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Helios Dura Regeneration Matrix is indicated as a dura substitute for the repair of the dura mater.

Helios Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. The single-use device is supplied sterile in sheet form in a variety of sizes ranging from 6.5 - 250 cm² (~1 - 40-in²) to be trimmed and sutured or onlayed by the surgeon to meet the individual patient's needs.

The provided FDA 510(k) clearance letter and summary for the Helios Dura Regeneration Matrix do not contain the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system. The document describes a medical device, specifically a dura substitute, and its equivalence to a predicate device. The performance data section refers to standard device characterization, design validation, biocompatibility, shelf-life, and packaging testing, which are typical for physical medical implants, not for AI-powered diagnostic or assistive technologies.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as it pertains to an AI system.

Based on the provided text, the device is a physical dura substitute and not an AI/software device whose performance would be measured with the kind of criteria listed in your prompt.

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ArtiFascia is indicated as dura substitute for the repair of dura mater. ArtiFascia is indicated for defects of 25cm² (3.87 in²) or less in area. For example, 6 cm X 4 cm (24 cm²) would be an acceptable defect size.

ArtiFascia is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia is packaged in a single-use peelable package and is provided sterile, nonpyrogenic. ArtiFascia readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.

The provided document describes the K223445 premarket notification for the ArtiFascia device, a dura substitute. The studies primarily focus on demonstrating the device's substantial equivalence to a legally marketed predicate device (Cerafix Dura Substitute). As such, the "acceptance criteria" discussed are largely in the context of equivalence testing and meeting safety and performance benchmarks comparable to the predicate, rather than an AI/ML specific performance metric. The studies described are primarily bench testing, biocompatibility studies, and animal studies, followed by a clinical study. There is no mention of Artificial Intelligence or Machine Learning in the provided document, so there will be no information on acceptance criteria or studies related to AI/ML device performance (e.g., sensitivity, specificity, MRMC studies, standalone performance).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the tests performed and the results demonstrating compliance or superiority to the predicate device. For the clinical study, the primary endpoint served as the key acceptance criterion for effectiveness.

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

• Bench Testing:

  • In-Vitro Degradation: 96 samples (overall)
  • Other bench tests: Specific sample sizes are not explicitly stated for individual tests, but implied to be sufficient for statistical significance.
  • Data Provenance: Not explicitly stated, implied to be laboratory-generated.

• Biocompatibility Studies:

  • Implantation (ISO 10993-6:2007) / First Animal Study: 19 animals (rabbits)
  • Implantation (ISO 10993-6:2016) / Second Bridging Study: 9 animals (rabbits)
  • Other biocompatibility tests: Sample sizes are not explicitly stated but are standard for the ISO methods referenced (e.g., cell cultures for cytotoxicity, animal subjects for sensitization/irritation/toxicity).
  • Data Provenance: Laboratory research, animal studies conducted under Good Laboratory Practices (GLP).

• Clinical Study (NEOART study):

  • Test Set (Initial Study): 78 subjects treated (58 in ArtiFascia group, 20 in control group). Total enrolled randomized and treated subjects was 85.
  • Test Set (Long-term data collection): 32 subjects underwent MRI and/or neurological assessment (25 ArtiFascia, 7 control).
  • Data Provenance: Multi-center, prospective, randomized, controlled, single-blinded, parallel group study. Conducted at 7 clinical sites outside-of-the-US.

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

• Bench Testing: Ground truth is established by standardized test methods and measurements. Expert interpretation is often part of the process (e.g., visual examination for morphological irregularities), but the number and qualifications of experts are not specified.
• Biocompatibility Studies: Ground truth is based on standard test results and observations (e.g., "Non-cytotoxic," "Non-sensitizing"). Pathologists/toxicologists would interpret results, but specific numbers and qualifications are not provided.
• Animal Studies: Assessments included clinical assessments of animal well-being and histological examination of the treatment area. Pathologists/veterinarians would be involved in interpretation, but specific numbers and qualifications are not provided.
• Clinical Study:
  • Primary Endpoint (CSF fistula/pseudomeningocele): Assessed by MRI imaging and direct observation by clinicians.
  • Secondary Endpoint (MRI assessment): "confirmed in an assessment of a blinded, independent radiologist." The specific number of radiologists is not mentioned, nor are their detailed qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

• Bench Testing, Biocompatibility, Animal Studies: Adjudication methods are not explicitly described but are inherent to following validated test protocols and reporting objective measurements.
• Clinical Study:
  • Primary Endpoint: Assessment was based on MRI imaging and clinical observation. No explicit multi-reader adjudication method (e.g., 2+1, 3+1) is mentioned for the primary endpoint's determination.
  • MRI assessment (Secondary/Long-term): Confirmed by a "blinded, independent radiologist." This implies a single independent read, rather than a multi-reader consensus/adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

No. The provided text does not mention any AI or Machine Learning components. Therefore, no MRMC study involving AI-assisted human readers was conducted or reported.

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

No. The provided text does not mention any AI or Machine Learning components. Therefore, no standalone algorithm performance study was conducted or reported.

7. The Type of Ground Truth Used

• Bench Testing: Objective physical measurements and observations based on standardized test methods (e.g., force, pressure, visual inspection, length measurements).
• Biocompatibility: Results derived from established ISO standard test methods, involving cell culture assays, animal models, and chemical analysis, interpreted by qualified personnel (e.g., toxicologists, pathologists).
• Animal Studies: Histological examination of tissues and clinical observation of animal well-being.
• Clinical Study:
  • Primary Endpoint: Clinical observations (wound drainage), and MRI imaging interpreted by clinicians and an independent, blinded radiologist. This is effectively expert consensus/clinical outcome based on imaging and direct observation.
  • Secondary Endpoints: Direct observation for wound healing/device handling, and MRI imaging for tissue changes.
  • Long-term follow-up: MRI imaging and neurological assessment (clinical observation).

8. The Sample Size for the Training Set

Not applicable/Not mentioned. Since no AI/ML component is mentioned, there is no discussion of a training set for an algorithm.

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

Not applicable. See point 8.

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SYNTHECEL® Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.

SYNTHECEL® Dura Repair is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SYNTHECEL® Dura Repair functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SYNTHECEL® Dura Repair is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.

The document provided is a 510(k) premarket notification for the SYNTHECEL Dura Repair device, seeking substantial equivalence to previously cleared predicate devices. It describes the device, its intended use, and the non-clinical performance data used to support its equivalence.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" in a table format with specific numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing and biocompatibility. The reported performance is a statement of equivalence rather than meeting pre-defined numerical thresholds for a novel device.

However, based on the "Non-Clinical Performance Data" section, we can infer the areas of evaluation and the general outcome:

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

The document does not provide specific sample sizes for the mechanical testing (e.g., number of samples for burst strength or suture pull-out strength). It also does not specify the country of origin of the data or whether the non-clinical performance data was retrospective or prospective. It simply states that "Mechanical testing data was collected," implying lab-based testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to the provided document. The submission is for a medical device (dura repair), and the "test set" in this context refers to physical samples undergoing mechanical and biological evaluations, not diagnostic outputs requiring expert interpretation for ground truth establishment.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data (e.g., medical imaging) to resolve discrepancies. The provided document focuses on non-clinical performance data of a physical device.

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:

This is not applicable. The device is SYNTHECEL Dura Repair, a physical medical device, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

This is not applicable. The device is a physical dura repair product, not an algorithm.

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

For the non-clinical performance data:

• Mechanical Testing (Burst Strength, Suture Pull-Out Strength): The "ground truth" is established through standardized laboratory testing methods that quantify physical properties according to accepted engineering and medical device standards. The comparison is against predicate device performance, implying the predicate's performance serves as the benchmark.
• Biocompatibility: The "ground truth" is established by adhering to international standards (ISO 10993-1) which define acceptable biological responses (e.g., non-irritating, non-cytotoxic).

8. The sample size for the training set:

This is not applicable. The submission is for a physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a physical medical device.

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The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.

The DuraSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The DuraSure is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The DuraSure is designed to repair the body's natural organs.

Here's a breakdown of the acceptance criteria and the study details for the DuraSure Biologic Patch, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document focuses on "pre-clinical" testing, which includes both in-vitro (bench) testing and an in-vivo animal study.

• Bench Testing (Tensile, Elongation, Burst Strength, Suture Retention, Thickness):

  • Sample Size: Not explicitly stated for each test (e.g., "All DuraSure patches passed the acceptance criteria"). However, results are given as "mean" values, implying multiple samples were tested for each characteristic.
  • Data Provenance: Not specified, but generally refers to laboratory testing conducted by the manufacturer or contracted labs. The country of origin is not mentioned. This is retrospective data collected for the 510(k) submission.

• In-vivo Animal Study:

  • Sample Size: Forty-nine (49) rabbits.
  • Data Provenance: Not explicitly stated, but implies a controlled laboratory setting for animal research. This is prospective data collected during the study.

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

• Bench Testing: No experts are typically used to establish ground truth for this type of quantitative functional testing. The "ground truth" is defined by the physical measurement methods and the device specifications.
• In-vivo Animal Study:
  • Number of Experts: At least one. The document states, "All slides were evaluated by a veterinary pathologist for neuropathological changes in brain tissue, dural integrity, neoduralization and local tissue reaction according to ISO 10993-6 and FDA Guidance."
  • Qualifications: "veterinary pathologist." No further details on years of experience or specific sub-specialties are provided.

4. Adjudication Method for the Test Set

• Bench Testing: Not applicable. These are objective measurements following established test methods.
• In-vivo Animal Study: Not explicitly described. It states "All slides were evaluated by a veterinary pathologist." This implies a single expert assessment. If multiple pathologists were involved, no method for resolving disagreements (e.g., 2+1, 3+1) is mentioned.

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

No, an MRMC comparative effectiveness study was not done. The studies presented are pre-clinical (bench and animal studies) and do not involve human readers evaluating cases.

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

No, this question is not applicable. The DuraSure Biologic Patch is a physical medical device (surgical patch material), not an AI algorithm or software device. Therefore, a standalone performance evaluation of an algorithm is not relevant.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth is based on objective quantitative measurements obtained using standardized test methods (e.g., Instron for tensile/elongation/suture retention, pressure sensors for burst strength, thickness gauges).
• In-vivo Animal Study: The ground truth for the animal study was established through histopathological evaluation by a veterinary pathologist, based on internationally recognized standards (ISO 10993-6) and FDA guidance for dural substitute devices. This includes macroscopic and microscopic evaluations, with scoring.

8. The Sample Size for the Training Set

This question is not applicable. The DuraSure Biologic Patch is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

This question is not applicable, as there is no training set for a physical medical device.

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The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.9 in2 (31.7cm2) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size.

Cerafix® Dura Substitute is a resorbable implant for repair of dural defects. The device can be applied as an onlay matrix or sutured in place. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.

The provided text describes the Cerafix® Dura Substitute, a medical device for dura mater repair, and its equivalence to predicate devices, particularly focusing on expanding its indicated defect size and application method. The document, however, does not contain a detailed study proving acceptance criteria for an AI/ML device. Instead, it discusses the substantial equivalence of the Cerafix® Dura Substitute based on technological characteristics and animal studies, which is typical for a 510(k) submission for a non-AI medical device.

Therefore, many of the requested points regarding AI/ML device acceptance criteria and studies cannot be answered from this document. I will focus on the information that is present regarding the non-AI device.

Acceptance Criteria and Device Performance (Based on the non-AI device context):

The document describes "Indications for Use" and "Technological Characteristics" which serve as the de facto acceptance criteria for the expanded use of the Cerafix® Dura Substitute via a 510(k) submission. The "reported device performance" is primarily demonstrated through equivalence to a predicate device and side-by-side animal studies.

Regarding AI/ML Specific Information (points 2-9):

The provided document describes a 510(k) submission for a physical medical device (Cerafix® Dura Substitute), not an AI/ML driven software device. Therefore, the following points are not applicable to this submission based on the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, as this is a physical device, not an AI/ML algorithm requiring a test set for performance evaluation in the described manner.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm's predictions is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. The "ground truth" for this physical device's performance is derived from biological/physiological responses in animal models and comparison to known predicate device performance.
8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant "Study" for the physical device:

• Study Type: Side-by-side animal implantation studies.
• Model: Canine duraplasty model.
• Procedure: Dural defects (18 mm x 25 mm) created. Both the subject device (Cerafix® Dura Substitute) and the predicate device were implanted without the use of suture (onlay).
• Outcome Measured: "Equivalent safety and performance" between the subject and predicate devices.
• Conclusion: This animal study supported the expanded indication for onlay application and reinforced the safety and performance for dura repair. The justification for the increased defect size (from 4.4 in² to 4.9 in²) is stated as "Data included in this submission to justify defect increase," but the specific data from that justification is not detailed in this summary.

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DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

DuraGen® Secure Dural Regeneration Matrix is an absorbable implant for the repair of dura mater. This absorbable, sutureless onlay graft is comprised of a porous, highly purified collagen matrix and a thin layer of hydroxypropyl methyl cellulose (HPMC). HPMC is a non-cytotoxic, non-immunogenic, biocompatible plant-derived cellulose-based material. The addition of HPMC results in a dural graft which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.

The provided text describes a 510(k) premarket notification for the DuraGen® Secure Dural Regeneration Matrix. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a novel functionality. Therefore, the requested information elements related to performance metrics, statistical studies, expert adjudication, and training/test set details are not applicable in the context of this regulatory document.

However, I can extract the relevant information concerning the device, its intended use, and the single test result mentioned:

Device & Indications for Use:

• Device Name: DuraGen® Secure Dural Regeneration Matrix
• Indications for Use: Indicated as a dura substitute for the repair of dura mater.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

• Sample size used for the test set and data provenance: Not applicable. The "test set" in this context refers to the samples used in the viral inactivation study. The document states "These processes were performed in a validated scaled down process that is representative of all Integra LifeSciences Corporation's collagen products," but does not specify the sample size for this specific study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a laboratory study assessing viral inactivation, not an expert-driven performance evaluation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI-based diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the viral inactivation study was the measured reduction in viral titers following the specified treatment processes, evaluated against the standards of ISO 22442-3.
• The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm or a training set in that context.
• How the ground truth for the training set was established: Not applicable.

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Durepair is indicated as a dura substitute for the repair of the dura mater.

Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile, in a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.

The document describes the Durepair Dura Regeneration Matrix, a collagen implant for repairing dura mater defects. This is a 510(k) submission, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

Key Takeaway: The entire submission focuses on demonstrating that a manufacturing process change for the Proposed Durepair Device does not alter its fundamental technological characteristics, material, indications for use, or safety and effectiveness compared to the Predicate Durepair Device. Therefore, the "acceptance criteria" discussed are largely related to ensuring the proposed device performs comparably to the predicate across various physical, mechanical, and biological properties.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides "Table 2 – Summary of Bench Top Testing" and "Table 3 – Summary of Biocompatibility Testing" which directly address acceptance criteria and the performance of the Proposed Durepair device.

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The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.4 in2 (28.3 cm2) or less in area. For example, 4.0 in x 1.1 in (10.1 cm x 2.8 cm) would be an acceptable defect size.

Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.

The provided document is a 510(k) summary for the Cerafix Dura Substitute. It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's a breakdown of the acceptance criteria and study information provided:

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

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance values for each criterion in the way one might expect for a diagnostic or AI device. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device.

The primary "acceptance criteria" implicitly revolve around demonstrating equivalent performance to the predicate device in terms of:

• Safety and Efficacy: No significant differences in adverse events or repair outcomes.
• Biocompatibility: No new biocompatibility concerns.
• Mechanical Properties: Equivalent per unit area to the predicate.
• Neoduralization and Resorption: Similar mechanisms and timelines to the predicate.
• Absence of Complications: No CSF leaks, hydrocephalus, hemorrhage, or infection.

The reported device performance is that the subject device (new Cerafix Dura Substitute) was found to be equivalent to the predicate device (previously cleared Cerafix Dura Substitute - K153613) in all these aspects.

Key Comparison Points and Performance (Implicit Acceptance Criteria and Reported Performance):

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The "test set" was the animal study.
  • Canine Bilateral Duraplasty Model: "Each time point evaluated 3 test and 3 control animals, each with 2 defects."
  • This means a total of 6 animals per time point (3 for subject device, 3 for predicate device).
  • Since it states "at both time points" (implying at least two), it would be a minimum of 12 animals in total (6 animals x 2 time points), generating 24 defects.
• Data Provenance: The study was a "canine bilateral duraplasty model." This indicates it was a prospective animal study. The country of origin of the data is not specified.

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

• Ground Truth Establishment: For the animal study, tissue samples were processed by histopathology techniques and analyzed for dural integrity/neoduralization and local tissue reactions according to ISO 10993-6.
• Number and Qualifications of Experts: The document does not specify the exact number or qualifications of the individuals who performed the histopathology analysis or interpreted the results. It only mentions "tissue samples from each defect site were processed by histopathology techniques and analyzed."

4. Adjudication method for the test set

• The document does not describe an adjudication method for the animal study results. The histopathology analysis would likely have been performed by a qualified pathologist, but no multi-reader review or consensus method 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

• No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (dura substitute), not an AI algorithm. Therefore, there is no discussion of human readers or AI assistance.

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

• No, a standalone (algorithm only) performance study was not done. This is a hardware medical device, not an algorithm.

7. The type of ground truth used

• For the animal study, the ground truth was established through histopathology analysis (morphological and cellular evaluation of tissue samples) and clinical observations (e.g., absence of CSF leaks, neurological evaluations). These are essentially expert observations/assessments based on established scientific methods.

8. The sample size for the training set

• This device is not an AI algorithm; therefore, there is no training set in the context of machine learning. The "predicate device" study (K153613) serves as a baseline/reference, from which the current subject device draws its "equivalent" conclusions regarding mechanical and biocompatibility data.

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

• Not applicable, as there is no training set for an AI algorithm. The performance of the predicate device (K153613) was established through its own set of non-clinical and potentially animal/clinical studies, which presumably used similar ground truth methods (e.g., pathology, clinical assessment).

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The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 1.9 in² (12.5cm²) or less in area. For example, 1.2 in x 1.6 in (3 cm x 4 cm) would be an acceptable defect size.

Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.

The provided text describes the Cerafix® Dura Substitute, a medical device intended for the repair of dura mater, and its journey through FDA 510(k) clearance. The document details the device's characteristics, indications for use, and the non-clinical testing performed to establish its substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for many of the mechanical and biological tests were framed as "Equivalent to Predicate or Reference Device" or "Meets Final Device Specification." For some, specific thresholds were mentioned.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each mechanical test (e.g., number of samples tested for tensile strength or burst strength). It mentions "side-by-side bench testing versus the predicate or commercially available reference device" for mechanical tests, and for biocompatibility, it refers to standard ISO/ASTM tests using animals (e.g., guinea pigs, rabbits, mice) and cell cultures. The data provenance is pre-clinical testing, likely conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human data, as this is a pre-market clearance based on non-clinical data.

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

Not applicable. The "ground truth" for this device's clearance is based on established scientific principles and comparison to legally marketed predicate devices through defined acceptance criteria in mechanical and biocompatibility testing, not on expert consensus of clinical data.

4. Adjudication method for the test set

Not applicable. This device clearance relies on objective laboratory and animal testing, not human-based adjudication of clinical outcomes or images.

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 document pertains to the pre-market clearance of a physical medical implant (dura substitute), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for this regulatory submission is a combination of:

• Predicate Device Equivalence: The primary ground truth is established by demonstrating that the Cerafix® Dura Substitute's technological characteristics, performance, and safety are substantially equivalent to a legally marketed predicate device (Ethisorb™ Dura Patch) and a reference device (DuraGen Plus™ Dural Regeneration Matrix).
• Established Scientific Standards: Compliance with ISO and ASTM standards for biocompatibility and mechanical properties (e.g., non-cytotoxic, non-pyrogenic, appropriate burst strength).
• Animal Study Outcomes: Equivalence in safety and performance based on side-by-side animal implantation studies compared to the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device's pre-market clearance, as it's not a machine learning model.

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

Not applicable, as there is no training set.

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Collagen Dural Regeneration Matrix is intended for use as a dura substitute for the repair of dura mater.

Collagen Dural Regeneration Matrix is a white, non-friable, resorbable and biocompatible type I collagen matrix made from purified bovine Achilles tendon. Collagen Dural Regeneration Matrix is a porous, sponge-like collagen matrix with one smooth surface that conforms to the contours of the defect site. It is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

This document is a 510(k) premarket notification for a medical device called "Collagen Dural Regeneration Matrix." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the information provided is geared towards comparing the new device to an existing one.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for performance in a quantitative manner as one might find for a diagnostic device. Instead, it demonstrates substantial equivalence by comparing various parameters of the new device to its predicate. The "results" in the tables below effectively serve as the device performance against the implicit acceptance criteria of being "similar to predicate device" or "adequate."

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

This is not applicable in the context of this 510(k) premarket notification in the way it would be for an AI/diagnostic device.

• Test Set: The "test set" here refers to the actual Collagen Dural Regeneration Matrix devices and components subjected to various in vitro and in vivo tests. The exact number of samples used for each bench test is not specified in the summary, but it would typically involve replicates to ensure statistical validity.
• Data Provenance:
  • In Vitro Characterization: Laboratory internal testing data.
  • Biocompatibility: Laboratory testing following ISO standards.
  • Animal Efficacy Study: Conducted using a rabbit model.
  • Retrospective/Prospective: The testing described is prospective, in that samples of the new device were specifically manufactured and tested for this submission.

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

• This is not applicable for a device like a dural regeneration matrix. Ground truth for its performance is established through physical, chemical, and biological testing as outlined in the tables, rather than expert interpretation of images or clinical data.
• For the animal study, the assessment of dura repair and resorption would typically be conducted by veterinary pathologists or qualified researchers. No specific number or qualifications are given in this summary.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth is established through objective laboratory and animal testing, not human readers or consensus.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that analyze images or data for human interpretation, often involving AI. The Collagen Dural Regeneration Matrix is a physical implant, not a diagnostic tool incorporating AI.

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 not an AI device.

7. The Type of Ground Truth Used

The ground truth for the device's performance and safety was established through:

• Physical and Chemical Properties: Measured quantitatively (e.g., pH, tensile strength, burst strength, dimensions, permeability, hydrothermal transition temperature) and qualitatively (e.g., conformability, color, physical integrity).
• Biocompatibility Endpoints: Based on standardized in vitro and in vivo assays (e.g., cytotoxicity, sensitization, systemic toxicity, genotoxicity, pyrogenicity, implantation responses).
• Animal Study Outcomes: Observation and assessment of dura repair and resorption in a rabbit model.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable, as there is no training set for this device.

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