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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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SurgiLattice™ scaffold is indicated for use as a bioabsorbable 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. SurgiLattice scaffold is also indicated for the repair of hernia and other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.

SurgilLattice scaffold is a bioabsorbable surgical mesh manufactured from poly-butylene succinate (PBS). PBS is an absorbable polymer that is processed into monofilament fibers and knitted into a surgical scaffold. PBS degrades through the process of hydrolysis, is absorbed over time, and is ultimately eliminated as CO2 and H2O. It has been developed to optimize absorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with 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 the SurgiLattice™ scaffold, a surgical mesh. The document focuses on demonstrating substantial equivalence to a predicate device (GalaFLEX® scaffold) rather than providing detailed acceptance criteria and a study report as one might find for a de novo device with novel performance metrics.

Therefore, the requested information in the form of a table of acceptance criteria and a description of a single study proving the device meets those criteria is not explicitly presented in this document. Instead, the document describes performance testing that establishes comparability to the predicate device to demonstrate substantial equivalence.

Here's an attempt to extract the relevant information based on the provided text, noting where specific details are not available or are framed in terms of comparability rather than predefined acceptance criteria for novel performance:

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

As mentioned, the document does not present explicit acceptance criteria in the typical sense for a new device's performance metrics. Instead, it aims to show comparability to a legally marketed predicate device. The "acceptance criteria" can be inferred as "comparable to the predicate device" for various characteristics.

2. Sample sizes used for the test set and the data provenance

The document mentions several studies, primarily animal models:

• Rabbit Biocompatibility Study (Subcutaneous implantation):
  • Sample Size: Not explicitly stated as a number of animals, but refers to implantation with histology at "4, 12 and 26 weeks" and "using partially-degraded mesh (representing 116 weeks)". This implies multiple time points, likely requiring multiple animals or sites per animal.
  • Provenance: Pre-clinical, GLP rabbit studies, in vivo. Country of origin is not specified.
• Porcine Hernia Repair Model:
  • Sample Size: Not explicitly stated.
  • Provenance: Functional porcine model, in vivo. Country of origin is not specified.
• In Vitro Degradation Studies:
  • Sample Size: Not explicitly stated (e.g., number of samples tested).
  • Provenance: In vitro studies.
• Bench Testing:
  • Sample Size: Not explicitly stated (e.g., number of mesh samples tested).
  • Provenance: Bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies described are primarily animal model and bench tests, not human reader studies requiring expert consensus on image interpretation or clinical outcomes.

4. Adjudication method for the test set

This information is not provided in the document. Given the nature of the studies (animal models, bench tests), an adjudication method as typically used in human reader studies (e.g., 2+1, 3+1) would not apply. Results would likely be based on objective measurements, histological analysis by a pathologist, and possibly statistical comparisons.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or described in this document. This is a medical device (surgical mesh), not an AI diagnostic imaging tool.

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

This question is not applicable. The device is a surgical mesh, not a software algorithm.

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

The "ground truth" for the performance evaluations described includes:

• Histology/Pathology: For biocompatibility, local tissue reaction, and tissue ingrowth in rabbit and porcine models.
• Objective Physical/Mechanical Measurements: For properties like mesh thickness, density, pore diameter, burst strength, bending stiffness, tensile strength, suture pull-out, and tear strength from bench testing.
• Chemical Analysis: For molecular weight in the porcine study and for in vitro degradation.
• Comparison to Predicate: The ultimate "ground truth" for demonstrating substantial equivalence is showing that the device performs similarly to the legally marketed predicate device across relevant metrics.

8. The sample size for the training set

This question is not applicable. This is a physical medical device (surgical mesh), not a machine learning model that requires a training set.

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

This question is not applicable.

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GalaSTITCH™ Absorbable Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery.

GalaSTITCH Absorbable Monofilament Suture (GalaSTITCH) is identical to the predicate TephaFLEX Absorbable Monofilament Suture (TephaFLEX) in regard to materials, design, and manufacturing processes. The product is being rebranded and will be commercialized by Tepha, Inc.'s wholly owned subsidiary, Galatea. GalaSTITCH is constructed of poly-4-hydroxybutyrate (P4HB) which is a biologically derived polymer that is extruded into monofilament fibers. The sterile P4HB suture is offered as undyed (clear) and dyed (violet) and meets all standards (except diameter) set by the United States Pharmacopeia (USP) for synthetic absorbable sutures. P4HB bioabsorbs through a process of hydrolysis and hydrolytic enzymatic digestion.

This document is a 510(k) summary for the GalaSTITCH Absorbable Monofilament Suture. It states that the device is identical to a previously cleared predicate device, TephaFLEX Absorbable Monofilament Suture (K082178), in terms of materials, design, and manufacturing processes. The submission is a "Special 510(k)" primarily for rebranding and a minor clarification to a contraindication statement in the labeling.

Therefore, the information requested regarding acceptance criteria and study data to prove device performance is not present in this document because no new testing was performed for this 510(k) submission.

The document explicitly states:
"There have been no changes to the P4HB material, design specifications, or the manufacturing processes for purposes of this submission. The GalaSTITCH suture is identical to the TephaFLEX predicate; therefore, no additional testing was necessary to demonstrate safety and performance."

This means that the safety and performance of the GalaSTITCH suture are based on its equivalence to the predicate device, TephaFLEX, for which testing would have been performed and documented in its original K082178 510(k) submission.

In summary, none of the requested information (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, or training set ground truth establishment) can be extracted from this specific document.

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GalaFORM 3D scaffold 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. GalaFORM 3D scaffold 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.

GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold has a 3D curvature supported with a P4HB rim 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 with 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 the GalaFORM 3D device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting pre-defined acceptance criteria through a specific performance study in the way one might evaluate a diagnostic algorithm or a similar device.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

1. No Acceptance Criteria or Reported Device Performance Table: The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or other performance metrics) nor does it report specific performance values against such criteria.
2. No Test Set Information (Sample Size, Data Provenance, Experts, Adjudication): The document mentions an "animal study" but does not detail the size of a "test set" in the context of clinical or diagnostic performance, its data provenance, the number and qualifications of experts, or adjudication methods. The animal study focused on tissue response, resorption, and strength characteristics, not diagnostic or clinical accuracy.
3. No MRMC Comparative Effectiveness Study: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention any human readers or AI assistance.
4. No Standalone Performance Study: While an animal study was done, it was not described as a standalone performance study in the context of an algorithm or diagnostic device.
5. Type of Ground Truth: The "ground truth" in the animal study would presumably be derived from histopathology and physical measurements (e.g., burst strength) in animal tissues, not expert consensus or patient outcomes in a diagnostic context.
6. No Training Set Information: The document makes no mention of a training set, as it is not describing an AI/algorithm-based device that would require such.
7. No Ground Truth for Training Set: Consequently, there is no information on how ground truth for a training set was established.

Summary of what the document does provide regarding studies:

• Animal Studies:
  • Purpose: To characterize tissue response, resorption profile, and strength characteristics of the device after implantation and to verify no changes due to the modified manufacturing process (addition of a rim for 3D shape).
  • Design: Subject device (GalaFORM 3D) and predicate (GalaFLEX scaffold) subcutaneously implanted in rabbits.
  • Time Points: Necropsies performed at 4, 8, 12, and 40 weeks.
  • Findings: Local tissue reaction was similar between the predicate and the shaped mesh. No statistically significant difference (p>0.05) in burst strength between the curved mesh and GalaFLEX groups at each time point, indicating comparable bioresorption. Similar molecular weights of the polymer also supported comparable resorption.
• Biocompatibility Testing: Conducted per ISO 10993-1:2009 for an implant device in contact with tissue and bone for greater than 30 days. Results supported biocompatibility and safety.

The information primarily describes pre-clinical testing to demonstrate the safety and comparable performance characteristics of the physical mesh material itself, rather than the performance of a diagnostic or AI-driven device against specific clinical acceptance criteria.

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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.

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GalaFLEX mesh is indicated for use as a transitory 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.

GalaFLEX mesh is a sterile, knitted, resorbable mesh, constructed of non-dyed monofilament fibers made from poly-4-hydroxybutyrate (P4HB). It is provided in single sheets of varying widths, lengths and shapes, and may also be cut to the shape or size desired for a specific application.

The provided text describes the regulatory filing for the GalaFLEX® Mesh, a surgical mesh. This document focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study with detailed acceptance criteria for an AI device. Therefore, a direct table of acceptance criteria and reported device performance in the context of an AI study (as requested in the prompt) cannot be extracted from this text.

However, I can extract the information related to the study performed to establish substantial equivalence for the GalaFLEX® Mesh device itself based on its safety and performance.

Here's the breakdown of the information relevant to the device's evaluation, framed to address the prompt's categories where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As this K140533 filing is a medical device submission (GalaFLEX® Mesh) and not an AI device, the "acceptance criteria" are related to demonstrating substantial equivalence for the surgical mesh. These criteria are comparative metrics against predicate devices and biocompatibility standards. "Reported device performance" refers to the results of these tests for the GalaFLEX® Mesh.

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

• Sample Size for Test Set:
  • Mechanical Testing: Not explicitly stated, but the tests performed were comparative burst strength, suture pull-out strength, tensile strength, and tear resistance strength. The number of samples for each test is not specified.
  • In vivo Testing: Not explicitly stated for the subcutaneous implantation study, but it was performed in rabbits.
  • Biocompatibility Testing: Not explicitly stated for each test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity), except for the remark that the subcutaneous implantation studies were conducted in "rabbits" (plural, but not an exact number).
• Data Provenance: The studies were internal testing by Tepha, Inc. The in vivo and biocompatibility studies involved animal subjects (rabbits). It is not specified if any human data was used, but the context is pre-market notification (510(k)) based on substantial equivalence, often relying on non-clinical data. These studies are prospective from the perspective of their execution for this submission.

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

This type of information is generally not applicable to a 510(k) submission for a non-AI medical device. "Ground truth" in this context refers to the measured physical properties of the mesh and biological responses in animal models, not expert interpretations of images or patient data. The "experts" would be the scientists and engineers conducting the tests and interpreting the results according to established scientific and regulatory standards (e.g., ISO-10993). No specific number or qualifications are mentioned for these individuals beyond the performing entity being Tepha, Inc.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here comprises physical and biological measurements. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on subjective interpretations (e.g., image reading) in clinical trials or AI performance evaluations, not for objective mechanical or biocompatibility testing.

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 510(k) submission for a surgical mesh, not an AI device. Therefore, no MRMC study, human reader performance, or AI assistance elements are present or relevant in this document.

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

Not applicable. This is a surgical mesh, not an algorithm or AI device.

7. The Type of Ground Truth Used

• Mechanical Testing: Objective physical measurements (e.g., burst strength, tensile strength) determined by standardized test methods.
• In vivo Testing: Biological observation and measurement of strength retention in animal models.
• Biocompatibility Testing: Bioreactivity responses (e.g., cytotoxicity, irritation, sensitization, toxicity, pyrogenicity, genotoxicity, implantation reactions) according to ISO-10993 standards and protocols.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no "training set." The development of the GalaFLEX® Mesh would involve research, material science, and engineering, not machine learning training.

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

Not applicable. Since there is no training set for an AI algorithm, there is no corresponding ground truth to establish.

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TephaFLEX braided sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

TephaFLEX suture is a sterile, braided, surgical suture constructed of poly-4-hydroxybutyrate (P4HB). The suture consists of an inner core of multifilament fibers covered by a braided sheath made of multifilament fibers. The suture is provided dyed (D&C Violet No. 2) or un-dyed and is offered in a variety of cut lengths, with or without needles attached.

The provided document describes the acceptance criteria and the study that proves the TephaFLEX Braided Suture meets these criteria. Since this is a medical device (suture) and not an AI/ML device, many of the requested fields (e.g., sample size for training set, number of experts, MRMC studies, standalone performance) are not applicable.

Here's the information extracted from the document:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size:
     • Biocompatibility: Not explicitly stated as "sample size" but involved "12, 26, 52 and 78 week Subcutaneous Implantation studies in rabbits." This implies a cohort of rabbits used over these time points.
     • In vivo implantation for strength/mass loss: Conducted in "rabbits." The exact number of rabbits is not specified in the provided text.
     • Physical/Mechanical testing: Not specified, but generally follows standardized testing procedures for medical devices.
   • Data Provenance: The studies were conducted by Tepha, Inc. and are retrospective in nature, as they involve testing of a manufactured device. The origin of the animal subjects (rabbits) is not specified but is assumed to be within a controlled lab environment.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This is a medical device (suture) and the assessment criteria are based on standardized physical, mechanical, chemical, and biological tests, rather than expert interpretation of images or clinical data. The "ground truth" is defined by compliance with USP and ISO standards and observed biological responses.

3. Adjudication method for the test set:

   • Not Applicable. As the assessment is based on objective laboratory and in vivo testing against established standards, an adjudication method for conflicting expert opinions is not relevant.

4. 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 medical device, not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant here.

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

   • Not Applicable. There is no algorithm involved; this is a physical medical device.

6. The type of ground truth used:

   • Laboratory Testing and Standards Compliance: The ground truth is established by meeting predefined threshold values for physical and mechanical properties as outlined in USP 33 ( Suture Diameter, Knot Pull Tensile Strength, and Needle Attachment Strength) and demonstrating non-toxic responses and equivalent in vivo performance according to ISO-10993 for biocompatibility studies and in vivo strength retention studies.

7. The sample size for the training set:

   • Not Applicable. This is a medical device for which "training set" is not a relevant concept. The device's characteristics are inherent to its design and manufacturing process, not learned from a dataset.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set, this question is not relevant.

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TephaFLEX Melt blown Matrix is intended to reinforce soft tissue where weakness exists in patients undergoing surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

The TephaFLEX Meltblown Matrix is a resorbable construct prepared from poly-4-hydroxybutyrate (P4HB) and is provided either non-dyed or dyed with D&C Violet No. 2. It is a porous, fibrous structure composed of thin P4HB fibers that result in a non-woven mesh like fabric. It is provided in single sheets of varying widths, lengths and shapes ranging from 1x1 to 10x14 inches.

This document describes the TephaFLEX® Meltblown Matrix, a resorbable surgical mesh, and its substantial equivalence to predicate devices, rather than an AI-powered device. Therefore, many of the requested categories related to AI device performance are not applicable.

Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:

Acceptance Criteria and Device Performance for TephaFLEX® Meltblown Matrix

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

The document establishes "substantial equivalence" to predicate devices as the primary acceptance criterion. Performance is evaluated through comparative mechanical testing and in vivo animal testing against these predicates. While specific quantitative acceptance criteria values are not explicitly stated, the conclusion is that the new device is "Substantially Equivalent" to the predicates.

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 mentions "Mechanical testing, biocompatibility testing, and in vivo animal testing" were performed. However, specific sample sizes for these tests are not provided. The provenance of the data (country of origin, retrospective/prospective) is also not specified.

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 relates to AI interpretation or expert consensus on clinical data. For this device, "ground truth" would be established through physical and biological testing parameters, likely overseen by engineers, material scientists, and animal study veterinarians. The document does not specify the number or qualifications of individuals involved in generating or interpreting these test results.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for evaluating the physical properties of a surgical mesh.

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 document describes a medical device (surgical mesh), not an AI algorithm. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This document describes a medical device (surgical mesh), not an AI algorithm.

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

The "ground truth" for this device is based on standardized mechanical property measurements and in vivo animal study observations, compared against the performance of legally marketed predicate devices. This is a scientific and engineering ground truth, not a clinical ground truth established by expert consensus, pathology, or outcomes data in humans.

8. The sample size for the training set

Not applicable. This document describes a medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not applicable. There is no training set for this type of medical device.

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TephaFLEX light mesh 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 for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

The TephaFLEX light mesh is a resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB). The mesh is prepared from non-dyed or dyed (D&C Violet #2) monofilament P4HB fiber that is knitted into a surgical mesh. It is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application.

The provided document describes the TephaFLEX® Light Mesh, a surgical mesh, and its substantial equivalence to predicate devices. However, the document does not contain details of a clinical study or a study proving the device meets specific acceptance criteria in the manner typically associated with diagnostic AI/imaging devices.

The "Safety and Performance" section states: "Mechanical testing, biocompatibility testing, and in vivo animal testing was performed based on recommendations identified in the FDA surgical mesh guidance document: The Guidance for the Preparation of a Pre-market Notification Application for a Surgical Mesh. Specifically, comparative burst strength, suture pull-out strength, tensile strength and tear resistance strength was characterized. In vivo strength retention was characterized via a subcutaneous implantation study. The mechanical and in vivo data collected determined the mesh to be substantially equivalent to the predicate devices."

This indicates that the "study" conducted was a series of non-clinical performance tests (mechanical and animal studies) to demonstrate substantial equivalence, rather than a clinical trial with human subjects, a test set, or ground truth as understood in the context of an AI/imaging device.

Therefore, many of the requested categories (2-7, 9) are not applicable or cannot be extracted from this document, as they pertain to clinical studies or AI algorithm evaluation.

Here's the information that can be extracted or deduced:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. No clinical test set involving human data for algorithm evaluation is described. The "test set" refers to mechanical and animal studies. Details on the sample sizes for these tests (e.g., number of animals, number of mesh pieces tested for mechanical properties) are not provided in the summary.
• Data Provenance: The studies were internal (Tepha, Inc.) and based on FDA guidance for surgical mesh. The "in vivo animal testing" implies animal studies, but the origin country for these studies is not specified. They were likely prospective, conducted for this submission.

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

• Not applicable. This pertains to clinical studies involving expert review, which is not described.

4. Adjudication Method for the Test Set:

• Not applicable. This pertains to clinical studies involving expert review.

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 surgical mesh, not an AI/imaging device, and thus no MRMC study was performed.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used:

• Not applicable to clinical ground truth for AI algorithms. For the non-clinical studies:
  • Mechanical testing: The "ground truth" would be the established performance characteristics of the predicate devices and accepted industry standards for surgical mesh properties.
  • Biocompatibility: The "ground truth" would be established safety profiles for materials and predicate devices, assessed through standardized biocompatibility tests.
  • In vivo strength retention: The "ground truth" would be the expected or observed strength retention profiles of the predicate devices in animal models.

8. The sample size for the training set:

• Not applicable. This refers to training data for an AI algorithm. No AI algorithm is part of this device.

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

• Not applicable. This refers to training data for an AI algorithm.

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TephaFLEX mesh 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 for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

The TephaFLEX mesh is a resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB). The mesh is prepared from non-dyed or dyed (D&C Violet #2) monofilament P4HB fiber that is knitted into a surgical mesh. It is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application.

This is a medical device submission (K113723) for TephaFLEX® Mesh, which is a surgical mesh. The provided document does not describe an AI/ML powered device, but rather a traditional medical device that undergoes mechanical and biological testing for safety and performance. Therefore, many of the requested fields related to AI/ML device studies will not be applicable.

Here's the breakdown of the information as it relates to the provided document:

Acceptance Criteria and Device Performance

The "Safety and Performance" section states that "Mechanical testing, in vivo animal testing, and biocompatibility testing, were performed based on recommendations identified in the FDA surgical mesh guidance document." The conclusion is that the mesh was determined to be "substantially equivalent to the predicate devices."

The specific acceptance criteria are not explicitly detailed in quantifiable targets within the provided summary, but rather by comparison to predicate devices and established guidance. The reported performance is that the device met these comparative standards.

Study Details (as applicable)

Since this is a traditional medical device and not an AI/ML device, many of the requested fields are not applicable.

1. Sample sizes used for the test set and the data provenance:

   • The document mentions "in vivo animal testing" (subcutaneous implantation study) and "mechanical testing." Specific sample sizes for these tests are not provided in this summary.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this is not an AI/ML device relying on expert-established ground truth from images or data. The testing involves physical and biological evaluations.

3. Adjudication method for the test set:

   • Not applicable. The testing methods for mechanical and in vivo studies would follow standard scientific protocols for data collection and analysis, not expert adjudication in the context of diagnostic interpretation.

4. 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 not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

6. The type of ground truth used:

   • For mechanical testing: The "ground truth" would be the direct physical measurement of properties like burst strength, tensile strength, etc., compared against specified benchmarks or predicate device performance.
   • For in vivo animal testing: The "ground truth" would be the observed biological response and strength retention in the animal model, again compared to expected outcomes or predicate device performance.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that uses a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device that uses a training set.

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