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Polyform Syntheic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The subject device consists of monofilament polypropylene fibers knitted into a sheet. It is rectangular in shape and available in two sizes, 10 x 15 cm and 15 x 20 cm. Surgeons implanting the subject device cut the mesh to the size and shape needed for an individual patient. The subject device is single use only, supplied sterile, and individually packaged in a Tyvek/Mylar pouch. The subject and predicate device are identical.

This document is a 510(k) premarket notification for a medical device called Polyform™ Synthetic Mesh. It is a letter from the FDA to Boston Scientific Corporation, dated December 15, 2017, confirming that the device has been determined to be substantially equivalent to a legally marketed predicate device.

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

Key Takeaway: The submission for the Polyform™ Synthetic Mesh is based on substantial equivalence to a predicate device (K051245), not on a new performance study that establishes design-specific acceptance criteria for the new device. The "modification" for the current submission is an update to the device's Instructions For Use (IFU), and the document explicitly states: "No performance data are needed to support the modifications to the instructions for use."

Therefore, many of the typical questions regarding acceptance criteria and performance studies for a new device's design are not applicable in this 510(k) summary. The acceptance criteria here would primarily relate to the demonstration of identical or highly similar technological characteristics and intended use to the predicate device.

Analysis based on the provided document:

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

   Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance
   Material Composition: Must be identical or substantially similar to predicate.	The subject device consists of "monofilament polypropylene fibers knitted into a sheet," which is implicitly identical or substantially equivalent to the predicate, as the document states "The subject and predicate device are identical."
   Physical Form/Design: Must be identical or substantially similar to predicate.	"It is rectangular in shape and available in two sizes, 10 x 15 cm and 15 x 20 cm." This is implicitly identical or substantially equivalent to the predicate, as the document states "The subject and predicate device are identical."
   Sterility: Must be supplied sterile.	"The subject device is single use only, supplied sterile, and individually packaged in a Tyvek/Mylar pouch." (Implicitly meets standard sterility requirements, consistent with predicate).
   Intended Use/Indications: Must be identical to predicate.	"Polyform Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect."

The document explicitly states: "The subject and predicate device have the same intended use." |
| Technological Characteristics: Must be identical or substantially similar to predicate. | "The subject and predicate device are identical; and accordingly, they have the same technological characteristics." |
| Performance Data: No new performance data needed for the specific modification. | "The Polyform Synthetic Mesh submitted herein is a modification of the predicate mesh device, Polyform Synthetic Mesh (K051245). The modification is an update to the device instructions for use packaged with the product. No performance data are needed to support the modifications to the instructions for use." This explicitly states that no new performance data was required for this specific submission due to the nature of the change (IFU update). The original predicate device's clearance would have been based on its own performance data or substantial equivalence at that time. |
| Predicate Device History: Predicate not subject to design-related recall. | "The predicate device has not been subject to a design related recall." |

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

   • Not Applicable. The submission is not based on a new performance study requiring a test set for design validation. It relies on the substantial equivalence to a predicate device, and the specific modification (IFU update) did not necessitate new performance data.

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

   • Not Applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission.

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

   • Not Applicable. No new test set requiring adjudication was conducted for this 510(k) submission.

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-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

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

   • Not Applicable. This is a physical medical device (surgical mesh), not an algorithm or software.

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

   • Not Applicable for this specific 510(k) submission. The "ground truth" for this submission hinges on the established safety and efficacy of the predicate device, and the demonstration that the subject device is identical to it, with only a change to the Instructions For Use. The original predicate clearance (K051245) would have relied on its own data or prior predicate, which might have included various types of evidence.

8. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a training set.

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

   • Not Applicable. (See point 8)

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Vertessa® Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or laparoscopic abdominal procedures.

Vertessa® Lite devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa "Lite will be available in a rectangular flat sheet mesh and rectangular strip mesh designs.

The flat sheet mesh designs are available in the following sizes: 8 x 16 cm, 8 x 18 cm, 8 x 20 cm, 8 x 22 cm, 8 x 24 cm, 8 x 26 cm, 10 x 16 cm, 10 x 18 cm, 10 x 20 cm, 10 x 22 cm, 10 x 24 cm, 10 x 26 cm, and 11 x 30 cm.

The strip mesh designs are available in the following sizes: 4 x 16 cm, 4 x 18 cm, 4 x 20 cm, 4 x 22 cm, 4 x 24 cm, 4 x 26 cm, 5 x 18 cm, 5 x 20 cm, 5 x 20 cm, 5 x 22 cm, 5 x 24 cm, 5 x 26 cm, and 6 x 30 cm.

This document is a 510(k) premarket notification for the Vertessa® Lite surgical mesh by Caldera Medical, Inc. It aims to demonstrate substantial equivalence to a predicate device, not to establish new safety and effectiveness through a traditional clinical study with acceptance criteria in the way a diagnostic AI device would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device are not applicable or not present in this document. This submission primarily focuses on physical and material characteristics and demonstrates comparability to an existing device.

Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not:

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

This document does not present acceptance criteria for a diagnostic performance metric (like sensitivity, specificity, or AUC) as expected for an AI device. Instead, it compares the physical and mechanical properties of the new Vertessa® Lite to its predicate device. The "acceptance criteria" here are implied to be "comparable to the predicate device" for the listed mesh characteristics.

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 explicitly stated in terms of number of mesh samples tested for each characteristic. This kind of detail is typically in the test reports, which are summarized here.
• Data provenance: Not specified in the provided text. The studies would have been conducted internally or by a contracted lab.

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 submission does not involve human expert interpretation for "ground truth" establishment in the context of a diagnostic AI device. The ground truth refers to the physical and chemical properties measured by standard test methods.

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

• Not applicable. There is no "adjudication" necessary as this is not a diagnostic interpretation study.

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 not an AI device, and therefore no MRMC study was conducted or is relevant.

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

• Not applicable. This is not an AI algorithm; it's a medical device (surgical mesh).

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

• The "ground truth" or reference for the performance evaluation consists of established physical, mechanical, and biological testing standards and methods for surgical mesh materials. For example, tensile strength is measured against established engineering principles, and biocompatibility is assessed against ISO 10993 standards. The comparative aspect is against the properties of the predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device that requires a training set.

In summary: K150016 is a 510(k) premarket notification for a Class II surgical mesh. Approval is based on demonstrating substantial equivalence to a previously cleared predicate device (Vertessa® Lite, K123337) by showing comparable physical, mechanical, and biocompatibility characteristics, rather than meeting specific diagnostic performance acceptance criteria typical for an AI/CADe device. The "study" involves physical and biological testing of the mesh and comparison to the predicate, as outlined in FDA guidance for surgical mesh.

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Vertessa® Lite Y-Mesh may be used a bridging material for as sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Vertessa® Lite Y-Mesh devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite Y-Mesh devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit clear mesh. Vertessa® Lite Y-Mesh will be available in a y-shape design of five different sizes (22 x 4 x 3 cm, 22 x 4 x 4 cm, 22 x 5 x 4 cm, 26 x 4 x 3 cm, 26 x 5 x 4 cm).

I am sorry, but the provided text is a 510(k) summary for a medical device (surgical mesh). It does not describe a study involving an AI or an algorithm, nor does it present acceptance criteria or performance data in the context of an AI device.

Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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Restorelle Y Contour Polypropylene Mesh device is indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle Y Contour Polypropylene Mesh is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It is designed for the treatment of vaginal vault prolapse. The Y shape design allows the two Y-leg segments to be attached to the anterior and posterior vaginal walls. The base of the Y segment is designed to attach to the sacral ligament.

The provided document is a 510(k) summary for the Restorelle Y Contour Polypropylene Mesh. It is a submission for a Special 510(k), which indicates that the device has the same technological characteristics as a previously cleared predicate device (Restorelle Y Contour, K123914), with only minor changes.

Due to the nature of a Special 510(k) for a surgical mesh, the focus of the submission is on demonstrating that the changes made do not affect the safety or effectiveness of the device compared to the predicate. The "performance data" section explicitly states:

"The changes proposed in this Special 510(K) were evaluated through sterilization validation and packaging integrity testing."

This means there was no clinical study comparing the device's performance in patients, nor was there an AI component. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, expert opinions, and comparative effectiveness studies for an AI/device performance assessment is not applicable to this document.

Here's a breakdown based on the information provided and the nature of this 510(k):

1. Table of acceptance criteria and the reported device performance

   • Acceptance Criteria (for a Special 510(k) on this device type): The primary acceptance criteria for this Special 510(k) revolved around demonstrating that the modified device maintained equivalent sterility and packaging integrity to its predicate device. This is typically assessed against established standards for sterilization validation (e.g., ISO 11137 for radiation sterilization, or other relevant standards for the chosen sterilization method) and packaging integrity (e.g., ASTM F88, F1929, F2096).
   • Reported Device Performance: The document states that the changes "were evaluated through sterilization validation and packaging integrity testing." It then concludes that the device "is substantially equivalent to its proposed predicate device." While specific numerical performance values against the acceptance criteria are not provided in this summary, the FDA's clearance (K140116) indicates that these tests met the required acceptance criteria.

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

   • N/A. This 510(k) is for a physical surgical mesh and does not involve a "test set" of data in the context of an AI or diagnostic device. The "testing" involved physical validation of manufacturing processes (sterilization and packaging).

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)

   • N/A. Ground truth establishment by clinical experts is not applicable to this type of device submission.

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

   • N/A. Not applicable.

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 a physical surgical mesh, not a diagnostic device involving human readers or AI.

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

   • No. Not applicable to this device.

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

   • N/A. Not applicable. The "ground truth" for this submission would be adherence to validated manufacturing and quality control standards (e.g., successful sterilization, intact packaging) to ensure the device performs as intended and is safe for use.

8. The sample size for the training set

   • N/A. Not applicable. This device does not use a training set as it's not an AI or machine learning product.

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

   • N/A. Not applicable.

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Restorelle M and XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle M and Restorelle XL Polypropylene Mesh are provided as sterile mesh constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. Restorelle M is a flat mesh measuring 10cm x 15cm. Restorelle XL is a flat mesh measuring 30cm. Both are designed for the treatment of apical vaginal prolapse.

The provided document is a 510(k) summary for a medical device (surgical mesh), which focuses on demonstrating substantial equivalence to a predicate device. This type of regulatory submission does not typically contain the detailed information requested regarding acceptance criteria and a study proving a device meets those criteria in the way a clinical trial or performance study report would.

510(k) submissions, especially for devices claiming substantial equivalence based on material and design similarities, often rely on non-clinical data (e.g., material properties, dimensions) and comparison to a legally marketed predicate. They don't usually involve acceptance criteria related to AI/algorithm performance, human reader studies, or detailed ground truth establishment as would be present for AI/ML-based medical devices or devices with novel performance claims requiring rigorous clinical validation.

Therefore, many of your requested points cannot be answered from the provided text.

Here's an analysis of what can be extracted and what cannot:

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

• Acceptance Criteria: The document implies that the acceptance criteria for the subject devices (Restorelle M & XL) are that they are "substantially equivalent" to the predicate device (Restorelle L) in terms of indications, materials, and technological characteristics. The specific metrics for "performance" are based on physical properties, not clinical outcomes in a comparative study.
• Reported Device Performance: The document reports the physical characteristics of both the subject and predicate devices. The "performance" is demonstrated by the equivalence of these characteristics.

The overarching "acceptance criterion" as explicitly stated in the Conclusions: "The performance and non-clinical referenced demonstrate that the Restorelle M and XL Polypropylene Mesh devices are substantially equivalent to Restorelle L Polypropylene Mesh."

The following information cannot be found in the provided 510(k) summary:

• 2. Sample size used for the test set and the data provenance: Not applicable here as this is a physical device comparison, not a data-based algorithm.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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, as this is not an AI/ML device or an imaging device requiring human reader interpretation.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable as this is not an AI/ML device requiring clinical ground truth for performance. The "ground truth" for this submission is the established properties and safety of the predicate device.
• 8. The sample size for the training set: Not applicable (no AI/ML model).
• 9. How the ground truth for the training set was established: Not applicable (no AI/ML model).

Summary of the Study/Evidence Provided:

The "study" in this context is the submission for a 510(k) premarket notification. The company Coloplast A/S is seeking clearance for two new mesh sizes (Restorelle M and XL) by demonstrating their substantial equivalence to a previously cleared predicate device, Restorelle L (K122440).

The core of the study is a comparison of technological characteristics. The "performance" is proven by showing that the new devices share the "same materials, features, intended use, and technological characteristics" as the predicate device, with the only difference being the mesh size.

This is a non-clinical comparison study, relying on the established safety and effectiveness of the predicate device rather than new clinical trials on the subject devices themselves.

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Vertessa™ Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Vertessa Lite Y-Mesh is designed to be used in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa Lite Y-Mesh is provided sterile and is comprised of non-absorbable macroporous monofilament polypropylene warp knit blue mesh in a y-shape design.

The provided text is a 510(k) summary for the Vertessa Lite Y-Mesh device, which is a surgical mesh for treating vaginal vault prolapse. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with a detailed performance analysis as might be done for an AI/ML device.

Therefore, many of the requested elements are not applicable or cannot be extracted from this type of document. This document outlines bench and failure mode testing and biocompatibility testing to show substantial equivalence, but it does not describe a study involving human subjects or AI/ML performance.

Here's an attempt to address your points based on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with corresponding "device performance" in the way one might expect for a clinical study with a primary endpoint. Instead, it lists various mesh characteristics that were assessed and states that the device "passed all testing requirements" or "demonstrates substantial equivalence."

Study Description: Substantial Equivalence Evaluation

The study described is an evaluation to demonstrate substantial equivalence of the Vertessa Lite Y-Mesh to two predicate devices: Alyte Y-Mesh Graft (K101722) by C.R. Bard, Inc. and Restorelle Y-Mesh (K112322) by Coloplast A/S. This evaluation was based on non-clinical bench testing, simulated use, surgeon feedback, and validation testing, in accordance with FDA guidance documents for surgical mesh.

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

• Sample Size (Test Set): Not specified. The document mentions "non-clinical bench, simulated use, surgeon feedback and validation testing," but does not provide specific sample quantities for these tests (e.g., number of mesh samples tested for tensile strength, number of surgeons providing feedback).
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal to Caldera Medical or conducted by contracted labs validating performance against established standards and predicate devices. The study is non-clinical as it involves laboratory and bench testing, not patient data.

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

• Number of Experts: Not specified. "Surgeon feedback" is mentioned, but the number of surgeons, their qualifications, or how their feedback was used to establish a "ground truth" (as typically understood in AI/ML contexts) for performance metrics is not detailed.
• Qualifications: "Surgeon" is the only qualification mentioned.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML product requiring diagnostic output adjudication. The evaluation involved testing physical and material characteristics against standards and predicate device performance.

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

• MRMC Study Done? No. This type of study is typically performed for diagnostic devices, especially those incorporating AI, to assess reader performance with and without AI assistance. The Vertessa™ Lite Y-Mesh is a surgical implant, not a diagnostic device.
• Effect Size: Not applicable.

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

• Standalone Study Done? Not applicable in the context of AI/ML algorithms. The device itself is the physical mesh. Its performance (e.g., tensile strength, biocompatibility) is evaluated directly, which could be considered "standalone" in the sense that its inherent properties are tested independent of user interaction during the test, but this is not analogous to an AI algorithm's standalone performance.

7. Type of Ground Truth Used

The "ground truth," in this context, is primarily derived from:

• Established Mechanical and Material Specifications: Performance characteristics (e.g., tensile strength, pore size, stiffness) are compared against known properties of the predicate devices and general standards for surgical mesh.
• Biological Safety Standards: Biocompatibility testing results are compared against established FDA guidance and ISO standards (e.g., ISO-10993).
• Sterilization and Shelf Life Standards: Testing results are compared against FDA guidance and ASTM standards (e.g., ASTM F-1980-07).
• Predicate Device Performance: The "truth" for demonstrating substantial equivalence is the existing, legally marketed predicate devices' performance and characteristics.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable, as there is no training set for this type of medical device.

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Restorelle Y Contour is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle L Contour is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a Y shaped mesh that is designed for the treatment of apical vaginal prolapse.

The provided text is a 510(k) summary for a medical device (Restorelle® Y Contour, a surgical mesh) and does not contain information about acceptance criteria or a study proving device performance using AI or clinical outcomes data. This document is focused on demonstrating substantial equivalence to a predicate device based on material, design, and intended use.

Therefore, many of the requested categories related to AI models and clinical studies cannot be populated from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

No explicit acceptance criteria or reported device performance in the context of an AI model or clinical trial with specific performance metrics are provided. The document focuses on demonstrating equivalence to a predicate device.

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

Not applicable. No test set for an AI model or clinical study data is reported.

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. No ground truth established by experts for a test set is reported.

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

Not applicable. No test set requiring adjudication is reported.

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. No MRMC study or AI assistance is mentioned.

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

Not applicable. No standalone algorithm performance is mentioned.

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

Not applicable. No ground truth in the context of an AI model or clinical study is reported. The regulatory filing establishes "ground truth" through comparison to an existing predicate device based on its established safety and efficacy.

8. The sample size for the training set

Not applicable. No training set for an AI model is mentioned.

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

Not applicable. No ground truth for a training set is mentioned.

Summary of available information from the document:

This 510(k) submission for the Restorelle® Y Contour surgical mesh demonstrates substantial equivalence to a predicate device (Restorelle® Y), rather than providing novel performance data from a specific study against acceptance criteria.

The basis for equivalence is primarily due to:

• Identical materials: Non-absorbable, monofilament polypropylene mesh.
• Identical intended use: As a bridging material for sacrocolposuspension/sacrocolpopexy for vaginal vault prolapse.
• Identical technological characteristics except for a minor dimension change (sacral flap reduced from 4 cm to 3 cm).
• Identical pore size and sterilization method.

The manufacturer states: "Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle Y Contour since the proposed mesh is identical in materials and design as that used in the predicate Restorelle Y device. The results and data from these studies are applicable to the Restorelle Contour device."

Therefore, the "proof" the device meets implied safety and effectiveness criteria is by demonstrating it is functionally the same as a previously cleared device. No new studies were conducted or reported for this submission to establish new performance metrics.

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Vertessa™ Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or lagaroscopic abdominal procedures.

Vertessa™ Lite devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa™ Lite devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa™ Lite will be available in a two rectangular flat sheet mesh designs.

The provided text is a 510(k) summary for the Vertessa™ Lite surgical mesh. It describes the device, its intended use, technological characteristics, and demonstrates substantial equivalence to a predicate device through performance testing. However, it does not describe a study involving an AI/CADe device or any sort of "device performance" in terms of clinical outcomes, diagnostic accuracy, or human reader improvement with AI.

Therefore, I cannot directly answer your prompt's specific questions regarding acceptance criteria and a study proving device performance in the context of an AI/CADe device. The document is for a medical device (surgical mesh), not an AI system.

However, I can extract the information related to the acceptance criteria and performance summary for the surgical mesh itself, as described in the 510(k) summary. I will present this information in a way that aligns with your prompt structure, while noting the difference in device type.

Device Type: Surgical Mesh (Vertessa™ Lite) - NOT an AI/CADe device.
Premarket Submission Number: K123337

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vertessa™ Lite surgical mesh were based on demonstrating substantial equivalence to its predicate device, Vertessa™ (K120327). This was achieved by assessing various mesh characteristics against established standards and guidelines.

Study Proving Device Meets Acceptance Criteria:

The study referenced is a series of "mechanical bench and validation testing" and other compliance tests (biocompatibility, sterility, accelerated aging) conducted on the Vertessa™ Lite device. This testing was performed to demonstrate "function equivalence based upon key device characteristics and its intended use to the predicate device, Vertessa™."

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

• Sample Size: Not explicitly stated in terms of a specific number of units for each test. The summary indicates "results from testing," implying that a sufficient number of samples were tested to demonstrate equivalence.
• Data Provenance: The tests were conducted by Caldera Medical, Inc. (the manufacturer). This is internal testing data. The country of origin of the data is implicitly the United States, as Caldera Medical, Inc. is located in Agoura Hills, CA. The nature of the data is prospective, as it involves newly manufactured devices undergoing specific tests.

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

• Not Applicable: This is a physical medical device (surgical mesh), not a diagnostic or AI device that requires expert ground truth for its performance assessment. The "ground truth" for these tests is based on objective measurements against established engineering standards and regulations, and comparison to the predicate device.

4. Adjudication method for the test set

• Not Applicable: As this is primarily bench testing against objective physical/chemical properties and regulatory standards, an adjudication method for a "test set" (in the sense of a clinical or image-based study) is not relevant.

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 not an AI-assisted diagnostic device. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or mentioned.

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

• Not Applicable: This device is a surgical mesh; it does not involve algorithms or AI.

7. The type of ground truth used

• The "ground truth" for the performance evaluation of the surgical mesh was based on:
  • Objective physical and mechanical properties: Measured values (e.g., tensile strength, pore size, thickness) compared against the predicate device and potentially industry standards.
  • Regulatory standards and guidance: Compliance with FDA guidance for surgical mesh characteristics, biocompatibility (ISO-10993), sterility (FDA Guidance K90-1), and accelerated aging (ASTM F-1980-07).
  • Predicate device characteristics: The characteristics of the legally marketed predicate device, Vertessa™ (K120327), served as the benchmark for demonstrating "substantial equivalence."

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device where a "training set" in the computational sense would be used.

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

• Not Applicable: See point 8.

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The Upsylon Y mesh is intended for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Upsylon Mesh is a preformed Y shaped lightweight polypropylene mesh consisting of two vaginal mesh arms and one sacral mesh arm. The Upsylon mesh is blue in color with a non-colored centering line.

The provided text describes a 510(k) premarket notification for the Upsylon Y mesh. This is a traditional medical device submission seeking substantial equivalence to existing devices, primarily relying on bench testing and qualitative assessments rather than clinical studies with explicit acceptance criteria related to device performance in a living system.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert involvement, and multi-reader multi-case studies, which are typical for AI/CADe submissions, is not applicable to this 510(k) submission for a surgical mesh.

However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence to the predicate devices.

Here's a breakdown of the available information:

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

The document doesn't explicitly state quantitative acceptance criteria in a table format for specific performance metrics the way a diagnostic device might. Instead, it states that the performance testing "demonstrate equivalence of the Upsylon Y mesh to the predicate meshes." This implies the performance fell within a range considered acceptable for substantial equivalence to the predicate.

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

• Sample Size for Test Set: Not explicitly stated as a number of devices or cases in the provided text. The performance testing was carried out on "samples" of the Upsylon Y mesh, aged at T=0 and T=7 months accelerated aging.
• Data Provenance: The testing was "bench and user evaluation" conducted by Boston Scientific. This indicates in-house testing. The "user evaluation in cadavers" is a laboratory-based assessment, not a clinical trial on human subjects.

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

• Not applicable. This submission focuses on material and mechanical properties, as well as a cadaver-based user usability assessment, not diagnostic accuracy or expert consensus on clinical findings. Therefore, "ground truth" in the diagnostic sense is not relevant.

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

• Not applicable. Adjudication methods are typically used in clinical trials or studies where expert disagreement on a finding needs to be resolved for ground truth establishment. This was a bench and cadaver-based study.

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/CADe system. Therefore, an MRMC study and AI assistance evaluation are not relevant.

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

• Not applicable. This device is hardware; it does not involve algorithms or AI.

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

• Not applicable in the traditional sense of diagnostic ground truth. For the mechanical and material testing, the "ground truth" would be established by validated test methods and engineering standards, comparing the results statistically or comparatively to the predicate devices. For the user evaluation, the "ground truth" would be the successful placement and evaluation of the mesh by the users in a cadaver model.

8. The sample size for the training set:

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

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

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

In summary: K122794 for the Upsylon Y mesh is a 510(k) submission based on substantial equivalence, primarily supported by bench performance testing (mechanical properties) and a user evaluation in cadavers. It is not a submission for a diagnostic AI/CADe device, and therefore, many of the requested criteria related to clinical studies, human readers, and AI performance are not relevant or present in the provided document. The "acceptance criteria" were qualitative, focused on demonstrating equivalence to predicate devices through engineering and simulated-use testing.

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NovaSilk Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

NovaSilk Mesh is an implantable, permanent, non-resorbable, synthetic support mesh manufactured from knitted, monofilament polypropylene. It is square in shape, measuring 150mm x 150mm, and 0.25mm thick.

Here's an analysis of the provided text regarding the NovaSilk Mesh device, specifically addressing the acceptance criteria and study information:

Based on the provided K122968 510(k) summary, the device is NovaSilk Mesh, and this submission is for a "Traditional 510(k) with Narrowed Indications." This type of submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device, rather than new extensive clinical trials for performance. Therefore, many of the typical "acceptance criteria" and "study" details you'd find for a new, novel AI or diagnostic device will not be present.

Acceptance Criteria and Reported Device Performance

The provided documentation does not define specific quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or numerical efficacy targets that the NovaSilk Mesh needs to meet. This is characteristic of a 510(k) submission for a surgical mesh, where the primary focus is on demonstrating substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) process):

Study Details:

Given that this is a 510(k) for substantial equivalence of a surgical mesh, the "study" is primarily a non-clinical comparison and verification of physical and material properties against predicate devices. There is no mention of a clinical study or performance study in the context of diagnostic accuracy, AI performance, or human reader improvement, as these types of studies are generally not required for this class and type of device in a 510(k).

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

   • Test Set Sample Size: Not applicable in the context of a clinical performance study as might be expected for an AI device. The testing refers to non-clinical bench testing.
   • Data Provenance: Not specified, but the testing was likely conducted in a lab setting by the manufacturer or contracted labs. Retrospective/prospective terms do not apply here.

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

   • Not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of device submission. The "ground truth" for the non-clinical testing is compliance with established engineering and safety standards.

3. Adjudication method for the test set:

   • Not applicable. There is no expert adjudication process for this type of non-clinical testing.

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 MRMC study was done. This is not an AI device or a diagnostic device where human reader performance would be a relevant metric.

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

   • Not applicable. This is not an algorithm or AI device.

6. The type of ground truth used:

   • For the non-clinical performance data mentioned ("Design verification, biocompatibility, sterilization, and shelf life testing"), the "ground truth" is adherence to established industry standards, regulatory guidelines (e.g., ISO standards for biocompatibility), and internal design specifications for surgical meshes.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable.

Summary of Approach:

The provided document describes a 510(k) submission for a surgical mesh device. The regulatory strategy is based on demonstrating substantial equivalence to previously cleared predicate devices (NovaSilk Mesh K053414 and Vertessa K120327). This involves showing that the subject device has identical or similar technological characteristics (materials, design, fundamental scientific technology) and identical or narrower indications for use compared to the predicates.

The "performance data summary" refers to non-clinical testing (design verification, biocompatibility, sterilization, and shelf life testing) that was previously completed on the predicate NovaSilk Mesh, which then supports the substantial equivalence claim for the new NovaSilk Mesh (subject device) because the subject device is technologically identical. No new clinical performance data or studies defining specific acceptance criteria in terms of clinical outcomes or reader performance are presented in this 510(k) summary.

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