(113 days)
GalaFLEX LITE Scaffold is intended to reinforce soft tissue, where weakness exists, in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
GalaFLEX LITE Scaffold is a sterile, single-use device for prescription use only. It is a bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is a biologically derived polymer which is extruded into monofilament fibers and knitted into a surgical scaffold. The P4HB material is the predicate device, TephaFLEX Light Mesh (K113721) and the reference device, Phasix Mesh (K142818) in terms of formulation and the manufacturing processes. P4HB is absorbed by the body through a process of hydrolysis and hydrolytic enzymatic digestion typically within 18 to 24 months. The material components and manufacturing processes used to produce the subject device is substantially equivalent to the subject device will only be offered as a nondyed (clear) surgical scaffold. The subject device has the predicate device: soft tissue repair/reinforcement.
The provided text describes a 510(k) premarket notification for a medical device called GalaFLEX LITE Scaffold. It asserts that the device is substantially equivalent to a legally marketed predicate device, TephaFLEX Light Mesh (K113721). However, the document does not contain acceptance criteria for device performance, nor does it detail a study that explicitly proves the device meets such criteria using the requested information formats.
Instead, the document states:
- "The subject device met all of the performance requirements as described."
- "All samples utilized in the performance testing were representative of the subject device in terms of device design, manufacturing, packaging and sterilization."
- "The testing results demonstrate that GalaFLEX LITE Scaffold is substantially equivalent to the predicate device, TephaFLEX Light Mesh (K113721)."
This implies that performance testing was conducted, but the specific metrics, thresholds for acceptance, and detailed results are not provided in this summary. The text refers to "physical and functional characteristics as recommended in the Surgical Mesh guidance" and an "in vivo rabbit study for the subject device includes the performance specifications and absorption time," but no data from these tests are quantified or presented as acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information is typically found in the full 510(k) submission or associated test reports, not usually in the summary letter provided.
§ 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.