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ATRISORB®-D FreeFlow™ Barrier is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. ATRISORB®-D FreeFlow™ Barrier has been shown to reduce bacterial colonization of the barrier.

The ATRISORB®-D FreeFlow™ Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline exists as a sterile, synthetic flowable polymeric solution composed of poly(DL-lactide) (PLA) dissolved in N-methyl-2-pyrrolidone (NMP). It is mixed with doxycycline hyclate prior to formation to give a 4% doxycycline concentration. The barrier precipitates to a firm consistency upon contact with water and bioabsorbs over time. One sterile unit consists of a pouched syringe with 715 mg of the ATRISORB® polymer formulation, a syringe with 35 mg doxycycline hyclate, a blunt tip cannula, and a product insert. The barrier functions by isolating the regenerative surgical site from adjacent gingival connective tissue and epithelium, facilitating population of the site with cells from the periodontal ligament and adjacent alveolar bone. The doxycycline hyclate reduces bacterial colonization of the barrier and surgical site.

Here's a breakdown of the acceptance criteria and the study details for the ATRISORB®-D FreeFlow™ Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device and proving the additional claim of reducing bacterial colonization. The acceptance criteria are largely implied by the need to show superiority or equivalence to the predicate in key areas, and the device performance is reported based on the clinical study.

• Tissue Irritation (In Vivo): No significant tissue irritation observed in two nonclinical dog studies.
• Biocompatibility (Predicate): Extensive biocompatibility studies on predicate (ATRISORB® GTR Barrier) and ATRISORB®-D Barriers (varying doxycycline concentrations) support safety. |
  | Sterilization Efficacy | - Device is terminally sterilized by Cobalt-60 gamma irradiation.
• Gamma irradiation at levels up to 39.4 kGy does not significantly alter chemical structure, potency, or ability of doxycycline hyclate to form clinically acceptable barriers. |
  | Physical/Handling Characteristics (Simulated Use) | - All ATRISORB®-D FreeFlow™ Barriers (with four different PLA molecular weights) passed simulated use test criteria, verifying appropriate molecular weight limit.
• Average thickness (0.474-3.584 mm) is slightly less than predicate's (0.729-3.178 mm), supporting suitability for intended use. |
  | Doxycycline Release (In Vitro) | - Greater than 90% cumulative release of doxycycline from barriers into water at 24 hours. |
  | Doxycycline Bioactivity (In Vitro) | - ATRISORB®-D Barrier with 5% doxycycline showed bioactivity against periodontal pathogens (Actinobacillus actinomycetemcomitans and Porphyromonas gingivalis) in time kill assay and agar diffusion techniques. |
  | Reduction of Bacterial Colonization (Clinical Study - Primary Objective) | - ATRISORB®-D FreeFlow™ Barrier treatment group demonstrated significantly greater reductions for total anaerobes and counts of P. intermedia/P. nigrescens compared to the ATRISORB® GTR Barrier control.
• Reductions approaching significant levels for F. nucleatum counts.
• Doxycycline levels in gingival crevicular fluid were consistently higher than minimum inhibitory concentrations of common periodontal pathogens. |
  | Clinical Efficacy (Secondary Objective - to be reported later) | - Efficacy endpoints (horizontal attachment level, vertical attachment level, probing depth, and percent defect closure) at Month 6.
  (Note: This data was not reported in the provided summary but was an objective of the study.) |
  | Bioabsorption | - The barrier bioabsorbs over several months, remains intact during the critical period for regeneration, and eliminates the need for a second surgical procedure. |

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

• Test Set Sample Size: Not explicitly stated as a single number. The "six-month clinical study" was conducted at "three different centers." While the number of subjects and defects isn't provided, it was a comparative study between two treatment groups.
• Data Provenance: Prospective clinical study. The country of origin is not explicitly stated in the provided text, but generally, FDA submissions imply studies conducted within or recognized by the US regulatory framework.

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

• This information is not provided in the text. Given the nature of a clinical study for a periodontal device, "ground truth" would typically come from clinical assessments performed by trained dental professionals (e.g., periodontists or dentists) and microbiological analysis. However, the exact number and qualifications of these experts are not specified.

4. Adjudication Method for the Test Set

• This information is not provided in the text. Clinical studies often employ blinding and/or independent adjudication for outcome assessments, but the specific method is not mentioned here.

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, an MRMC comparative effectiveness study involving AI assistance was not done. This device is a physical barrier for guided tissue regeneration, not an AI diagnostic or assistance tool. Therefore, the concept of "human readers improving with AI" is not applicable.

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

• No, a standalone algorithm performance study was not done. This is a medical device (a bioabsorbable barrier itself), not a software algorithm.

7. The Type of Ground Truth Used

• The ground truth in the clinical study was established by:
  • Microbiological analysis: Direct measurement of total anaerobic bacterial counts and specific periodontal pathogens (P. intermedia/P. nigrescens, F. nucleatum).
  • Clinical parameters: Measured changes from baseline for horizontal attachment level, vertical attachment level, probing depth, and percent defect closure (though these efficacy endpoints were to be reported later).
  • Doxycycline levels: Measurement of doxycycline in gingival crevicular fluid.

8. The Sample Size for the Training Set

• This concept is not applicable to this device. This is a physical medical device, not a machine learning model that requires a training set. The "development" and "testing" involved in-vitro characterization, animal studies, and human clinical trials, which are different from machine learning training and testing.

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

• This concept is not applicable as there is no "training set" in the machine learning sense for this device.

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ATRISORB® GTR Barrier is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. ATRISORB® GTR Barrier is not intended for use in defects outside the indications statement.

The ATRISORB® polymer formulation is a sterile, synthetic flowable polymeric formulation which is bioabsorbable and has been developed for GTR procedures by Atrix Laboratories, Inc. It consists of a polymer of lactic acid, poly(DL-lactide) (PLA), dissolved in N-methyl-2-pyrrolidone (NMP). The finished device is provided in two different packaging configurations: the ATRISORB® GTR Barrier Kit (case kit) and the ATRISORB® GTR Barrier multipack (multipack). The case kit contains the polymer formulation, a barrier forming case with porous pads and spacers, sodium chloride solution, and instructions for use. The multipack contains three dose packs of the polymer formulation, three 18 gauge cannulae, and instructions for use. The barrier functions by isolating the surgical site to facilitate regeneration. It can be preformed using the case or applied directly in situ. The formed barrier is a film that solidifies and bioabsorbs over several months.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for ATRISORB® GTR Barrier

The ATRISORB® GTR Barrier aims for substantial equivalence to the predicate device, GORE-TEX® Periodontal Material, for guided tissue regeneration (GTR) in treating Class II furcation defects in humans. Additionally, it claims bioabsorbability and the elimination of a second surgical procedure for removal.

The primary clinical endpoints for demonstrating equivalence were:

• Vertical attachment level gain
• Horizontal attachment level gain
• Pocket depth improvement
• Gingival margin location (change)
• Bleeding on probing score (change)
• Gingival index score (change)
• Plaque index score (change)

1. Table of Acceptance Criteria and Reported Device Performance

The study design aimed to show that ATRISORB® GTR barrier was not clinically inferior to GORE-TEX® periodontal material. The null hypothesis tested for some measures was that GORE-TEX® was clinically superior by at least 0.5 mm. The "acceptance criteria" can be inferred from the statistical conclusions, where clinical equivalence was demonstrated if the null hypothesis of significant inferiority was rejected, and confidence intervals supported equivalence.

Overall Conclusion: The studies consistently showed that the ATRISORB® GTR Barrier met the acceptance criteria for substantial equivalence to the GORE-TEX® Periodontal Material across all measured clinical endpoints, and successfully demonstrated the additional claims of bioabsorbability and safety.

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

• Test Set (Pivotal Clinical Trial):
  • 162 subjects were randomized and entered into the 52-week study.
  • 82 subjects received ATRISORB® GTR barrier.
  • 80 subjects received GORE-TEX® periodontal material.
  • For the Week 52 analysis, N varied slightly due to potential dropouts or complete data availability: 66 for ATRISORB® and 63-64 for GORE-TEX® across different measurements.
• Data Provenance: The study was a "multicenter clinical trial" in humans. The text does not specify the country of origin, but given the US FDA submission, it is highly probable it was conducted in the United States or under US regulatory oversight. The study was prospective as it involved randomization and follow-up over 52 weeks.

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

The text does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish the "ground truth" for the clinical measurements in the pivotal human trial.

However, clinical trials for periodontal research typically involve:

• Periodontists or trained dental professionals to conduct the surgical procedures and perform clinical measurements (e.g., probing depth, attachment levels, gingival/plaque indices). These measurements themselves serve as the ground truth for that specific patient's condition at that time point.
• For diagnostic accuracy studies, "ground truth" is typically established by consensus of multiple expert readers. For clinical endpoints as measured here, the measurements taken by qualified clinicians during the follow-up themselves constitute the "ground truth" for that trial. The multicenter nature implies multiple clinical sites with their own trained staff.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method like 2+1 or 3+1 for the clinical measurements. In clinical trials, especially multicenter ones, standardized protocols, calibration of examiners, and blinding (where possible) are used to ensure consistency and reliability of measurements. The "multicenter study with a parallel design" suggests that each site followed a common protocol for data collection.

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

No, an MRMC comparative effectiveness study was not conducted. This study was a clinical trial comparing two medical devices (ATRISORB vs. GORE-TEX) in human patients for treatment outcomes, not an AI efficacy study involving multiple readers interpreting cases. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, this is a medical device (a barrier for guided tissue regeneration), not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this context. The device directly interacts with human tissue.

7. The Type of Ground Truth Used

For the pivotal clinical trial (test set), the ground truth for effectiveness was clinical measurements (e.g., vertical attachment level, horizontal attachment level, pocket depth) taken directly from human patients by trained clinicians at specified time points, and clinical observations (e.g., bleeding on probing, gingival index, plaque index, postoperative complications).

For bioabsorbability and biocompatibility, the ground truth was established by:

• Histological examination in animal studies to confirm barrier degradation and tissue response.
• Clinical observation and follow-up in human trials for tissue compatibility and absence of adverse reactions.

8. The Sample Size for the Training Set

This document describes a medical device, not an AI algorithm, so there is no "training set" in the context of machine learning. The studies described (in vitro, animal, and human clinical trials) are for evaluating the safety, biocompatibility, and effectiveness of the physical device.

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

As there is no "training set" for an AI algorithm in this context, this question is not applicable. The device's "training" or development would have involved iterative research and development, preclinical testing, and eventually clinical trials to refine its formulation and application, culminating in the studies described to demonstrate its safety and efficacy.

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I'm sorry, but without further context, I cannot fulfill your request. The provided text is a letter from the FDA regarding a substantially equivalent determination for a medical device. It does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

To answer your questions, I would need a document that describes:

• The specific acceptance criteria for the device's performance.
• The details of the study conducted to prove the device meets these criteria.
• Information about the test and training sets, including sample sizes, data provenance, and how ground truth was established.
• Details about expert involvement and adjudication methods.
• Whether any comparative effectiveness studies were performed.

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