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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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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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PuraStat-OM adheres to oral tissue and forms a protective barrier over the wound to prevent further irritation and contamination. It provides a moist wound environment required for optimal wound healing.

Manages pain of, for example:

• All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa
• Canker sores and cold sores
• Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders
• Soft tissue pain from orthodontics
• Aphthous ulcers
• Extraction site pain
• Oral mucositis and stomatitis (may be caused by chemotherapy or radiotherapy)

PuraStat-OM 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 an oral hydrogel wound dressing with the sterile application nozzle. The gel's primary mode of action is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process.

PuraStat-OM 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.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:

Device: PuraStat-OM (an oral hydrogel wound dressing)
Predicate Device: McMerlin Dental Company's SOCKIT!® Oral Hydrogel Wound Dressing (K063148)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the purpose of demonstrating substantial equivalence. Instead, it describes a comparison of technological characteristics and performance data between the subject device (PuraStat-OM) and the predicate device (SockIt!® Gel) to argue for their substantial equivalence. The "criteria" are implicitly defined by the properties measured and compared.

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

The study described is nonclinical performance (bench testing) and GLP biocompatibility testing.

• Sample Size for Test Set: Not explicitly stated with a specific number of units for each test. The document refers to "PuraStat-OM" and "SockIt!® Gel" being tested, implying samples of each device were used. For biocompatibility, testing is typically done on multiple samples.
• Data Provenance: The biocompatibility testing was conducted as per ISO 10993-1 and consistent with FDA Guidance, indicating standard laboratory practices. The bench testing (complex modulus, viscosity, pH, etc.) was a "side-by-side comparison" of the subject and predicate devices. This is retrospective in the sense that it compares a new device to an already marketed predicate, but the testing itself would have been conducted prospectively for the submission. The origin of the data is laboratory testing.

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

N/A. This document describes nonclinical, laboratory-based performance testing and biocompatibility assessments, not a study requiring human readers or expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

N/A. Not applicable to nonclinical performance or biocompatibility testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not mentioned as this submission focuses on nonclinical and bench testing to demonstrate substantial equivalence based on technological characteristics and biocompatibility, not comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a physical medical device (hydrogel), not an imaging/AI algorithm.

7. The Type of Ground Truth Used

For the biocompatibility tests (e.g., Cytotoxicity, Sensitization, Irritation), the "ground truth" is defined by established biological safety standards and methodologies (ISO 10993-1). For the bench tests (e.g., Complex Modulus, Viscosity, pH), the "ground truth" is the measured values obtained using validated laboratory methods and instruments. These are objective physical and chemical properties.

8. The Sample Size for the Training Set

N/A. This is not an AI/machine learning device that requires a training set.

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

N/A. Not applicable.

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PuraStat-GI 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.

PuraStat-GI 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-GI 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-GI achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

The provided text describes a 510(k) premarket notification for the device PuraStat-GI, a hemostatic device for intraluminal gastrointestinal use.

It details bench testing, animal studies, and clinical studies of the device. However, it does not explicitly state specific acceptance criteria (e.g., "The device must achieve hemostasis in X% of cases with Y% confidence interval"). Instead, it presents reported device performance and implies that these results demonstrate substantial equivalence to a predicate device, thereby meeting the FDA's requirements for market clearance.

Therefore, the response below will present the reported device performance from the provided text and note the absence of explicitly stated numerical acceptance criteria.

Acceptance Criteria and Study Details for PuraStat-GI

While the document does not explicitly list specific numerical "acceptance criteria" that the device must meet (e.g., "hemostasis rate must be >X%"), it presents the performance data of PuraStat-GI from three clinical studies, alongside a comparison to a predicate device in bench and animal testing, to demonstrate substantial equivalence. The implied acceptance is that the device's performance is comparable to or better than established benchmarks in terms of safety and effectiveness for its intended use.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Note: The acceptance criteria are "implied" based on the presentation of data to support device clearance, rather than explicit numerical targets defined in the document.

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

The provided text details three clinical studies that serve as the "test set" for human performance data for PuraStat-GI:

• Subramaniam (2019): N=100 patients
• de Nucci (2020): N=77 patients
• Subramaniam (2020): N=46 patients

Total clinical patients: 223 patients.

Data Provenance: The document states these are "results of three clinical studies of the use of PuraStat® that have been reported in the literature." This indicates these were likely retrospective analyses of previously conducted and published clinical trials. The specific countries of origin for these studies are not specified in the provided document.

Additionally, a GLP gastrointestinal mucosal defect study was conducted in a porcine model with a comparative side-by-side assessment against the predicate device. The sample size for this animal study is not specified.

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

The document does not provide information on the number of experts used to establish ground truth in the clinical studies, nor their specific qualifications. Typically, clinical study results (like hemostasis success, re-bleed rates, and adverse events) are determined by the treating physicians and study investigators, who are medical professionals specializing in endoscopy and gastroenterology, but their specific roles in "ground truth" establishment are not detailed here.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical studies presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The clinical studies presented solely evaluate the performance of PuraStat-GI itself. There is no mention of human readers (clinicians) assessing cases with and without AI assistance, as would be typical for an MRMC study comparing AI-assisted performance to human-only performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the clinical studies presented, along with the animal and bench testing, represent "standalone" performance of the PuraStat-GI device. The device is a physical hemostatic agent, not an AI algorithm. Its performance metrics (hemostasis rate, re-bleed rate, etc.) are a direct measure of the device's efficacy without human-in-the-loop assistance in the sense of an AI diagnostic. The human "in the loop" delivers the device, but the device's hemostatic action is independent.

7. The Type of Ground Truth Used

The ground truth for the clinical studies appears to be based on clinical outcomes and physician assessment during and after endoscopic procedures. This includes:

• Observation of hemostasis during endoscopy.
• Follow-up for delayed bleeding or re-bleeding events.
• Reporting of adverse events.

For the animal study, the ground truth was also based on direct observation of hemostasis and re-bleeding rates in the porcine model.

8. The Sample Size for the Training Set

The document does not mention a training set for PuraStat-GI. PuraStat-GI is a medical device (hemostatic gel), not a machine learning or AI algorithm that typically requires a training set. The clinical studies, animal studies, and bench tests are for validation and performance assessment, not for training.

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

As PuraStat-GI is not an AI algorithm, there is no "training set" in the conventional sense, and thus no ground truth was established for a training set. The development of the device itself would have involved extensive research and pre-clinical testing, but these are not referred to as a "training set" in the context of this document.

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PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as press, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.

PuraDerm Gel consists of a synthetic, peptide-based hydrogel material provided in a prefilled syringe. PuraDerm Gel is comprised of 2.5% (w/v) of a synthetic repeating peptide (acetyl-[arginyl-alany]-asparty]-alany] 4-amide tetrahydrochloride in sterile water for injection. The peptide is synthesized by standard solid-phase chemistry with no raw materials of animal or cellular origin.

The PuraDerm Gel solution is sterile-filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel.

PuraDerm Gel forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of nanofibrils formed from individual peptide monomers. These fibrils are 10-20 nm in diameter and are interwoven to create an ordered structure with 50-100 nm pore sizes. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM").

The gel is delivered to the intended application site(s) via a polypropylene applicator nozzle tip.

The provided FDA 510(k) document for PuraDerm Gel (K193085) does not describe an acceptance criterion or a study that proves the device meets an acceptance criterion.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that does not require premarket approval. This is achieved by showing that the device has the same intended use and the same technological characteristics as the predicate, or that differences in technological characteristics do not raise different questions of safety and effectiveness.

Here's why the requested information isn't present:

• No new performance data: The document explicitly states: "Because there is no change to the device, source material, or manufacturing compared to the predicate K143058, the existing biocompatibility, sterilization, and shelf life information from K143058 fully applies. GLP pyrogenicity testing showed that the device is considered to be nonpyrogenic. New performance testing was not necessary to support the additional indications or the updates to the IFU."
• Focus on equivalence: The entire "Substantial Equivalence Discussion" (Section 6) and "Conclusions" (Section 8) are dedicated to comparing the proposed device with the predicates based on their characteristics and indications for use, rather than presenting results from a new performance study against defined acceptance criteria.

Therefore, I cannot populate the requested table and details because the provided text explicitly states that new performance testing was not done and thus no acceptance criteria or study results for K193085 are discussed.

The document essentially leverages the prior clearance (K143058) for its technical characteristics and expands its indications based on equivalence to another predicate (K991202) for those specific indications.

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PuraSinus® is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.

PuraSinus® is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period.

PuraSinus® 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 wound dressing with or without the optional sterile application nozzle. PuraSinus® forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue.

PuraSinus® 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. PuraSinus® can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.

This document ("510(k) Summary for PuraSinus®") does not describe an AI/ML device, nor does it present the acceptance criteria and study proving a device meets those criteria in a format applicable to AI/ML device performance. This is a 510(k) submission for a medical device (a bioresorbable nasal dressing and sinus stent) where the key demonstration of substantial equivalence relies on comparison to a predicate device through bench testing and a small retrospective case series, rather than formal performance goals met by an AI/ML algorithm.

Therefore, many of the requested categories for defining acceptance criteria and study details for an AI/ML device cannot be extracted from the provided text. However, I can still interpret the information regarding the "performance data" that was presented to support the device.

Here's an analysis based on the provided text, interpreted as much as possible in the context of your request for device performance, but noting the relevant limitations due to the nature of the device:

Device Name: PuraSinus®

Type of Device: Bioresorbable nasal dressing and sinus stent (not an AI/ML device)

Acceptance Criteria and Reported Device Performance (as far as applicable to this non-AI device):

Study Details (as derived from the text):

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: 19 sequential patients.
   • Data Provenance: Retrospective case series. The country of origin is not explicitly stated but implied to be where the clinical institution(s) conducting the FESS procedures are located (no specific country mentioned).

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

   • Not applicable in the AI/ML sense. The "ground truth" for the clinical performance (re-bleeding, adhesion formation, adverse events) would have been established by the treating physicians/surgeons during post-operative patient follow-up. The document does not specify the number or qualifications of these clinical evaluators.

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

   • Not explicitly described. Clinical outcomes (adhesions, re-bleeding, adverse events) were reported, presumably as direct observations during patient follow-up, not through a formal adjudication process like one used for AI/ML image review.

4. 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/ML device. The "comparison" was PuraSinus® performance to literature reported performance of a predicate device (MeroGel®).
   • Comparison: PuraSinus® showed an adhesion rate of 16% compared to a literature-reported adhesion rate of 27% for MeroGel® in similar procedures. This is a comparison of device outcome, not human reader performance.

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

   • Not applicable as this is not an AI/ML device.

6. The type of ground truth used:

   • Clinical Outcomes/Observations: Directly observed post-operative clinical outcomes (adhesion formation, re-bleeding, adverse events) by treating physicians.
   • Bench Test Results: Quantitative measurements from laboratory tests (Complex Modulus, Viscosity, Injection Force).
   • Rabbit Model: In vivo animal study data for material comparison.

7. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as this is not an AI/ML device.

Summary of Device Performance Evidence (based on the provided text):

The primary evidence presented to demonstrate the substantial equivalence and performance of PuraSinus® focused on:

• Bench Testing: Comparative physical and mechanical properties of PuraSinus® and the predicate device (MeroGel®).
• Animal Model: A side-by-side comparison in a rabbit model to address material differences between PuraSinus® and MeroGel®, concluding no impact on safety or effectiveness.
• Retrospective Case Series (Human Data): A small series (19 patients) showing favorable clinical outcomes (no re-bleeding, low and mild adhesion rates) compared to literature data for the predicate device.

The document emphasizes that PuraSinus® is the "identical product" to the previously cleared PuraDerm Gel (K140358), leveraging its biocompatibility and product characterization studies.

The acceptance of this device by the FDA (as indicated by the clearance letter K183015) was based on the provided data demonstrating substantial equivalence to the predicate device, not on meeting specific, pre-defined performance thresholds for an AI/ML algorithm.

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OTC:

PuraDerm is used for the management of minor cuts, minor abrasions, minor wounds and minor burns (1st degree burns).

Rx:

Under the supervision of a health care professional PuraDerm is used for the management of partial and full-thickness wounds, such as pressure ulcers, diabetic ulcers, and surgical wounds.

PuraDerm™ Gel 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 wound dressing with or without the optional sterile application nozzle. PuraDerm forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue.

PuraDerm 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. PuraDerm can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.

The provided text describes the 510(k) premarket notification for the PuraDerm Gel, which is a wound dressing. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance-based acceptance criteria through an AI study.

Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria (especially related to AI performance, human-in-the-loop, MRMC studies, ground truth establishment for AI models, etc.) is not present in the provided document.

The document details:

• Device Description: PuraDerm Gel (a sterile gel of synthetic peptide and sterile water).
• Intended Use: Management of minor cuts, abrasions, minor burns (OTC), and management of partial and full-thickness wounds (Rx).
• Comparison to Predicate Devices: DuoDerm® Hydroactive® Gel and Woun'Dres® Collagen Hydrogel. The comparison focuses on presentation, function, and indication for use, highlighting similar material properties and hydration function.
• Performance Data: This section mentions non-clinical performance testing, specifically in vivo performance testing in an established porcine wound healing model and biocompatibility testing. It states that DuoDerm was used as the control device in the animal study.
• Statement of Substantial Equivalence: Concludes that PuraDerm is as safe, as effective, and performs as well as the proposed predicate(s) based on benchtop and animal testing.

There is no mention of:

• Acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) for an AI device.
• An AI component or algorithm within the PuraDerm Gel device.
• Test sets, training sets, or data provenance relevant to AI model development or validation.
• Experts establishing ground truth for AI model testing.
• Adjudication methods for AI model ground truth.
• Multi-Reader Multi-Case (MRMC) studies or human reader improvement with AI assistance.
• Standalone AI performance or human-in-the-loop performance studies.
• Ground truth types (pathology, outcomes data, etc.) in the context of AI.

In summary, the provided text does not contain the information requested in the prompt because it pertains to a traditional medical device (wound dressing) submission focused on substantial equivalence to existing predicate devices, not an AI/ML-enabled device.

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