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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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