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Phasix™ ST Umbilical Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving the repair of umbilical hernias.

Phasix™ ST Umbilical Hernia Patch is a sterile, single-use device for prescription use only. It is a self-expanding, fully resorbable mesh with a resorbable hydrogel coating and a positioning pocket and strap. Phasix™ ST Umbilical Hernia Patch is comprised of 2 layers of poly-4hydroxybutyrate (P4HB), with the posterior side being co-knitted with polyglycolic acid (PGA) fibers, identical to the mesh component of the secondary predicate device (Phasix™ ST Mesh with Open Positioning System). P4HB degrades through hydrolysis and a hydrolytic enzymatic digestive process and is essentially completely resorbed in 12-18 months. Phasix™ ST Umbilical Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC), and polyethylene glycol (PEG) based hydrogel. The hydrogel is identical to both the primary predicate device (Ventralex™ ST Hernia Patch (K101928) and the secondary predicate device (Phasix™ ST Mesh with Open Positioning System, K190185). The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth. The visceral side of the mesh is the resorbable hydrogel coating, which separates the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration in saline, the coating becomes a hydrated gel that is resorbed from the site in less than 30 days. Phasix™ ST Umbilical Hernia Patch contains SorbaFlex™ Memory Technology, which provides memory and stability to the mesh, facilitating ease of initial insertion, proper placement and fixation of the device. The SorbaFlex™ Memory Technology is comprised of an extruded polydioxanone (PDO) resorbable monofilament contained within a knitted P4HB containment sleeve. PDO is resorbed within 24-32 weeks. The PDO ring and hybrid positioning straps (comprised of P4HB and polypropylene materials that are connected by overlapping the materials and sewing them together with clear PP monofilament, with a delineation marker dyed blue with [phthalocyaninato(2-)] copper), are based on the design of the primary predicate Ventralex™ ST Hernia Patch (K101928). The subject device has the identical intended use as the primary and predicate devices; soft tissue repair/reinforcement.

The provided document does not describe acceptance criteria for a software device or a study proving that a software device meets those criteria.

Instead, the document is a 510(k) premarket notification summary for a physical medical device: Phasix™ ST Umbilical Hernia Patch.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for a software device.

The document discusses the following types of testing for the physical medical device:

• Biocompatibility Testing: Conducted in accordance with ISO 10993-1. Many tests were not repeated as the materials were the same as previously cleared predicate devices. Tests included material chemical characterization (gravimetric analysis, GCMS, LCMS-UV-CAD, HS-GCMS, ICPMS, GPC), cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, LAL, subacute/subchronic/chronic toxicity, genotoxicity (AMES, Mouse Lymphoma), and implantation tests.
• Product Testing (Performance Testing): This included "Substantial Equivalency Testing" covering physical characteristics (mesh weave, pore size, thickness, weight per unit area, stiffness, dimensions) and functional characteristics (ball burst strength, suture retention strength, tear strength, PGA pull-out strength, three-tack pluck force, gel disruption analysis). It also included functional testing of the subject device (25-degree recoil, containment sleeve puncture, strap attachment strength, pocket integrity), resorption profile of the ring and containment sleeve (in-vitro degradation of PDO), design validation usability testing, and human factors/simulated testing.
• Animal Studies: No new animal studies were conducted for the subject device. Instead, the safety and performance were evaluated based on animal and histological data from reference devices (Phasix™ Mesh, Phasix™ ST Mesh) and predicate devices (Phasix™ ST Mesh with Open Positioning System, Ventralex™ ST Hernia Patch). The PDO ring material was previously evaluated in a rat model.

If you have a document pertaining to a software device, please provide that, and I will do my best to extract the requested information.

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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:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. 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.

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