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The Apyx is intended for attaching sutures to ligaments of the pelvic floor.

The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor / suture assembly is deployed to the target site from the cartridge with an applicator. An optional use retriever may be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx also includes an optional securement element which may be used as a suture retention device to distribute suture tension over a larger tissue area and aid in wound healing.

The Apyx device is a single use device which is supplied sterile.

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format of a clinical or performance study with specific metrics like sensitivity, specificity, or AUC, as these would be associated with diagnostic or AI-powered devices.

However, based on the information provided, here's a breakdown of what can be extracted regarding performance and testing:

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

The document mentions various tests conducted, generally implying that the device met the requirements of these tests to demonstrate safety and effectiveness. Since specific numerical acceptance criteria (e.g., "pull-out strength > X N") and the exact reported performance values are not explicitly stated, I will infer the acceptance as "Met requirements" based on the conclusion of substantial equivalence.

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

• Sample size for test set: The "Cadaver Testing" section does not specify the number of cadavers or the number of anchors tested. It uses general phrasing like "users," "all anchor delivery and retrieval procedures," and "All anchors."
• Data provenance: Not explicitly stated, but cadaver testing implies a controlled laboratory environment. The country of origin of the data is not mentioned. It is prospective testing carried out for regulatory submission.

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

• This information is not provided. The cadaver testing describes the actions of "users" (implying medical professionals) who delivered and retrieved anchors, but doesn't mention independent expert assessment or ground truth establishment in a formalized way for outcomes like accuracy or safety observed during the testing. The "ground truth" here is the observed outcome of the procedure itself (e.g., successful placement, no damage).

4. Adjudication method for the test set

• Not applicable/Not described. The cadaver testing describes qualitative observations of successful delivery, retrieval, and proper fixation. There's no mention of an adjudication process for resolving disagreements between multiple observers, as might be seen in diagnostic studies.

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 device is a surgical instrument (fixation device), not an imaging or AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness are not relevant or discussed.

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

• No. This device is a manual instrument for surgical use, not an algorithm.

7. The type of ground truth used

• For the cadaver testing, the ground truth was the direct observation of the physical outcome and success of the procedure (e.g., "anchors were accurately delivered," "no damage observed," "properly fixed"). This is akin to direct experimental observation and physical verification rather than consensus, pathology, or outcomes data in a clinical trial.

8. The sample size for the training set

• Not applicable. This device is a physical medical instrument, not a machine learning algorithm, so there is no "training set."

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

• Not applicable, as there is no training set for a physical medical instrument.

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The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.

The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament.

The provided text describes the Saffron™ Fixation System, a medical device for attaching sutures to pelvic floor ligaments. The document does not contain information about acceptance criteria for a study or a study proving the device meets these criteria in the context of an AI/ML powered device.

Instead, the document details a 510(k) premarket notification for a traditional medical device, focusing on demonstrating substantial equivalence to a predicate device based on non-clinical performance data (biocompatibility, mechanical/performance testing, sterilization, and packaging).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets these criteria, as the input document does not pertain to an AI/ML powered device or a clinical study with detailed acceptance criteria of that nature.

Here's why the provided text cannot answer your questions and what it does contain:

• No mention of AI or ML: The Saffron™ Fixation System is a mechanical device, not an AI/ML powered device. Therefore, questions about "human readers improve with AI vs without AI assistance" or "standalone (algorithm only without human-in-the-loop performance)" are irrelevant.
• No clinical study for effectiveness: The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This means there's no clinical trial data to establish effectiveness in a human population.
• Focus on Substantial Equivalence via Non-Clinical Data: The FDA clearance for this device is based on demonstrating that it is "substantially equivalent" to an existing legally marketed device (predicate device). This is primarily achieved through showing similar technological characteristics and non-clinical performance data (e.g., strength, material safety, sterility) rather than a clinical effectiveness study against predefined acceptance criteria.
• "Acceptance Criteria" in this context refers to regulatory compliance: The "acceptance criteria" for this device are broadly the standards and test results that show it meets its intended function safely and effectively, and is comparable to the predicate device, as outlined in the various ISO standards and FDA guidances cited. They are not framed as specific performance metrics from a clinical study.
• Ground Truth: For a traditional mechanical device like this, "ground truth" for training or testing isn't applicable in the same way it is for AI. Performance is assessed through engineering tests (e.g., tensile strength, penetration force).

If you were expecting information on an AI/ML powered device, please provide a different document.

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The Apyx is intended for attaching sutures to ligaments of the pelvic floor.

The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor/suture assembly is deployed to the target site from the cartridge with an applicator. An optional retriever can be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx device is a single use device which is supplied sterile.

The provided text describes a 510(k) submission for the Apyx device, which is intended for attaching sutures to ligaments of the pelvic floor. The submission claims substantial equivalence to the predicate device, POP Medical Solutions, NeuGuide (K160569). However, the document does not contain a table of acceptance criteria and reported device performance or information about a specific study proving the device meets acceptance criteria related to efficacy metrics for an AI/ML algorithm.

The information provided is primarily related to the mechanical and biocompatibility testing of the Apyx device as a medical instrument, not an AI/ML system. Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving an AI/ML device meets them, as those details are not present in the provided text.

Based on the available text, I can only extract general performance data categories and a cadaver study description for the mechanical device as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML device. It lists general performance data categories for the Apyx medical device (a mechanical fixation device), along with a summary of cadaver testing.

The subsequent questions (2-9) are specifically tailored to the evaluation of an AI/ML-based medical device. Since the provided document describes a mechanical medical instrument (Apyx) and not an AI/ML product, these questions are not applicable to the information given. The text does not mention any AI/ML components, software algorithms, or their performance evaluation. Therefore, I cannot answer questions 2 through 9 based on the provided input.

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NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.

The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. It is a single use instrument, supplied sterile and pre-loaded. The NeuGuide device comprises three elements, the anchor-suture unit, an applicator, and a thimble with work channel.

The provided text describes the NeuGuide device, specifically its indications for use, comparison to a predicate device, and performance data. However, it does not include detailed "acceptance criteria" for performance metrics like accuracy, sensitivity, or specificity, nor does it provide a "study that proves the device meets the acceptance criteria" in the context of typical AI/software device studies.

Instead, the document focuses on the mechanical, material, and functional characteristics of the NeuGuide device itself, along with general performance tests to confirm its safety and fundamental functionality compared to a predicate device.

Given this, I will extract and infer information from the provided text to best answer your request, focusing on the available performance data described.

Here's the breakdown of the information that can be extracted or reasonably inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are essentially a "pass" or "fail" for various engineering and biocompatibility tests. No specific numerical thresholds are given in the summary, just the conclusion of "Pass according to predefined acceptance criteria."

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

• Sample Size: Not explicitly stated for most tests. For "Anchor pull-out force in porcine ligament in situ," the sample is "porcine ligament in situ," which implies an ex vivo or in vivo animal model, but the number of samples is not given.
• Data Provenance: The tests are largely laboratory-based performance tests for a medical device (NeuGuide) developed by Pop Medical Solutions Ltd. in Israel. The document does not specify country of origin for test data beyond the company's location. The testing appears to be prospective with respect to the device's design confirmation.

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

This information is not applicable to the studies described. The "ground truth" here is determined by engineering standards (e.g., ASTM, ISO, USP) and the physical properties of the device materials and mechanics, not by expert interpretation of medical images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective measurements and compliance with established standards, not expert adjudication of subjective assessments.

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 manual surgical instrument, not an AI or imaging diagnostic device that would involve human readers.

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

Not applicable. This device is a manual instrument, not an algorithm or AI system. Its performance is always human-in-the-loop (the surgeon). The studies focus on the intrinsic properties and functionality of the device itself.

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

The ground truth for the various tests described is based on established engineering standards, material science specifications, and validated laboratory methodologies. For example:

• Biocompatibility: ISO 10993 standards.
• Corrosion: ASTM F2129, ASTM F1089.
• Suture testing: USP 37-NF32 standards.
• MRI Compatibility: Standards for MR Conditional labeling.
• Sterilization: ETO validation to SAL 10-6.

For functional tests like "Anchor pull-out force," the "ground truth" would be the measured physical force required for pull-out, compared against a predefined engineering specification.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."

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

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

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The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.

The EndoFast Reliant™ LAP is indicated for fixation of surgical prosthetic material to tissues for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.

The EndoFast Reliant™ SCP (Sacrocolpopexy) is a sterile, single use system which consists of the following parts:

• 3 metal Fixation Devices; each preloaded with a spider fastener composed of . metal and includes the MRI Safety Information that is stated in the labeling.
• . Plastic Handle; connects to the Fixation Device.
• . Surgical mesh composed of monofilament polypropylene material; cut in a rectangular shape of 8x20cm.

The device is introduced through a 5mm trocar in a laparoscopic approach. The mesh is attached to the vaginal vault and the vagina is pulled towards the posterior pelvic bony part. The other end of the mesh is attached to the promontorium, using two fixation points, to restore the normal anatomical position of the uterus and cervix.

The EndoFast Reliant™ LAP (Laparoscopic) is a sterile, single use system which consists of the following parts:

• 3 metal Fixation Devices, each preloaded with a spider fastener composed of . metal and include the MRI Safety Information that is stated in the labeling.
• Plastic Handle; connects to the Fixation Device. .

The fasteners are introduced through a 5mm trocar in laparoscopic procedures.

This document primarily details the substantial equivalence of the "EndoFast Reliant™ SCP" and "EndoFast Reliant™ LAP" devices to predicate devices. It describes various performance and non-clinical tests conducted, but it does not provide specific acceptance criteria or detailed study results in a format that would allow for the direct extraction of "reported device performance" to compare against acceptance criteria for an AI/software device.

The document focuses on the physical and functional characteristics of a surgical mesh fixation system, not on an AI or software device. Therefore, many of the requested categories for AI/software studies are not applicable or cannot be extracted from this text.

However, I can extract the information related to the performance testing that was conducted for this medical device, which is a physical surgical tool.

Acceptance Criteria and Study for EndoFast Reliant™ SCP and LAP (Surgical Devices)

This submission describes the performance testing of the EndoFast Reliant™ SCP and EndoFast Reliant™ LAP, which are physical surgical devices for mesh fixation. The document emphasizes substantial equivalence to predicate devices based on a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted but does not explicitly state quantitative acceptance criteria or detailed numerical performance results in a table format for direct comparison. Instead, it broadly states that tests were performed to "demonstrate appropriate functionality," "validate endurance," "verify deployment reliability and pullout force," and "assure adequate performances." The overall conclusion is substantial equivalence, implying that the device met internal criteria derived from the predicate.

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

The document mentions "two cadaver studies were performed" but does not specify the sample size (number of cadavers or fasteners tested) for these studies or any other non-clinical tests.

The data provenance is from non-clinical tests and cadaver studies, implying laboratory and controlled anatomical specimen testing rather than human clinical data. The studies were conducted by the applicant, Israel Biomedical Innovations Ltd.

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

This information is not applicable or not provided as the tests are non-clinical, mechanical, and sterilization validations, not involving human expert assessment for "ground truth" in the context of diagnostic interpretation.

4. Adjudication Method

This information is not applicable or not provided as the tests are non-clinical and do not involve human diagnostic interpretation.

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

This is not applicable as the device is a physical surgical tool, not an AI or imaging diagnostic aid for human readers.

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

This is not applicable as the device is a physical surgical tool, not an AI algorithm.

7. Type of Ground Truth Used

For the non-clinical tests:

• Engineering specifications and standards: For functional characteristics, endurance, reliability, pull-out force (e.g., meeting predefined force thresholds, successful deployment rates).
• Biological safety standards: For sterilization (SAL 10⁻⁶) and biocompatibility (ISO 10993-1, G95-1).
• Comparative data: For pull-out tests, implicitly comparing against the performance of predicate devices.
• Anatomical relevance: For cadaver studies, simulating surgical use.

8. Sample Size for the Training Set

This is not applicable as this document describes a physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable as the device is a physical medical device, not an AI or machine learning model.

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Anchorsure is indicated for attaching suture to ligaments of the pelvic floor.

Anchorsure is a suture kit that consists of monofilament polypropylene suture, an anchor, an anchoring handle, and a surgical needle.

The ANCHORSURE device is a suture kit used for attaching sutures to ligaments of the pelvic floor. The submission evaluates the device against its predicate, the GYNECARE PROLENE FASTENER SYSTEM (K042603).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ANCHORSURE device are based on demonstrating that it meets established performance requirements and standards. The reported device performance is that it "meets the established performance requirements and standards."

Note: The document states that "Results of verification testing indicate that the product meets the established performance requirements and standards." Specific numerical acceptance values are not provided in this summary but are implied by adherence to standards like USP.

Study Details

Based on the provided information, the studies conducted are performance tests primarily focused on the physical and material properties of the device, rather than a clinical study evaluating human outcomes or an AI-driven analysis.

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

• Test Set Sample Size: Not explicitly stated for each test. The sample sizes would be determined by the specific protocols for each performance test (e.g., number of sutures tested for strength, number of anchors for pullout strength).
• Data Provenance: The tests are likely performed in a laboratory setting by the manufacturer, Neomedic International, S.L., located in Spain, or by a contract testing facility. This is an in vitro evaluation, not involving human subjects or real-world clinical data. Therefore, the concept of "country of origin of the data" in a clinical sense, or "retrospective/prospective," is not directly applicable.

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

• Not applicable. For these performance tests, "ground truth" is established by adherence to recognized national and international standards and test methods (e.g., USP standards for materials and mechanical properties, ISO standards for sterilization and biocompatibility). The expertise lies in performing the tests according to these standards and interpreting the results against the specified criteria. There isn't a "ground truth" established by human experts in the context of clinical interpretation or diagnosis.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image-based evaluations where multiple human readers assess a case. For physical performance tests, the results are typically quantitative measurements that are compared directly to pre-defined numerical or qualitative acceptance criteria.

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

• No. An MRMC study is not relevant here as this is a physical device undergoing performance testing, not a diagnostic or AI-assisted system that would involve human readers interpreting cases.

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

• No. This is not an AI-enabled device or an algorithm. It's a physical surgical tool.

7. The Type of Ground Truth Used:

• For sterilization, packaging, and mechanical tests, the ground truth is established by adherence to industry-recognized standards and test methods (e.g., USP, ISO).
• For biocompatibility, the ground truth was "biocompatibility testing completed on the Surelift Prolapse System (K102815) was used to support the biocompatibility of Anchorsure." This means the biocompatibility of the materials used in Anchorsure was confirmed by previous, cleared testing of a similar device using the same materials, ensuring compliance with relevant biocompatibility standards.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not a machine learning model or an AI algorithm.

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

• Not applicable. (See point 8).

In summary, the ANCHORSURE device underwent rigorous laboratory-based performance testing against established industry standards for sterilization, packaging, biocompatibility, and mechanical properties. The aim was to demonstrate that the device's physical and material characteristics meet the necessary safety and effectiveness requirements, rather than evaluating its performance in a clinical setting with human readers or AI algorithms.

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The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, nonwoven surgical mesh and suture to ligaments of the pelvic floor.

The GYNECARE PROLENE Fastener consists of the implantable nonabsorbable PROLENE polypropylene Fastener.

The provided text describes the 510(k) Premarket Notification for the GYNECARE PROLENE Fastener System. This document focuses on establishing substantial equivalence to predicate devices through various performance tests, primarily mechanical and in-vivo evaluations of the fastener's strength and attachment capabilities.

The primary goal of this submission is not to validate an AI/ML device, but rather a medical device (a surgical fastener). Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, and standalone algorithm performance) are not applicable or extractable from this type of document.

The document describes engineering bench testing and an in-vivo comparison study, which are standard for physical medical devices.

Here's the information that can be extracted or inferred from the provided text, adapted to the context of a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail table format. Instead, it lists various performance tests conducted to demonstrate safety and performance, implying that the device successfully met the requirements of these tests for substantial equivalence. The "reported device performance" is qualitative – the device passed these tests.

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For mechanical testing, this typically refers to the number of fasteners or constructs tested in each experimental arm. For the in-vivo comparison, it would refer to the number of subjects (animals or cadaveric specimens) or sites studied.
• Data Provenance: Not explicitly stated. For in-vitro (bench) testing, the data is generated in a lab setting. For the in-vivo comparison, it's likely institutional, but the country of origin or whether it's retrospective/prospective is not mentioned.

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

This is not applicable for this type of device submission. Ground truth, in the context of physical device performance, is established through direct measurement (e.g., force, displacement) by engineers and scientists, not through expert consensus of visual data.

4. Adjudication Method for the Test Set

This is not applicable. As there is no "ground truth" established by experts in the sense of image interpretation, there is no adjudication method needed. Results are typically objectively measured and analyzed statistically.

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

This is not applicable as the device is a surgical fastener, not an AI/ML diagnostic tool or an imaging system requiring human interpretation.

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

This is not applicable as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be objective scientific measurements from the mechanical testing and the in-vivo comparison.

• Mechanical Tests: Ground truth is established by physical measurement of forces, displacements, and material properties.
• In-Vivo Comparison: Ground truth is established by measurable biological or biomechanical outcomes reported in the study (e.g., tissue pullout force observed in live tissue or cadaveric models).

8. The Sample Size for the Training Set

This is not applicable as this is a physical medical device and does not involve AI/ML models that require a "training set."

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

This is not applicable for the same reason as above.

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