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HEMOPORE® is intended for use in patients undergoing nasal/simus surgery as a temporary wound dressing.

HEMOPORE® functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation.

It acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema.

HEMOPORE® is a sterile fragmentable nasal dressing of 8 cm composed of poly(DL-lactide-cos-caprolactone) urethane and blended with a chitosan derivate and a violet color additive.

After insertion of HEMOPORE®in the nasal cavity, fluids will be absorbed by the dressing, which helps to control bleeding after surgery.

The dressing fragments within several days by hydrolyzing ester bonds, whereafter it is drained from the nasal cavity via the natural mucus flow.

The HEMOPORE® is sterilized in a blister package. The device is single-use, cannot be resterilized, and is a prescription product.

This document is a 510(k) Pre-market Notification for the HEMOPORE® device. The provided text describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results with reported device performance metrics against those criteria, or information regarding sample sizes, data provenance, expert involvement, or MRMC studies that would be typically found in a clinical study report or a more comprehensive technical document.

Therefore, many of the requested items cannot be extracted from this document.

Here's what can be extracted based on the provided text, and where information is missing:

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

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

• Sample size for test set: Not provided. The document mentions "in vitro testing" and "biocompatibility testing" but does not specify the number of samples used for these tests.
• Data provenance: Not provided. The type of study (e.g., retrospective or prospective) is not mentioned beyond "in vitro 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/Not provided. The testing described (biocompatibility, degradation, shelf-life, absorption, thrombogenicity) appears to be laboratory-based physical and chemical performance testing, not human-read clinical data that would require expert ground truth establishment.

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

• Not applicable/Not provided, for the same reasons as item 3.

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

• No. This is not an AI/imaging device. No MRMC study was conducted or mentioned.

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

• Not applicable. This is a medical device (intranasal splint/dressing), not an algorithm.

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

• For the performance testing mentioned (biocompatibility, degradation, shelf-life, absorption, thrombogenicity), the "ground truth" would be established by standardized laboratory methods, physical/chemical measurements, and potentially comparison to predicate devices' known performance characteristics. There is no mention of clinical ground truth such as pathology or outcomes data in this summary.

8. The sample size for the training set

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

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

• Not applicable. (See item 8).

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NASOPORE ® FD is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption.

NASOPORE "FD is composed of a bioresorbable poly(DL-lactide-co-s-caprolactone) urethane that fragments within several days after insertion in the nasal cavity, whereafter it is drained from the nasal cavity via the natural mucus flow.
The NASOPORE® FD size and type are indicated on the label and are packed in a blister. NASOPORE "FD is indicated for single-use.
The modification in this submission concerns a line extension to the predicate device NASOPORE "with a NASOPORE" FD that fragments faster than the cleared predicate device.

The document provided describes the NASOPORE FD nasal dressing, a line extension of the NASOPORE nasal dressing. The purpose of this submission is to demonstrate substantial equivalence to the predicate device (K052099; NASOPORE nasal dressing). The performance data presented focuses on in vitro testing to show that the technological characteristics and performance criteria of the new NASOPORE FD are comparable to the currently cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines "Performance Data" from in vitro testing to demonstrate comparability. While not explicitly termed "acceptance criteria," these are the parameters used to establish substantial equivalence.

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The Neurolac® nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide- co-e-caprolactone) tube to provide a protective environment for peripheral nerve reqeneration after injury and to create a conduit to quide axonal growth across a nerve gap. Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes. The modification in this submission concerns a line extension to the predicate devices with a thinner wall thickness.

The provided document describes a 510(k) submission for a line extension to the Neurolac® Nerve guide, with the modification being a thinner wall thickness. The study is an in vitro comparison of the new thinner-walled device to the predicate device (K032115).

Here's a breakdown of the acceptance criteria and study as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each property. Instead, it demonstrates comparability to the predicate device. The implicit acceptance criterion is that the thinner-walled Neurolac nerve guides perform equivalently to the current cleared Neurolac nerve guides.

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

The document does not specify the sample size for the in vitro tests.
The data provenance is presented as in vitro testing, not explicitly stating country of origin, though the submitter is based in The Netherlands. It is a retrospective comparison as it compares to an already cleared predicate device.

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

Not applicable. This is an in vitro test for material properties and device performance, not a study requiring expert clinical assessment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is an in vitro test for material properties and device performance.

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/imaging device.

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

Not applicable. This is not an algorithm/software device. The performance data presented are for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" here is the established performance characteristics of the predicate device (Neurolac nerve guides K032115), against which the new thinner-walled device is compared. This is based on previously established performance data for the predicate and fundamental material science.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in this type of in vitro device comparison study. The study focuses on demonstrating comparability to a predicate device.

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

Not applicable, as there is no training set mentioned or implied. The "ground truth" for comparison is the documented performance of the predicate device, which would have been established through its own preclinical studies and regulatory clearance process.

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Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.

Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-s-caprolactone) urethane that fragments within several days after insertion in the outer and / or middle ear, whereafter it will fall out of the ear or leaves the body by the natural mucus flow. The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.

The provided text describes a 510(k) premarket notification for the Nasopore® Ear device and focuses on its substantial equivalence to predicate devices rather than a detailed clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not explicitly present in the provided document.

However, based on the spirit of the request and what is available, here's a structured interpretation:

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

The document does not explicitly define quantitative "acceptance criteria" in the way one might expect for a diagnostic AI device (e.g., target sensitivity/specificity). Instead, the "performance" verification focuses on design characteristics demonstrating safety and equivalence.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as no "test set" in the sense of patient data for evaluating diagnostic performance (like an AI model) was used. The evaluation was based on design verification tests (in-vitro) and comparison to a predicate device.
• Data Provenance: The data primarily relates to in-vitro testing and manufacturing process descriptions. There is no mention of country of origin for patient data or whether it was retrospective or prospective, as no clinical study focused on patient outcomes was presented for this device. The biocompatibility claim relies on prior approval of the predicate device (Nasopore® Nasal Dressing).

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" establishment by medical experts for a diagnostic performance test set is described.

4. Adjudication method for the test set

Not applicable. No diagnostic test set or adjudication process 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 device is a medical implant (ear packing) and not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical implant and not an algorithm or AI.

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

The "ground truth" in this context is the established safety and efficacy of the predicate devices. For biocompatibility, the ground truth is the previous determination of "satisfactory biocompatible" for the poly(DL-lactide-co-s-caprolactone) urethane material used in the Nasopore® Nasal Dressing. For functional aspects, the ground truth is the known performance and indications for use of the predicate devices (Nasopore® Nasal Dressing and Invotec Ear Tampon).

8. The sample size for the training set

Not applicable. No training set for an AI/algorithm is mentioned.

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

Not applicable.

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Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing outer ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.

Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-sscription caprolactone) urethane that fragments within several days after insertion in the outer ear, whereafter it is drained from the cavity. The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.

The provided text describes the 510(k) summary for the Nasopore® Ear device, focusing on its substantial equivalence to predicate devices rather than a standalone performance study with specific acceptance criteria and detailed device performance metrics.

Therefore, many of the requested details about acceptance criteria, a specific study proving it, sample sizes, expert involvement, and ground truth establishment are not available in the provided document. The submission relies on demonstrating substantial equivalence based on the device's material composition and intended use being similar to existing cleared devices, rather than an independent performance study with defined acceptance criteria.

Here's a breakdown of what can be gleaned from the text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not set numerical acceptance criteria for the Nasopore® Ear device's performance in a clinical study. Instead, it relies on demonstrating substantial equivalence to predicate devices (Invotec Ear Tampon (Wick) w/String and Nasopore® Nasal Dressing). The "performance data" mentioned refers to design verification tests (in vitro degradation and shelf life), which are engineering tests, not clinical performance metrics against specific acceptance criteria.

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

• Sample Size: Not applicable/Not mentioned. The document does not describe a clinical test set with human or animal subjects for performance evaluation against specific criteria.
• Data Provenance: Not applicable/Not mentioned for a clinical test set. The "performance data" mentioned (in vitro degradation, shelf life testing) would typically be conducted in a lab setting.

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

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

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

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

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

• MRMC Study: No. This is not an AI-assisted device. The Nasopore® Ear is a physical medical device.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: Not applicable for a typical clinical performance study. The "ground truth" for the claims in this submission is the established safety and effectiveness of the predicate devices and the physical/chemical properties verified by design tests.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not mentioned. This is not an AI device that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

In summary, the 510(k) submission for Nasopore® Ear relies on a demonstration of "substantial equivalence" to legally marketed predicate devices, rather than a de novo clinical performance study with explicit acceptance criteria. The performance data mentioned (in vitro degradation, shelf life) are design verification tests, not clinical performance metrics. The underlying rationale is that if the new device is made of the same material, uses the same manufacturing process, and is intended for a similar use as a previously cleared device, then its safety and effectiveness are considered substantially equivalent.

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Nasopore is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption.

Nasopore is composed of a fragmentable poly(DL-lactide-co-e-caprolactone) urethane that fragments within several days after insertion in the nasal cavity, whereafter it is drained from the nasal cavity via the natural mucus flow. The Nasopore size and type are indicated on the label and are packed in a Tyvek pouch. Nasopore is indicated for single-use.

The provided 510(k) submission for POLYGANICS' KOS2099 Nasopore® nasal dressing is a submission for a Class I device and relies primarily on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not typically required or present for a Class I device 510(k) relying on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for specific tests. The submission mentions "design verification tests and analyses" and "biocompatibility, mechanical and physical property testing and in vitro fragmentation testing." These are typically conducted on a limited number of device samples in a lab setting, not a clinical "test set" in the context of human subjects.
• Data Provenance: The device's performance data is derived from in-vitro testing and pre-clinical analyses (e.g., biocompatibility) conducted by the manufacturer, Polyganics BV, likely in The Netherlands (their submitted address). It is retrospective in the sense that it's laboratory testing and comparisons, not a prospective clinical trial on human subjects for this 510(k) submission.

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

This information is not applicable and not provided in this type of 510(k) submission. For a Class I device demonstrating substantial equivalence, especially one relying on pre-clinical data and comparison to predicates, external experts determining ground truth for a clinical test set are not typically involved or required. The "ground truth" for the device's technical specifications and performance characteristics would be established by Polyganics' internal R&D and QA teams based on established test methods and standards (e.g., ISO 10993).

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies where multiple readers interpret clinical data (e.g., medical images) and their disagreements need resolution to establish a consensus ground truth. This 510(k) relies on lab-based testing and performance verification, not clinical interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of results and is not relevant for this device (a nasal dressing). The submission's focus is on the device's physical and biological properties and its equivalence to existing products.

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

This concept is not applicable to this device. "Standalone" performance is usually refers to the accuracy of an AI algorithm in performing a task without human intervention. The Nasopore® nasal dressing is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's safety and effectiveness is established through:

• Pre-clinical verification testing: This includes in-vitro fragmentation testing, shelf-life testing, biocompatibility testing (ISO 10993 standards), and mechanical/physical property testing. The results of these tests and their adherence to accepted scientific methods and standards form the basis of the "ground truth" for the device's functional characteristics.
• Comparison to predicate devices: The "ground truth" for its clinical utility (e.g., separating adhesions, controlling bleeding) is established through its substantial equivalence to legally marketed predicate devices with proven clinical histories.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The concept of a "training set" (used for machine learning algorithms) does not apply to this physical medical device. The device was designed and developed based on scientific and engineering principles, not trained on a dataset.

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

This information is not applicable and not provided for the same reasons as point 8.

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The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Neurolac® (4-10 mm) is designed to be a flexible and transparent resorbable poly(DL-lactide-co-s-caprolactone) tube to provide a protective environment for peripheral nerve regeneration, for nerves with an internal diameter ≤ 9.5 mm, after injury and to create a conduit to guide axonal growth across a nerve gap. Neurolac® (4-10mm) nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes (4, 5, 6, 7, 8, 10 mm).

The provided text describes a 510(k) premarket notification for the Neurolac® (4-10 mm) nerve guide. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, specific performance studies with sample sizes, expert involvement, and ground truth establishment are not typically part of a 510(k) submission and are not present in the provided documents.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document because this is a 510(k) submission demonstrating substantial equivalence to predicate devices, rather than a de novo submission or PMA requiring explicit performance acceptance criteria and reporting. The "Performance Data" section in {1} outlines what kind of tests were performed (in vitro, in vivo), but doesn't list specific quantitative acceptance criteria or results in a table format.

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

Again, this level of detail for specific test sets with sample sizes and data provenance (country, retrospective/prospective) is not explicitly provided in the context of the 510(k) submission. The document mentions "design verification tests and analyses" and "in vivo nerve function recovery," but doesn't detail the sample sizes or provenance for these tests. The primary "study" is the comparison to predicate devices and reliance on pre-existing data (K032115).

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

This information is not provided. The 510(k) process for this device relies on demonstrating equivalence rather than establishing new clinical ground truth through expert consensus.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided. MRMC studies are typically for evaluating diagnostic imaging devices or other technologies where human readers interpret results, which is not directly applicable to a nerve guide.

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

This information is not applicable/not provided. The Neurolac® nerve guide is a medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the Neurolac® (4-10 mm) nerve guide's safety and effectiveness relies on:

• Substantial Equivalence to Predicate Devices: The primary "ground truth" is that the Neurolac® (4-10 mm) nerve guide is substantially equivalent in design, fundamental technology, and intended use to previously cleared devices:
  • Salumedica™ nerve cuff, Salumedica, K002098
  • Neurogen™ nerve guide, Integra life science, K011168
  • Neurolac® nerve guide, Polyganics BV, K032115 (the 1-3 mm version)
• Pre-clinical data: "Biocompatibility, mechanical and chemical and physical property testing, in vitro degradation testing and performance testing, clinical testing and testing in an animal model provide scientific evidence that Neurolac (1-3 mm) nerve quide (510(k) 032115) is safe for implantation." {1}
• Literature and Comparison: "Evaluation of the Polyganics Neurolac (4-10 mm) nerve guide based on results from literature and the comparison of the Neurolac (4-10 mm) nerve guide with its predicate devices, shows that the material of which the Neurolac (4-10mm) nerve guide is made, is safe for implantation." {1}

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" is typically associated with machine learning algorithms, which is not applicable here. The safety and effectiveness are established through reference to predicate devices and pre-clinical data, not an AI training process.

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

As explained above, this concept of "training set" and associated ground truth establishment is not applicable to this device.

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The VivoSorb Sheet is indicated for the use as a temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

The VivoSorb Sheet is designed to be a flexible and transparent resorbable Device poly (DL-lactide-co-s-caprolactone) sheet to provide support to soft tissue Description where weakness exists. The VivoSorb Sheet is provided sterile in Tyvek pouch packages in a variety of sizes.

This document is a 510(k) summary for the VivoSorb Sheet, a medical device. It does not describe an AI/ML powered device, therefore the standard acceptance criteria for such a device are not applicable.

Here's an analysis of the provided information, focusing on the device's performance claims and the study used to support them, based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in a quantitative manner as would be expected for an AI system, nor does it present specific numerical performance targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

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

• Sample Size for Test Set: The document does not specify the sample sizes used for the "design verification tests" or "animal tests." It only lists the types of tests performed (e.g., in vitro suture retention, degradation, aging, mechanical, biocompatibility, animal tests).
• Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "design verification tests and analyses" and "animal tests."

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

This information is not applicable to this document as it describes a physical medical device and its performance, not an AI/ML system that requires ground truth established by experts. The "ground truth" here would be the physical properties and biological responses observed in the tests.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. No expert adjudication method is described or required for the device's physical and biological testing.

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

This information is not applicable. The device is a physical surgical mesh, not an AI system intended to assist human readers. Therefore, an MRMC study is not relevant.

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

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

7. The Type of Ground Truth Used

For this physical device, the "ground truth" was established through:

• Objective Measurement/Pathology: This would include direct measurements from the "in vitro suture retention testing," "in vitro degradation testing," "aging testing," and "mechanical testing." For "biocompatibility testing" and "animal tests," "pathology" (histological analysis, observation of biological responses) would be used to assess safety and interaction with biological tissues.
• Literature and Predicate Device Comparison: The determination of "substantial equivalence" also relies on the established performance and safety profiles of the predicate devices and existing scientific literature.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

This information is not applicable. As it's not an AI/ML model, there is no "training set" and associated ground truth in that context. The "ground truth" for the device's development would be based on engineering principles, material science, and biological understanding, informed by pre-clinical testing mentioned in point 7.

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The Neurolac® nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide-co-ε-caprolactone) tube to provide a protective environment for peripheral nerve regeneration after injury and to create a conduit to guide axonal growth across a nerve gap.
Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes.

The Neurolac® Nerve Guide is a medical device designed to assist in the regeneration of peripheral nerves after injury. The device manufacturer, Polyganics BV, submitted a 510(k) premarket notification to the FDA to demonstrate its substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not specify quantified acceptance criteria (e.g., specific thresholds for suture retention strength or nerve function recovery). Instead, the performance data focused on demonstrating safety and effectiveness through various tests and analyses, indicating that the device performs comparably to predicate devices. The implicit acceptance criteria were that the device's performance data, alongside biocompatibility and comparison to predicate devices, would be sufficient to establish substantial equivalence.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not explicitly stated for each test.
  • For the "In vivo nerve function recovery," it states "an animal model" was used, but the number of animals or specific experimental subjects is not provided.
  • For "In vitro suture retention testing" and "In vitro degradation testing," the number of samples or replicates used in these tests is not specified.
• Data Provenance: The studies were conducted by Polyganics BV, a company based in The Netherlands.
  • The in vitro tests (suture retention, degradation) are laboratory-based.
  • The in vivo test was conducted using "an animal model." The specific type of animal, the location of the animal study, or if it was retrospective or prospective is not detailed, but it would have been a prospective study to evaluate the device's performance.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This is a medical device for nerve repair, and the evaluation did not involve human-in-the-loop diagnostic performance or
expert interpretation of images to establish ground truth in the context of AI/diagnostic device studies. Instead, its performance was assessed through physical, chemical, and biological testing.

4. Adjudication Method for Test Set:

Not applicable. As described above, the study does not involve human readers interpreting data that would require adjudication.

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

Not applicable. This device is a passive nerve guide, not an AI or diagnostic tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

6. Standalone (Algorithm Only) Performance:

Not applicable. The Neurolac® Nerve Guide is a physical medical device, not an algorithm. Its performance is inherent to its physical and biological properties.

7. Type of Ground Truth Used:

The "ground truth" for evaluating the Neurolac® Nerve Guide was established through:

• Direct measurement and observation: For in vitro tests like suture retention and degradation, the "ground truth" was empirical data derived from standardized laboratory tests.
• Biological outcomes: For in vivo nerve function recovery, the "ground truth" would be the observed biological response to the device in an animal model, such as nerve regeneration, functional recovery, and histological assessments. These would be determined by objective measurements and scientific observation in a controlled experimental setting.
• Comparison to predicate devices: The "ground truth" for substantial equivalence was the established performance and safety profiles of the legally marketed predicate devices (Neurotube™ and NeuroGen™).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning system, so there is no "training set" in the conventional sense.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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