(94 days)
The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.4 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):
| Acceptance Criteria (Implicit) | Reported Device Performance (Subject Device) |
|---|---|
| Principles of Operation: Cut by surgeon, placed with tensionless suture, 2-3mm suture line, 1cm overlap. | Equivalent to predicate device. |
| Material of Construction: Porous polymer matrix, Porous PGLA / PDO matrix. | Equivalent to predicate device. |
| Surgical Application Restrictions: No specific orientation requirement. | Equivalent to predicate device. |
| Sterility: Sterile, SAL 10-6. | Equivalent to predicate device. |
| Packaging: Double sterile pack, nested pouch in chipboard envelope. | Equivalent to predicate device. |
| Pyrogenicity: Non-pyrogenic. | Equivalent to predicate device. |
| Resorbable: Yes. | Equivalent to predicate device. |
| Biocompatibility: Biocompatible. | Equivalent to predicate device (no new biocompatibility testing was conducted; relied on previous submission for predicate). |
| Mechanical Properties: Equivalent per unit area. | Equivalent to predicate device (no new mechanical testing was conducted; relied on previous submission for predicate). |
| Clinical Performance (Animal Study): Absence of CSF leaks, hydrocephalus, hemorrhage, infection. | No CSF leaks observed in either group throughout the duration of both studies. All animals appeared healthy with normal neurological evaluations. |
| Clinical Performance (Animal Study): Neoduralization and absorption mechanism. | Similar in the mechanism of neoduralization and absorption, independent of the size of the induced dural defect. Demonstrated signs of resorption with infiltration of fibrovascular connective tissue and successful neoduralization. |
| Clinical Performance (Animal Study): Overall safety and efficacy. | Equivalent clinical performance at each time point, successfully repaired induced dural defects independent of defect size. Demonstrates equivalent safety and efficacy when compared to the predicate device. |
| Indications for Use: Repair of dura mater for defects up to 4.4 in² (28.3 cm²). | The subject device supports repair of dura mater for defects up to 4.4 in² (28.3 cm²), which is a larger indicated defect size than the predicate device (1.9 in² (12.5cm²)). The side-by-side animal study concluded equivalency independent of defect size, supporting this larger indication. |
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).
§ 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).