(125 days)
The CODMAN Dural Graft Implant is intended for use in procedures where the repair or substitute of the patient's dura mater is needed.
The CODMAN Dural Graft Implant is a collagen sponge manufactured from processed bovine tendons. It is a sterile, absorbable implant intended for the repair of the patient's dura matter. The CODMAN Dural Graft Implant is designed to be a sutureless, onlay graft, but tensionless sutures can be used if preferred by the surgeon.
The CODMAN Dural Graft Implant was evaluated through biocompatibility, physical/mechanical testing, and an animal study, with results compared to a predicate device, DuraGen Dural Graft Matrix (K982180), Codman Bicol Collagen Sponge (preamendment), and Codman Ehtisorb™ Dura Patch (K991413).
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (CODMAN Dural Graft Implant) | Reported Device Performance (Predicate Device) |
|---|---|---|
| Biocompatibility | No signs of toxicity | Not explicitly stated but inferred to be acceptable given substantial equivalence claim |
| Physical and Mechanical Properties | Similar thickness, tensile strength, suture retention strength, burst strength, and surface structure | Baseline for comparison |
| In Vivo Performance (Animal Study) | No CSF leakage, infection, hydrocephalus, hemorrhage, or toxicity | No CSF leakage, infection, hydrocephalus, hemorrhage, or toxicity |
| Histopathologic Samples (Animal Study) | Similar adhesion formation, device resorption, foreign body reactions, and tissue vascularization | Baseline for comparison |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Type: This dossier describes performance testing (biocompatibility, physical/mechanical, and an animal study) rather than a clinical study with human subjects.
- Sample Size:
- Biocompatibility: Not explicitly stated, but typically involves in vitro and/or in vivo tests on cell samples or small animals.
- Physical and Mechanical Testing: Not explicitly stated, but typically involves multiple samples for each test (e.g., thickness, tensile strength, burst strength).
- Animal Study: The number of animals used is not specified.
- Data Provenance: The studies are described as "Device Testing" and "an animal study." This suggests prospective data generation specifically for the purpose of this submission. The country of origin for the studies is not specified, but the applicant, Codman & Shurtleff, Inc., is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Animal Study Adjudication: Histopathologic samples were analyzed. While not explicitly stated, it is inferred that veterinary pathologists or similar qualified experts would have assessed these samples. The number of experts is not specified.
- Physical/Mechanical Testing: These tests typically rely on standardized laboratory protocols and instrumentation, rather than expert consensus on a 'ground truth' in the same way clinical image interpretation would.
4. Adjudication Method for the Test Set:
- Animal Study: The document mentions "Histopathologic samples from animals implanted with either CODMAN Dural Graft Implant or its predicate device were similar in terms of adhesion formation, device resorption, foreign body reactions, other tissue reactions, and device vascularization." This implies a comparison of findings, likely by qualified experts. However, a specific adjudication method (e.g., 2+1, 3+1) is not provided. It's more likely an independent assessment by pathology experts.
- Other tests: Not applicable, as these are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The evaluation involved a direct comparison of physical properties and in vivo performance in an animal model between the new device and predicate devices. This type of study is more relevant for diagnostic devices interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable as this is a medical implant, not an AI algorithm.
7. The Type of Ground Truth Used:
- Physical and Mechanical Testing: The "ground truth" was established by objective measurements against predefined specifications or benchmarks, and direct comparison to the predicate device.
- Animal Study: The "ground truth" for in vivo performance (e.g., CSF leakage, infection) and histopathologic findings (e.g., adhesion formation, resorption, foreign body reactions) was established through direct observation, clinical assessment, and microscopic evaluation by qualified personnel (e.g., veterinarian, pathologist).
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 882.5900 Preformed craniosynostosis strip.
(a)
Identification. A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.(b)
Classification. Class II (performance standards).