(84 days)
For use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.
The PRECLUDE ACUSEAL Dura Substitute is composed of expanded polytetrafluoroethylene (ePTFE) and an amorphous fluoropolymer (PATT) layer positioned within the plane of the device. This device is intended to be used for temporary or permanent repair of dura mater during neurosurgery.
The provided text is a Premarket Notification Summary (510(k)) for the PRECLUDE® ACUSEAL Dura Substitute. This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove that the device meets specific acceptance criteria through a clinical trial with a predefined set of performance metrics. Therefore, much of the requested information regarding acceptance criteria and performance data in a structured study format is not explicitly present in the provided text.
However, I can extract information related to the device's demonstrated safety and effectiveness, which serves a similar purpose in the context of a 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) submission focusing on substantial equivalence, explicit "acceptance criteria" for a specific study are not defined in the provided text. Instead, the device's performance is reported in terms of its demonstrated safety and effectiveness through various studies and clinical history.
| Performance Aspect | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | Possesses the requisite characteristics to function safely in its intended uses. | Demonstrated through biocompatibility data. |
| In Vivo Animal Testing | Functions safely and effectively as a dura substitute. | |
| Mechanical Strength | Performs in a substantially equivalent manner when compared to cited predicates. | Indicated by mechanical strength data and numerous comparative studies. |
| Clinical Performance (Predicate Device) | Performs safely and effectively as a dura substitute; no known adverse reactions in various patient populations (adults/children, male/female) for cranial and spinal dural repair. | Demonstrated by over 40,000 dural implants of the PRECLUDE® Dura Substitute over the past decade. |
| Structural, Biocompatibility, Biomechanical Characteristics (Predicate Device) | Has the necessary characteristics to function effectively as a dura substitute. | Demonstrated by collected clinical data. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The text mentions "clinical experience with more than 40,000 dural implants" over the past decade for the PRECLUDE® Dura Substitute (predicate device). This serves as the primary "test set" for demonstrating clinical performance, even though it's related to the predicate. For the applicant device (PRECLUDE® ACUSEAL Dura Substitute), animal testing was conducted, but a specific sample size for that is not provided.
- Data Provenance: Not specified in terms of country of origin. The clinical data on the predicate device is implied to be retrospective, referring to "clinical experience" and data collected over a decade. The animal testing on the applicant device would be prospective.
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)
Not explicitly stated. The "clinical experience" and "clinical series" referenced for the predicate device would involve medical professionals, but their specific number, roles in establishing ground truth, or qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not explicitly stated. This level of detail regarding clinical study design for data adjudication is not typically included in a 510(k) summary focused on substantial equivalence.
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 a dura substitute, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, an MRMC study or AI assistance related to human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the in vivo animal testing for the applicant device, the ground truth would be based on direct observation of the animal's physiological response and the device's function as a dura substitute.
- For the clinical experience with the predicate device, the "ground truth" is implied to be real-world clinical outcomes and observations by treating physicians, potentially corroborated by patient follow-up data. The text mentions "no known adverse reactions" and that the device "performs safely and effectively."
8. The sample size for the training set
The concept of a "training set" is not applicable in the context of this traditional medical device submission. This refers to physical implant studies and clinical experience, not machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the machine learning sense. The "ground truth" for the demonstrations of safety and efficacy (clinical experience, animal studies) was established through direct observation, medical assessments, and long-term follow-up in the respective studies.
§ 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).