Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device