(128 days)
GalaFORM 3D scaffold is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaFORM 3D scaffold is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.
The provided text describes the GalaFORM 3D device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting pre-defined acceptance criteria through a specific performance study in the way one might evaluate a diagnostic algorithm or a similar device.
Therefore, I cannot extract the requested information from the provided text for the following reasons:
- No Acceptance Criteria or Reported Device Performance Table: The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or other performance metrics) nor does it report specific performance values against such criteria.
- No Test Set Information (Sample Size, Data Provenance, Experts, Adjudication): The document mentions an "animal study" but does not detail the size of a "test set" in the context of clinical or diagnostic performance, its data provenance, the number and qualifications of experts, or adjudication methods. The animal study focused on tissue response, resorption, and strength characteristics, not diagnostic or clinical accuracy.
- No MRMC Comparative Effectiveness Study: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention any human readers or AI assistance.
- No Standalone Performance Study: While an animal study was done, it was not described as a standalone performance study in the context of an algorithm or diagnostic device.
- Type of Ground Truth: The "ground truth" in the animal study would presumably be derived from histopathology and physical measurements (e.g., burst strength) in animal tissues, not expert consensus or patient outcomes in a diagnostic context.
- No Training Set Information: The document makes no mention of a training set, as it is not describing an AI/algorithm-based device that would require such.
- No Ground Truth for Training Set: Consequently, there is no information on how ground truth for a training set was established.
Summary of what the document does provide regarding studies:
- Animal Studies:
- Purpose: To characterize tissue response, resorption profile, and strength characteristics of the device after implantation and to verify no changes due to the modified manufacturing process (addition of a rim for 3D shape).
- Design: Subject device (GalaFORM 3D) and predicate (GalaFLEX scaffold) subcutaneously implanted in rabbits.
- Time Points: Necropsies performed at 4, 8, 12, and 40 weeks.
- Findings: Local tissue reaction was similar between the predicate and the shaped mesh. No statistically significant difference (p>0.05) in burst strength between the curved mesh and GalaFLEX groups at each time point, indicating comparable bioresorption. Similar molecular weights of the polymer also supported comparable resorption.
- Biocompatibility Testing: Conducted per ISO 10993-1:2009 for an implant device in contact with tissue and bone for greater than 30 days. Results supported biocompatibility and safety.
The information primarily describes pre-clinical testing to demonstrate the safety and comparable performance characteristics of the physical mesh material itself, rather than the performance of a diagnostic or AI-driven device against specific clinical acceptance criteria.
§ 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.