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SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes.

SurgiMend is specifically indicated for:

• · Plastic and reconstructive surgery
• · Muscle flap reinforcement
• · Hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

SurgiMend is an acellular dermal tissue derived from bovine dermis. The device is available in solid, fenestrated, and perforated configurations. The device is supplied sterile in a variety of sizes, shapes, and thicknesses.

The provided text is a 510(k) Premarket Notification for a medical device (SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction), seeking substantial equivalence to a predicate device. It is a regulatory document and does not describe a study involving an AI/Machine Learning device or a diagnostic product that would require acceptance criteria in the sense of performance metrics (like sensitivity, specificity, accuracy) typically associated with AI models or diagnostic tests.

Instead, the "acceptance criteria" and "study" described in this document relate to the physicochemical, mechanical, and biological properties of the medical mesh device itself, and the "study" is a comparison to a predicate device to demonstrate substantial equivalence for regulatory approval.

Therefore, many of the requested items in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable (N/A) to this type of device and regulatory submission.

However, I can extract and present the information that is relevant to the document provided, reinterpreting "acceptance criteria" and "study" within the context of a medical device 510(k) submission for a surgical mesh.

Device: SurgiMend® MP Collagen Matrix for Soft Tissue Reconstruction

Type of Device: Surgical Mesh (Class II)

Purpose of Submission (510(k)): To demonstrate substantial equivalence to a legally marketed predicate device (SurgiMend® Collagen Matrix for Soft Tissue Reconstruction, K083898).

Here's an interpretation of the requested information based on the provided document:

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

Primary Endpoint: Mechanical strength to support soft tissue reinforcement.
Secondary Endpoints: Revascularization and tissue integration of perforated test and non-perforated control configurations.

Result: Studies demonstrated "the basic properties of the subject device after implantation remain unchanged from the predicate." |
| Indended Use: Equivalent to predicate. | Same Indications for Use as the predicate: implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes, specifically for plastic and reconstructive surgery, muscle flap reinforcement, and hernia repair (abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias). The minor modification (perforations) does not change intended use. |
| Safety & Effectiveness: No new issues raised. | The modifications do not change the intended use, nor alter the fundamental scientific technology of the device, and do not raise any new issues of safety and effectiveness. |

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

• Test Set Sample Size: No specific numerical sample size for "test sets" in the context of an AI model is provided. This document refers to pre-clinical studies (animal models) and mechanical testing of the device itself.
  • Mechanical Testing: Not specified, but implied to be sufficient for compliance with FDA guidance.
  • Animal Implantation Studies: "three different animal models" were used (rat hernia repair, rat intra-abdominal, rat intra-muscle implant). The number of animals per model is not specified.
• Data Provenance: Not specified, but implied to be from studies conducted by or for TEI Biosciences Inc. (now Integra LifeSciences Corporation), located in the USA. These are pre-clinical (animal) studies, not human retrospective/prospective data.

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

• N/A. This is not an AI/diagnostic device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device's performance relates to its physical, mechanical, and biological properties as measured in laboratory and animal studies, not human expert consensus on images.

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

• N/A. Not applicable to this type of device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• N/A. This is a surgical mesh, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

• N/A. This is a physical medical device, not an algorithm.

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

• For mechanical performance: The "ground truth" is established by direct physical measurements according to specified ASTM/ISO standards and compliance with FDA guidance for surgical mesh, likely verified by internal quality control.
• For biocompatibility: The "ground truth" is established by standard biocompatibility testing protocols, referencing the predicate device's confirmed biological safety.
• For in vivo performance: The "ground truth" is established through direct observation and measurement in animal models (e.g., assessing mechanical strength of repair, revascularization, tissue integration post-implantation). This would involve histological analysis and biomechanical testing of harvested tissues.

8. The sample size for the training set:

• N/A. This is not an AI/ML device, so there is no training set in that context. The "training" in this context would be the predicate device's historical performance data.

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

• N/A. As above, no training set for an AI model. The "ground truth" for the predicate device's established safety and effectiveness would have been based on its own prior regulatory approvals, mechanical testing, biocompatibility studies, and potentially human clinical experience that led to its initial market clearance.

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PriMatrix is intended for the management of wounds that include:

• Partial and full thickness wounds
• Pressure, diabetic, and venous ulcers
• Second-degree burns
• Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• Trauma wounds abrasions, lacerations and skin tears
• Tunneled/undermined wounds
• Draining wounds

PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surqeon to meet the individual patient's needs.

This document is a 510(k) premarket notification clearance letter for the PriMatrix Dermal Repair Scaffold. It is important to note that this document does not contain a study that proves the device meets specific acceptance criteria in the manner you've described.

The letter explicitly states: "No additional verification and validation test data were required as part of this submission. This 'traditional' 510(k) was submitted to clarify and correct the labeling, without changing the Intended Use of PriMatrix."

This 510(k) submission is for a device that is substantially equivalent to a previously cleared predicate device (PriMatrix Dermal Repair Scaffold, K131286). Substantial equivalence means that the device has the same intended use and technological characteristics as the predicate, or, if there are differences, those differences do not raise different questions of safety and effectiveness.

Therefore, your request for acceptance criteria and study details cannot be fulfilled from this document. This document confirms a regulatory clearance based on substantial equivalence, not a new study demonstrating performance against a specific set of acceptance criteria.

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PriMatrix is intended for the management of wounds that include:

• Partial and full thickness wounds
• Pressure, diabetic, and venous ulcers
• Second-degree burns
• Surgical wounds-donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• Trauma wounds-abrasions, lacerations, and skin tears
• Tunneled/undermined wounds
• Draining wounds

PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

The provided text is a 510(k) premarket notification for a medical device called "PriMatrix Dermal Repair Scaffold." This document describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria, a specific study proving the device meets these criteria, or any details related to AI/algorithm performance. Therefore, I cannot extract the requested information regarding AI device evaluation.

The relevant sections of the input text for medical device regulation are highlighted below, but they do not pertain to the performance evaluation of an AI-powered device.

Device Information:

• Proprietary name: PriMatrix Dermal Repair Scaffold
• Common name: Animal-derived, dermal extracellular matrix wound care product
• Classification: Unclassified
• Intended Use: Management of various types of wounds (partial and full thickness, pressure, diabetic, and venous ulcers, second-degree burns, surgical wounds, trauma wounds, tunneled/undermined wounds, draining wounds).

Substantial Equivalence:

The device claims substantial equivalence to:

• PriMatrix (TEI Biosciences, K083440)
• DressSkin (TEI Biosciences, K023778)

Summary of Technological Characteristics and Biocompatibility:

• PriMatrix is an acellular dermal tissue matrix.
• It is described as substantially equivalent to other wound care products in design and application.
• Biocompatibility was assessed through tests including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity.
• Manufacturing methods were tested for viral inactivation.

The document focuses on regulatory approval based on substantial equivalence to existing devices and biocompatibility, not on the performance evaluation of a new AI algorithm.

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PriMatrix Ag Antimicrobial is intended for the management of wounds that include:

• Partial and full thickness wounds
• Pressure, diabetic, and venous ulcers
• Second-degree burns
• Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence
• Trauma wounds-abrasions, lacerations, and skin tears
• Tunneled/undermined wounds
• Draining wounds

PriMatrix Ag Antimicrobial is an acellular dermal tissue matrix derived from fetal bovine dermis. PriMatrix Ag Antimicrobial is supplied sterile in a variety of sizes that can be trimmed by the surgeon to meet the individual patient's needs. The Ionic Silver content is intended to prevent microbial colonization of the device.

The provided text describes a 510(k) premarket notification for a medical device called PriMatrix Ag Antimicrobial Dermal Repair Scaffold. The submission focuses on establishing substantial equivalence to legally marketed predicate devices and demonstrates biocompatibility and antimicrobial effectiveness.

However, the document does not contain information related to a study that establishes acceptance criteria for its performance in the context of diagnostic accuracy, such as sensitivity, specificity, or AUC, as would be common for AI/ML-driven diagnostic devices. The device described is a dermal repair scaffold with antimicrobial properties, not an AI/ML diagnostic tool. Therefore, many of the requested categories (e.g., test set sample size, ground truth establishment, MRMC studies, standalone performance) are not applicable to the type of device being described.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a dermal repair scaffold and not a diagnostic device, the "acceptance criteria" discussed are largely related to biocompatibility and antimicrobial effectiveness, rather than diagnostic performance metrics like sensitivity or specificity.

Regarding the other requested information:

• 2. Sample size used for the test set and the data provenance: Not applicable. The studies described are laboratory and animal model tests, not human diagnostic test sets.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here. Ground truth for antimicrobial effectiveness was established through standard microbiological and animal model assays.
• 4. Adjudication method (e.g., 2+1, 3+1, none) 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. This device is not an AI/ML-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For biocompatibility, the ground truth was established by standard toxicology and biological safety testing methods. For antimicrobial effectiveness, the ground truth was established by microbiological culture (CLSI Disc Susceptibility testing) and bacterial enumeration in an animal model.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the K100261 submission for PriMatrix Ag Antimicrobial is for a biological wound care product with antimicrobial properties, not an AI/ML-driven diagnostic medical device. Therefore, the typical "acceptance criteria" and "study" details requested for AI/ML devices (like sensitivity, specificity, test/training sets, expert adjudication, MRMC studies) are not present in this document. The provided text details the device's biocompatibility and antimicrobial efficacy through laboratory and animal model testing to demonstrate its safety and function.

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SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Plastic and reconstructive surgery Muscle flap reinforcement Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias

SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

This document is a 510(k) Premarket Notification for a medical device called SurgiMend Collagen Matrix for Soft Tissue Reconstruction. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text.

The document primarily states:

• Device Description: SurgiMend is an acellular dermal tissue matrix derived from bovine dermis for soft tissue reinforcement and repair.
• Intended Use: Plastic and reconstructive surgery, muscle flap reinforcement, and hernia repair.
• Predicate Devices: SurgiMend (K071807) and TissueMend (K020488) from TEI Biosciences.
• Technological Characteristics: Substantially equivalent to other surgical meshes.
• Biocompatibility: A rigorous assessment by an independent laboratory demonstrated biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular implantation, hemolysis, and pyrogenicity). Viral inactivation methods were also tested.

Essentially, this submission asserts that the new SurgiMend device is safe and effective because it is fundamentally the same as devices already on the market, which presumably had their safety and effectiveness established through other means (e.g., prior clinical data for older predicate devices, or through general knowledge of the safety of collagen matrix materials). There is no "study that proves the device meets the acceptance criteria" in the format of specific performance metrics against pre-defined thresholds.

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PriMatrix is intended for the management of wounds that include:

• . Partial and full thickness wounds
• . Pressure, diabetic, and venous ulcers
• . Second-degree burns
• . Surgical wounds-donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• . Trauma wounds-abrasions, lacerations, and skin tears
• . Tunneled/undermined wounds
• Draining wounds .

PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

The provided text is a 510(k) Premarket Notification for the PriMatrix Dermal Repair Scaffold. This type of regulatory submission in the US is for devices that are demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific performance criteria against a disease state or condition.

Therefore, the document does not contain the kind of information requested in your prompt regarding acceptance criteria, device performance metrics, study designs (test sets, training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance), or statistical results like effect sizes.

Instead, the submission focuses on:

• Device Description: What the device is (acellular dermal tissue matrix).
• Intended Use: The types of wounds it's meant to manage.
• Substantial Equivalence: Claiming similarity in function and intended use to existing devices (PriMatrix K061407 and Oasis K061711).
• Biocompatibility Assessment: Mentioning tests performed (cytotoxicity, sensitization, etc.) to demonstrate safety.
• Manufacturing Methods: Stating that viral inactivation levels were assured.

Consequently, I cannot fill out the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the information provided in this 510(k) summary.

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SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Plastic and reconstructive surgery, Muscle flap reinforcement, Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias, Reinforcement of soft tissues repaired by sutures or sutures anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

SurgiMend is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

This 510(k) premarket notification for SurgiMend Collagen Matrix for Soft Tissue Reconstruction does not contain a study that proves the device meets specific acceptance criteria in the way described in the request. This document is a Summary of Substantial Equivalence, not a clinical study report with performance metrics against acceptance criteria.

The purpose of a 510(k) submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness. It does not typically involve the setting of specific quantitative performance acceptance criteria or a study designed to prove the device meets these criteria in the context of device performance as one might expect for a diagnostic or AI-driven device.

Therefore, many of the requested fields cannot be directly extracted from this document as they are not relevant to a 510(k) submission for a surgical mesh.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not establish or report specific quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and biocompatibility.

The closest the document comes to "performance" is the biocompatibility assessment.

Biocompatibility Assessment:

• Criteria: Demonstrated biocompatibility (no cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity).
• Reported Performance: "A rigorous biocompatibility assessment performed by an independent laboratory demonstrated the biocompatibility of SurgiMend."
• Viral Inactivation: "The manufacturing methods for SurgiMend have also been tested by an independent laboratory to assure appropriate levels of viral inactivation."

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

• Sample size for test set: Not applicable. This 510(k) submission did not involve a "test set" in the context of evaluating a device's performance against specific metrics using collected data (e.g., patient images or clinical outcomes). The evaluation was primarily a comparison to predicate devices and laboratory biocompatibility testing.
• Data provenance: Not applicable in the context of clinical data for performance evaluation. Biocompatibility testing was performed by "an independent laboratory."

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

• Not applicable. No "ground truth" was established for a "test set" in this type of submission. The safety and effectiveness are inferred from the substantial equivalence to predicate devices and biocompatibility testing.

4. Adjudication method for the test set

• Not applicable. There was no test set requiring adjudication in 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 a diagnostic imaging device or an AI-assisted tool. Therefore, an MRMC study is irrelevant.

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

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

7. The type of ground truth used

• Not applicable. No ground truth in the sense of clinical outcomes, pathology, or expert consensus on data was used for performance evaluation of the device in this submission. The "truth" for this submission is related to the established safety and effectiveness of the predicate devices and the direct demonstration of biocompatibility for SurgiMend.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" for this type of medical device submission (a surgical mesh).

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

• Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary: This 510(k) document is a regulatory submission for a surgical mesh, demonstrating substantial equivalence to already approved predicate devices and reporting on standard biocompatibility testing. It does not present a clinical study with detailed performance metrics, acceptance criteria, or ground truth establishment as would be required for different types of devices, especially those involving diagnostics or AI.

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PriMatrix is intended for the management of wounds that include:

• Partial and full thickness wounds .
• Pressure, diabetic, and venous ulcers .
• Second-degree burns .
• Surgical wounds-donor sites/grafts, post-moh's surgery, post-laser surgery, . podiatric, wound dehiscence
• Trauma wounds-abrasions, lacerations, and skin tears .
• Tunneled/undermined wounds .
• Draining wounds .

PriMatrix is a collagen wound dressing. The device is supplied sterile and is provided in sheet form in a variety sizes to be trimmed by the surgeon to meet the individual patient's needs.

The provided text describes a 510(k) premarket notification for the PriMatrix Dermal Repair Scaffold. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove device performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample size, ground truth, and expert involvement are not applicable to this 510(k) submission.

Here's a breakdown of the available information based on your request:

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

• Not Applicable. This 510(k) submission does not present a table of acceptance criteria or specific device performance metrics from a new clinical study. The submission focuses on demonstrating substantial 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. The submission does not describe a "test set" in the context of device performance evaluation against specific criteria. It relies on the known performance and characteristics of the predicate device and biocompatibility testing.

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. There is no "ground truth" establishment in the context of a clinical test set described for this 510(k) submission.

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

• Not Applicable. No adjudication method for a test set 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

• Not Applicable. This is a medical device (wound dressing), not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not Applicable. This is a physical medical device (wound dressing), not an algorithm.

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

• Not Applicable. As no clinical study against novel ground truth is presented, this is not relevant. The basis for approval is substantial equivalence to the predicate device.

8. The sample size for the training set

• Not Applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set."

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

• Not Applicable. See point 8.

Summary of what was presented in the 510(k) submission:

The 510(k) Pre-market Notification for the PriMatrix Dermal Repair Scaffold focuses on demonstrating substantial equivalence to an already legally marketed predicate device, DressSkin (K023778), also manufactured by TEI Biosciences.

The evidence provided for this substantial equivalence includes:

• Summary of Technological Characteristics: PriMatrix is stated to be "substantially equivalent to other wound dressings with respect to its design as a flexible, collagen sheet which can be used to cover wounds."
• Biocompatibility Assessment: A "rigorous biocompatibility assessment performed by an independent certified laboratory" demonstrated the biocompatibility of PriMatrix.
  • Tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity.
• Viral Inactivation: The manufacturing methods were tested by an independent laboratory to assure safe levels of viral inactivation.

The FDA reviewed this submission and determined that PriMatrix is substantially equivalent to the predicate device for the stated indications for use, thereby allowing the device to be marketed.

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CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

CosMatrix is a remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

The provided text is a 510(k) Premarket Notification for the CosMatrix device, which is a surgical mesh. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a dedicated study.

Therefore, many of the requested sections regarding acceptance criteria, study details, and ground truth establishment are not applicable to this document as it describes a substantial equivalence submission, not a performance study that measures specific metrics against predefined acceptance criteria.

Here's a breakdown based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The 510(k) submission seeks to establish substantial equivalence to predicate devices, not to meet pre-defined performance acceptance criteria with specific metrics. The "performance" described is in terms of biocompatibility and design characteristics being similar to predicate devices.

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

Not applicable. This document does not describe a clinical performance study with a test set. It describes a biocompatibility assessment and comparison to predicate devices.

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

Not applicable. No ground truth establishment by experts for a test set is described in this regulatory submission.

4. Adjudication Method for the Test Set

Not applicable. As no test set performance is being evaluated against ground truth, there is no adjudication method 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

Not applicable. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reading performance with or without AI assistance is irrelevant and not described.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The concept of "ground truth" as it pertains to assessing the accuracy of a diagnostic or predictive device is not relevant to this submission for a surgical mesh. The "truth" being established is that the device is safe and effective via substantial equivalence to existing devices.

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not an AI model requiring a training set.

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

Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

Summary of Relevant Information from the Document:

While the document doesn't fit the requested structure for AI/diagnostic device performance studies, here's what it does provide:

• Device Information: CosMatrix is a remodelable collagen matrix derived from bovine skin for reinforcing soft tissues in plastic and reconstructive surgery.
• Intended Use: Implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
• Equivalence Claim: Substantially equivalent in function and intended use to:
  • TissueMend (TEI Biosciences, K020455)
  • Permacol (Tissue Science Laboratories, K013625)
  • SIS Plastic Surgery Matrix (Cook Biotech, K034039)
• Biocompatibility Assessment: A rigorous assessment was performed by an independent certified laboratory.
  • Tests Performed: Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity.
  • Result: Demonstrated biocompatibility.
• Manufacturing Methods: Tested by an independent laboratory to assure safe levels of viral inactivation.

This 510(k) application focuses on showing that CosMatrix shares similar technological characteristics (design, material origin - bovine, remodelable nature) and has an equivalent safety profile (biocompatibility, viral inactivation) to other legally marketed predicate devices, thereby establishing "substantial equivalence" as required by the FDA's 510(k) pathway. It does not involve performance criteria and studies typical for AI-enabled devices or diagnostic tools.

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Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

Xenform Soft Tissue Repair Matrix is an acellular collagen material intended to be utilized for surgical procedures pertaining to the pelvic floor. Xenform Soft Tissue Repair Matrix is supplied sterile and provided in sheet form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs. Xenform Soft Tissue Repair Matrix is manufactured from bovine skin, one of the purest sources of collagen available. The source material is solely derived from cattle obtained in compliance with US and European regulatory requirements.

The provided text is a 510(k) summary for a medical device (Xenform Soft Tissue Repair Matrix) and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

Instead, this document focuses on demonstrating that the device is "substantially equivalent" to a previously marketed predicate device (also named Xenform, K051190) based on its design, intended use, technological characteristics, and biocompatibility.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information. The document primarily describes the device, its intended use, and its equivalence to a predicate, along with a summary of biocompatibility testing. It doesn't detail a study designed to measure specific performance outcomes against predefined acceptance criteria for the new device.

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