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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.

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The Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias, including hiatal hernias.

The Phasix™ ST Mesh is a fully resorbable mesh with a resorbable hydrogel coating. It is a sterile mesh prosthesis designed for the reinforcement and reconstruction of soft tissue deficiencies. Phasix ™ ST Mesh is co-knitted using poly-4-hydroxybuterate (P4HB) and polyglycolic acid (PGA) fibers. P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and then knitted into a surgical mesh. P4HB degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to reinforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected healing period. Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months indicates loss in mechanical integrity and strength. While fiber segments were observed at 18 months, they continued to degrade. Phasix™ ST Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral side of the mesh is a resorbable hydrogel coating, separating the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

The provided text describes a 510(k) premarket notification for the "Phasix ST Mesh," a surgical mesh. The document details the device's description, indications for use, technological comparison to predicate devices, and performance data from various studies.

Here's an analysis of the requested information based on the provided text, categorized by the questions asked:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense with specific thresholds. Instead, the performance data is presented as a demonstration that the device's characteristics are "comparable" to a predicate device or that differences "do not adversely affect safety and performance."

Therefore, I will interpret "acceptance criteria" as implied benchmarks for comparability to the predicate devices and summarize the reported performance in relation to these comparisons.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to two retrospective clinical studies. Combining them gives a total number of patients whose data was reviewed.

• Sample Size for the Test Set (Clinical Studies):
  • Study 1: 50 patients
  • Study 2: 180 patients
  • Total: 230 patients
• Data Provenance:
  • Both studies are explicitly stated as retrospective reviews.
  • Both studies were conducted at a single institution. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S. company (Davol Inc., Warwick, RI), making it highly probable the studies were conducted in the United States.

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)

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study data (e.g., for diagnosing recurrences or assessing complications). For retrospective reviews, the data is typically pulled from existing medical records, where diagnoses and assessments would have been made by the treating clinicians. The study design does not specify a separate "ground truth" adjudication panel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method (like 2+1 or 3+1 consensus) for the clinical study data. As indicated in point 3, the studies are retrospective reviews, implying that the outcomes (recurrences, complications) were determined based on existing clinical records by the treating physicians or the physicians performing the follow-up procedures (EGD, UGI, BS).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

The Phasix ST Mesh is a physical surgical implant, not an AI software/device that assists human readers/clinicians in interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm-only) performance study was not done, as the device is a physical surgical mesh and not an algorithm or AI software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the clinical studies, the "ground truth" for assessing device safety and performance appears to be based on:

• Clinical outcomes data: This includes objective follow-up data (Esophagogastroduodenoscopy (EGD), Upper Gastrointestinal (UGI) series, Barium Swallow (BS)) and non-objective follow-up (unspecified clinical assessments).
• Medical records: The retrospective nature of the studies means that existing medical records were reviewed for reported complications, recurrences, and successful repairs.

For the animal studies, the "ground truth" involved histological and mechanical assessments conducted by researchers to characterize mechanical strength, tissue response, and resorption profile.

8. The sample size for the training set

This question is not applicable in the context of this device submission. The Phasix ST Mesh is a physical medical device (surgical mesh), not an AI algorithm or a device that requires a "training set" in the machine learning sense. The performance data consists of biocompatibility testing, animal studies, bench testing, and retrospective clinical reviews, none of which utilize a "training set."

9. How the ground truth for the training set was established

As in point 8, this question is not applicable because there is no "training set" for this physical medical device.

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