(89 days)
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.
| Acceptance Criteria (from Proposed Indications for Use) | Reported Device Performance |
|---|---|
| Indicated as a dura substitute for the repair of dura mater. | Subject device (Cerafix® Dura Substitute) has identical technological characteristics, principles of operation, material performance, and biocompatibility to the reference device (previously approved Cerafix® Dura Substitute, K153613, K161278). The reference device was indicated for dura mater repair. Side-by-side animal studies in a canine duraplasty model (dural defects 18 mm x 25 mm) showed "equivalent safety and performance between the subject and predicate device." |
| Indicated for defects of 4.9 in² (31.7 cm²) or less in area. | Previously, the device was indicated for defects of 4.4 in² (28.3 cm²). The submission includes "Data included in this submission to justify defect increase" (though the data itself is not presented in this summary). The side-by-side animal study utilized dural defects of 18 mm x 25 mm (equal to 4.5 cm² or ~0.7 in²), which is consistent with the general purpose of evaluating a dura substitute but is smaller than the maximum defect size being justified. The equivalence argument for the larger defect size relies on "Data included in this submission to justify defect increase" in comparison to the reference device, which had a slightly smaller indicated defect size. |
| May be applied as an onlay matrix or sutured in place. | The previous version (reference device) was applied with "tensionless suture application." The primary predicate device (DuraMatrix™ Collagen Dura Substitute) "can be cut by surgeon and placed on dural defect and used as an onlay membrane or sutured in place." The subject device has "Equivalent" principles of operation to the predicate regarding application methods. Side-by-side animal implantation studies were performed with the subject and predicate device "utilizing dural defects (18 mm x 25 mm) without the use of suture (onlay)." Results showed "equivalent safety and performance." |
| Biocompatibility: Biocompatible | Biocompatibility testing was previously submitted for K153613 and K161278 and confirmed. "Biocompatible" is listed as a common characteristic with both the reference and predicate devices. |
| Sterility: Sterile, SAL 10⁻⁶ | "Sterile, SAL 10⁻⁶" is listed as a common characteristic with the reference device. "Sterile" is listed for the predicate. |
| Pyrogenicity: Non-pyrogenic | "Non-pyrogenic" is listed as a common characteristic with the reference and predicate devices. |
| Resorbable: Yes | "Yes" is listed as a common characteristic with the reference device. The predicate is listed as "Not Applicable," but the subject device's resorbable nature is considered "Equivalent to reference device." |
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:
- 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.
- 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.
- 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-assisted 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 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.
- The sample size for the training set: Not applicable. This is not an AI/ML algorithm that requires a training set.
- 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.
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).