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Nexpowder™ is used for hemostasis of nonvariceal gastrointestinal bleeding.

The Nexpowder is used for hemostasis of non-variceal gastrointestinal bleeding. It is a prescription only, single-use device provided with a powder pre-packaged in a vial, and a delivery system, which consists of a spray body, a connector and a delivery catheter is inserted through an endoscope's working channel to deliver the powder to the intended hemostasis target site. Nexpowder is almost identical to the currently marketed device (K202929) and has the same technological characteristics and mechanism of action, but differs in the indications for use, where the subject device is also indicated for lower GI bleeding.

Here's a breakdown of the acceptance criteria and study information for the Nexpowder™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device, which implies that the Nexpowder™ should perform comparably to the predicate for the expanded indications. The reported performance is primarily about showing comparability.

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

• Sample Size: A total of 260 lower GI cases.
• Data Provenance: Clinical data was collected:
  • Outside the United States (OUS)
  • Prospective study conducted in Korea.
  • Retrospective studies conducted in Korea.
  • Aggregated data collected in the European Union (EU).

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

The document does not specify the number of experts used to establish ground truth for the clinical studies, nor does it detail their qualifications (e.g., "radiologist with 10 years of experience"). It generally refers to "clinical data" without providing these specifics.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the test set.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with AI vs. without AI assistance. This device is a physical hemostatic device, not an AI/software device, so an MRMC study would generally not be applicable in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as Nexpowder™ is a physical medical device (hemostatic powder and delivery system), not an algorithm or software. There is no "algorithm only" performance to be assessed.

7. Type of Ground Truth Used

The "ground truth" for the clinical studies would be clinical outcomes related to hemostasis of non-variceal gastrointestinal bleeding. This would involve medical assessment of whether bleeding was successfully stopped using the device.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a physical medical device, not an AI/software product, so the concept of a training set as often discussed in AI studies is not applicable here. The "training" for the device would be its prior development and testing, including the clinical data supporting its previous clearance (K202929).

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

As above, the concept of a "training set" in the AI sense is not applicable. For the development and prior clearance (K202929) of Nexpowder, the "ground truth" would have been established through a combination of:

• Pre-clinical testing: Laboratory and animal studies to demonstrate the hemostatic properties and safety of the powder and delivery system.
• Clinical studies (for K202929): Data from human trials (likely for upper GI bleeding) to establish safety and effectiveness, similar to the type of clinical outcome data described above for the lower GI indication expansion.

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PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.

PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel-filled syringe via the polypropylene adapter (Class 1 - 510k Exempt) also commercially available (Class 1, 510k Exempt). PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

The provided text is a 510(k) summary for the PuraStat device. It states that the subject device (K242250) is identical to the predicate device (K222481) except for the final sterilization method. The document explicitly states that the "device is identical to the predicate device and has the same intended use."

Therefore, the performance data provided is to demonstrate equivalence to the predicate device, not to establish new performance criteria for the subject device. It relies on the predicate's performance to establish substantial equivalence.

Based on the provided information, I can answer some of your questions and explain why others cannot be answered from this specific document:

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

   • This document does not provide a table of acceptance criteria and reported device performance for the new device in the general sense of clinical performance or accuracy for an AI/diagnostic device.
   • Instead, it states, "The subject device is identical to the predicate device...an equivalence demonstration was performed following the final sterilization change. The bench testing and biocompatibility testing provided in this submission assess the equivalence demonstration."
   • The "acceptance criteria" here are to show that the change in sterilization does not alter the device's fundamental properties or safety, ensuring it performs identically to the predicate device. Specific numerical performance metrics for hemostasis are not detailed in this filing, as they would have been established and accepted for the predicate device.

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

   • This information is not provided in this 510(k) summary. The testing mentioned (bench testing and biocompatibility) is related to the change in sterilization, not a clinical trial to establish new efficacy for the device's intended use.

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 is not applicable and is not mentioned. The device is a hemostatic gel, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis.

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

   • Not applicable as this is not an AI/diagnostic device based on expert interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This is not an AI-assisted diagnostic device.

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

   • Not applicable. The device is a physical hemostatic gel, not an algorithm.

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

   • Not applicable in the context of an AI/diagnostic ground truth. The "ground truth" for this filing is that the subject device, with its new sterilization, is functionally identical and safe compared to the predicate through bench and biocompatibility testing. Clinical efficacy would have been established for the predicate device, likely through clinical studies demonstrating hemostatic success (e.g., control of bleeding, resolution of bleeding events), which would have served as the "ground truth" for its performance.

8. The sample size for the training set

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

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

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

Summary of Relevant Information from the Document:

• Device Name: PuraStat
• Intended Use: Hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. Not indicated for arterial Forrest 1a bleeding.
• Key Change from Predicate: Final sterilization method (replaced by gamma radiation sterilization).
• Performance Data Provided: Bench testing and biocompatibility testing to demonstrate equivalence between the subject device (with new sterilization) and the predicate device.
• Conclusion: The subject device is substantially equivalent to the predicate (K222481) as the change in sterilization does not raise any new questions of safety and effectiveness, and the device remains identical in material, formulation, manufacturing, and final product specifications. The performance of the predicate device is implicitly relied upon.

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PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.

PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter. PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

The provided document is a 510(k) Premarket Notification from the FDA for a device called PuraStat. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the typical sense of a diagnostic or AI-driven medical device evaluation.

The document states that the PuraStat device is identical to its predicate device (PuraStat-GI, K210098). Therefore, most performance data, including bench testing, animal testing, and biocompatibility testing, were referenced from the predicate device's filing.

However, there is an additional indication for PuraStat: "primary non-variceal gastrointestinal (GI) bleeding." To address this new indication, the submission references a clinical study found in the literature. This study evaluates the safety and effectiveness of PuraStat for this specific use, which can be interpreted as demonstrating the device's acceptable performance for this particular indication.

Based on the provided text, here's a breakdown of the requested information, focusing on the Branchi et al. Study which supports the additional indication:

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

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it defines primary and secondary endpoints for the clinical study, and the reported results of these endpoints demonstrate the device's performance that was deemed acceptable by the FDA for the new indication.

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

• Sample Size: 111 patients with gastrointestinal bleeding.
• Data Provenance: Retrospective and prospective. The study was a "prospective, consecutive open-label, multi-center study" conducted between July 2017 and December 2018 at 15 endoscopy departments in Germany.

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

The document does not provide details on the number or qualifications of experts establishing ground truth within the Branchi et al. Study. The study design indicates a multi-center observational study, suggesting that treating physicians at each of the 15 endoscopy departments made the assessments of hemostasis and rebleeding. These would presumably be "experts" in gastrointestinal endoscopy, but no specific qualification (e.g., "radiologist with 10 years of experience") or number is detailed.

4. Adjudication method for the test set

The document does not specify an adjudication method (like 2+1, 3+1). The nature of the study (observational, multi-center) suggests that assessments were likely made by the treating clinicians at each site. There is no mention of independent adjudication of 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a hemostatic device, not an AI-driven diagnostic or assistive technology for human readers. Therefore, the concept of improving human readers with AI assistance is not applicable.

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

No, PuraStat is a physical hemostatic gel, not an algorithm. Its performance is always in a "human-in-the-loop" scenario, as it is applied by an endoscopist.

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

The ground truth for the Branchi et al. Study was based on clinical outcomes and expert observation during and after endoscopic procedures:

• Procedure success (hemostasis): Assessed by the endoscopist during the procedure.
• Therapy success (prevention of rebleeding): Defined by the absence of clinical signs of gastrointestinal bleeding (hematemesis, melena, hematochezia) in association with cardiovascular stability or a stable hemoglobin level, assessed at 3 and 7 days after application.
• Adverse events: Recorded over 30 days post-procedure.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning. The Branchi et al. Study is a clinical trial evaluating the device's performance, not training an algorithm.

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

Not applicable, as there is no "training set" in the context of this device.

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Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding.

The Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding. The Nexpowder™ is a prescription only, single-use device provided with a pre-packaged powder, a vial, and a Delivery System, which consists of a Spray body, a Connector and a Delivery Catheter. The powder vials are provided in a sterile condition with gamma radiation sterilization and the non-sterile external Spray Body delivery system with its sterile Connector and sterile Delivery Catheter. The hemostatic powder agents of the Nexpowder™ are primarily composed of succinic anhydride ({-poly-L-lysine) and oxidized dextran and are endoscopically applied through a catheter channel of the delivery system to control qastrointestinal bleeding in the upper qastrointestinal tract. Utilizing the installed battery power, air pressures are generated from the air pump placed in the spray body of Nexpowder™ delivery system to provide effective physical force to move the hemostatic powder agent into the delivery catheter. The hemostatic agents of the Nexpowder™ ultimately get sprayed onto the hemostasis target site in the gastrointestinal tract. Nexpowder is excreted from the patient's gastrointestinal or digestive system primarily by peristalsis of the human digestive system within the three days.

The device described is Nexpowder™, a hemostatic device for intraluminal gastrointestinal use. The information provided outlines the device's characteristics and the studies performed to demonstrate its safety and effectiveness for FDA 510(k) clearance.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device (Hemospray® Endoscopic Hemostat) and the various testing performed to demonstrate substantial equivalence, particularly in terms of hemostatic efficacy and safety. The performance metrics focus on initial hemostasis rates, re-bleeding rates, and the absence of adverse events.

2. Sample Size for the Test Set and Data Provenance

The "test set" for performance evaluation consists of both animal studies and human clinical data.

• Animal Studies (Porcine Studies I & II):

  • Sample Size:
    • Study I: 6 Nexpowder™ treated, 6 Hemospray® treated (predicate), 3 sham controls (total 15 pigs).
    • Study II: 6 Nexpowder™ treated, 3 Hemospray® treated (predicate) (total 9 pigs).
  • Data Provenance: Prospective animal studies conducted in a controlled environment (porcine model for upper gastrointestinal bleeding).

• Human Clinical Data (Real-world evidence from OUS market):

  • Sample Size:
    • Clinical Study A: 76 patients (37 Nexpowder™ in test group)
    • Clinical Study B: 56 patients
    • Clinical Study C: 17 patients
    • Clinical Study D: 41 patients
    • Clinical Study E: 50 patients (Retrospective Aggregated Data Collection survey)
    • Total: 240 patients (excluding the 39 from study A that likely received a comparator or were not Nexpowder treated based on the provided numbers, and noting that the document states "315 patients with an additional 50 patients from a Retrospective Aggregated Data Collection survey" which doesn't perfectly match the sum of individual study patient numbers provided. Assuming the sum of reported patients in the table are the test set.)
  • Data Provenance: Real-world evidence (RWE) from the OUS (outside U.S.) market. Clinical Studies A, B, C, D are likely retrospective or prospective observational studies from OUS. Clinical Study E is explicitly stated as a "Retrospective Aggregated Data Collection survey." The specific countries of origin are not detailed in this summary.

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

This information is not explicitly provided in the given text.

• For the animal studies, histopathological evaluation was performed, implying expert pathologists. However, the number and qualifications are not mentioned.
• For the human clinical data, clinical outcomes (hemostasis, re-bleeding, adverse events) are reported, which by definition would be assessed by medical professionals. However, the specific number of experts, their role in establishing "ground truth," or their qualifications (e.g., "radiologist with 10 years of experience") are not detailed. It's common in clinical trials for treating physicians to establish these outcomes.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the given text.

• For the prospective clinical study (Study A), it is described as "Prospective, Multicenter, Single-blind (subject) Controlled Clinical Trial." This suggests formal data collection, but it does not specify if an independent adjudication committee was used for outcomes like hemostasis or adverse events, or if a 2+1/3+1 consensus method was employed for ground truth establishment.
• For the other clinical studies and the retrospective survey, the adjudication method for reported outcomes is not mentioned.

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

An MRMC study is typically performed for diagnostic imaging devices where human readers interpret images with and without AI assistance. This device, Nexpowder™, is a hemostatic device, not an imaging or diagnostic device. Therefore, an MRMC comparative effectiveness study as described (human readers with/without AI assistance) would not be applicable and was not performed.

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

This question is also not applicable in the context of Nexpowder™ as it is a physical medical device (hemostatic powder and delivery system), not an AI algorithm. The device's performance is inherently "standalone" in how it acts on the tissue, but it still requires a human operator (endoscopist) for delivery. There is no AI component to the device itself that would be evaluated in an "algorithm only" manner.

7. The Type of Ground Truth Used

• Animal Studies:
  • Direct observation: Initial hemostasis, re-bleeding episodes.
  • Histopathology: Microscopic examination of tissue at the device application site, likely confirmed by expert pathologists.
• Human Clinical Data:
  • Clinical Outcomes: Initial hemostasis, re-bleeding events, and adverse events as observed and documented by treating clinicians. This represents clinical consensus based on standard medical practice and diagnostic criteria.

8. The Sample Size for the Training Set

This information is not applicable as Nexpowder™ is a physical medical device, not an AI, algorithm-driven, or machine learning device that requires a "training set." The development of the device involves engineering, chemical formulation, and preclinical testing, rather than data-driven model training.

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

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

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PuraStat-GI is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding.

PuraStat-GI is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter.

PuraStat-GI is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat-GI achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

The provided text describes a 510(k) premarket notification for the device PuraStat-GI, a hemostatic device for intraluminal gastrointestinal use.

It details bench testing, animal studies, and clinical studies of the device. However, it does not explicitly state specific acceptance criteria (e.g., "The device must achieve hemostasis in X% of cases with Y% confidence interval"). Instead, it presents reported device performance and implies that these results demonstrate substantial equivalence to a predicate device, thereby meeting the FDA's requirements for market clearance.

Therefore, the response below will present the reported device performance from the provided text and note the absence of explicitly stated numerical acceptance criteria.

Acceptance Criteria and Study Details for PuraStat-GI

While the document does not explicitly list specific numerical "acceptance criteria" that the device must meet (e.g., "hemostasis rate must be >X%"), it presents the performance data of PuraStat-GI from three clinical studies, alongside a comparison to a predicate device in bench and animal testing, to demonstrate substantial equivalence. The implied acceptance is that the device's performance is comparable to or better than established benchmarks in terms of safety and effectiveness for its intended use.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Note: The acceptance criteria are "implied" based on the presentation of data to support device clearance, rather than explicit numerical targets defined in the document.

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

The provided text details three clinical studies that serve as the "test set" for human performance data for PuraStat-GI:

• Subramaniam (2019): N=100 patients
• de Nucci (2020): N=77 patients
• Subramaniam (2020): N=46 patients

Total clinical patients: 223 patients.

Data Provenance: The document states these are "results of three clinical studies of the use of PuraStat® that have been reported in the literature." This indicates these were likely retrospective analyses of previously conducted and published clinical trials. The specific countries of origin for these studies are not specified in the provided document.

Additionally, a GLP gastrointestinal mucosal defect study was conducted in a porcine model with a comparative side-by-side assessment against the predicate device. The sample size for this animal study is not specified.

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

The document does not provide information on the number of experts used to establish ground truth in the clinical studies, nor their specific qualifications. Typically, clinical study results (like hemostasis success, re-bleed rates, and adverse events) are determined by the treating physicians and study investigators, who are medical professionals specializing in endoscopy and gastroenterology, but their specific roles in "ground truth" establishment are not detailed here.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical studies presented.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The clinical studies presented solely evaluate the performance of PuraStat-GI itself. There is no mention of human readers (clinicians) assessing cases with and without AI assistance, as would be typical for an MRMC study comparing AI-assisted performance to human-only performance.

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

Yes, the clinical studies presented, along with the animal and bench testing, represent "standalone" performance of the PuraStat-GI device. The device is a physical hemostatic agent, not an AI algorithm. Its performance metrics (hemostasis rate, re-bleed rate, etc.) are a direct measure of the device's efficacy without human-in-the-loop assistance in the sense of an AI diagnostic. The human "in the loop" delivers the device, but the device's hemostatic action is independent.

7. The Type of Ground Truth Used

The ground truth for the clinical studies appears to be based on clinical outcomes and physician assessment during and after endoscopic procedures. This includes:

• Observation of hemostasis during endoscopy.
• Follow-up for delayed bleeding or re-bleeding events.
• Reporting of adverse events.

For the animal study, the ground truth was also based on direct observation of hemostasis and re-bleeding rates in the porcine model.

8. The Sample Size for the Training Set

The document does not mention a training set for PuraStat-GI. PuraStat-GI is a medical device (hemostatic gel), not a machine learning or AI algorithm that typically requires a training set. The clinical studies, animal studies, and bench tests are for validation and performance assessment, not for training.

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

As PuraStat-GI is not an AI algorithm, there is no "training set" in the conventional sense, and thus no ground truth was established for a training set. The development of the device itself would have involved extensive research and pre-clinical testing, but these are not referred to as a "training set" in the context of this document.

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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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The COOK Hemospray device is intended for hemostasis of non-variceal bleeds in the GI (gastrointestinal) tract. It is for prescription use only.

Hemospray is an inert, bentonite powder developed for endoscopic hemostasis. The powder is delivered by use of a carbon dioxide powered delivery system and through a catheter inserted through the working channel of an endoscope which provides access to the bleed. Each device contains approximately 20g of powder.

This document is a 510(k) Premarket Notification for a medical device called the Hemospray Endoscopic Hemostat. The submission primarily addresses a minor design change to an existing predicate device to correct a failure mode related to the activation knob. Because the changes are focused on a revised manufacturing process and an improved safety feature (the activation knob's tensile strength) rather than a change in the therapeutic mechanism or intended use, many of the typical acceptance criteria for AI/ML-based devices, such as those related to diagnostic performance or multi-reader studies, are not applicable here.

Therefore, I cannot populate the table and sections as requested for an AI/ML device's acceptance criteria and study proving performance. This document concerns a physical medical device and primarily focuses on mechanical performance and safety, not on the performance of a software algorithm.

However, I can extract information related to the device's functional acceptance criteria as demonstrated through bench testing for the design modification.

Here's how I can interpret and present the available information in the context of your request, focusing on the specific modification made to the physical device:

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

Note: The acceptance criteria and performance data provided relate to the mechanical integrity of the modified activation knob, not to an AI/ML algorithm's diagnostic or therapeutic performance.

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: Not explicitly stated as a number of units, but "All tested samples" implies a complete test of the sample set prepared.
• Data Provenance: The testing was "bench testing" conducted by the manufacturer, Wilson-Cook Medical, Inc., located in Winston-Salem, North Carolina. This is prospective testing performed for the purpose of this 510(k) submission.

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

• Not applicable. This study is not evaluating a diagnostic or AI/ML device requiring clinical expert ground truth for image interpretation or diagnosis. It focuses on the mechanical performance of a device component. The "ground truth" for the new design specification was established based on a human factors study evaluating the maximum force a user could apply.

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

• Not applicable. No adjudication method is described, as the evaluation is based on objective physical measurements (tensile strength) against a defined design specification, rather than subjective 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

• Not applicable. This study is not an MRMC study and does not involve AI assistance. It evaluates a mechanical design change to a physical hemostatic device.

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

• Not applicable. This study does not involve an algorithm.

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

• The "ground truth" for the new tensile strength design specification was established based on a human factors study that evaluated the maximum force a user could apply to the red activation knob during use. The success of the device was then determined by objective mechanical testing to confirm that the component met this established design specification.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; therefore, there is no "training set." The human factors study provided data to establish the design specification.

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

• Not applicable. As above, no training set for an AI/ML algorithm. The design specification (which could be considered a form of "ground truth" for the mechanical test) was established through a "human factors study that evaluated the maximum force a user could apply to the red activation knob during use."

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The COOK Hemospray® Endoscopic Hemostat is used for hemostasis of non-variceal gastrointestinal bleeding.

The Hemospray® Endoscopic Hemostat is a prescription use device consisting of a hemostatic agent and a delivery system. The hemostatic agent is (b) (4) | bentonite powder, a naturallysourced aluminum phyllosilicate clay. The delivery system is an endoscopic accessory used for spraying the powder onto the bleeding surface. The delivery device consists of a 220cm polyethylene application catheter, a handle with a pressurized CO2 cartridge, and a powder chamber containing approximately 20g of the Hemospray® material is propelled through the application catheter by release of CO2 from the cartridge located in the device handle. A trigger valve with an activation button allows the physician to control the amount of powder delivered to the affected area. Each actuation of Hemospray® delivers of CO2 and (b) gram of (b) (4) bentonite. Use of the complete 20-gram canister can produce a volume increase within the lumen of the bowel of 3 liters. In the presence of blood, the (b) (4) bentonite may swell 10-15% in volume.

The delivery system is offered in two configurations (i.e., two different outer diameters of the powder delivery catheter). The HEMO-7 version is used with a 2.8mm endoscope accessory channel, and the HEMO-10 version is used in a 3.7mm endoscope accessory channel.

The Hemospray® Endoscopic Hemostat is designed for hemostasis of non-variceal gastrointestinal bleeding. The acceptance criteria for the device are derived from a combination of non-clinical, animal, and clinical studies, as well as literature reviews and post-market data. The studies aim to demonstrate the device's biocompatibility, sterility, shelf life, and its ability to achieve acute hemostasis while minimizing risks such as re-bleeding, perforation, and other adverse events.

Here's a breakdown of the acceptance criteria and the studies proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set (Clinical Data):

  • Pilot Study: 20 patients. Hong Kong, China. Prospective.
  • SEAL Registry: 89 evaluable patients (N=92 enrolled, 3 excluded). Canada, Denmark, England, France, Germany, Italy, Holland. Post-market, observational survey.
  • HALT Study: 64 enrolled patients (interim report). EU and Canada. Post-market, single-arm study.
  • APPROACH Study: 50 enrolled patients. Canada. Post-market, single-arm, prospective observational cohort study.
  • Literature Review: 30 relevant studies, comprising 522 patients. Geographically diverse (Europe, Asia, Canada). Retrospective and prospective studies, case series, case reports, and registry-derived studies.
  • Emergency Use: 5 critically ill patients. United States. Pre-market.
  • Total Clinical Data (overall summary): 750 patients.

• Training Set: Not explicitly stated for specific clinical studies, as many were observational or post-market with concurrent data collection. For the algorithm (if applicable, which is not the primary focus for a physical device in this context), this information would be separate. For the manufacturing/design aspects, non-clinical and bench testing would conceptually be "training data" for product development cycles.

  • Biocompatibility: GLP porcine gastric bleeding animal study (subchronic toxicity and implantation).
  • Performance - Animal: 6 Hemospray® treated animals, 3 sham control (total N=9). Porcine gastric bleeding model.

3. Number of Experts to Establish Ground Truth for Test Set & Qualifications

• For the clinical studies (Pilot, HALT, APPROACH), the ground truth for outcomes like hemostasis, re-bleeding, and adverse events was established by treating physicians (endoscopists/gastroenterologists) at the respective clinical sites. The text doesn't specify the exact number or years of experience for individual experts, but it implies qualified medical professionals for each study. For example, the HALT study had 10 enrollment sites, meaning at least 10 primary investigators or teams. The APPROACH study had 4 clinical sites.
• The SEAL Registry explicitly states that "all physician participants were trained on the use of the Hemospray® kit by Wilson-Cook Medical, Inc. personnel." This implies a level of qualification and standardized training for those assessing outcomes.
• The overall literature review compiled data reported by clinician-authors in their respective publications.

4. Adjudication Method for the Test Set

• The document does not explicitly detail a centralized adjudication method (e.g., 2+1, 3+1 structure with an independent committee) for the clinical studies. For single-center or multi-center, physician-reported outcomes, the assessment of hemostasis, re-bleeding, and adverse events would typically be performed by the local site investigators guided by the study protocol definitions.
• For the SEAL Registry, "No queries or audits to identify and correct missing data were performed," indicating a lack of formal adjudication beyond initial reporting.
• The HALT study mentions endoscopically-confirmed recurrent bleeds, suggesting a visual assessment by the clinician performing the endoscopy.

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

• No MRMC comparative effectiveness study was done. The studies presented are primarily single-arm studies evaluating the performance of Hemospray® alone or in conjunction with other standard therapies.
• The document does compare Hemospray® results to "Standard of Care per ASGE" in Table 20 (APPROACH study results) and generally discusses how Hemospray® "rivaled standard of care (SOC) with 63% initial hemostasis and 38% re-bleed rate" for patients on antithrombotic therapy. However, these are comparisons to historical or published SOC rates, not from a direct head-to-head MRMC study.
• No effect size of human readers improving with AI vs. without AI assistance is provided, as this is a physical medical device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Not applicable as the Hemospray® Endoscopic Hemostat is a physical medical device. Performance is inherently tied to its application by a human operator (physician) in a clinical setting.

7. Type of Ground Truth Used

• Clinical Studies (Pilot, HALT, APPROACH, Emergency Use): Clinician assessment and observation (endoscopic visualization) of bleeding cessation, re-bleeding, and adverse events, as defined by study protocols. Outcomes data (e.g., mortality).
• Animal Study: Gross and histologic assessment of regional and systemic effects by veterinary pathologists/researchers.
• Bench Studies: Objective measurements against predefined engineering specifications (e.g., pressure, density, functional checks).
• Biocompatibility: Laboratory testing results based on ISO and ASTM standards.
• Literature Review: Aggregated clinical outcomes reported in peer-reviewed publications.

8. Sample Size for the Training Set

• Animal Study: 6 Hemospray® treated animals, 3 sham control (total N=9). While not a "training set" in the machine learning sense, this GLP porcine study served as crucial in vivo data for validating effectiveness and safety prior to widespread human use.
• Biocompatibility: Various numbers for different tests (e.g., guinea pigs for sensitization, rabbits for pyrogenicity, cell lines for cytotoxicity). The "subchronic toxicity and implantation" was evaluated in the porcine animal study.
• Non-clinical/Bench Studies: Performed on device prototypes and finished devices; specific sample sizes for each bench test are not always detailed but are implicit in the "Passed" results.
• First-in-Human Pilot Study (20 patients): Could be considered early "training" or "feasibility" data for refining clinical protocols and understanding human safety.

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

• Animal Study (Porcine Model): Ground truth for hemostasis was established by direct observation during the procedure and confirmed by follow-up. Safety endpoints (gross and histologic assessment of regional and systemic effects) were established by detailed pathological examination of tissues collected at termination by trained veterinary pathologists.
• Biocompatibility Testing: Ground truth established according to standardized international (ISO, ASTM) and national (USP) testing protocols, which define specific biological responses (e.g., non-cytotoxic, non-irritant) under controlled laboratory conditions.
• Bench Testing: Ground truth established through engineering specifications and predefined pass/fail criteria for physical and functional parameters of the device and its components, measured using calibrated equipment.

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