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Endoform™ Reconstructive Template – PLGA is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing material to obtain the desired surgical outcome.

Endoform™ Reconstructive Template – PLGA is a surgical mesh comprised of multiple layers of ovine-derived extracellular matrix reinforced with poly(lactic-co-Glycolic) acid (PLGA). The device design includes a range of shapes, sizes, and thicknesses in surface areas up to 400cm², to give a range of strengths as required for a particular implant procedure. Devices are terminally sterilized by ethylene oxide (EO) sterilization.

This FDA 510(k) clearance letter and supporting summary for the Endoform™ Reconstructive Template – PLGA device does not involve artificial intelligence (AI) or machine learning (ML). Therefore, many of the requested elements for AI/ML device validation are not applicable.

The device is a traditional medical device (surgical mesh) and its substantial equivalence is demonstrated through non-clinical performance data and comparison to a predicate device. There is no mention of an algorithm, AI assistance, or human readers.

However, I can extract the information relevant to its acceptance criteria and the study that proves it meets those criteria, based on the provided document.

Acceptance Criteria and Study Proof for Endoform™ Reconstructive Template – PLGA

Since this is a traditional medical device (surgical mesh) and not an AI/ML device, the concept of "acceptance criteria" is related to meeting performance specifications and demonstrating biocompatibility and safety comparable to a predicate device, rather than diagnostic accuracy metrics. The "study" refers to non-clinical testing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of tests conducted and the conclusion that the device meets specifications, rather than providing specific numerical acceptance criteria and results in a table format common for AI/ML.

For this device, the "acceptance criteria" are implied by the performance characteristics demonstrated to be "substantially equivalent" to the predicate device and meeting recognized standards.

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OviTex PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

OviTex PRS Long-Term Resorbable (OviTex PRS LTR) is a sterile reinforced tissue matrix composed of biological tissue (ovine extracellular matrix) and Poly(lactic co-glycolic acid). The device contains bidirectional fenestrations to allow for multidirectional stetch. The polymer imparts additional structure to the ECM and maintains device integrity through the initial phases of healing. OviTex PRS is provided in various shapes and sizes to suit surgeon preference and nature of the soft tissue repair in plastic and reconstructive surgery. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

This document is a 510(k) Premarket Notification from the FDA regarding the OviTex PRS (Long-Term Resorbable) surgical mesh. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the way typically seen for AI/ML devices.

However, I can extract information related to acceptance criteria and testing for this non-AI medical device based on the provided text, and structure it in a way that aligns with your request for an AI device, noting where information is not applicable.

Acceptance Criteria and Device Performance for OviTex PRS (Long-Term Resorbable)

The provided document describes a 510(k) submission for a non-AI surgical mesh, OviTex PRS (Long-Term Resorbable). The "acceptance criteria" and "device performance" in this context refer to non-clinical testing to ensure the safety and effectiveness of a modified version of an already cleared device, and not to the performance of an AI algorithm. Therefore, many of the requested fields for AI performance studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated for each test. For the "additional device offerings" (25cm diameter circle and 25x30cm oval), tests for endotoxin and ethylene oxide residuals were conducted. The number of units tested is not provided.
• Data Provenance: Not specified, but generally, such non-clinical tests are performed in a laboratory setting by the manufacturer or contracted labs. The data is prospective, generated specifically for this submission.

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

• Not applicable. This is a non-AI medical device; "ground truth" established by human experts is not relevant to the non-clinical tests described (shelf life, endotoxin, etc.). These tests rely on laboratory equipment and standardized methodologies to determine objective measurements against predefined limits.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations involving human interpretation. The tests described are objective, quantitative laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This document pertains to a medical device (surgical mesh), not an AI algorithm, and 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 medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests (shelf life, endotoxin, ethylene oxide residuals, packaging integrity), the "ground truth" is derived from objective, quantitative measurements against established scientific and regulatory standards (e.g., ISO 10993-7:2008 for biocompatibility tests, internal specifications for shelf life). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or prognostic device.

8. The Sample Size for the Training Set

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

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

• Not applicable. This is a medical device, not an AI algorithm.

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The CanGaroo® RM Antibacterial Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the Caroo RM Antibacterial Envelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo RM Antibacterial Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, and other neurostimulator devices.

The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope. Overall clinical benefit has not yet been evaluated.

The CanGaroo® RM Antibacterial Envelope consists of decellularized, non-crosslinked, Iyophilized extracellular matrix (ECM) and resorbable ring-shaped poly(lactide-co-qlycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for exudate. The drug-eluting polymer discs are secured between the multilaminate sheets on each side of the envelope.

The CanGaroo RM Antibacterial Envelope is intended to securely hold an implantable electronic device (IED) to create a stable environment when implanted in the body, while reducing bacterial colonization with rifampin and minocycline eluted from resorbable polymer discs in the envelope. The CanGaroo RM Antibacterial Envelope is based on the existing CanGaroo Envelope (K201313), with the addition of drug-eluting disc components with the antibiotics rifampin and minocvoline.

The CanGaroo RM Antibacterial Envelope is provided sterile in two sizes and is intended for single use in a single patient only.

The provided text is a 510(k) summary for the CanGaroo RM Antibacterial Envelope. This document describes the device, its intended use, and substantial equivalence to a predicate device, supported by performance data. However, it does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance in the typical sense of AI model testing (like accuracy, F1-score, etc.).

Instead, this document focuses on demonstrating that the device is safe and effective and performs at least as well as a predicate device through various types of non-clinical testing. The "acceptance criteria" here would be the successful completion of these tests, meeting certain pre-defined thresholds for physical, functional, antibacterial, and biocompatibility properties.

Therefore, I cannot directly provide the information in the format requested for AI/software-based device performance. The document describes a medical device (surgical mesh envelope), not an AI/software device that would typically have specific accuracy or similar metrics.

However, I can interpret the available information to address some of your points in the context of this physical medical device:

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

Based on the document, the "acceptance criteria" are implied by the successful completion of various tests. The "reported device performance" are the qualitative results of these tests.

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

• Sample Sizes: The document does not specify exact sample sizes for each test (e.g., number of animals in in-vivo studies, number of envelopes for bench testing). It uses general terms like "a panel" for organisms.
• Data Provenance: The document does not state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of pre-clinical testing for medical device clearance, these would inherently be prospective studies conducted according to specific protocols.

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

This question is not applicable. The "ground truth" for this device's performance is established through objective laboratory and animal testing following standardized protocols (e.g., ISO, AATCC methods), not through expert consensus on medical images or clinical outcomes.

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

Not applicable. This concept applies to human interpretation of data, typically in clinical trials or image labeling, not to the objective results of bench and animal testing.

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

Not applicable. This is not an AI-assisted device for diagnostic interpretation; it is a physical implantable medical device.

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

Not applicable. This is not an AI algorithm. Its performance is inherent to the physical and chemical properties of the device itself.

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

The "ground truth" for this device's performance is based on:

• Standardized laboratory tests: (e.g., AATCC 100 for antibacterial activity, physical and functional bench tests).
• Biocompatibility standards: (ISO 10993 series).
• In-vivo animal model results: (bacterial clearance, pharmacokinetics).
  These are objective, empirical measures, not subjective expert consensus or clinical outcomes data in humans for this pre-market submission.

8. The sample size for the training set

Not applicable. This refers to an AI/machine learning model. This is a physical medical device; 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 a physical medical device.

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OviTex PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

OviTex PRS is a sterile reinforced tissue matrix composed of biological tissue (ovine extracellular matrix) and Polyglycolic Acid (PGA) or Polypropylene (PP), known as OviTex PRS (STR) (or OviTex PRS Short Term Resorbable) and OviTex PRS PP (or OviTex PRS Permanent), respectively. The device contains unidirectional fenestrations to allow for stretching in a uniaxial direction. The polymer imparts additional structure to the ECM and maintains device integrity through the initial phases of healing. OviTex PRS is provided in various shapes and sizes to suit surgeon preference and nature of the soft tissue repair in plastic and reconstructive surgery. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

The provided text is a 510(k) summary for the OviTex PRS surgical mesh. It describes the device, its intended use, and compares it to a legally marketed predicate device (Endoform Restella).

However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The OviTex PRS is a surgical mesh, a physical medical device, not an AI/ML software device. Therefore, the requested information regarding AI/ML device performance metrics, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details are not applicable to this submission.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section discusses non-clinical testing related to the physical properties of the mesh (tensile strength, compliance, suture retention) and shelf-life, which are relevant for a physical surgical mesh. This section confirms that the two-layer OviTex PRS (STR) devices meet specifications and that the shelf life extension for OviTex PRS Permanent was validated.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and AI/ML study results because the provided text pertains to a physical medical device (surgical mesh), not an AI/ML device.

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PERI-GUARD is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias).

SUPPLE PERI-GUARD is intended for use as a prosthesis for soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral. incisional, inguinal, lumbar, scrotal, and umbilical hernias).

PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25℃ (68-77°F).

PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.

PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.

The provided document is a 510(k) summary for medical devices, specifically Peri-Guard and Supple Peri-Guard surgical meshes. This type of document is used to demonstrate substantial equivalence to a predicate device, not to present a study proving a device meets specific acceptance criteria for AI/ML performance.

Therefore, the information required to answer your prompt regarding acceptance criteria and performance studies (e.g., sample sizes, expert involvement, adjudication methods, MRMC studies, ground truth establishment, training set details) is not present in the provided text. The document focuses on demonstrating the safety and effectiveness of a material and physical design change (sterilization method and packaging) for a surgical mesh, not on evaluating the performance of an AI-driven medical device.

To directly address your request for a table of acceptance criteria and study details, based solely on the provided text, I must state that this information is not available.

The document details non-clinical bench testing and animal studies to support the substantial equivalence claim for the modified surgical mesh. These studies are focused on material properties, biocompatibility, and physical performance of the mesh, and not on the performance of an AI model.

Here's how I would summarize the relevant information from the document, while acknowledging the absence of AI/ML-specific details you requested:

Acceptance Criteria and Device Performance (as described for the surgical mesh, not an AI device):

The document does not present a table of quantitative acceptance criteria for the mesh's performance in the way one would for an AI model (e.g., sensitivity, specificity, AUC thresholds). Instead, it discusses the equivalence of the modified device to its predicate through various non-clinical and animal studies. The overall "acceptance criterion" implicit in a 510(k) is the demonstration of substantial equivalence to a predicate device, meaning the new device is as safe and effective as the legally marketed predicate.

Reported Device Performance (for the surgical mesh):

The document states that the results of performance testing demonstrate that the modified PERI-GUARD and SUPPLE PERI-GUARD devices are substantially equivalent to the predicate devices.

Specific performance aspects evaluated include:

• Bench Testing: Visual, Suture retention, Dimensional, Burst strength, Collagenase digestion, Denaturation Temperature, Water Permeability, Pliability, Chemical and heavy metal residuals, Bioburden, Pyrogenicity/Endotoxins, Temperature Excursion Testing.
  • Conclusion: The results of these tests support substantial equivalence.
• Animal Studies:
  • Implantation (Porcine incisional hernia repair model for 6 months per ISO 10993-6): "No test material-related changes among clinical observations, bodyweights, veterinary physicals, clinical pathology parameters, mortality, significant macroscopic or microscopic differences, tensile or burst strength, or clinical performance between the subject and predicate devices..."
    • Conclusion: "The subject and predicate devices performed equivalently and had an equivalent safety profile in the in vivo porcine model for incisional hernia repair."
  • 3-week Rat Calcification Potential Study: "No significant mineralization was noted microscopically for either the subject or predicate device."
    • Conclusion: "No significant difference in calcification potential."
• Biocompatibility: Demonstrated biocompatibility in accordance with ISO 10993-1:2018 for a permanent implant, including cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, genotoxicity, implantation, hemolysis, and subchronic toxicity endpoints.
• Shelf Life: 1-year shelf life claim supported by aging testing.
• Sterilization and Packaging: Validation per ISO 11137 parts 1 and 2 (sterilization) and ISO 11607-1 (packaging integrity, supported by ASTM F88-15 and ASTM F2096-11).
• Human Factors Testing: Confirmed that redesigned packaging allows for aseptic transfer without compromising sterility and does not impact the tissue patch surface.

Detailed breakdown of AI/ML specific information (Not Found in these documents):

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable. Studies conducted were animal (porcine and rat) and bench tests.
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 the mesh's performance attributes (e.g., tensile strength, burst strength, calcification) is established through standardized laboratory and animal model measurements, not expert consensus interpreting images/data.
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.
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 (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance relies on direct physical measurements (e.g., tensile strength, burst strength), chemical analysis (e.g., residuals), and histopathological evaluation in animal models. It's not a diagnostic AI that generates predictions requiring expert-adjudicated ground truth labels.
8. The sample size for the training set: Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary is for a traditional medical device (surgical mesh) and lacks any information pertaining to AI/ML device performance, acceptance criteria, or study methodologies.

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OviTex PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one time use.

OviTex PRS (Long-Term Resorbable) is a surqical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices sewn together with resorbable Poly(lactic-co-glycolic Acid) ("PLGA") suture for use in plastic and reconstructive surgery. The 2-8 ply devices are available in surface areas up to 434 cm² in various shapes.

This document is a 510(k) Premarket Notification from the FDA for the OviTex PRS (Long-Term Resorbable) surgical mesh. While it discusses the device's characteristics and its comparison to a predicate device, it does not contain information about the acceptance criteria and study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

The document indicates that substantial equivalence was not based on an assessment of clinical performance data. Instead, it relies on preclinical, mechanical, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested points cannot be answered 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

The document states: "New bench testing included mechanical strength, suture retention, endotoxin, and compliance testing. Results of the testing confirms that the proposed device meets all product specifications." However, it does not provide the specific acceptance criteria (e.g., tensile strength > X N, suture retention > Y N) or the quantitative reported device performance for these tests.

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

• Bench Testing (Mechanical, Suture Retention, Endotoxin, Compliance): The sample sizes for these tests are not provided. Data provenance is not specified beyond "Preclinical testing."
• Biocompatibility Assessment: Not specified.
• Implantation Study: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of studies described (mechanical, biocompatibility, implantation) for a surgical mesh. These studies do not typically involve experts establishing ground truth in the way an AI/ML diagnostic device would for image interpretation.

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

Not applicable for the types of studies 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

No, an MRMC study was not done. This device is a surgical mesh, not an AI/ML 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 or software device.

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

• Bench Testing: Engineering specifications and standardized test methods.
• Biocompatibility: ISO 10993 standards and toxicological risk assessment.
• Implantation Study: Histopathological evaluation of tissue response compared to the predicate, as per ISO 10993-6. This could be considered a form of "pathology" ground truth. The study concluded that the subject device was "classified as a non-irritant" and had "advanced to complete resorption by 78 weeks."

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary Table (Limited Information Available from Document):

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VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.

VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet rendering the Sheet a gelatinous, tissue adherent layer. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the VersaWrap device, which certifies its substantial equivalence to a predicate device.

The document discusses the device description, indications for use, and confirms that non-clinical tests were performed. However, it does not detail specific acceptance criteria (e.g., performance metrics, thresholds) or the study design, sample sizes, ground truth establishment, or expert involvement that would typically be associated with proving these criteria were met for a new AI/medical device.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies because this information is not present in the provided text.

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PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.

PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age, originating from the United States.

There are two types of PSDV-SG configurations based on the tissue buttress thickness range. The Standard configuration has a tissue buttress thickness range of 0.20-0.60mm. The Thin configuration has a tissue buttress thickness range of 0.20-0.40mm.

The product consists of a loading unit which includes two (2) buttresses, one for the anvil and one for the cartridge side of the stapler. The buttresses are held in a foam/sheath configuration for loading of the buttress to the stapler jaws. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch.

PSDV-SG utilizes animal tissue; patient must be informed prior to any procedure.

PSDV-SG is provided sterile and intended for single use. Sterilization is accomplished via ethylene oxide (ETO). The bovine pericardium buttress and acrylic adhesive are considered permanent implants per ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

This document describes the PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) device, which is a surgical mesh intended for staple line reinforcement. It is a Special 510(k) submission, meaning the changes are relatively minor compared to a predicate device.

Based on the provided text, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner with numerical targets for clinical performance metrics (e.g., specific reduction in anastomotic leaks, burst pressure thresholds). Instead, it focuses on demonstrating substantial equivalence to a predicate device by showing that the technological characteristics and performance (functional, manipulation, dimensional, usability, and shelf-life) are similar.

The "performance" described is largely comparative to the predicate device and verification/validation results. The core of the performance claim is that the device maintains the same intended use, indications for use, materials, and principles of operation as the predicate, despite changes in size and design for stapler compatibility.

Note: The document states "Verification and validation of the product have been completed using the same test methods as the predicate device, or accepted industry standard methods. No new issues of safety and effectiveness have been identified." This implies that the results from these tests met the internal acceptance criteria established by the manufacturer, which were aligned with the predicate or industry standards. However, the specific numerical acceptance criteria (e.g., minimum burst pressure, maximum staple pull-through force) are not provided in this summary.

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

The document states "Testing performed to support the new product models subject of this submission included manipulation, functional, and dimensional testing, as well as usability and shelf-life." It does not provide details on the sample sizes used for these tests.

Regarding data provenance:

• Country of Origin: Not specified for the testing data.
• Retrospective or Prospective: Not specified. These appear to be benchtop and perhaps simulated use tests, not clinical studies involving patients.

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

N/A. This submission focuses on engineering and bench testing performance for substantial equivalence, not clinical diagnostic accuracy or efficacy. There is no mention of "ground truth" derived from expert review in the clinical sense.

4. Adjudication Method for the Test Set

N/A. As there's no mention of expert review or clinical studies for ground truth establishment, no adjudication method is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of a human reader or AI comparative effectiveness study. This device is a surgical mesh, not a diagnostic imaging or AI-assisted interpretation device.

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

N/A. This device is a physical surgical mesh, not a software algorithm.

7. The Type of Ground Truth Used

For the engineering and functional tests conducted, the "ground truth" would be established by:

• Measurement Standards: Adherence to predefined dimensional and physical property specifications.
• Performance Specifications: Meeting functional requirements (e.g., tear strength, adhesion, burst pressure if these were tested) derived from predicate device performance or industry standards.
• Visual Inspection: For manipulation and usability tests, often a qualitative or semi-quantitative assessment against predefined criteria.

No pathology or outcomes data is mentioned as "ground truth" in this context of bench testing for substantial equivalence for the device itself.

8. The Sample Size for the Training Set

N/A. This device is not an AI/ML algorithm that requires a training set.

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

N/A. Not an AI/ML device.

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The Nexo-Gide™ Bilayer Collagen Membrane is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The Geistlich Nexo-Gide™ device, manufactured by Geistlich Pharma AG, is a resorbable collagen membrane of porcine origin, consisting of a compact smooth structure and of a porous structure that serves as an interface between the tendon and the surrounding tissues. Nexo-Gide™ Bilayer Collagen Membrane will be used as a tendon protector sheet that provides a nonconstricting, protective encasement for injured tendon, in the same manner as other tendon cover products like the predicate device TenoGlide (K053655, Integra Life Science).

The Nexo-Gide membrane is made of collagen type I and III without further cross-linking or chemical additives and is sterilized by gamma irradiation. The available sizes are 20x30mm, 30x40mm and 40x50 mm.

The provided text describes a medical device called Nexo-Gide™ Bilayer Collagen Membrane and its substantial equivalence determination to a predicate device, Tendon Wrap Tendon Protector (TenoGlide). However, the document does not describe a study involving an AI or algorithmic device that requires the detailed acceptance criteria and study information typically associated with such submissions (e.g., sample size, expert ground truth, MRMC study, training set details).

This document is a 510(k) summary for a physical medical device (a collagen membrane), not an AI/algorithm-based diagnostic or assistive device. Therefore, the questions related to AI/algorithm performance metrics, ground truth establishment by experts, MRMC studies, training set sizes, and data provenance in the context of an algorithm are not applicable to this submission.

The "Performance Data" section (Page 8-9) details bench testing and animal studies conducted to demonstrate that the Nexo-Gide membrane is substantially equivalent to its predicate.

Here's an attempt to extract relevant information from the provided text, while acknowledging that many of your questions are not applicable due to the nature of the device:

Device: Nexo-Gide™ Bilayer Collagen Membrane (a physical collagen membrane)

Purpose of Study/Submission: To demonstrate substantial equivalence to a predicate device (Tendon Wrap Tendon Protector) for the management and protection of tendon injuries.

Key Findings: The studies concluded that Nexo-Gide™ is substantially equivalent to the predicate device in terms of safety and effectiveness, despite differences in tissue source (porcine vs. bovine) and composition (Type I and III collagen vs. cross-linked Type I collagen and GAG).

1. Table of Acceptance Criteria and Reported Device Performance

The document describes pre-determined acceptance criteria for various bench tests and animal study outcomes, indicating that the device "passed" or "met all acceptance criteria" and demonstrated "similar performance." Specific numeric acceptance criteria are provided for mechanical properties.

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VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.

VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. Versa Wrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet after the Sheet is positioned. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.

This document is a 510(k) summary for the VersaWrap device, which is a resubmission (K203600) based on a previously cleared device (K200311). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given document.

Here's what can be extracted and inferred based on the nature of a 510(k) submission for a device that is "identical to the predicate device" with "differences in the indication for use" that "do not affect the safety and effectiveness":

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" for performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this 510(k) submission. This is because it's a re-submission of an "identical" device. The acceptance criteria for this submission would have been demonstrating:

• Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
• Safety and Effectiveness for Modified Indications: That the modified indications for use still fall within the demonstrated safety and effectiveness profile of the original device and its predicate.

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

• Sample Size (Test Set): Not applicable for this 510(k) submission, as it relies on previous testing of the identical predicate device. No new test set data is presented.
• Data Provenance: No new data provenance information is provided as the submission relies on "prior non-clinical testing and animal model studies" for the predicate device. The document does not specify the country of origin or whether these prior studies were retrospective or prospective.

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

• Not applicable, as no new test set requiring new ground truth establishment is detailed in this 510(k) summary. The summary refers to existing non-clinical and animal model studies, but does not provide details on how ground truth was established within those studies.

4. Adjudication method for the test set:

• Not applicable, as no new test set or clinical study requiring adjudication is detailed in this 510(k) summary.

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. The VersaWrap device is a surgical mesh/implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

• No. This device is a physical surgical implant, not an algorithm or software. Standalone algorithm performance is not applicable.

7. The type of ground truth used:

• For the original predicate device (K200311), the ground truth for safety and effectiveness would have been established through a combination of:
  • Non-clinical testing: (e.g., mechanical properties, biocompatibility, degradation profiles).
  • Animal model studies: (e.g., observation of healing, adhesion formation, tissue response in vivo).
  • Literature review and comparison to existing similar devices.
• This 510(k) summary (K203600) states that "The prior non-clinical testing and animal model studies were used to support the modified indications." This implies the same types of ground truth from the predicate were leveraged.

8. The sample size for the training set:

• Not applicable. This device is not an AI model, so there is no concept of a "training set" in the context of machine learning.

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.

In summary: This 510(k) submission (K203600) is for a physical surgical implant (VersaWrap) that is identical to an already cleared predicate device (K200311), with minor modifications to the Indications for Use that do not impact its fundamental safety or effectiveness. Therefore, the submission primarily focuses on demonstrating this equivalence and does not present new clinical study data, detailed acceptance criteria, or performance metrics in the way an innovative diagnostic or AI device might. The "study" proving the device meets the (implicit) acceptance criteria is the demonstration of substantial equivalence through comparison to the predicate and leveraging its existing non-clinical and animal model data.

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