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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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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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