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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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Transorb™ Self-Gripping Resorbable Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair.

Transorb™ Self-Gripping Resorbable Mesh is designed for ventral hernia repair when placed in an extraperitoneal space by open surgical approach. Transorb™ Self-Gripping Resorbable Mesh is made of a fully resorbable bi-dimensional Poly-L-lactide, poly-trimethylene carbonate copolymer (PLLA/TMC) monofilament textile with monofilament PLLA/TMC absorbable grips on one side. Transorb™ Self-Gripping Resorbable Mesh is available in different shapes and sizes. Transorb™ Self-Gripping Resorbable Mesh is a macro-porous mesh knitted from resorbable monofilament PLLA/TMC yarns. It has been designed to reinforce soft tissues where weakness exists by providing strength and tissue integration throughout the expected healing period. Transorb™ Self-Gripping Resorbable Mesh has absorbable PLLA/TMC grips on one side that facilitate positioning and contribute to fixation. The PLLA/TMC mesh and grips degrade and resorb in vivo by hydrolysis in 36 to 60 months and are metabolized by the body into CO2 and H₂O.

The provided text describes a 510(k) premarket notification for a medical device called "Transorb™ Self-Gripping Resorbable Mesh." This submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria for a new claim typically associated with AI/ML devices or novel therapies. Therefore, the information typically requested in your prompt regarding acceptance criteria, study types, ground truth, and expert involvement for AI/ML performance is not present in this regulatory document.

However, I can extract the performance data and "acceptance" (pass/fail) criteria as presented for the biocompatibility and bench testing components of this surgical mesh.

Here's the information based on the provided text, structured as much as possible according to your request, but acknowledging the inherent differences in regulatory submissions for a surgical mesh versus an AI/ML diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (surgical mesh), "acceptance criteria" are implied by compliance with established standards and the outcome of "Pass" for various tests. The reported device performance is that it passed these tests, thus meeting the implied criteria.

Notes on Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (TIGR® Matrix Surgical Mesh K191749), showing that differences do not raise new questions of safety or effectiveness. For biocompatibility tests, the criterion is to "Pass" the specific ISO 10993 standard. For bench tests, the conclusion is frequently stated as "substantially equivalent" to the predicate.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for each test in terms of a numerical count of units or animals. The text mentions broad categories like "PLLA/TMC monofilament yarn (up to 21g)" for composition and lists different product codes/sizes (e.g., TSB1510, TSB2020, TSB3030, TSB4030) that imply various units were tested across the different evaluations. For animal studies, it mentions "large animal model" (porcine) and "rabbit study."
• Data Provenance: The studies were internal preclinical (bench and animal) tests conducted by the manufacturer or their testing partners. There is no specific country of origin mentioned for the data, beyond the manufacturer being based in France. The studies are prospective in nature, designed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable in the context of your question. This document pertains to a physical medical device (surgical mesh) and its performance in bench and animal studies, not an AI/ML device requiring expert adjudication of outputs to establish ground truth from clinical images or data. The "ground truth" here is the physical and biological reality as measured by the various test methods (e.g., breaking strength, tissue ingrowth observations).

4. Adjudication Method for Test Set

• Not Applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used to establish a consensus ground truth in clinical evaluations, especially for AI/ML diagnostic tools. For this surgical mesh, performance is measured against established scientific and engineering principles via tests (e.g., ISO standards, ASTM standards, histological examination).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI/ML-assisted ones) to assess the impact of the device on human reader performance. This submission is for a surgical implant, where such studies are not typically performed or required to demonstrate substantial equivalence. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This concept is specific to AI/ML algorithms evaluated independently of human interaction. The Transorb™ mesh is a physical implant, not a software algorithm. Its performance is evaluated through physical, chemical, and biological testing, outlined as biocompatibility, bench testing, and animal studies.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Compliance with International Standards: For biocompatibility (ISO 10993 series) and some physical properties (e.g., ISO 3801, ISO 9073-2, ISO 13934-1, ISO 4674).
• Predicate Device Comparison: For mechanical properties and physical aspects, the device's performance is compared to the predicate device (TIGR® Matrix Surgical Mesh, K191749), with substantial equivalence being the goal.
• Histology/Pathology: For animal studies, tissue repair, tissue integration, local tissue effects, and degradation profile were assessed via histological examination.
• Direct Measurement: For parameters like pore size, surface density, thickness, bursting strength, suture pull-out strength, etc., direct measurements are taken.

8. Sample Size for the Training Set

• Not Applicable. This device is a physical surgical mesh, not an AI/ML algorithm that requires a training set. The term "training set" is not relevant in this context.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for this device, the question of how its ground truth was established is not relevant.

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The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The BioBrace™ implant is a bioresorbable, biocomposite scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn (75 denier, 15 um filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm³, and median pore diameter of 19 µm. The highly-porous collagen sponge comprises the majority of implant surface area (0.7 m²/gram) versus the PLLA filaments alone (0.2 m²/gram), creating a large biologic matrix for cellular ingrowth. BioBrace implants are approximately 3 mm thick, provided in two rectangular sizes of 5 x 250mm and 23 x 30mm, and are designed for soft tissue and tendon augmentation and reinforcement. The BioBrace implant is single-use and supplied sterile with SAL of 10°.

The provided text describes the BioBrace™ Implant, a bioresorbable, biocomposite scaffold intended for reinforcement of soft tissue. The document focuses on demonstrating the substantial equivalence of the BioBrace™ Implant to a predicate device (STR GRAFT, K121216) and several reference devices rather than establishing novel acceptance criteria for a new type of device. Therefore, the information provided relates to testing parameters and comparable performance, rather than distinct acceptance criteria for the device's function as an AI or diagnostic tool.

The document does not describe a study involving an AI algorithm or human-in-the-loop performance, so many of the requested categories for AI-related studies are not applicable.

Here's the information extracted from the provided text, primarily focusing on the performance data and comparative studies as they relate to device safety and effectiveness.

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

The document does not explicitly present a table of "acceptance criteria" with direct quantitative thresholds that the device had to meet to be proven effective in a standalone capacity. Instead, it details performance tests conducted and compares the results to predicate/reference devices or established biological norms. The implied acceptance criteria are that the BioBrace™ Implant performs equivalently to the predicate device and demonstrates acceptable biocompatibility, mechanical integrity, and biological response.

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The TIGR Matrix Surgical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repar of hernias or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.

The TIGR™ Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers. possessing different degradation characteristics. The fast-resorbing fiber, making up approximately 40% of the matrix by weight, is a copolymer of glycolide, lactide, and trimethylene carbonate. The slow-resorbing fiber, making up approximately 60% of the matrix by weight, is a copolymer of lactide, and trimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers. In vitro testing showed that the fast-resorbing fiber (glycolide, lactide and trimethylene carbonate) loses its mechanical strength after 2 weeks and in vivo studies in the abdominal wall of sheep showed that the fast-resorbing fiber is fully absorbed after 4 months. The same in vitro testing showed that the slow-resorbing fiber (lactide and trimethylene carbonate) maintains its mechanical strength for 6 months and in vivo studies in the abdominal wall of sheep indicated that the slow-resorbing fiber is absorbed after approximately 36 months.

The provided text discusses the TIGR Matrix Surgical Mesh and its substantial equivalence to predicate devices, focusing on technical characteristics and clinical performance to support its expanded indications for use and extended shelf life.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it argues for substantial equivalence based on the device being the same as a reference predicate (K163005) and having similar characteristics to a primary predicate (K161424). Performance is discussed qualitatively and through comparative attributes.

Below is a table summarizing the claimed performance and characteristics, primarily in comparison to the predicate devices:

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Data Test Set (for hernia repair):

  • Sample Size: 91 patients.
  • Data Provenance: Real-world clinical evidence from a surgical hernia program. Implied to be retrospective as it describes data collected between 8/2011 and 9/2015. The geographic origin is not explicitly stated but "US clinics" is mentioned, suggesting U.S. data.

• Bench, Animal, Biocompatibility, Human Factors Testing: These tests are stated to be "described in (K163005)" for the reference predicate. Specific sample sizes for these tests are not provided in this document, but they were part of the previous submission for the K163005 clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For the clinical data regarding hernia repair:

• The ground truth was established by surgeons' clinical practice within a Clinical Quality Improvement (CQI) program.
• The document implies that these were multiple surgeons as part of a "surgical hernia program."
• Qualifications: Not explicitly stated, but they are referred to as "surgeons" performing "abdominal wall reconstruction (AWR) operations," indicating medical expertise in this surgical field. Years of experience are not mentioned.

4. Adjudication Method for the Test Set

• The clinical data was collected as part of a Clinical Quality Improvement (CQI) program and reflects "real-world clinical evidence."
• There's no mention of an independent adjudication method (e.g., 2+1, 3+1 consensus by external experts) for the patient outcomes (recurrence, complications). The outcomes were presumably recorded by the treating surgical team as part of their standard clinical practice and CQI process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done.
• The clinical data presented is on the performance of the TIGR Matrix Surgical Mesh itself, not on how human readers/surgeons improve with or without AI assistance. This device is a surgical mesh, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical surgical mesh, not an algorithm or AI product. Its performance is intrinsic to the material and its interaction with the human body, not a software component.

7. Type of Ground Truth Used

• Clinical Outcomes Data: For the hernia repair clinical data, the ground truth was based on documented patient outcomes (recurrence rates, wound complication rates, mesh-related complications) as observed and recorded in real-world clinical practice.

8. Sample Size for the Training Set

• Not applicable. This submission pertains to a physical medical device (surgical mesh), not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
• The clinical data of 91 patients served to support the expanded indication, which could be considered an evaluation of the device in practice.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for an AI/ML algorithm. The clinical outcomes data cited (91 patients) was collected from routine surgical practice as described in point 3 without specific ground truth establishment for a training set.

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GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery.

Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include:

-Hernia repair as suture line reinforcement

-Muscle flap reinforcement

-General tissue reconstructions

The subject GORE® BIO-A® Tissue Reinforcement is a bioabsorbable web structure that functions as a surgical mesh for soft tissue reinforcement while providing a scaffold for tissue ingrowth. It is used to reinforce soft tissue during the phases of wound healing by filling soft tissue deficits. The device elicits a physiologic tissue response which fills the deficit with native tissue and gradually absorbs the device. The implanted GORE® BIO-A® Tissue Reinforcement is a textured porous fibrous web surface on both surfaces composed solely of synthetic bioabsorbable poly (glycolide:trimethylene carbonate) copolymer (PGA:TMC). In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months. The GORE® BIO-A® Tissue Reinforcement is available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The device is sterilized by gamma irradiation validated to an SAL of 10°. It is for single use only.

I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain the information needed to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The 510(k) submission for the GORE BIO-A Tissue Reinforcement, K191773, explicitly states:

• "No bench, animal, or clinical studies were required to support the labeling modification." (Page 4, under "Summary of Performance Testing")
• The entire submission is focused on a "labeling change that is not related to any safety or effectiveness issue" and clarifies that there are "no differences in technological characteristics between the subject and predicate device." (Page 4, under "Differences in Technological Characteristics")

Therefore, the document does not discuss:

1. A table of acceptance criteria or reported device performance from a new study.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Types of ground truth used.
8. Sample size for training sets.
9. How ground truth for training sets was established.

This is a regulatory clearance for a labeling change only, implying that the device itself was previously cleared or is substantially equivalent to a cleared predicate, and no new performance data was submitted or required for this specific 510(k) application.

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Phasix ST Mesh with Open Positioning System 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.

The open positioning system is intended to facilitate the placement, positioning and fixation of the mesh during open ventral hernia repair.

Phasix™ ST Mesh with Open Positioning System is a sterile, single-use device for prescription use only. It is a bi-layer mesh comprised of Phasix™ ST Mesh (K173143, forms posterior layer) and Phasix™ Mesh (K161424, forms anterior layer) stitched together with a 10 mil P4HB monofilament. The combination of the two distinct layers forms a pocket to accommodate a preinserted removable accessory. The subject device is designed for reinforcement of soft tissue deficiencies during open ventral hernia repair. The subject device and reference device have identical intended use for the mesh i.e. soft tissue repair/ reinforcement.

The removable open positioning system is an accessory with polypropylene (PP) handle attached to a Polytetrafluoroethylene (PTFE) guide. The accessory comes preinserted into the mesh pocket to aid with placement, positioning, and fixation. The center marking on the positioning guide will aid with proper centering and orientation over the defect. The accessory is removed following the initial fixation and then discarded. The intended use of the accessory is similar to the SorbaFlex Memory Technology utilized in the Ventrio™ ST Hernia Patch (K101920).

The provided text is a 510(k) summary for the Phasix ST Mesh with Open Positioning System, a surgical mesh device. The document details the device's characteristics, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:

No specific acceptance criteria table or quantitative performance metrics are explicitly stated in the provided document beyond qualitative "Pass" results for biocompatibility and statements that performance tests "successfully met the established acceptance criteria." The document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices through various tests rather than setting and meeting independent quantitative acceptance criteria for device performance.

However, we can infer the types of acceptance criteria that were likely in place based on the tests conducted and the general regulatory framework for medical devices. The "study" proving the device meets these (largely implied) acceptance criteria refers to the various performance tests and animal studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not provide a specific table of quantitative acceptance criteria with corresponding performance values. Instead, it reports qualitative "Pass" results for biocompatibility and states that "performance test results demonstrate that subject device successfully met the established acceptance criteria."

Here's a conceptual representation based on the tests mentioned:

2. Sample Size Used for the Test Set and Data Provenance

• Biocompatibility Testing: The specific sample sizes for each in vitro biocompatibility test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity/sensitization) are not explicitly stated in the summary.
• Product (Bench) Testing: The specific sample sizes (n-values) for each mechanical test (e.g., number of meshes tested for tear strength, number of accessories for removal force) are not explicitly stated.
• Animal Studies: The study was "a comprehensive 4 week GLP study in a porcine model." The number of porcine subjects is not specified.
• Data Provenance: All data appears to be prospective testing conducted specifically for this 510(k) submission. The country of origin for the data generation (where the tests were performed) is not specified, but given the submitter (Davol Inc., C. R. Bard, Inc. located in Warwick, RI, USA), it's highly likely the studies were conducted in the USA or by labs compliant with US regulations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable in the context of this 510(k) summary. The device is a physical surgical mesh, not an AI/software device that requires ground truth derived from expert consensus for image interpretation or diagnosis. The "ground truth" for the performance sections is established through validated laboratory testing methods and histological/mechanical evaluation in the animal study.
• For the "Design Validation Usability Test," it implicitly involves users (likely surgeons or medical professionals) to validate the device's usability, but the number or their qualifications are not specified.

4. Adjudication Method for the Test Set

• This information is not applicable as it typically refers to the process of reconciling disagreements among multiple human readers for diagnostic interpretation (e.g., in AI studies).
• For the bench and animal studies, "adjudication" would involve standard laboratory practices for data collection, analysis, and statistical evaluation, overseen by internal quality systems. The specific mechanisms for resolving data discrepancies, if any, are not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging AI devices where the performance of human readers with and without AI assistance is evaluated. The Phasix ST Mesh is a physical surgical device, not a diagnostic tool.

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

• No, this is not applicable. The device is a surgical mesh; it does not involve algorithms or AI that would have a standalone performance. Performance is evaluated through bench testing and preclinical animal models.

7. The Type of Ground Truth Used

• Biocompatibility Testing: Ground truth is established by standard, recognized in vitro and in vivo biological assays with predefined endpoints and pass/fail criteria (e.g., cytotoxicity, systemic toxicity, sensitization).
• Product (Bench) Testing: Ground truth is established by engineering specifications, material science principles, and validated test methods to measure physical and mechanical properties. The "acceptance criteria" for these tests would be derived from these engineering specifications and comparison to predicate device characteristics.
• Animal Studies: Ground truth is established by histopathological evaluation, gross anatomical observation (e.g., tissue attachments, mesh contracture), and mechanical testing of tissue samples (e.g., T-peel analysis) by qualified personnel (e.g., pathologists, veterinary specialists), against predefined biological response expectations and comparative analysis with predicate devices.

8. The Sample Size for the Training Set

• Not applicable. The Phasix ST Mesh is not an AI/machine learning device; therefore, there is no "training set." The testing performed is for device validation and verification, not for training a model.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set, this question is irrelevant.

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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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TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.

TIGR® Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different degradation characteristics. The fast-resorbing fiber, making up approximately 40% of the matrix by weight, is a copolymer of glycolide, lactide, and trimethylene carbonate. The slow-resorbing fiber, making up approximately 60% of the matrix by weight, is a copolymer of lactide, and trimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers.

This document is a 510(k) premarket notification for the TIGR® Matrix Surgical Mesh. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on demonstrating this equivalence through comparative performance data rather than independent clinical efficacy trials with pre-defined success metrics.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (TIGR® Matrix Surgical Mesh, K092224). The reported device performance is compared directly against that of the predicate.

Note: For the subject device, most parameters are presented as being equivalent or meeting the same threshold as the predicate. Changes in thickness, size range, and shelf life are noted but justified as not impacting substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

This is not a traditional "test set" in the context of an AI/algorithm study. The studies described are in vitro (bench testing) and in vivo (animal studies) non-clinical tests.

• Bench Testing: The document does not specify exact sample sizes for each bench test beyond "mean" values, indicating multiple samples were tested. The data provenance is internal testing performed by Novus Scientific AB or contract laboratories (BIOMATECH and NAMSA). This is prospective testing for the subject device and referenced predicate data for the predicate device.
• Animal Studies:
  • Rat Study: 30 rats in total (2 groups of 5 rats for each of 3 time periods - 1, 3, and 6 months).
  • Sheep Study: 13 sheep in total. Each observation period (4, 9, 15, 24, 36 months) comprised 3 sheep with 10 test meshes and 2 control meshes.
  • Data Provenance: Prospective animal studies. Locations of animal studies are not explicitly stated, but the contract labs (BIOMATECH and NAMSA) are mentioned for biocompatibility, which might overlap.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of this device and study type. Ground truth for non-clinical studies is based on standardized test methods, biological endpoints (e.g., histology), and laboratory analyses conducted by qualified personnel following GLP requirements.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for human expert review in diagnostic studies. Here, evaluation is based on scientific methods and observable biological/material responses.

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 is a surgical mesh, not a diagnostic AI system or medical imaging device that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical studies:

• Bench Testing: Ground truth is established by physical measurements and adherence to specified standards (e.g., ASTM D3787, ISO 9073-4, ASTM D1388, ASTM D6775).
• Biocompatibility Testing: Ground truth is established by universally recognized biological responses documented through various ISO 10993 tests (e.g., cytotoxicity, genotoxicity, irritation, systemic toxicity, local effects after implantation). This includes microscopic observations and chemical characterization.
• Animal Studies: Ground truth is based on observed biological responses, tissue remodeling, implant degradation, and histological analysis within the animal models.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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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.

The proposed 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.

This document is a 510(k) premarket notification for the Phasix™ ST Mesh, a surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies. Therefore, the information typically requested in your prompt (acceptance criteria, specific study designs, sample sizes for training/test sets, ground truth establishment for AI/algorithm-based devices, MRMC studies, etc.) is not present in this document, as it pertains more to software or diagnostic device submissions.

However, I can extract the information provided regarding performance data relevant to establishing substantial equivalence.

Here's a summary of the performance data reported:

1. A table of acceptance criteria and the reported device performance
   - This document does not provide a table of acceptance criteria with specific numerical targets and reported performance values. Instead, it lists the types of tests performed to demonstrate substantial equivalence, implying that the results of these tests were deemed acceptable by the FDA for the purpose of 510(k) clearance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   - Not applicable. This document describes pre-clinical (biocompatibility, bench, and animal) studies, not human clinical trials. Sample sizes for these studies are not specified in this summary. Data provenance (country of origin, retrospective/prospective) is not detailed.

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. Ground truth establishment by experts is typically relevant for diagnostic devices or AI algorithms. This document concerns a surgical mesh.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   - Not applicable. Adjudication methods are relevant for studies involving human interpretation, often in diagnostic contexts.

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. MRMC studies are used for evaluating diagnostic performance, particularly of AI-assisted systems.

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)
   - Not applicable in the context of an AI/diagnostic device. For the animal studies, the "ground truth" would be established by direct observation and analysis of the implanted mesh and surrounding tissues, likely involving histology/pathology conducted by veterinarians and researchers.

8. The sample size for the training set
   - Not applicable. This device is a physical surgical mesh, not an algorithm that requires a training set.

9. How the ground truth for the training set was established
   - Not applicable. This device is a physical surgical mesh, not an algorithm that requires a training set.

Summary of Performance Data (as provided in the document for K143380):

The performance data provided supports the substantial equivalence determination for the Phasix™ ST Mesh. The general approach was to compare the new device to existing predicate devices (TephaFLEX® Mesh and Ventralight™ ST Mesh) that are already legally marketed.

• Genotoxicity
• Sensitization
• Intracutaneous Reactivity
• Local and Systemic Toxicity (4 and 13 week)
• Local Toxicity (4, 8, 13, and 20 week)
• Systemic Toxicity (Acute)
• Pyrogenicity | Demonstrated that the materials (P4HB, PGA, hydrogel coating) are biocompatible, addressing risks associated with component interactions, in accordance with FDA guidance (Blue Book Memorandum #G95-1 and ISO-10993). Implies results met acceptance criteria for biocompatibility. |
  | Electrical Safety / EMC | None required | Not applicable as the device has no electrical or metal components. |
  | Software V&V Testing | None required | Not applicable as the device does not contain software. |
  | Bench Testing | - Mesh weave characteristics
• Device stiffness
• Mesh pore size
• Burst strength
• Mesh density
• Tear resistance
• Mesh thickness
• Suture pullout strength
• In vitro degradation study | Performed to compare the proposed Phasix™ ST Mesh to the predicate TephaFlex® Mesh and Ventralight™ ST Mesh.
  The in-vitro degradation study demonstrated that PGA fibers and hydrogel coating do not impact the resorption profile of the P4HB mesh.
  Implies results demonstrate substantial equivalence for physical and performance characteristics per FDA guidance for surgical mesh. |
  | Animal Studies | In vivo porcine studies at 4, 12, and 24 weeks | Characterized mechanical strength, tissue response, and resorption profile in comparison to predicate devices. The implication is that these studies showed comparable performance to the predicates. |
  | Clinical Study | None required | No clinical study was required to support the 510(k) clearance for Phasix™ ST Mesh, indicating that the preclinical data (biocompatibility, bench, and animal studies) were sufficient to establish substantial equivalence. |

Conclusion:

The document states that "All test results provided in this submission demonstrate that the proposed Phasix™ ST Mesh is substantially equivalent to the cited TephaFlex® Mesh and Ventralight™ ST Mesh predicates." This means the conducted tests (biocompatibility, bench, and animal studies) produced results that satisfied the FDA's requirements for demonstrating that the device is as safe and effective as the predicate devices, despite minor technological differences.

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The Phasix™ Plug and Patch is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

The proposed Phasix™ Plug and Patch utilizes a fully resorbable poly-4-hydroxybutrate (P4HB) polymer material pre-formed into a three-dimensional (cone shape) configuration constructed of a fluted outer layer and multiple inner layers (petals) of mesh attached at the tip. The inner petals and cones are sewn together at the tip with a single P4HB monofilament thread. The inner petals allow the device to conform readily to defects of various sizes while the structure of the small inter-fiber pores of the P4HB mesh allows for a prompt fibroblastic response and allows tissue in-growth. The cone shape configuration of the device allows it to expand and reduce in conformation with the immediate anatomy so that the repair is tension-free. The petals can be removed to customize the Phasix Plug to each individual patient. The Phasix Plug is available in several sizes. A flat mesh onlay patch is packaged with each Phasix Plug. The onlay is also fully resorbable and is made from the same P4HB monofilament as the Phasix Plug. Unlike the plug, the onlay patch is available in only one size but is customizable.

The provided text describes the Phasix™ Plug and Patch device and its predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain the specific type of information requested about acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The document is a 510(k) summary for a surgical mesh, which is a physical medical device, not an AI or algorithm-based diagnostic tool. Therefore, many of the requested points (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable or not present in this type of submission for a physical surgical implant.

Here's a breakdown based on the information available in the provided text, and where it falls short of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the format requested for a quantifiable acceptance criteria and performance metrics. The document broadly states that "performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device."

Instead of a table with specific acceptance criteria, the document describes the types of tests performed:

• Bench Testing:
  • Physical characteristics: mesh weave, mesh pore size, device density, device thickness, device stiffness.
  • Performance evaluations: burst strength, tear resistance, suture pullout strength.
• Preclinical Studies:
  • Porcine model (simulated ventral hernia repair): mechanical analysis, histological analysis, molecular weight properties post-implantation.
  • In-vivo rat study: percentage area mesh contracture and host inflammatory/fibrotic response post-implantation.
• Biocompatibility Testing: Conducted according to ISO 10993-1 standards.

The document concludes that "All test results provided in this submission support the safety and effectiveness of the proposed Phasix Plug and Patch device for its intended use and demonstrate that the proposed Phasix Plug and Patch device is substantially equivalent to its predicate devices, PerFix Light Plug and TephaFlex Mesh." This is the general acceptance criterion for a 510(k) submission – demonstrating substantial equivalence to a legally marketed predicate device.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified for any of the individual tests. The text mentions a "comprehensive study... in a porcine model" and "An in-vivo study... in rats," but doesn't give numbers of animals used.
• Data Provenance: Not specified for individual tests. The studies are described as "preclinical" and "in-vivo," indicating animal model testing rather than human clinical data. The country of origin of the data is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This document describes a physical medical device, not a diagnostic algorithm that would require expert-established ground truth from images or other data. The "ground truth" here would be the physical measurements, biological responses in animal models, and integrity of the device itself.

4. Adjudication Method for the Test Set

N/A. As above, this is not applicable for the type of device and studies described.

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

N/A. This is a physical surgical mesh, not an AI or imaging diagnostic device. No human readers or AI assistance are involved in its performance or evaluation in this context.

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

N/A. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's evaluation would be:

• Pre-defined physical specifications (e.g., mesh weave, pore size, density, thickness, stiffness).
• Quantifiable mechanical properties (e.g., burst strength, tear resistance, suture pullout strength).
• Biological outcomes in animal models (e.g., mechanical analysis, histological analysis, molecular weight properties post-implantation, percentage area mesh contracture, host inflammatory/fibrotic response).
• Biocompatibility as defined by ISO 10993-1 standards.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a "training set."

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

N/A. Not an AI/ML device.

In summary: The provided document is a 510(k) summary for a surgical mesh, which evaluates the physical and biological properties of the device to demonstrate substantial equivalence to predicate devices. It does not contain the information points typically associated with the development and validation of an AI/algorithm-driven device like acceptance criteria based on diagnostic performance, expert-established ground truth, or multi-reader studies.

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