(127 days)
GalaSHAPE™ 3D 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. GalaSHAPE™ 3D 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.
GalaSHAPE 3D is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold has a slight 3D curvature 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 over 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 a 510(k) premarket notification for a medical device called GalaSHAPE 3D, a bioresorbable surgical mesh. The document focuses on demonstrating substantial equivalence to a predicate device (K140533 GalaFLEX scaffold), rather than presenting a study to prove the device meets pre-defined acceptance criteria in the typical sense of a diagnostic or algorithmic device.
Therefore, the requested information elements (acceptance criteria table, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission.
This document is a regulatory filing, and its core purpose is to show that the new device (GalaSHAPE 3D) is as safe and effective as a device already legally marketed (GalaFLEX scaffold). It does this by comparing technological characteristics, biocompatibility, and animal study results.
Here's an explanation based on the provided text's context:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not present specific quantitative acceptance criteria for device performance that GalaSHAPE 3D needed to meet as a new device. Instead, it aims to demonstrate substantial equivalence to a predicate device (GalaFLEX scaffold). The performance is reported in terms of comparability to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Animal Study: The document mentions an animal study involving rabbits ("subcutaneously implanted in rabbits").
- Sample Size: The exact number of rabbits used is not specified in the provided text.
- Data Provenance: The country of origin and whether it was retrospective or prospective is not specified. However, animal studies are inherently 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 Applicable. This is not a study involving human interpretation or diagnoses that would require expert-established ground truth. The animal study involved measuring tissue response, resorption profiles, and strength characteristics, which are objective measures, not subjective expert interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method is mentioned as the study did not involve subjective assessments requiring human consensus.
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 physical surgical mesh, not a diagnostic imaging or AI-assisted device. Therefore, a MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the animal study: The ground truth was based on objective biological and mechanical measurements, specifically:
- Tissue response (presumably histological examination, although not explicitly stated)
- Resorption profile (implied by molecular weight changes and strength retention over time)
- Strength characteristics (burst strength).
- These are not "expert consensus" in the way a diagnostic algorithm's ground truth would be established.
8. The sample size for the training set:
- Not Applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists.
In summary, the provided text describes a regulatory filing for a surgical mesh, focusing on demonstrating substantial equivalence to a predicate device. It includes findings from an animal study comparing the new device to the predicate in terms of tissue response, resorption, and strength. The detailed elements requested in the prompt, which are typically relevant for AI/ML or diagnostic device evaluations, are not applicable to this context.
§ 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.