(144 days)
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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