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The Scout Vessel Guard System is indicated as a cover for vessels during anterior vertebral surgery.

The Synthes Scout Tack Fixation is a method of fixation of the Scout Vessel Guard to bone. The single-use Scout Tack implant is made of a titanium alloy (TAN, per ASTM F1295-05, "Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)," January 1, 2005). It has a low profile head. The tack is inserted by light impaction through the Scout Vessel Guard into lumbar vertebral bone. The Scout Tack implant can be used as an alternative to, or a complement to, suturing the Scout Vessel Guard in place.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for each test (pullout, dynamic mechanical, dynamic biomechanical, and usability). However, it implies that the tests involved sufficient samples to draw conclusions about equivalence or superiority.

The data provenance is not explicitly stated as "country of origin," but the testing was conducted by Synthes, an American company. The tests are described as "non-clinical," and the phrase "cadaver lab testing" suggests a controlled, pre-clinical environment. The study is retrospective in the sense that it evaluates the device's performance against established predicate devices and methods.

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

The document does not mention the number of experts used or their specific qualifications for establishing ground truth in the non-clinical tests. For usability testing in cadaver labs, it is implied that surgeons or trained professionals evaluated the device, but their number and specific qualifications (e.g., years of experience, specialty) are not provided.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method. The evaluation of test results (e.g., pullout strength measurements, mechanical properties) would typically involve engineering analysis and comparison against pre-defined thresholds or predicate device performance. For usability, it's likely a qualitative assessment by the testing personnel.

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

No, an MRMC comparative effectiveness study was not done. The tests described are non-clinical, mechanical, and biomechanical evaluations, along with cadaver lab usability, not studies involving multiple human readers interpreting cases.

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

Not applicable. This device is a physical medical device (tack fixation) and not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests was based on direct measurements of mechanical properties (e.g., pullout strength, dynamic response) and observations of usability in a cadaver model, compared against the performance of established predicate devices and traditional fixation methods (suturing). There is no "pathology" or "outcomes data" ground truth as this is a pre-clinical evaluation.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning algorithm, 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 for this type of device.

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The MiMedx HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.
Fusion surgery, Adjacent level surgery, Artificial Disc Implantation, Implant or Hardware Removal, Trauma, Vascular Surgery in the Spine.

The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is slippery, clear, pliable, conformable, nanoporous permanent vessel cover that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.

The provided text does not describe acceptance criteria for a device, nor does it detail a study proving the device meets acceptance criteria.

This document is a 510(k) summary for the HydroFix™ Vaso Shield, which is a regulatory submission to the FDA (Food and Drug Administration) for market clearance based on substantial equivalence to existing devices. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies in the context of AI/software devices.

Here's why the prompt's requested information is not present and what this document does describe:

• Acceptance Criteria & Device Performance (Table): This document does not establish performance criteria for an AI/software device. Instead, it compares the HydroFix™ Vaso Shield to predicate devices based on "technological characteristics and performance criterion" evaluated through in vitro testing. There's no table presenting acceptance criteria for an AI solution nor reported device performance in terms of metrics like accuracy, sensitivity, or specificity.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts relevant to studies evaluating AI/software devices, often involving medical imaging, diagnosis, or risk prediction. This 510(k) pertains to a physical medical device (a vessel cover), not an AI algorithm. Therefore, such information is entirely absent.
• "Study that proves the device meets the acceptance criteria": The "study" mentioned here is in vitro testing (Simulated Use and Environmental conditioning testing) to demonstrate substantial equivalence to predicate devices, not a clinical or performance study of an AI system.

Information that is present in the document:

• Proprietary Name: HydroFix™ Vaso Shield
• Common Name: Vessel Guard or Cover
• Indications for Use: As a cover for vessels during anterior vertebral surgery.
• Device Description: Flexible sheet of polyvinyl alcohol (PVA) material, slippery, clear, pliable, conformable, nanoporous, permanent vessel cover that minimizes tissue contact between vessels and the spine. Provided sterile and hydrated.
• Substantially Equivalent Devices (Predicates): K090022 Paradis Vaso Shield™, K100905 HydroFix™ Vaso Shield, K101826 HydroFix™ Vaso Shield, K101805 HydroFix™ Vaso Shield.
• Performance Evaluation (used for substantial equivalence):
  • In Vitro Testing: Simulated Use and Environmental conditioning testing for 49℃ to 54℃ high temperature exposure limit.
• Limitations/Warnings included in the FDA Letter:
  • "The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established."
  • The indication for use "as a cover for vessels during anterior vertebral surgery" must be prominently displayed in all labeling.

In conclusion, this document describes a physical medical device and its clearance process through the FDA's 510(k) pathway, which is based on demonstrating substantial equivalence to existing devices, rather than a performance study of an AI system against specific acceptance criteria.

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The HydroFix Vaso Shield™ is indicated for use as a cover for vessels following anterior vertebral surgery.

The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is a slippery, clear pliable, conformable, nanoporous provided in valled over that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.

Acceptance Criteria and Study for HydroFix™ Vaso Shield (K101805)

The provided document describes the 510(k) premarket notification for the HydroFix™ Vaso Shield. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a new study with predefined acceptance criteria. Instead, the "acceptance criteria" are implied by the demonstration of comparable performance to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions a "Large Animal Implantation A sheep model (animal study)." It does not specify the exact number of sheep used in the study.
• Data Provenance: The study was an in vivo animal study conducted on sheep. The country of origin for the data is not specified. It is a prospective study as an experiment was conducted to generate the data for the 510(k) submission.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the animal study. Veterinary surgeons or researchers would likely have been involved in the implantation and assessment of the devices in the sheep model.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the animal study data. The results would likely have been analyzed and interpreted by the research team involved.

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

No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of images or other data, which is not applicable to this physical implantable device.

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

No. This is not
applicable. The HydroFix™ Vaso Shield is a physical implantable device, not an algorithm or software. Its performance is assessed through its physical interaction with tissues in vivo.

7. Type of Ground Truth Used

The ground truth for the in vivo testing was established through direct observation and assessment of the implanted devices in the animal model. This would likely involve:

• Direct observation/histology: Assessing the physical separation of soft tissue, the presence or absence of vessel damage, and tissue responses at the implant site.
• Pathology: Likely the most definitive ground truth, involving histological examination of tissues around the implant to confirm device presence, tissue separation, and absence of adverse reactions or damage.

8. Sample Size for the Training Set

No training set is mentioned or applicable. This device's performance was evaluated through an in vivo study, not through a machine learning or algorithm-based approach that requires training data.

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

Not applicable, as no training set was used.

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The Scout Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.

The Scout Vessel Guard is a permanent, non-absorbable membrane made of hydrogel. It is packaged wet in phosphate buffered saline (PBS). This device is designed to be placed between the anterior spine and proximate vessels during anterior lumbar surgery, and is flexible, allowing it to contour to the anatomy. The Scout Vessel Guard can be affixed to bone and/or soft tissue.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synthes Scout Vessel Guard:

Acceptance Criteria and Device Performance for Synthes Scout Vessel Guard

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the sample sizes used for each test. The studies mentioned are non-clinical (benchtop/materials testing) and a cadaver lab for usability. Therefore, the data provenance is from laboratory tests and cadaveric studies, not human patient data, and thus, country of origin is not applicable in the typical sense. The studies appear to be prospective in their execution, as they were conducted to verify the device's performance.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document. For the non-clinical and cadaveric studies, "ground truth" would likely be established by engineering standards and anatomical observations rather than expert consensus on patient data.

4. Adjudication Method for the Test Set:

This information is not provided in the document. As the studies were non-clinical and cadaveric, an adjudication method in the traditional sense for human patient data (e.g., 2+1 radiologist review) would not be applicable.

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

No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical data was not needed for this device." This indicates that studies involving human readers and clinical cases were not part of the submission to demonstrate effectiveness or comparing human performance with and without AI assistance.

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

Based on the provided information, the device is a physical medical device (a vessel guard made of hydrogel). Therefore, the concept of an "algorithm only" or "standalone" performance for AI does not apply. The device itself is the primary component, and its performance is evaluated through material and mechanical testing, and usability in a cadaveric setting.

7. Type of Ground Truth Used:

The ground truth used for this device's acceptance was based on:

• Engineering specifications and standards: For suture retention, tensile strength, pore size, and material stability.
• Biocompatibility standards (ISO 10993): For biological safety.
• Anatomical and surgical observations: For usability in a cadaver lab, ensuring the device could be placed and contoured as intended.

8. Sample Size for the Training Set:

This information is not applicable. The Synthes Scout Vessel Guard is a physical medical device, not an AI or software device that undergoes training with a dataset.

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

This information is not applicable, as the device is not an AI or software device that requires a training set.

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XYLOS™ Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.

XYLOS™ Vessel Guard is a flexible, non-resorbable, implantable sheet composed of microbialderived cellulose. The device is presented ready-to-use in a sterile double-pouched package. It is intended for one time use.

The provided K100984 510(k) summary for the XYLOS™ Vessel Guard focuses on demonstrating substantial equivalence to predicate devices through material similarity and biomechanical testing, rather than clinical performance based on a study with acceptance criteria often associated with AI/software devices. Therefore, a direct response to some of the specific questions is not possible from the provided text, as they pertain to aspects that are not relevant to this type of medical device submission.

However, I can extract the relevant information and indicate where details regarding AI-specific criteria are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable/not provided in the context of this 510(k) submission. The device is a physical implantable sheet, and its substantial equivalence was demonstrated through benchtop biomechanical testing and material comparison, not through a clinical study with a "test set" of patient data or clinical outcomes.

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

This information is not applicable/not provided. Ground truth, in the context of AI or diagnostic studies, refers to a definitive diagnosis or outcome, usually established by experts. For this device, "ground truth" would relate to the established material properties and biomechanical performance standards of the predicate devices. These are typically assessed by engineers and materials scientists in laboratory settings.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert opinions when establishing ground truth in clinical or image-based studies. Since this submission relies on benchtop testing and material comparisons, such adjudication is not relevant.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpreting data or images. The XYLOS™ Vessel Guard is an implantable surgical aid, and its effectiveness is demonstrated through its physical properties and biological compatibility, not through an assessment of human reader performance.

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

No, a standalone performance study was not done. This concept applies to AI algorithms that operate independently. The XYLOS™ Vessel Guard is a passive physical device.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Established Material Composition: The chemical and biological identity to the predicate MTA™ Protective Sheet.
• Established Biomechanical Performance Standards: The tensile strength and suture pull-out performance as demonstrated by the predicate devices (Replication Medical Vessel Guard, PRECLUDE® IMA Sleeve, PRECLUDE® Vessel Guard).

Essentially, the ground truth for this submission is the well-characterized properties and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The concept of a "training set" applies to machine learning or AI models, where data is used to teach the algorithm. This device is a physical product, not an algorithm.

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

This information is not applicable/not provided for the same reasons as #8.

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The MiMedx Group, Inc. HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.

The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.

The provided text describes a 510(k) summary for the MiMedx HydroFix™ Vaso Shield, focusing on demonstrating its substantial equivalence to predicate devices rather than establishing novel acceptance criteria for device performance as an AI device. Therefore, a direct table of "acceptance criteria" and "reported device performance" in the context of an AI device's metrics (like sensitivity, specificity, etc.) is not applicable here.

However, I can extract the performance criteria that were evaluated to show substantial equivalence and explain the study conducted.

Here's a breakdown of the requested information based on the provided text, interpreted for a medical device (not an AI device):

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

The document does not specify quantitative "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes comparative performance against predicate devices to demonstrate "comparable" or "equivalent" performance.

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

• Sample size for in vitro testing: Not specified.
• Sample size for in vivo testing: Not specified, only mentions "a porcine model," implying one or more animals were used.
• Data provenance: The in vivo study was conducted in a "porcine model," indicating animal data. The location or specific details of where the in vitro testing occurred are not provided. Both types of studies appear to be prospective, as they were conducted to demonstrate substantial equivalence for this specific 510(k) application.

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

This information is not applicable and not provided in the document. The studies conducted (in vitro and in vivo animal studies) do not involve human expert interpretation for "ground truth" in the way an AI device study would. The performance was likely assessed by researchers and possibly veterinary professionals in the case of the porcine model.

4. Adjudication method for the test set

Not applicable and not provided. This concept is typically relevant for human-interpreted diagnostic findings, not for the physical performance testing of a medical device described here.

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

Not applicable. This is a medical device, not an AI device. No MRMC study involving human readers or AI assistance 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 physical medical device, not an algorithm or AI.

7. The type of ground truth used

For the in vitro and in vivo studies, the "ground truth" would be objective measurements and observations of the device's physical and functional characteristics (e.g., how well it holds a suture, its light reflectivity) under controlled experimental conditions. It is not based on expert consensus, pathology, or outcomes data in the typical sense of diagnostic ground truth.

8. The sample size for the training set

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

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

Not applicable. As above, this is a physical medical device, not an AI model.

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The SpineMedica Paradis Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.

The SpineMedica Paradis Vaso Shield™ is a flexible sheet of 30 Wt.1% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.

The provided 510(k) summary for the SpineMedica Paradís Vaso Shield™ indicates that performance standards were met and testing was performed to demonstrate substantial equivalence to predicate devices. However, the document does not describe specific acceptance criteria or a detailed study that proves the device meets those criteria with quantitative results.

Instead, the submission relies on the concept of "substantial equivalence" to previously cleared devices. This means the device is considered safe and effective because it has the same indications for use, design, function, and/or materials as legally marketed predicate devices. The 510(k) summary explicitly states: "Testing performed indicates the SpineMedica Paradis Vaso Shield™ is substantially equivalent to predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer questions about sample sizes, expert ground truth establishment, or specific study methodologies (like MRMC or standalone performance) because these details are not present in the provided document.

The 510(k) process for this device did not involve presenting new clinical or performance data against specific acceptance criteria in the same way a de novo or PMA submission might. The FDA's letter (K093551) confirms substantial equivalence and primarily focuses on labeling requirements and limitations regarding claims not established (e.g., reducing adhesion formation).

Summary of what can be inferred from the document:

The 510(k) submission for the "SpineMedica Paradís Vaso Shield™" demonstrates substantial equivalence to predicate devices rather than presenting a study with explicit acceptance criteria and corresponding performance data. The document does not contain the detailed information necessary to answer the questions posed regarding specific acceptance criteria, study methodology, sample sizes, expert qualifications, or ground truth establishment.

The FDA's review concluded that the device is substantially equivalent based on its stated indications for use, design, function, and materials being similar to pre-existing, legally marketed devices. The FDA's letter primarily focused on clarifying labeling requirements and limitations, especially concerning unproven claims.

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The SpineMedica Paradís Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.

The SpineMedica Paradís Vaso Shield™ is a flexible sheet of 30 Wt.% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.

Here's an analysis of the provided text regarding the SpineMedica Paradís Vaso Shield™:

Acceptance Criteria and Study for SpineMedica Paradís Vaso Shield™

This 510(k) summary for the SpineMedica Paradís Vaso Shield™ largely focuses on establishing substantial equivalence to predicate devices rather than proving specific numerical performance metrics through a clinical study with predefined acceptance criteria. The "studies" mentioned are primarily non-clinical evaluations to demonstrate safety and effectiveness in line with its function as a vessel cover.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify sample sizes for any of the non-clinical tests. Since these were laboratory and engineering tests, the concept of "data provenance" (country of origin, retrospective/prospective) in the clinical sense doesn't directly apply here. The tests were likely conducted in a controlled laboratory environment.

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

This information is not provided in the document. For non-clinical tests like dimensional analysis or biocompatibility, "ground truth" is typically established by validated testing methods and adherence to recognized standards, rather than expert consensus in the way it's used for diagnostic imaging studies.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., medical images) by multiple experts. The tests performed for this device were primarily objective engineering or biological assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of AI vs. Without AI Assistance

No. This device is a physical medical device (vessel shield), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

No. As noted above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Engineering Specifications: For dimensional analysis, package integrity, suture pull out strength, shelf-life, distribution simulation, environmental conditioning, and sterilization validation, the ground truth was established by predetermined engineering specifications, national/international standards, and regulatory requirements (e.g., ISO standards for biocompatibility/sterilization).
• Biological Response: For biocompatibility and pyrogenicity, ground truth was established by observing the biological response of cells/animals to the material in accordance with established biological safety testing protocols (e.g., ISO 10993 series).
• User Feedback (simulated clinical environment): For the simulated clinical environment, ground truth was likely based on user (surgeon) feedback and assessments that the device's design met their needs, though the specifics of this evaluation are not detailed.

8. The Sample Size for the Training Set

This information is not applicable and not provided. As a physical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would be informed by material science, engineering principles, and clinical need.

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

This information is not applicable and not provided. There is no "training set" for this type of device.

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The EnGuard™ Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.

The Replication Medical Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery. The Vessel Guard is available in several sizes and is manufactured from biocompatible materials.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:

Overview:

This 510(k) submission for the Replication Medical Vessel Guard is primarily based on substantial equivalence to legally marketed predicate devices, rather than a novel clinical effectiveness study with specific performance metrics. Therefore, explicit "acceptance criteria" in the sense of predefined numerical thresholds for a new study's performance are not presented. Instead, the substantial equivalence argument itself serves as the "proof" that the device meets the necessary safety and effectiveness standards, as demonstrated by the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission (substantial equivalence), the "acceptance criteria" are predominantly related to demonstrating similar technological characteristics, biocompatibility, and mechanical integrity to the predicate devices. Explicit numerical performance metrics for a novel clinical study are not specified.

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

• Sample Size for Test Set: Not applicable in the context of a new clinical test set. The submission relies on preclinical testing (biocompatibility, suture pullout) and the established safety and effectiveness of predicate devices. There is no mention of a human test set in this summary for the purpose of demonstrating device performance against specific clinical efficacy criteria.
• Data Provenance: The preclinical data (biocompatibility, suture pullout) would have been generated internally by Replication Medical, Inc. The basis for substantial equivalence is "legally marketed predicate devices" which would be subject to FDA regulations in the United States.

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

Not applicable. This submission does not describe a clinical study where human experts would establish a "ground truth" for a test set. The "ground truth" for the device's acceptable performance is established through equivalence to the predicate devices and standard preclinical testing.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set described that would require an adjudication method.

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

No. There is no mention of an MRMC study or any clinical comparative effectiveness study in this 510(k) summary. This type of study is more common for diagnostic imaging devices or devices where human interpretation plays a key role in effectiveness.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. This device is a physical implant (vessel cover), not an algorithm or software. Therefore, an "algorithm only" or "standalone" performance study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (W.L. Gore & Associates, Inc.'s PRECLUDE Vessel Guard and PRECLUDE IMA Sleeve).
• Biocompatibility Standards: Adherence to established standards for biocompatibility testing for long-term implants.
• Mechanical Performance Standards: Equivalence to predicate devices in mechanical tests like suture pullout, implying an acceptable level of mechanical integrity.

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set for an AI/ML algorithm.

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