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The Ventralight ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

The Ventralight ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, 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) summary for the Ventralight ST Mesh, a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on quantitative performance metrics like sensitivity, specificity, or F-score often associated with AI/ML-based devices.

Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable in this context.

Here's an analysis based on the information provided, highlighting the aspects that are relevant to this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of traditional surgical mesh device, "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device, focusing on similar safety and effectiveness. The performance is assessed through non-clinical testing.

• PGA pullout strength testing completed.
• Burst strength testing completed.
• Tear strength testing completed.
• Suture retention strength testing completed.
• Dry bond strength testing completed.
• Hydrogel disruption testing after laparoscopic deployment completed.

Conclusion: "Results of testing demonstrate that the Ventralight ST Mesh design meets product specifications and intended uses." |
| Biocompatibility: Device materials should be biocompatible and comparable to the predicate device. | Biocompatibility Testing: Completed (similar to predicate device, as there were no material changes). |
| Tissue Interaction (reduced attachment, ingrowth): The device should demonstrate similar tissue ingrowth and minimal tissue attachment as the predicate device. | Animal Study Results (4-week post-implantation porcine model, comparative): Evaluated:

• Tissue attachment
• Mesh contracture
• Tissue in-growth
• Host inflammatory and fibrotic response
  Conclusion: Results indicated similar performance to the predicate device ("performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device."). |
  | Sterilization: Device sterilization method should be effective and comparable to the predicate. | Sterilization: Stated as "the same as the predicate device." |
  | Packaging: Device packaging should maintain integrity and sterility. | Packaging: Stated as "the same as the predicate device." Tested seal strength and package qualification. |

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

• Sample Size: Not explicitly stated with specific numbers, but the document mentions a "4 week post-implantation study in a porcine model." This implies a limited number of animal subjects. Bench testing also does not specify the number of samples tested for each metric, but these are typically standardized tests performed on multiple samples.
• Data Provenance: The animal study was conducted in a "porcine model," indicating an animal study rather than human clinical data. Bench testing is laboratory-based. This is prospective testing of the device.

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

• This concept is not applicable here because "ground truth" in this context would refer to objective measurements from bench tests or histological evaluations from the animal study. These would typically be performed and interpreted by laboratory technicians or veterinary pathologists, not "experts" in the sense of clinical reviewers establishing diagnostic truth for AI.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are used when multiple human readers interpret an image or clinical case and their interpretations need to be reconciled to establish a ground truth. For bench tests and animal studies, results are typically quantitative measurements or pathological findings with established protocols.

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 was not done. This type of study is relevant for AI/ML diagnostic devices, not for a surgical mesh.

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

• Not applicable. This is a physical surgical device, not an algorithm.

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

• For the animal study: Pathology/Histology (e.g., evaluating tissue attachment, ingrowth, inflammatory response) and observational data from the porcine model.
• For bench testing: Objective physical measurements (e.g., strength values, disruption levels) using laboratory equipment and established test methods.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set in the computational sense. The "training" for the device's development would be through design iterations, material science knowledge, and manufacturing processes.

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

• Not applicable. Since there is no training set in the AI/ML context, there is no "ground truth" to establish for a training set. The device design and materials are based on established engineering principles and prior knowledge from the predicate device.

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

The Proposed Product, Bard® PERFIX™ Light Plug is a pre-formed three-dimensional (cone shape) device constructed of a fluted outer layer and multiple inner layers of mesh attached at the tip. The device has a large pore design and is constructed of knitted polypropylene monofilaments. The pores in the mesh allow for tissue ingrowth. A separate flat, pre-shaped onlay patch (2.3" x 5.4") will be packaged with each device. The Bard® PERFIX™ Light Plug will be offered in a range of sizes with the largest being the extra large PerFix™ Plug 1.5" x 2.0" (4.1cm x 5.0cm). The extra large size consists of three (3) preformed medium shells held in place, side by side, inside a pre-formed large shell. The small, medium and large sizes consist of an outer cone with 2 pieces of mesh (petals) to help the plug maintain its fluted form. The inner petals and cones are sewn together at the tip with a single polypropylene monofilament thread.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard® PERFIX™ Light Plug:

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The study conducted to demonstrate the safety and effectiveness and to meet the acceptance criteria of the Bard® PERFIX™ Light Plug was a series of laboratory bench tests and biocompatibility testing. This was a comparative study against legally marketed predicate devices: Bard® Soft Mesh, Bard® PERFIX™ Plug, Bard® Mesh Dart, and Ethicon Mersilene Mesh.

The study aimed to show substantial equivalence of the new device to these predicates, as required for a 510(k) premarket notification. The guidance followed was "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" (March 2, 1999).

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

• Sample Size for Test Set: The document does not specify the exact sample sizes for each of the laboratory bench tests (e.g., number of mesh samples tested for tensile strength).
• Data Provenance: The data is from laboratory bench testing, implying it was conducted in a controlled lab environment. The document does not explicitly state the country of origin, but given it's a 510(k) submission to the FDA, it's presumed the testing was conducted in a manner acceptable for US regulatory purposes, likely either domestically or by a certified international lab. The study is retrospective in the sense that it's comparing a new device against existing, predicate devices using established testing methods.

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

This type of information is not applicable to this submission. The "ground truth" for this device, which is a physical surgical mesh, is established through objective, quantifiable laboratory measurements of its physical, mechanical, and biological properties, not by human expert assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. The data presented relies on objective laboratory measurements rather than subjective expert consensus or adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers evaluate cases with and without AI assistance. The Bard® PERFIX™ Light Plug is a physical surgical implant, so an MRMC study is not relevant.

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

A standalone performance study was performed, but it's not an "algorithm only" study. It's a "device only" study focusing on the intrinsic material and design characteristics of the surgical mesh without human interaction during the performance testing itself. The laboratory bench tests (thickness, pore size, stiffness, tensile strength, etc.) and biocompatibility tests represent the standalone performance of the device's physical and biological properties.

7. Type of Ground Truth Used

The ground truth used was based on objective, quantifiable laboratory measurements of the physical, mechanical, and material properties (biocompatibility) of the device and its predicates. These measurements are considered the "true" performance characteristics against which the new device was compared to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable. The Bard® PERFIX™ Light Plug is a physical medical device, not a machine learning algorithm or AI model that requires a "training set" in the computational sense. The design and manufacturing process for the device would have been developed through R&D and engineering processes, not through machine learning training.

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

This is not applicable for the same reason as #8. There is no "training set" in the context of this device. The "ground truth" for the device's design and manufacturing would come from engineering specifications, material science principles, and established medical device standards.

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The Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects.

The modified Bard 3DMAX Mesh is anatomically designed to fit the inguinal 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.

The provided text describes a 510(k) premarket notification for a medical device, the Bard 3DMAX Mesh. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this type of regulatory submission and is not present in the provided text.

The "study" referenced in the document is a comparison to predicate devices, focusing on technological characteristics, performance, and intended use, rather than a clinical trial with acceptance criteria for a new AI or diagnostic device.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

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

The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, or accuracy. The "performance" assessment focuses on demonstrating substantial equivalence to predicate devices.

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

This information is not provided in the document. The "testing" mentioned refers to laboratory and biocompatibility tests, not a clinical test set with human subjects or data provenance in the context of AI.

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)

This information is not applicable and not provided. The assessment relies on laboratory and biocompatibility testing, not expert-adjudicated ground truth data for a diagnostic algorithm.

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

This information is not applicable and not provided.

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

This information is not applicable and not provided. The Bard 3DMAX Mesh is a surgical mesh, not an AI-powered diagnostic tool, so MRMC studies are irrelevant to this device.

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

This information is not applicable and not provided.

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

The "ground truth" equivalent for this device is based on biocompatibility testing standards and laboratory tests comparing material properties and performance characteristics to the existing predicate devices.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of a physical surgical mesh.

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

This information is not applicable and not provided.

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Bard Composix L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

The Composix® L/P Mesh, will consist of a layer of polypropylene mesh and a layer of expanded polytetrafloroethylene (ePTFE) stitched together using Polytetrafluroethylene (PTFE) monofilament thread sewn in a lock stitch formation. The polypropylene layer is knitted from 0.0048 inch polypropylene monofilament, which is identical to the currently marketed Large Pore Soft™ Mesh. The thickness of the ePTFE layer is identical to the currently marketed Composix® E/X Mesh. As with the currently marketed Composix E/X, the peripheral edge of the polypropylene mesh will be heat sealed to the ePTFE layer.

The layers of the Composix L/P Mesh will be sewn together using rows of interspaced stitching, which will allow the surgeon to tailor the product. Using the stitch pattern as a guide, the surgeon can tailor the product. For user convenience to facilitate the deployment of the larger sized Composix L/P products, the larger sizes of the Composix L/P products will be packaged with an Introducer Tool. This Introducer Tool is similar to the rolling tines/plunger assembly and T-handle of the PrecisionPass™ Delivery Device. The Introducer Tool consists of a handle with a thin stainless steel rod. The stainless steel rod is split into two pieces along its length and has ridges around the perimeter to facilitate use. Similar to the T-handle provided with the PrecisionPass Device, the Introducer Tool's T-cap will be used to secure the open end of the metal rolling tines during the rolling process, then removed prior to delivering the device through the trocar.

This document is a 510(k) Summary for the Bard Composix® L/P Mesh, a surgical mesh. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested elements for a typical AI/software device study are not directly applicable or available in this type of submission.

Here's an analysis of the provided text in relation to your questions:

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

This
submission does not define specific quantitative "acceptance criteria" in the way an AI/software device would, nor does it report numerical "device performance" in terms of accuracy, sensitivity, or specificity. The acceptance criteria in a 510(k) for a medical device like a surgical mesh are typically based on demonstrating substantial equivalence in materials, design, manufacturing, intended use, and performance characteristics to a legally marketed predicate device.

The "performance" reported primarily revolves around demonstrating that the new device is as safe and effective as the predicate devices.

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

The submission does not describe a "test set" in the context of evaluating an AI/software device. The performance data is based on "Biocompatibility and bench testing." These types of tests involve material samples and controlled laboratory experiments, not patient data in the typical sense of a "test set" for diagnostic performance. Therefore, sample sizes for patient data, country of origin, and retrospective/prospective nature are not applicable here.

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 a physical surgical mesh, not an AI/software device that requires expert-established ground truth on patient data.

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

Not applicable. This is a physical surgical mesh, not an AI/software device that requires expert adjudication.

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 physical surgical mesh, not an AI or diagnostic device that would involve human readers or MRMC studies.

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

Not applicable. This is a physical surgical mesh, not an algorithm.

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

The ground truth for a physical device like a surgical mesh is established through a combination of:

• Material specifications and standards: Confirming the physical and chemical properties of the materials meet established safety and performance benchmarks.
• Biocompatibility testing: Demonstrating the material does not cause adverse biological reactions.
• Bench testing: Laboratory tests to evaluate mechanical properties (e.g., tensile strength, tear resistance) and other functional aspects relevant to its use as a surgical mesh.
• Predicate device history: Relying on the established safety and effectiveness profile of the legally marketed predicate devices, combined with evidence that the new device is sufficiently similar.

The document states: "Biocompatibility and bench testing provided in this submission support the safety and effectiveness of Bard Composix® L/P Mesh for its intended use." and "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing Bard Composix® L/P Mesh is substantially equivalent to the referenced Predicate Products."

8. The sample size for the training set

Not applicable. This is a physical surgical mesh, not an AI/software device that requires a training set.

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

Not applicable. This is a physical surgical mesh, not an AI/software device that requires a training set with ground truth.

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Bard Modified Extra Large Composix Kugel Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

The modified XL Composix Kugel Mesh is a self-expanding, two-layered mesh with two extruded monofilament PET polymer "rings". The mesh is constructed of knitted polypropylene monofilament approximately 0.006" in diameter. The mesh is knitted to form a strong, porous, support material. The knit structure of the polypropylene mesh is identical to that of the predicate Composix Kugel Mesh product and allows for repair of the defect. The monofilament PET polymer "rings" add stability to the device enabling greater simplicity and assurance in the proper placement of the patch.

The provided text describes a 510(k) premarket notification for a medical device, the "Modified XL Composix Kugel Mesh." It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing a new device to an existing one, rather than presenting a detailed study proving the new device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not present in this document because they are generally not required for a 510(k) submission that relies on equivalence to a predicate device.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent:

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

   Acceptance Criteria	Reported Device Performance
   N/A	N/A

   Explanation: The document does not explicitly state acceptance criteria or provide a table of device performance against such criteria. The submission is based on demonstrating "substantial equivalence" to a predicate device, not on meeting predefined performance metrics through a clinical study.

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 for Test Set: Not applicable. No test set for a clinical study is described.
   • Data Provenance: Not applicable. The "Performance Data" section mentions "Bench testing," which is typically laboratory-based and doesn't involve patient data from specific countries or study designs (retrospective/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):

   • Number of Experts: Not applicable. No clinical test set requiring expert ground truth establishment is described.
   • Qualifications of Experts: Not applicable.

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

   • Adjudication Method: Not applicable. No clinical test set requiring adjudication is 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:

   • MRMC Study: No. This document describes a medical mesh device, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant or mentioned.
   • Effect Size: Not applicable.

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

   • Standalone Performance Study: Not applicable. This is a medical device (mesh), not a software algorithm.

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

   • Type of Ground Truth: Not applicable for a clinical study. For bench testing, the "ground truth" would be engineering specifications and validated measurement methods to assess the device's physical properties.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that would require training data.

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

   • Ground Truth Establishment for Training Set: Not applicable.

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The Salute® II Disposable Fixation Device is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

The Salute II Disposable Fixation Device consists of a handle, shaft/shaft tip and comes preloaded with 316L stainless steel wire. The device is used to deliver permanently implanted Q-shaped constructs (Q-Rings). Depending on user preference, the device is offered in an 18cm shaft preloaded with either 10 or 30 Q-Rings and a 38cm shaft (fits into a 5mm trocar) preloaded with either 10, 30, or 60 Q-Rings.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Salute II Disposable Fixation Device:

Crucially, the provided document is a 510(k) Summary and FDA clearance letter, not a detailed study report. Therefore, it focuses on demonstrating equivalence to a predicate device rather than presenting a comprehensive study with specific acceptance criteria, statistical power calculations, or detailed performance metrics. As a result, many of the requested items cannot be fully extracted or are explicitly stated as "Not Applicable" or "Not Provided."

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria or a direct comparison to specific reported device performance values in the way one might expect from a detailed clinical or performance study. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device through:

• Same intended use: The Salute II Disposable Fixation Device has the same intended use as the predicate device (fixation of prosthetic material and approximation of tissue in surgical procedures).
• Similar technological characteristics: Both devices place stainless steel wire into tissue/prosthetics to fixate prosthetics/approximate tissue using a handle and shaft to deliver 316L stainless steel Q-shaped constructs.
• Equivalent performance: Bench testing demonstrated the proposed product "delivers the same shape and comparably sized Q-rings, which provides equivalent fixation."

Therefore, the "acceptance criteria" here are less about numerical thresholds for sensitivity/specificity and more about establishing functional and safety equivalence to a legally marketed predicate device.

Table of Implicit Acceptance Criteria and Reported Device Performance:

Study Details

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

   • Test Set Sample Size: Not provided. The performance data is based on "bench testing" which implies mechanical or functional tests in a laboratory setting, not human subject data.
   • Data Provenance: Bench testing data, conducted by Davol, Inc. (submitter). Location of testing not specified, but typically conducted in-house by the manufacturer. Prospective, as it was conducted for the purpose of this submission. Since it's bench testing, country of origin related to patient data is not applicable.

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

   • Not applicable. As this relies on bench testing of physical characteristics (shape, size, fixation strength), expert review of patient data ground truth is not relevant. The "ground truth" for bench testing would be objective measurements and engineering specifications.

3. Adjudication method for the test set:

   • Not applicable. No human interpretation of complex medical data requiring adjudication.

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:

   • No. This is a medical device for surgical fixation, not an AI/imaging diagnostic device. MRMC studies are not relevant.

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

   • Not applicable. This is a manual surgical fixation device, not an algorithm.

6. The type of ground truth used:

   • For bench testing: Engineering measurements, physical specifications, and comparative performance against the predicate device in terms of Q-ring shape, size, and fixation equivalence.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI algorithm requiring a training set. If "training set" refers to design iterations or prototypes, that information is not provided.

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

   • Not applicable. Same as above.

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The Salute® Fixation System is indicated for use in a variety of laparoscopic/ endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

The Salute Fixation System consists of a reusable handle, shaft and shaft tip, as well as a sterile, disposable implant cartridge with wire survey ube and cover. The disposable implant cartridge comes prektades from 316L stainless steel wire. The device is used to deliver permanently maginn on Q-shaped rings (Q-ring). Depending on user preference, the handle may be used with an 18cm shaft or a 38cm shaft (fits into a 5mm trocal). Implant cartridges are offered with sufficient 316L stainless steel wire to form 10, 20, 30, or 50 Q-rings and are designed to work with either a 38cm shaft or an 18cm shaft. The handle and shaft are engraved with serial numbers, which must match in order for the device to function properly. The Instructions for Use (IFU) contain information to insure the implant cartridge is used with an appropriate shaft and to confir:: serial numbers of the shaft/handle match.

The provided documentation describes a premarket notification for the Salute® Fixation System (SFS). However, the document does NOT contain information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures.

The "Performance Data" section (G.) in the K050610 document on page 2/2 primarily discusses:

• Biocompatibility: Stating that biocompatibility testing will be completed and passed before a new PTFE material is released. This refers to material safety, not clinical performance metrics.
• Bench Testing: Stating that "Bench testing on the Proposed demonstrated the Q-ring shape and dimensions were substantially equivalent to the Predicate." This indicates equivalency in physical characteristics, not clinical effectiveness or performance against specific criteria.

Therefore, the requested information elements cannot be fully extracted from the provided text for a device performance study as typically understood in the context of AI/medical device performance evaluation.

However, I can extract and present the type of "performance data" that was provided, which is focused on substantial equivalence rather than traditional performance metrics and acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The document refers to "Bench testing," which implies physical tests on the device itself, not patient data.
• Data Provenance: Not applicable, as no human data or clinical study is described for performance evaluation.

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

• Number of Experts: Not applicable. Performance was assessed through bench testing and comparison to a predicate device, not by expert review of clinical cases.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. There was no test set requiring human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done.

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

• Standalone Performance: Not applicable. This device is a manual surgical fixation system, not an algorithm or AI.

7. The type of ground truth used:

• Ground Truth: The "ground truth" was the characteristics and performance of the predicate device (Salute Stapler and Staples by Onux Medical, Inc.) and the results of bench testing for physical properties (Q-ring shape, dimensions, etc.) and biocompatibility standards.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable. This document does not describe an AI/ML device or a training set.

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

• Ground Truth (Training Set): Not applicable.

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The Davol® Hysteroscopy Pouch Drape and Tubing Set is intended for the collection of distention and irrigation fluids during diagnostic or operative hysteroscopy.

The Davol Hysteroscopy Pouch Drape and Tubing Set consists of a Drape and Fluid Collection Tubing. The Drape is a blue polyethylene under-buttocks sheet with a clear, funnelshaped polyethylene fluid collection pouch. The sheet has a patient adhesive strip located at the edge closest to the pouch, as well as hand cuffs to facilitate placement under the patient. The cuffs are identified as left and right. The pouch is held open by a malleable wire support located at the top outside edge and it contains a spunbonded nylon fabric filtration screen to catch large tissue debris or surgical gauze, which prevents clogging the drainage port. The drainage port, located at the bottom of the pouch, has a hinged cap. The Fluid Collection Tubing includes a Drape Suction Set and an Outflow Tubing Set. The Drape Suction Set is supplied in a Y-configuration manufactured from three pieces of polyvinylchloride (PVC) tubing joined by a PVC Y-Connector. The Ouflow Tubing Set includes an anti-siphon feature which allows air to vent into the fluid path of the outflow tubing.

The provided text describes a 510(k) premarket notification for the Davol® Hysteroscopy Pouch Drape and Tubing Set. The submission focuses on establishing substantial equivalence to a predicate device, rather than providing a performance study with detailed acceptance criteria and results as typically found for novel device validations.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically seen in a performance study (e.g., accuracy, sensitivity, specificity, or objective metrics) is not applicable in this 510(k) submission. Instead, the submission relies on demonstrating substantial equivalence to a previously marketed predicate device. The "performance" is implicitly deemed equivalent if the technological characteristics and intended use are the same.

The comparison is presented in a "Comparison Chart" (Attachment 6-1) which lists features and whether both the new device (Davol Drape) and the predicate device (Microtek Drape) possess them. This serves as the basis for the "acceptance" of substantial equivalence.

Note: The "acceptance criteria" here are implicitly that the Davol Drape must possess the same features and intended use as the predicate Microtek Drape to establish substantial equivalence. The document explicitly states: "The Drape subject of this submission and the predicate product are identical as summarized in the Comparison Chart, Attachment 6-1."

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

Not Applicable. This submission is not a clinical performance study using a test set of patient data. It is a regulatory submission focused on comparing the design and intended use of a new device to a predicate device. Therefore, there is no "test set" in the context of clinical data.

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

Not Applicable. As there is no "test set" of clinical data being evaluated for performance, there are no experts establishing ground truth in that sense. The comparison of the device features was a direct comparison of physical and functional characteristics.

4. Adjudication Method for the Test Set

Not Applicable. No test set requiring expert adjudication was used.

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 drape and tubing set, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

Not Applicable. This device is a physical medical device (surgical drape and tubing) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is the known characteristics and intended use of the legally marketed predicate device (Microtek Medical, Inc. Under Buttocks Drape and Fluid Collection Pouch). The new Davol Drape was compared directly against these known characteristics.

8. The Sample Size for the Training Set

Not Applicable. This submission does not involve a "training set" in the context of machine learning or algorithm development. The device is a physical product.

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

Not Applicable. As there is no training set for an algorithm, this question is not relevant.

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