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The OnFlex™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

The OnFlex™ Mesh is a self-expanding, non-absorbable, sterile device made from monofilament polypropylene mesh and has a lightweight large pore design. This construction allows a prompt fibroblastic response through the interstices of the mesh as observed in a preclinical model, which may not correlate to performance in humans. The OnFlex™ Mesh has an anatomical shape design to cover potential defect areas. The OnFlex™ Mesh also contains a pocket on the larger medial apex of the mesh to facilitate insertion and positioning of the device.

The OnFlex™ Mesh contains SorbaFlex™ Memory Technology comprised of an absorbable PDO monofilament which forms an interrupted ring. SorbaFlex™ Memory Technology provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament is folded and welded onto itself at the ends. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 – 8 months. The PDO monofilament is dyed violet by adding D & C Violet No. 2. The interrupted ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the interrupted recoil ring during the degradation process. The interrupted ring, contained in the mesh tube, is sewn between two layers of mesh with polytetrafluoroethylene (PTFE) monofilament.

The OnFlex™ Mesh has a blue limit line at the lateral portion of the mesh, composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant, to provide visual feedback for where the device can be tailored. The OnFlex™ Mesh can be tailored at the opening of the interrupted ring or outside of the blue limit line.

The OnFlex™ Mesh is offered in two sizes: medium (0115410) and large (0115411). The OnFlex™ Mesh is considered a tissue contacting permanent implant.

The provided FDA 510(k) clearance letter for the OnFlex™ Mesh (K251955) indicates that this is a Special 510(k) submitted to notify the FDA of changes to the device labeling only. The device itself remains identical to its predicate, OnFlex™ Mesh (K142711), cleared in 2015.

Therefore, the submission explicitly states: "No non-clinical or clinical testing was provided in support of this Special 510(k)."

This means that the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, as no new testing was performed for this specific submission. The substantial equivalence is based on the device's identity to its predicate and the conclusion that the labeling changes do not affect safety or effectiveness.

Because no new studies were conducted or presented in this document for the K251955 submission, I cannot provide the requested information. The document focuses solely on demonstrating that the labeling updates do not alter the substantial equivalence to the original predicate device (K142711).

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Bard® Mesh is indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.

Bard® Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.

The Bard® Mesh is a nonabsorbable, sterile mesh designed for the reinforcement of soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. The Bard® Mesh Pre-Shaped is a nonabsorbable, pre-trimmed sterile mesh designed for reinforcement of inguinal hernias. The Bard® Mesh is offered in several sizes of rectangular flat sheets and in several pre-shaped configurations, known as Bard® Mesh Pre-Shaped. Bard® Mesh product family products consist of the standard, rectangular or square sizes which can be trimmed as needed to provide surgeons with more freedom to customize the prosthesis prior to implantation. The Bard® Mesh portfolio currently ranges from 1" x 4" to 10" x 14" rectangle mesh. The Bard® Mesh is comprised of knitted polypropylene monofilaments in a square or rectangular flat sheet with selvage edges. The Bard Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration with a pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair. All clinical, biological, and technical characteristics of the Bard® Mesh and Bard® Mesh Pre-Shaped are identical except that Bard® Mesh Pre-Shaped is only indicated for inguinal hernias due to the pre-cut/pre-shaped nature of the product.

The provided document is an FDA 510(k) clearance letter for a medical device called Bard® Mesh. However, this document does not contain the information typically found in a study demonstrating how an AI/algorithm-driven device meets acceptance criteria.

The Bard® Mesh is a surgical mesh, a physical medical device used to reinforce soft tissue, such as in hernia repair. It is a Class II device, and the clearance is based on its substantial equivalence to a preamendment predicate device (meaning it was marketed before May 28, 1976).

The document specifically mentions:

• "As there are no new or increased risks identified, no verification or validation activities are required for these labeling changes. Design verification testing was conducted to support the performance of the pre-shaped configuration." This indicates that for this type of physical device and the nature of the changes (labeling and a pre-shaped configuration), extensive clinical studies or complex performance evaluations are not required in the same way they would be for a novel diagnostic or AI-powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic algorithms, is not present in this 510(k) letter. This clearance is based on the device's established technological characteristics and historical use, demonstrating its equivalence to a long-marketed product, rather than proving performance against specific acceptance criteria through a new study as would be done for an AI device.

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Parietene™ macroporous mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.

Parietene™ macroporous mesh is designed for extraperitoneal mesh placement only, for the repair of abdominal wall hernias by laparoscopic or open approach.

Parietene™ macroporous mesh is a non-absorbable synthetic surgical mesh made of two-dimensional (2D) monofilament polypropylene knitted textile.

Parietene™ macroporous mesh is offered in square flat sheet version (50cm x 50cm).

The non-absorbable textile is designed to ensure long term reinforcement of soft tissues. The macroporous textile provides strength required to withstand biomechanical stresses throughout the healing period, while allowing for tissue ingrowth. As the textile integrates, host tissue ingrowth is intended to provide strength to the repair.

The detailed composition listed below refers to the estimated maximum amount of each material and substance to which a patient can be exposed when 1 unit of the largest size of Parietene™ macroporous mesh is implanted (i.e. PPM5050). This amount could be less if the mesh is trimmed by the practitioner prior to implantation.

Mesh composition: monofilament polypropylene yarn (up to 11.5 g)

This FDA 510(k) clearance letter is for a surgical mesh (Parietene™ Macroporous Mesh, PPM5050), not an AI-powered diagnostic device. Therefore, the requested information regarding AI device acceptance criteria, study methodologies (MRMC, standalone performance), expert ground truth establishment, training sets, and data provenance is not applicable to this document.

The document discusses the substantial equivalence of the new mesh size (50cm x 50cm) to previously cleared predicate devices based on:

• Performance testing: In-vitro (bench) tests for trocar compatibility, bursting strength, deflection, uniaxial tensile maximum force and elongation, and tear strength.
• Biocompatibility evaluation.
• Sterilization validation.
• Literature and MAUDE database review of predicate and reference devices.

There is no mention of an AI algorithm, human readers, or image interpretation in this clearance.

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Bard® Soft Mesh is indicated for the repair of ventral, incisional, and inguinal hernias.
Bard® Soft Mesh Pre-Shaped is indicated for the repair of inguinal hernias.

The Bard® Soft Mesh is a nonabsorbable, sterile mesh designed for reinforcement of soft tissue deficiencies in adults with ventral, incisional, and inguinal hernias. The Bard® Soft Mesh Pre-Shaped is a nonabsorbable, sterile mesh designed for reinforcement of soft tissue deficiencies in adults with inguinal hernias. The knit construction allows the mesh to be stretched in both directions, in order to accommodate and reinforce tissue defects. The Bard® Soft Mesh is comprised of knitted polypropylene monofilaments in a rectangular flat sheet ranging from 2" x 4" to 12" x 12" with smooth radiused corners. The Bard® Soft Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair.

This 510(k) clearance letter pertains to a surgical mesh (Bard Soft Mesh), not an AI/software device. Therefore, the detailed questions about acceptance criteria, study design referencing AI performance, expert consensus, MRMC studies, training and test sets, and ground truth establishment are not applicable to this submission.

The 510(k) is for changes to the labeling of an existing device, with no changes to the device itself. The primary purpose of the submission is to align the labeling with European medical device regulations and to document historical product changes (like adding a new size) that were previously handled via internal documentation.

Here's a breakdown of the relevant information provided in the document:

1. Acceptance Criteria and Device Performance:

Since this 510(k) is not for a new device or a functional change, but rather for labeling updates and documentation of previous minor changes, the concept of "acceptance criteria" for a new device performance study (like for an AI model) does not apply. The acceptance criteria here are implicitly related to demonstrating that the labeling changes and historical product modifications do not impact the safety or effectiveness of the device and maintain substantial equivalence to the predicate device.

The document states: "Through the risk analysis conducted, it was determined that the labeling changes described in this 510(k) do not result in any new or increased risks. As there are no new or increased risks identified, no verification or validation activities are required for these labeling changes."

"Non-clinical testing including mesh thickness, mesh knit construction, mesh pore size, mesh density, tensile strength, device stiffness, ball burst (strength), tear resistance, device stiffness, and suture pull out were considered in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh issued on March 2, 1999. The non-clinical testing supported those historical changes taken under documentation to file, including dimensional line extension, do not impact the safety or effectiveness of the subject device nor do they impact the substantial equivalence between the subject and predicate devices."

Therefore, the "performance" shown is that the device, with its updated labeling and previously documented size extension, continues to meet the physical and mechanical properties expected of a surgical mesh and is substantially equivalent to the predicate.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. This submission is based on non-clinical testing of physical device properties and a comparison to a predicate, not clinical studies with a "test set" of patient data for an AI model. The "test set" refers to the specific mesh samples used for physical and mechanical property testing. The document states "Non-clinical testing including mesh thickness, mesh knit construction, mesh pore size, mesh density, tensile strength, device stiffness, ball burst (strength), tear resistance, device stiffness, and suture pull out were considered," implying relevant samples of the mesh were tested, but specific sample numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of patient data. The "data" pertains to the characteristics of the physical mesh device.

3. Number of Experts used to establish ground truth:

• Not applicable. There is no "ground truth" establishment by experts in the context of an AI model's performance on patient data. The non-clinical testing results establish the performance of the physical device.

4. Adjudication Method:

• Not applicable. No expert adjudication process for an AI model's output is relevant to this submission.

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

• Not applicable. This is not an AI-assisted diagnostic device study.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This is not an algorithm.

7. Type of Ground Truth Used:

• Not applicable in the context of an AI model. The "ground truth" for this device's performance is established by objective non-clinical engineering and material property testing methods as per relevant standards (e.g., those referenced in the 1999 FDA guidance for surgical mesh).

8. Sample Size for Training Set:

• Not applicable. No AI model is being trained here.

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

• Not applicable.

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ProGrip™ self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissue where weakness exists.

The ProGrip™ self-gripping polypropylene mesh rectangular and square shapes are indicated for inguinal and ventral hernia repair.

Progrip™ self-gripping polypropylene mesh is designed to allow extraperitoneal mesh placement for the repair of inguinal and ventral hernias.

Progrip™ self-gripping polypropylene mesh is made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side. Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.

The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.

Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial box or envelope with the eIFU leaflet and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial box or envelope (single pack configuration: 1 unit per commercial box or envelope).

The provided document is a 510(k) premarket notification summary for a medical device (ProGrip™ Self-Gripping Polypropylene Mesh). It does not include acceptance criteria or detailed study results that would typically be reported for an AI/Software as a Medical Device (SaMD).

This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria based on a clinical trial or a machine learning model's performance metrics. As such, the information required cannot be fully extracted based on the input document.

However, I can extract what is mentioned about performance data and the general approach:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would be common for AI/SaMD devices. Instead, it describes performance testing aimed at demonstrating substantial equivalence to a predicate device.

• Simulated use in cadaver model: Surgeons prepared, introduced through trocar, deployed, placed, and fixated mesh. Verified product use in contact with tissue.
• Simulated use in abdominal simulator for trocar passage.
• Electronic Instructions For Use (eIFU) checked for clarity and understandability.
  Compliance: "The human factors engineering process applied to the ProGrip™ Self-Gripping Polypropylene Mesh complied with the requirements of IEC 62366-1: 2015 and associated FDA guidance documents." |
  | Sterilization, shelf-life, shipping, and biocompatibility are not impacted by changes | Not explicitly stated as "acceptance criteria met" but rather "not impacted by the proposed change," implying that previous validations for the predicate device still hold. |

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

Given this is a physical medical device (surgical mesh) and the performance data primarily consists of in vitro bench testing and human factors evaluation with cadaver/simulator models, the concept of a "test set" and "data provenance" (country, retrospective/prospective) as typically applied to AI/SaMD is not directly applicable.

• Sample Size for Test Set: Not specified in terms of number of cases or patients as it's not a clinical study on patient data for software performance.
  • For the in vitro bench tests, the number of samples tested for each physical/mechanical property is not provided.
  • For human factors evaluation, the number of participants (surgeons) or cadaver/simulator instances is not specified.
• Data Provenance: Not applicable in the context of this device's performance evaluation as described.

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

This information is not provided. This type of detail is usually relevant for AI/SaMD where expert annotations establish ground truth for model training and evaluation. For this physical mesh device, expert involvement is mentioned in the human factors evaluation (surgeons using the device in simulated scenarios), but not for establishing "ground truth" in the AI sense.

4. Adjudication Method for the Test Set

Not applicable for this type of device and study description. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert review processes to resolve disagreements when establishing ground truth for AI/SaMD.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI assistance on human reader performance, which is not relevant for a physical surgical mesh.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical mesh, not an algorithm.

7. The Type of Ground Truth Used

• For physical/mechanical tests: The "ground truth" would be established by standardized measurement techniques and validated in vitro testing methods, with comparison to the predicate device's known performance characteristics.
• For human factors evaluation: The "ground truth" was established by the observations and feedback of participating surgeons during simulated use, confirming that the device could be used effectively and safely via the laparoscopic approach. Compliance with IEC 62366-1: 2015 indicates a structured approach to usability validation rather than a "ground truth" in the AI sense.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/SaMD, there is no "training set."

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

Not applicable as there is no "training set."

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Progrip™ Self-Gripping Polypropylene Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair by open approach.

Progrip™ self-gripping polypropylene mesh is a sterile non-pyrogenic device made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side.

Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.

The non-absorbable textile is designed to ensure long term reinforcement of soft tissues.

The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.

Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial envelope with the Instructions for Use (IFU) and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial envelope (single pack configuration: 1 unit per commercial envelope).

The provided text is a 510(k) summary for the Progrip™ Self-Gripping Polypropylene Mesh (K232373). It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document discusses various performance tests conducted (sterilization, shelf-life, shipping, biocompatibility, in vitro bench tests) to demonstrate substantial equivalence to the predicate device. However, these are presented as evaluations against established standards and guidance documents, rather than against specific, numerical acceptance criteria for a new clinical study.

Furthermore, the document explicitly states: "This premarket submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This indicates that no clinical study was performed for this 510(k) submission.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this type of data is not present in the provided text. The submission relies on non-clinical performance and a comparison to predicate devices to establish substantial equivalence.

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Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.

The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.

This submission, K233402, describes a Special 510(k) for the Bard 3DMax Mesh, which focuses solely on labeling changes to align with European medical device regulations and other devices in the Davol Inc. portfolio. The submission explicitly states:

"No non-clinical or clinical testing was provided in support of this Special 510(k)." and "The purpose of this Special 510(k) is to notify FDA of the changes to the Bard® 3DMax™ Mesh labeling. There are no changes to the device itself."

Therefore, based on the provided document, there are no acceptance criteria or studies associated with this specific submission to describe regarding device performance, as the device itself (materials, design, manufacturing, etc.) has not changed from its predicate, K081010.

To provide the requested information, one would need access to the original 510(k) submission (K081010) that established the substantial equivalence of the device itself, rather than just its labeling.

Since the prompt asks for information from the provided input, and the input explicitly states no testing was done, I cannot fulfill the request for acceptance criteria and study details.

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The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sub lay approach in adults (greater than 21 years of age).

The T-Line Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using well-established standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line Hernia Meshare incorporated directly into the mesh body. The mesh design incorporates continuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaged onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.

This FDA 510(k) summary does not describe a study involving a medical device with acceptance criteria and performance results in the way one would typically expect for a diagnostic or AI-driven device. Instead, it concerns a surgical mesh (T-Line Hernia Mesh) and its substantial equivalence to previously cleared versions of the same product.

The primary goal of this submission (K232924) was to add a smaller size of the T-Line Hernia Mesh to its product line, based on customer feedback. Therefore, the "study" described is a performance evaluation to demonstrate that this new size meets the same safety and effectiveness standards as the existing, cleared mesh products.

Here's the breakdown based on your request, with an emphasis on how it applies to this specific submission:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: The document does not specify a distinct "test set" in the context of clinical data for the new, smaller mesh size. The performance evaluation likely involved bench testing of the new mesh size. The "sample size" for such tests would refer to the number of physical mesh samples subjected to various mechanical and material property tests. This information is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical trial data. The device is manufactured by Deep Blue Medical Advances, Inc. in Durham, NC, USA. The performance data would originate from their internal testing.
• Retrospective or Prospective: Not applicable for a device modification of this nature, which primarily relies on bench testing and comparison to previously cleared devices.

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 diagnostic device where expert ground truth on medical images or patient conditions is required. The assessment is based on engineering and material science principles, and comparison to existing, cleared products.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations. The evaluation focuses on physical and material properties and risk analysis.

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. This is not an AI-driven or diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• No. This is not an algorithm or software device.

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

• The "ground truth" here is implied by the established performance specifications and material properties of the previously cleared predicate T-Line Hernia Mesh devices (K230227, K221556, K193144), as well as relevant external standards for surgical mesh. The new, smaller mesh size must demonstrate that it meets these same pre-determined physical, chemical, and mechanical requirements.

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. As above, there is no training set for this type of device submission.

In summary: K232924 is a submission for a minor modification (addition of a smaller size) to an already cleared surgical mesh. The "study" involves performance testing and risk analysis to confirm that the new size maintains the same safety and effectiveness profile as the predicate devices, rather than a clinical study establishing new efficacy or diagnostic performance. The acceptance criteria are essentially that the modified device's performance, material characteristics, and risk profile are equivalent to its previously cleared versions and comply with relevant standards.

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The Pitch-Patch Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.

The Pitch -Patch Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The Pitch-Patch is a permanent implantable device for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile, by Gamma Irradiation to an SAL of 10-6.

The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a non-absorbable material that has a long history of use in the orthopedic market.

The provided text describes a medical device called the "Pitch-Patch Tissue Reinforcement Device" and its FDA 510(k) clearance application. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical surgical mesh device, not an AI software or system. Therefore, details like AI performance metrics (sensitivity, specificity, AUC), test set characteristics, expert ground truth establishment, MRMC studies, or training set details are not applicable to the information given.

The "Performance Data" section lists various mechanical and biological tests for the Pitch-Patch (e.g., Suture Retention, Ultimate Strength, Biocompatibility). These are typical for surgical mesh devices to demonstrate safety and effectiveness for their intended physical function, but they are not the type of acceptance criteria or studies relevant to AI/ML device performance.

Therefore, I cannot provide the requested information for an AI/ML device based on the input text.

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