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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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