human expert adjudication.

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

An MRMC study was not done. This type of study is relevant for AI/ML diagnostic or interpretative devices where human performance with and without AI assistance is evaluated. The EndoClot® PHS is a medical device for direct therapeutic intervention, not an AI/ML algorithm.

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

The "ground truth" used for this device evaluation consisted of:

• Objective physical measurements: For parameters like gas source pressure, spray pattern, delay time, powder feeding rate, water absorbency, and pH.
• Adherence to standardized biological safety tests: Biocompatibility, sterility, and chemical characterization tests following ISO and FDA guidelines.
• Observed physiological outcomes: In the in vivo swine model, the ability of the device to achieve hemostasis when applied to gastrointestinal bleeding. This can be considered a form of "outcomes data" in an animal model.
• Comparison to predicate device: The ultimate "ground truth" for substantial equivalence is the demonstration that the proposed device performs "similar to or better than" the legally marketed predicate device.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable as it refers to an AI/ML context that is not relevant to this device.

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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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The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the treatment site in endoscopic surgeries.

EndoClot® Applicator is a medical device composed of applicator (catheter, gas/powder mixing chamber), connecting tube and gas filter, with a tube connecting to gas source in hospital. The device has good biocompatibility. By combining with external gas source, it can deliver the powdered hemostatic agent to the treatment site in endoscopic surgical procedures.

This document is a 510(k) premarket notification for a medical device called the "EndoClot® Applicator," which is intended to assist in the delivery of a powdered hemostatic agent during endoscopic surgeries.

The acceptance criteria and study proving the device meets these criteria are not described in detail in the provided text in the way a clinical study for a new AI/software medical device would be. This document is a 510(k) summary for a Class II medical device, which demonstrates substantial equivalence to a previously cleared predicate device, rather than proving novel effectiveness through rigorous clinical trials and statistical goals.

Here's a breakdown based on the provided text, and where it falls short of the requested information for an AI/software device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present acceptance criteria in a quantitative, measurable way for performance as one would expect for an AI/software device (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" for a 510(k) are typically met by demonstrating:

• Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device.
• Meeting Recognized Standards: Compliance with relevant international and FDA-recognized standards for medical devices (e.g., biocompatibility, sterility, performance testing).

Reported Device Performance (as inferred from the document):

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

• Sample Size: Not specified in terms of clinical cases or patient data. The "tests" mentioned are non-clinical, involving materials, sterilization, and basic functional characteristics.
• Data Provenance: The tests were "conducted related non-clinical tests" by the submitter (EndoClot Plus Co., Ltd.). The location of the company is China (Suzhou Industrial Park). No human data or patient samples are referenced for these non-clinical tests.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable in this context. This device is a mechanical applicator, not an AI/software device requiring expert interpretation of diagnostic images or patient outcomes for ground truth establishment. The "ground truth" for this submission revolves around physical and chemical properties and functional equivalence to a predicate device, assessed through laboratory testing and engineering analysis, not expert clinical consensus.

4. Adjudication Method for the Test Set:

• Not applicable. There's no test set in the sense of clinical cases requiring adjudication by multiple readers or experts. Device testing (biocompatibility, sterility, etc.) typically involves passing pre-defined criteria in laboratory settings.

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

• Not performed/applicable. This type of study is specifically designed for AI/software devices where human readers' performance with and without AI assistance is evaluated. This 510(k) is for a mechanical medical device, not an AI.

6. Standalone (Algorithm Only) Performance:

• Not applicable. As this is a mechanical applicator, there is no "algorithm" or standalone software component to evaluate.

7. Type of Ground Truth Used:

• The "ground truth" for this device's substantial equivalence determination is based on engineering specifications, material properties, predicate device characteristics, and compliance with recognized international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, ISO 11607 for packaging). It is not based on expert consensus, pathology, or outcomes data from a clinical trial.

8. Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. As there is no training set, there is no ground truth establishment process for it relevant to AI/ML.

In summary: The provided document describes a 510(k) submission for a physical medical device (EndoClot® Applicator). The "proof" that it meets acceptance criteria (substantial equivalence) is primarily through non-clinical bench testing, material characterization, and direct comparison of design and intended use to a legally marketed predicate device (MEDAFOR DIRECT Gas-Assisted Application System in K123325). The document does not involve or require the types of studies (clinical trials, expert consensus, MRMC studies) typically associated with establishing performance and ground truth for AI/software medical devices.

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