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Purastat is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.

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 mucoadhesive hydrogel that provides a protective barrier over rectal mucosa. 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.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies for medical devices.

Instead, this document is an FDA 510(k) clearance letter and an associated 510(k) Summary. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (PuraStat-RM, K213552). The key assertion is that the subject device (PuraStat) is identical to the predicate device in most aspects, with the only exception being the final sterilization method (gamma radiation sterilization).

Therefore, the "performance data" referred to in the document is not a clinical study to prove new performance criteria but rather:

• Bench testing: To demonstrate that the change in sterilization method does not alter the physical or functional properties of the device.
• Biocompatibility testing: To ensure that the modified sterilization method does not introduce new biocompatibility concerns.

The document explicitly states: "The subject device is identical to the predicate device and has the same intended use, and an equivalence demonstration was performed following the final sterilization change. The bench testing and biocompatibility testing provided in this submission assess the equivalence demonstration."

Given this, the requested information elements related to a and clinical study with performance metrics, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not available in this document. The document relies on the predicate device's prior clearance to establish safety and effectiveness.

Here's what can be extracted based on the provided text, while acknowledging the limitations:

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

The document does not explicitly state quantitative acceptance criteria or specific numerical performance metrics for the subject device based on a new study. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The performance reported is that the subject device is "identical in material, formulation and manufacturing, and so final product specification" to the predicate, with the exception of the sterilization method.

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

Not applicable/Not provided in this document as it pertains to a new clinical performance study. The "test set" in this context refers to the samples used for bench and biocompatibility testing, but their specific sizes and provenance are not detailed.

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

Not applicable/Not provided. This type of information is typically for clinical performance studies, which were not the basis for this 510(k) clearance beyond the predicate's original clearance.

4. Adjudication method for the test set

Not applicable/Not provided.

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

Not applicable. This device is a medical product (a gel) for symptomatic management, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant here.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

Not applicable in the context of a new clinical performance study. For the equivalence demonstration, the "ground truth" (or reference) is the established safety and effectiveness profile of the predicate device previoiusly cleared by the FDA. The current submission's "truth" is that the modified device remains functionally and biologically equivalent to that predicate.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable.

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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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