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

PuraStat-RM 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 syringe via the polypropylene adapter.

PuraStat-RM is completely non-animal and non-plant derived and contains no drugs or biologics 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 information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria in the format requested.

The document is an FDA 510(k) premarket notification letter and summary for a device called PuraStat-RM. It focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical as well as some clinical performance data.

Here's what can be extracted from the text, addressing the requested points where possible, and noting when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Available: The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or a specific clinical outcome threshold) in the typical sense for an AI/diagnostic device. The clinical data presented focuses on improvement in symptoms rather than meeting pre-defined statistical endpoints for device performance against a gold standard or comparator.

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

• Test Set Sample Size: 21 patients.
• Data Provenance: United Kingdom, prospective, single-center case series.

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

• Not Available: The document does not describe the establishment of a "ground truth" by experts for the clinical study in the context of device performance evaluation. The study assessed patient-reported and physician-reported improvement in symptoms.

4. Adjudication Method for the Test Set

• Not Available: An adjudication method for a test set, typically involving multiple expert readers, is not described as this was a clinical outcome study rather than an AI diagnostic device evaluation.

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

• No: The document does not mention an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. The clinical study evaluated the device's effect on patients.

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

• Not Applicable: PuraStat-RM is a physical hydrogel device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

• Clinical Outcomes / Patient and Physician Reported Symptoms: The "ground truth" in this context was effectively patient-reported bleeding diaries and physician-reported rectal bleeding scores, indicating symptomatic improvement rather than a definitive diagnostic truth established by an independent gold standard.

8. Sample Size for the Training Set

• Not Applicable / Not Available: Since PuraStat-RM is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

• Not Applicable / Not Available: As above, this concept does not apply to this device.

Summary of the Clinical Study Presented:

• Study Design: Prospective, consecutive, open-label, single-center case series.
• Participants: 21 patients (18 men; 17 prostate, 2 vaginal, 2 rectal; median age 76 years) with severe refractory radiation proctopathy (RP) causing rectal bleeding.
• Intervention: PuraStat-RM applied endoscopically at four-weekly intervals, with more as required.
• Outcomes:
  • Median time from first treatment to follow-up: 12 months (range 3-18).
  • No patients lost to follow-up.
  • Only one patient had recurrence of significant bleeding among those >12 months beyond their first treatment.
  • 14 out of 16 patients observed post-treatment showed marked improvement in bleeding volume and frequency (subjectively patient-reported and objectively via 7-day bleeding diaries).
  • Median number of treatments: 3 (range 2-7).
  • Median amount of PuraStat-RM used: 5 mL (range 3-5 mL).
  • Rectal bleeding episodes (into toilet bowl) reduced from a median of 4.5 (range 0-27) prior to first treatment to 2 (range 0-16) prior to the third treatment.
• Conclusion drawn in the document: This data supports the safety and effectiveness for its intended use, contributing to the substantial equivalence determination.

In essence, the document details a clinical study that demonstrated the device's ability to reduce symptoms of rectal bleeding in patients with radiation proctopathy, based on patient and physician reports, rather than a study designed to meet specific statistical acceptance criteria for a diagnostic/AI performance measure.

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ProctiGard™ is indicated for the symptomatic management of rectal mucositis.

ProctiGard™ is a viscous, mucoadhesive liquid supplied in plastic bottles and is designed for the symptomatic management of rectal mucositis. When gently applied via the enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.

This 510(k) premarket notification is for ProctiGard™, a device indicated for the symptomatic management of rectal mucositis. The submission asserts substantial equivalence to a predicate device, MuGard® Mucoadhesive Oral Wound Dressing (K062795).

Here is an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

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

The submission does not describe a clinical "test set" or a clinical study involving human subjects for ProctiGard™. The device's substantial equivalence is primarily based on the identical composition and analogous mode of action to its predicate device, MuGard®, along with preclinical biocompatibility testing. The data provenance for the biocompatibility tests (guinea pigs, rabbits) is not specified geographically or as retrospective/prospective.

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

Not applicable. No clinical test set involving human subjects requiring expert ground truth establishment is described in this submission.

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

Not applicable. No clinical test set is described.

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. ProctiGard™ is a medical device (a protective coating), not an AI diagnostic tool.

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

Not applicable. ProctiGard™ is a medical device, not an AI algorithm.

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

The "ground truth" for the device's claims of safety and effectiveness relies on:

• Identity of Formulation: The chemical and physical composition of ProctiGard™ is stated to be identical to the legally marketed predicate device, MuGard®.
• Biocompatibility Standards: Compliance with ISO 10993 standards (in vitro cytotoxicity, sensitization, mucosal irritation in animal models) serves as the "ground truth" for safety.
• Analogous Mode of Action: The understanding that a protective layer over mucosa provides symptomatic relief, which was established for the predicate device.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The basis for approval is substantial equivalence to a predicate, supported by preclinical biocompatibility testing and identical formulation.

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

Not applicable. No training set is described.

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