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NEOVEIL® Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. NEOVEIL® Staple Line Reinforcement of staple lines during lung resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

NEOVEIL® Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid (PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6.

This document is a 510(k) summary for a medical device called NEOVEIL® Staple Line Reinforcement. It outlines a Special 510(k) submission, meaning the device is largely similar to a previously cleared predicate device with minor modifications. As such, the submission focuses on demonstrating substantial equivalence through non-clinical performance testing rather than new extensive clinical studies.

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

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

The document does not explicitly provide a table of acceptance criteria with numerical targets. Instead, it states that "The performance testing validated that NEOVEIL® Staple Line Reinforcement meets its product specification and performs as intended. Results confirm that the specification requirements for the subject device have been met."

The performance tests conducted include:

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

The document does not specify the sample size used for each of the internal tests. The testing was described as "simulated usability testing on final finished versions of NEOVEIL®™ using a relevant mechanical stapler." The data provenance is "internal GUNZE test methods," implying the testing was conducted by Gunze Limited. The country of origin for the data is not explicitly stated, but Gunze Limited is based in Japan. The testing described is prospective, as it was conducted to validate the modified device.

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 section is not applicable as the evaluation involved non-clinical performance testing of a physical device, not an AI or diagnostic tool where expert ground truth would be established.

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

This section is not applicable as the evaluation involved non-clinical performance testing of a physical device.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a physical medical device (staple line reinforcement), not an AI diagnostic tool. The "usability" mentioned refers to the device's interaction with a stapler, not human interpretation.

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

A standalone performance study was not applicable. This device is a physical product, not an algorithm.

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

The "ground truth" for the non-clinical performance testing was the product specifications and intended performance as defined by Gunze's internal test methods. The tests verified if the device functioned correctly (e.g., stapler insertion, firing, and staple formation) under simulated conditions.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reason as above.

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PELNAC® Meshed Bilayer Wound Matrix is indicated for the management of wounds including:

• · partial and full-thickness wounds,
• · pressure ulcers,
• · venous ulcers,
• · diabetic ulcers,
• · chronic vascular ulcers,
• · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
• · trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears), and
• · draining wounds.

The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.

PELNAC® Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine derived sponge layer and a silicone film layer. Slits are added to the silicone and collagen layers to aid in the drainage of exudate. When applied to full-thickness skin defects, PELNAC® provides a scaffold for cellular invasion and capillary growth. The device is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.

The provided document is a 510(k) Premarket Notification for the PELNAC® Meshed Bilayer Wound Matrix. It demonstrates substantial equivalence to a predicate device, INTEGRA™ Meshed Bilayer Wound Matrix (K081635), and a reference device, PELNAC™ Bilayer Wound Matrix (K191992).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

The document does not explicitly present a "table of acceptance criteria" with "reported device performance" in the format typically seen with quantitative thresholds for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it relies on comparative testing to the predicate device and established standards for safety and performance for medical devices.

The acceptance criteria are implicitly met by demonstrating conformance to recognized standards and by showing similar performance characteristics to the predicate and reference devices in non-clinical tests.

However, based on the Non-Clinical Performance Data section, we can infer the following performance characteristics and the fact that they were met:

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

The document primarily discusses non-clinical performance testing. For these tests, specific sample sizes are not explicitly stated. For example, how many samples of the device were tested for "tensile strength" or "pore size" is not provided. The data provenance is also not specified in terms of country of origin or whether it's retrospective or prospective for these non-clinical tests. However, the tests are laboratory-based, performed according to recognized standards (e.g., ISO, ASTM, USP, FDA guidance).

The document states: "Except for new viral inactivation studies performed on the subject device, all other animal tissue testing was leveraged from the reference device (K191992)." and "All biocompatibility testing of the subject device was leveraged from the reference device (K191992)." and "All sterilization, packaging and shelf life testing of the subject device was leveraged from the reference device (K191992)." This implies that many of the non-clinical tests were not repeated for the subject device but relied on data from the previously cleared reference device.

For the NPWT compatibility testing, it mentions "Side-by-side testing was conducted between the subject device in conjunction with NPWT, the predicate device in conjunction with NPWT, and NPWT without a wound matrix group." This implies a comparative test setup, but the number of test units or replicates used in this "simulated wound model" is not specified.

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

Not applicable. The reported studies are non-clinical performance tests evaluating physical, chemical, and biological properties, as well as compatibility with another medical device (NPWT). These types of studies do not typically involve human expert adjudication to establish ground truth in the way clinical studies for diagnostic devices do. Conformance to specifications and standards is assessed by laboratory testing and technical evaluation.

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

Not applicable. As this is non-clinical performance and safety testing, there is no "adjudication" of results in the context of clinical expert agreement for a ground truth. Test results are compared against defined specifications and regulatory standards.

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. The device is a "wound matrix," not an AI-powered diagnostic tool, and the studies described are non-clinical. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is not an algorithm or software requiring standalone performance evaluation.

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

For the non-clinical performance tests, the "ground truth" is defined by:

• Established industry standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 for sterilization, ASTM F1886 for packaging integrity).
• FDA guidance documents (e.g., regarding animal derived materials, viral safety).
• Product specifications for features like pore size, cross-linking, tensile strength, etc.
• Performance metrics of predicate/reference devices for comparative testing, particularly for NPWT compatibility.

There is no clinical "ground truth" derived from patient outcomes, pathology, or expert consensus required for this type of 510(k) submission focused on non-clinical substantial equivalence.

8. The sample size for the training set

Not applicable. This is a medical device for wound management, not a machine learning model. Therefore, there is no "training set" in the context of artificial intelligence/machine learning.

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

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

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PELNAC® Wound Matrix is indicated for the management of wounds including:

• · partial and full-thickness wounds,
• · pressure ulcers,
• · venous ulcers,
• · diabetic ulcers,
• · chronic vascular ulcers,
• · tunneled/undermined wounds,
• · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound deliscence),
• · trauma wounds (abrasions, lacerations, partial thickness burns and skin tears), and
• · draining wounds.

The device is intended for one-time use.

PELNAC® Wound Matrix is a single layer wound matrix of 100% atelocollagen sponge derived from porcine Achiles tendon that is applied directly to the wound surface. When applied to full-thickness skin defects, PELNAC® Wound Matrix provides a scaffold for cellular invasion and capillary growth. The device is offered in sheet form of various sizes and in two levels of thickness and is provided terminally sterilized by ethylene oxide. PELNAC® Wound Matrix is for single patient use and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.

The provided document is a 510(k) Premarket Notification for the PELNAC® Wound Matrix. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

Based on the content, the document does not provide the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the document details a comparative analysis for substantial equivalence, focusing on:

• Indications for Use: Demonstrating the PELNAC® Wound Matrix has the same indications as the predicate device (AVAGEN Wound Dressing).
• Technological Characteristics: Comparing material composition, construction, mode of action, and other attributes to the predicate and reference devices.
• Non-Clinical Performance Data: Listing the types of non-clinical tests performed (e.g., biocompatibility, sterilization, physical/chemical properties) and stating that results confirmed product specifications were met, leveraging data from a previously cleared device (K191992).

Therefore, I cannot populate the requested table or answer most of the specific questions as the information is not present in the provided text.

Here's why and what can be inferred:

• Acceptance Criteria & Reported Performance: Not explicitly stated as pass/fail criteria for a specific clinical or non-clinical performance study. The document states that "Results confirm that the product specifications for the subject device have been met" for the non-clinical tests, but the specifications themselves or the detailed results are not provided.
• Study Design: No clinical study proving device performance against acceptance criteria is described. The document explicitly states: "Clinical Performance Data: Not applicable to this submission."
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all concepts relevant to a clinical or AI-based performance study, none of which were conducted or are described for this 510(k) submission. The non-clinical tests mentioned (biocompatibility, sterilization, etc.) would have their own sample sizes and testing protocols, but these are not detailed in the summary.

In summary, the provided text describes a 510(k) submission focused on demonstrating substantial equivalence through a comparison of technological characteristics and leveraging existing non-clinical performance data, rather than a de novo study against explicit acceptance criteria.

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PELNAC™ Bilayer Wound Matrix is indicated for the management of wounds including:

• · partial and full-thickness wounds,
• · pressure ulcers,
• · venous ulcers,
• · diabetic ulcers,
• · chronic vascular ulcers,
• · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
• · trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and
• · draining wounds.
  The device is intended for one-time use.

PELNAC™ Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer and is offered in two versions: 1. Meshed Type (i.e., fenestrated) and 2. Non-Meshed Type (i.e., non-fenestrated). The collagen sponge layer should be applied to the wound surface. Both versions of the device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, PELNAC™ Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. PELNAC™ Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.

This document is a 510(k) premarket notification for the PELNAC™ Bilayer Wound Matrix. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that an AI/software device meets specific performance acceptance criteria for diagnostic tasks.

Therefore, most of the requested information regarding acceptance criteria for AI/software, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. This submission is for a material device (wound matrix) and the "study" mentioned is a human repeat insult patch test (HRIPT) and a clinical follow-up for a tissue-based medical device.

However, I can extract information related to the device's safety and performance testing as presented in the document, which serves a similar role to "acceptance criteria" for a physical medical device.

Acceptance Criteria and Study for PELNAC™ Bilayer Wound Matrix

The "acceptance criteria" for this device are established through demonstrating its substantial equivalence to a legally marketed predicate device (AVAGEN Wound Dressing) and conformity to recognized standards and guidance. The "study" refers to non-clinical and clinical testing performed to support this claim.

1. Table of "Acceptance Criteria" and Reported Device Performance

Since this is a physical medical device and not an AI/software, the "acceptance criteria" are not reported as diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are related to biocompatibility, sterility, physical/chemical properties, and clinical safety/tolerance. The "reported device performance" indicates whether the device met these established safety and performance benchmarks.

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

• Non-Clinical (In vitro/Bench/Animal Studies): The document states "final finished samples of PELNAC™ Bilayer Wound Matrix" were tested, but specific sample sizes for these tests (biocompatibility, physical/chemical, sterility, packaging) are not provided.
• Clinical Data:
  • Human Repeat Insult Patch Test (HRIPT): 56 subjects.
  • Finger Degloving Injuries Pilot Study: 18 subjects.
• Data Provenance: Not explicitly stated for all non-clinical tests. For the clinical studies:
  • The HRIPT and the finger degloving study were likely conducted by or sponsored by the manufacturer (Gunze Limited), which is based in Japan. The document does not specify the country of origin for the clinical data points, nor whether they were retrospective or prospective studies, though the nature of HRIPT and follow-up studies typically implies a prospective design.

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

• This device is a material device, not an AI/software. There is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The "ground truth" for the clinical study would be observed physiological responses to the device (irritation, sensitization, healing, lack of adverse immune response), assessed by qualified medical professionals involved in the study (e.g., dermatologists for HRIPT, surgeons for the finger injury study). The number and qualifications of these medical professionals are not specified in the provided text.

4. Adjudication Method for the Test Set:

• Not applicable for this type of medical device submission. Adjudication methods are typically relevant for human reader studies or expert consensus for ground truth establishment in AI/software evaluations. Clinical observations for this device would be direct assessments by the treating/evaluating clinicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging AI, not for a wound matrix medical device. The "clinical studies" described (HRIPT, finger degloving) are safety and performance studies for a material device, not diagnostic effectiveness studies comparing human readers with and without AI assistance.

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

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

7. The Type of Ground Truth Used:

• For Biocompatibility and Physical/Chemical Testing: The "ground truth" is adherence to established international standards (e.g., ISO 10993 series) and internal specifications, derived from scientific understanding of material safety and performance.
• For Clinical Studies (HRIPT, Finger Degloving): The "ground truth" is direct clinical observation and objective measurement of patient responses (e.g., absence of skin irritation/sensitization, absence of specific immune responses, healing progression, histological analysis reports). This is based on outcomes data and clinical assessment by medical professionals.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of algorithm development.

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

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

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NEOVEIL™ is indicated for use in surgical procedures in which soft tissue transection or resection with suture or staple line reinforcement is needed. NEOVEIL™ can be used for reinforcement of suture or staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

As packaged, NEOVEIL™ is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL TM are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL™ staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL™ is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m²).

The provided text describes a 510(k) submission for a medical device called NEOVEIL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against acceptance thresholds. Therefore, the concept of "acceptance criteria" as typically applied to performance claims (e.g., specific sensitivity/specificity targets for an AI algorithm) is not present. Instead, the "acceptance criteria" are implied by the comparison of technological characteristics and performance testing against a predicate device.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" in the context of substantial equivalence:

Table of Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a bench and in vivo animal testing to demonstrate substantial equivalence, not a study involving human subjects or AI performance. Therefore, many of your requested points related to AI algorithms, human readers, and ground truth in a clinical context are not applicable.

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

   • Test set size: Not explicitly stated in terms of number of samples for each test, but general in-vitro and in-vivo testing was performed.
   • Data provenance: Not explicitly stated, but it would be from internal lab testing (in vitro) and animal studies (in vivo). No information about country of origin of data is provided beyond the submitting company being from Japan. The studies are prospective in nature (designed to demonstrate equivalence).

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

   • Not applicable as this is a device based on material property testing and animal studies, not expert-adjudicated clinical data to establish diagnostic ground truth. The "ground truth" here is the performance of the predicate device and established engineering/biological benchmarks.

3. Adjudication method for the test set:

   • Not applicable for this type of device submission. Performance is measured against physical and biological parameters, not through expert adjudication of qualitative outcomes.

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

   • No. This is not an AI device.

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

   • No. This is not an AI device.

6. The type of ground truth used:

   • For in vitro tests: Physical and mechanical property measurements (e.g., tensile strength, thickness, density, stiffness) are compared against the known properties of the predicate device and/or defined engineering standards.
   • For in vivo tests: Biological responses and functional performance in animal models (e.g., free bleed, air leak, burst, resorption rates) are compared against observations with the predicate device or accepted physiological norms for successful surgical repair.

7. The sample size for the training set:

   • Not applicable. There is no AI model to train.

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

   • Not applicable. There is no AI model to train.

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