(346 days)
The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
SpinMedix Absorbable Fibrous Membrane provides a non-constricting protective layer between the injured tissue and surrounding tissues and may be secured in place using standard fixation techniques. It is designed for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. SpinMedix is composed of poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol), and is provided in a variety of sizes, ranging from 25mm * 25mm to 200mm * 300mm. It is a single use, sterilized, porous, polymeric membrane in double peel packages.
It appears you've provided a 510(k) submission document for a medical device called "SpinMedix Absorbable Fibrous Membrane." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, not typically a study proving the device meets acceptance criteria for an AI/CADe system.
The information provided describes:
- Device Name: SpinMedix Absorbable Fibrous Membrane
- Intended Use: Management and protection of tendon injuries where there has been no substantial loss of tendon tissue.
- Composition: Poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol).
- Testing: Mechanical performance, biocompatibility (ISO 10993-1), and an in vivo animal study (calcaneal tendon incision model and inguinal hernia model).
Crucially, this document does NOT describe an AI/CADe system or a study that would require acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC). The "acceptance criteria" and "study" you are asking for, with details like sample size for test/training sets, expert ground truth establishment, MRMC studies, etc., are specific to the validation of diagnostic AI algorithms, not for a physical medical implant like an absorbable fibrous membrane.
Therefore, I cannot extract the requested information from this document because it is not relevant to the type of device and study you are asking about.
To reiterate, the provided document does NOT contain information about:
- A table of acceptance criteria and reported device performance for an AI algorithm.
- Sample sizes for test sets for an AI algorithm or data provenance.
- Number of experts or their qualifications for establishing AI ground truth.
- Adjudication methods for AI ground truth.
- MRMC studies for human readers with/without AI assistance.
- Standalone AI performance.
- Type of ground truth (expert consensus, pathology, outcomes) for AI diagnostics.
- Sample size for a training set for an AI algorithm.
- How ground truth for a training set for an AI algorithm was established.
This document focuses on showing the physical implant is substantially equivalent to existing implants based on design, materials, performance (mechanical), and biological safety (biocompatibility, animal integration/resorption).
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.