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Ask a specific question about this device

The KnoxFog Anti-fogging Device is a temporary anti-fog coating and therein inhibits fogging on optical lenses. It is a laparoscopic accessory intended to facilitate intraoperative defogging of laparoscope lenses, thereby maintaining visualization of the surgical site and closed body cavity.

KnoxFog™ is intended for use as an anti-fog solution applied to rigid endoscope lenses prior to insertion into the body to maintain optical clarity during endoscopic procedures.

KnoxFog™ is a semi-sol gel anti-fog coating designed to prevent condensation on endoscopic lenses during surgical procedures. The device is supplied as a sterile solution in single-use containers for application immediately prior to endoscopic procedures. When applied to the endoscope lens, KnoxFog™ forms a transparent hydrophilic coating that prevents fog formation by maintaining optical clarity in high-humidity environments. The product is terminally sterilized using gamma radiation to ensure safety for use in surgical environments.

The provided FDA 510(k) clearance letter for the KnoxFog Anti-fogging Device focuses on the device's technical specifications and substantial equivalence to a predicate device, VitreOx™. However, it does not contain information typically associated with studies proving a device meets acceptance criteria for an AI/ML medical device, which would involve aspects like expert ground truth, multi-reader studies, or large data sets.

The document describes bench testing for an anti-fogging solution, not an AI/ML algorithm. Therefore, many of the requested points regarding AI/ML device studies (e.g., ground truth establishment, training sets, MRMC studies, standalone performance) are not applicable to the information provided.

I can, however, extract the acceptance criteria and performance data for the anti-fogging device based on the provided text.

Acceptance Criteria and Device Performance (KnoxFog Anti-fogging Device)

Based on the provided document, the "acceptance criteria" appear to be implicitly defined by the comparative performance against the predicate device, VitreOx™, specifically in terms of time-to-fog. Other tests (transportation, accelerated aging, biocompatibility) are also performance indicators but without explicit numerical acceptance thresholds provided beyond general "stability," "shelf-life claims," and "biocompatible."

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria": The document doesn't explicitly state numerical acceptance criteria for "Transportation Stability," "Accelerated Aging," or "Biocompatibility." Instead, it states that the tests verified stability, confirmed shelf-life claims, and demonstrated biocompatibility in accordance with standards. The time-to-fog analysis is the most quantitative comparative criterion mentioned.

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

• Sample Size: Not explicitly stated for any of the tests (Time-to-Fog, Transportation, Accelerated Aging, Biocompatibility). The text just mentions "comparative testing" and "studies."
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be bench testing performed by the manufacturer, UV ONE Hygienics, Inc. The document does not indicate if the data was retrospective or prospective in the medical context, as it's a materials science/engineering evaluation rather than a clinical study.

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

• Not Applicable. This device is an anti-fogging solution, not an AI/ML diagnostic or image interpretation device. The "ground truth" would be objective measurements of fogging, material stability, and biological reactions, not expert consensus on medical images.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is for assessment of an anti-fogging solution, not human interpretation of data requiring adjudication.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in interpreting medical images. This device is a topical anti-fogging agent. The "Performance Data" section details bench testing comparing the device's technical performance (time-to-fog, stability) to a predicate, not how it affects human readers.

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

• Not Applicable. This is not an algorithm. The performance data presented (time-to-fog, stability, biocompatibility) are inherently "standalone" in the sense that they measure the physical properties of the device itself.

7. The Type of Ground Truth Used

• Objective Measurements/Material Science:
  • For "Time-to-Fog Analysis": The ground truth is the measurable time until fog formation on the endoscope lens under specific conditions.
  • For "Transportation Testing": The ground truth relates to the physical integrity and continued functionality of the product after simulated transport.
  • For "Accelerated Aging": The ground truth is the product's stability and efficacy over time, extrapolated from accelerated conditions.
  • For "Biocompatibility Testing": The ground truth is established through standardized in vitro and in vivo biological tests (e.g., cytotoxicity, irritation) according to ISO 10993 standards.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML algorithm is involved.

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Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians. Neurovascular Insight V1.0 is intended to:

• Display and, if necessary, export neurological DICOM series and outputs provided by compatible processing docker applications, through the technical integration environment.
• Allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided by the technical integration environment as inputs to the docker application to reprocess the outputs. When available, Neurovascular Insight V1.0 display can be updated with the reprocessed outputs.
• If requested by an application, allow the user to confirm information before displaying associated outputs and export them.

The device does not alter the original image information and is not intended to be used as a diagnostic device. The outputs of each compatible application must be interpreted by the predefined intended users, as specified in the application's own labeling. Moreover, the information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. It is not intended to be used in lieu of the standard care imaging.

Trained professionals are responsible for viewing the full set of native images per the standard of care.

Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians.

It is worth noting that Neurovascular Insight V1.0 is an evolution of the FDA cleared medical device Olea S.I.A. Neurovascular V1.0 (K223532).

Neurovascular Insight V1.0 does not contain any calculation feature or any algorithm (deterministic or AI).

The provided FDA 510(k) clearance letter for Neurovascular Insight V1.0 states that the device "does not contain any calculation feature or any algorithm (deterministic or AI)." Furthermore, it explicitly mentions, "Neurovascular Insight V1.0 provides no output. Therefore, the comparison to predicate was based on the comparison of features available within both devices. No performance feature requires a qualitative or quantitative comparison and validation."

Based on this, it's clear that the device is a user interface and does not include AI algorithms or generate outputs that would require a study involving acceptance criteria for AI performance (e.g., sensitivity, specificity, accuracy). Therefore, the questions related to AI-specific performance criteria, ground truth establishment, training sets, and MRMC studies are not applicable to this particular device.

The "study" conducted for this device was a series of software verification and validation tests to ensure its functionality as a user interface and its substantial equivalence to its predicate.

Here's a breakdown of the requested information based on the provided document, highlighting where the requested information is not applicable due to the device's nature:

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

Note: As the device is a user interface without AI or output generation, there are no quantitative performance metrics like sensitivity, specificity, or accuracy that would typically be associated with AI algorithms. The acceptance criteria relate to the successful execution of software functionalities.

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

• Sample Size for Test Set: Not explicitly stated as a number of patient cases or images, as the testing was focused on software functionality rather than AI performance on a dataset. The testing refers to "software modules verification tests" and "software validation test."
• Data Provenance: Not applicable in the context of clinical data for AI development/validation, as the device doesn't use or produce clinical outputs requiring such data. The testing was internal software validation.

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

• Not Applicable: Given that the device is a user interface and does not utilize AI or produce diagnostic outputs, there was no need to establish clinical ground truth for a test set by medical experts in the traditional sense. The "ground truth" for its functionality would be the design specifications and successful execution of intended features. The document mentions "operators" who "reported no issue" during usability testing, but these are likely system testers/engineers, not clinical experts establishing diagnostic ground truth.

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

• Not Applicable: No clinical ground truth was established, so no adjudication method was required.

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

• No: The document explicitly states, "Neurovascular Insight V1.0 does not contain any calculation feature or any algorithm (deterministic or AI)." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

• No: The device does not contain an algorithm, only a user interface. Standalone algorithm performance testing is not applicable.

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

• Not Applicable: No clinical ground truth was established, as the device is a user interface without AI or diagnostic output generation. The "ground truth" for its validation was adherence to software specifications and intended functionalities.

8. The sample size for the training set

• Not Applicable: The device does not contain any AI algorithms, therefore, no training set was used.

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

• Not Applicable: No training set was used.

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Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

• Arsenic Trioxide (1 mg/ml)
• Bendamustine, (5 mg/ml)
• Blenoxane (15 mg/ml)
• Bleomycin (15 mg/ml)
• Bortezomib (1 mg/ml)
• Busulfan (6 mg/ml)
• Carboplatln (10 mg/ml)
• Carfilzomib (2 mg/ml)
• Cetuximab (2 mg/ml)
• Cisplatin (1 mg/ml)
• Cyclophosphamide (Cytoxan) (20 mg/ml)
• Cytarabine (100 mg/ml)
• Dacarbazine (DTIC) {10 mg/ml)
• Daunorubicin {5 mg/ml)
• Decitabine (5 mg/ml)
• Docetaxel (10 mg/ml)
• Doxorubicin HCL (2 mg/ml)
• Ellence (2 mg/ml)
• Erbitux (2 mg/ml)
• Eribilin Mesylate (0.5 mg/ml)
• Etoposide (Toposar) (20 mg/ml)
• Fludarabine (25 mg/ml)
• Fulvestrant (50 mg/ml)
• Gemcitabine (Gemzar) (38 mg/ml)
• Idarubicin (1 mg/ml)
• Ifosfamide (IFEX) (50 mg/ml)
• Irinotecan (20 mg/ml)
• Mechlorethamine HCL (1 mg/ml)
• Melphalan (5 mg/ml)
• Methotrexate (25 mg/ml)
• Mitomycin C (0.5 mg/ml)
• Mitoxantrone (2 mg/ml)
• Oxaliplatin (2 mg/ml)
• Paclitaxel (Taxol) (6 mg/ml)
• Paraplatin (10 mg/ml)
• Pemetrexed Disodium (25 mg/ml)
• Pertuzumab (30 mg/ml)
• Raltitrexed (0.5 mg/ml)
• Rituximab (Rituxan) (10 mg/ml)
• Temsirolimus (25 mg/ml)
• Thiotepa (10 mg/ml)
• Topotecan HCL (1 mg/ml)
• Trastuzumab (21 mg/ml)
• Trisenox (1 mg/ml)
• Velcade (1 mg/ml)
• Vinblastine (1 mg/ml)
• Vinorelbine (10 mg/ml)

Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100 mcg/2 ml)
• Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)

Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.

The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:

• Cytovene (10 mg/ml)
• Retrovir (10 mg/ml)
• Triclosan (2 mg/ml)
• Zoledronic Acid (0.8 mg/ml)

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves.

The provided text is an FDA 510(k) clearance letter and summary for a medical glove, not an AI-powered medical device. Therefore, many of the requested fields related to AI study design (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "number of experts," etc.) are not applicable and cannot be found in the document.

However, I can extract the acceptance criteria and performance data for the glove based on the provided information, focusing on the non-clinical and clinical tests described.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Succession™ Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:

• Failed ankle replacement
• Arthritis of ankle and subtalar joint
• Correcting neuromuscular imbalance of hindfoot, where bone fusion is required
• Revision of failed ankle and/or subtalar fusion
• Revision of failed Tibiotalocalcaneal (TTC) fusion
• Talar Avascular Necrosis (AVN)
• Charcot
• Trauma
• Neuroarthropathy
• Pseudoarthrosis
• Rheumatoid arthritis

The Succession™ AFN System is comprised of a set of straight 10mm, 11mm, and 12 mm diameter cannulated nails, 12.5mm diameter end caps, 5mm and 6mm diameter cortical screws, and accessory instrumentation. All implants are composed of Titanium (Ti-6Al-4V ELI) and provided to the user sterile packed with a combination of both sterile and non-sterile accessory instrumentation to assist in implantation. Each of the accessory instruments provided with the subject device contain substantially equivalent materials to the Oxford™ Ankle Fusion Nail System predicate device instrumentation, including stainless steel (ASTM F899 and ASTM F138 / ISO 5832-1) and Fluorinated Ethylene Propylene direct contacting materials.

During the procedure, following preparation of the tibial intramedullary canal (using the device accessory instrumentation) and placement of the intramedullary fixation nail, the provided 5mm screws are inserted into the medial to lateral (M/L) slots of the implant, allowing for fixation in the tibia, talus, and calcaneus. In both the talus and calcaneus, dynamic compression slots are included in the nail and are to be used with the internal and/or external methods of compression across the tibiotalar and subtalar joints. In addition, a 6mm screw is placed through the only angled posterior to anterior (P/A) slot located at the distal end of the nail implant, allowing for additional fixation between the calcaneus and talus. Following the placement of all screws, the end caps are implanted to add stability to the distal end of the nail and prevent excess bony ingrowth from occurring within the nail cannulation. Overall, the Succession™ Ankle Fusion Nail is intended to effectively fuse the tibiotalar and subtalar joints together, providing stability in the hindfoot region to facilitate tibiotalocalcaneal arthrodesis.

Based on the provided FDA 510(k) Clearance Letter, the Succession™ AFN System is an intramedullary fixation rod, and the clearance is primarily based on substantial equivalence to predicate devices. This means the device is demonstrated to be as safe and effective as a legally marketed device, not necessarily by proving it meets specific quantitative performance acceptance criteria for an AI/machine learning device.

The document provided does not contain information about an AI/ML-driven device's acceptance criteria or a study proving its performance. The "Non-Clinical and/or Clinical Tests Summary" in the document describes mechanical testing of the physical device (nails, screws, and accessories) for properties like torsional yield strength, driving torque, pullout strength, self-tapping force, cyclic fatigue, bending strength, torsional strength, and corrosion resistance.

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The provided text is solely about the substantial equivalence of a physical orthopedic implant.

If this were a document about an AI/ML device, the sections you requested would typically be found in a "Performance Benchmarking" or "Clinical Study" section, detailing the AI's accuracy, sensitivity, specificity, or impact on human performance, along with the study methodology.

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CUTIVA™ Topical Skin Adhesive (RM1700) is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. CUTIVA™ Topical Skin Adhesive (RM1700) should be used in conjunction with, but not in place of, deep dermal stitches.

The CUTIVA™ PLUS Skin Closure System (RM1739) is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CUTIVA™ PLUS Skin Closure System (RM1739) should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during the application of the liquid adhesive.

CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) are skin closure devices that are comprised of a 2-octyl cyanoacrylate liquid adhesive formulation. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. The CUTIVA™ PLUS Skin Closure System (RM1739) also incorporates a self-adhering mesh component that is applied to the wound prior to the application of the liquid adhesive to align the skin edges. The liquid adhesive is then applied to the mesh with the adhesive applicator to complete the device application.

Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) provide a physical barrier to microbial penetration as long as the adhesive film remains intact. In vitro studies have been performed to demonstrate the microbial barrier properties of CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) for 72 hours after device application. No clinical studies have been performed and no clinical benefit associated with the in vitro microbial barrier performance of the device has been demonstrated.

This FDA 510(k) clearance letter pertains to a topical skin adhesive, not an AI/ML medical device. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) is not applicable or cannot be extracted from this document, as these concepts are specific to the validation of AI/ML algorithms, not traditional medical devices like skin adhesives.

However, I can provide the available information regarding acceptance criteria and the study that supports the device, focusing on what is relevant for a non-AI/ML medical device.

Device Name: CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a traditional medical device (topical skin adhesive) and not an AI/ML algorithm, the "acceptance criteria" discussed are typically related to biocompatibility, physical properties, and safety, assessed against recognized standards. The document primarily focuses on biocompatibility testing as a "performance data" highlight for the labeling change.

• No evidence of systemic toxicity.
• Microscopically, the test article caused a minimal or no reaction.
• Worst-case exposure conditions were created by implanting the maximum dose. |
  | Biocompatibility (Reaction) | Minimal or no local reaction at the implantation site. | Microscopically, the test article was classified as causing a minimal or no reaction. |
  | Substantial Equivalence | The device is substantially equivalent to a legally marketed predicate device. | Both CUTIVA™ Topical Skin Adhesive (RM1700) and CUTIVA™ PLUS Skin Closure System (RM1739) were found substantially equivalent to their respective predicate devices (K234114) since they are the same devices with only packaging insert modifications. |

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of human subjects or a "test set" for performance evaluation in the context of an AI/ML algorithm. For the biocompatibility study, it involved "test animals" (rats), but the exact number is not provided.
• Data Provenance: The biocompatibility study was performed in accordance with ISO 10993-11:2017 standards, implying a controlled laboratory study. The country of origin is not specified, but the study method adheres to international standards. It is a prospective animal study for biocompatibility.

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

• Not applicable in the context of this device. The ground truth for biocompatibility studies is typically derived from established biological assays and pathological analysis by trained professionals (e.g., toxicologists, histopathologists), not from "experts" establishing ground truth in an image-reading or diagnostic context.

4. Adjudication Method for the Test Set

• Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used for human reader consensus in diagnostic studies, which is not relevant here.

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

• Not applicable. This is a traditional medical device (skin adhesive), not an AI/ML algorithm requiring an MRMC study to assess human reader improvement.

6. Standalone Performance Study (Algorithm Only)

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

7. Type of Ground Truth Used

• For Microbial Barrier Properties: In vitro laboratory testing results, comparing microbial penetration with and without the adhesive.
• For Biocompatibility: Histological examination and physiological observations on test animals (rats) to determine systemic toxicity and local tissue reaction, based on the criteria of ISO 10993-11:2017.

8. Sample Size for the Training Set

• Not applicable. This is a physical device, 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 AI/ML algorithm, there is no training set and thus no ground truth to establish for it.

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The Single Use Aspiration Needle NA-201SX-4021 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

The Single Use Aspiration Needle NA-201SX-4022 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

The Olympus Single Use Aspiration Needle NA-201SX-4021 and NA-201SX-4022 are designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. These devices are single-use, disposable, sterile (Ethylene Oxide) needles available in two models with different specifications:

• NA-201SX-4021:

• Working Length: 700mm
• Maximum Insertion Portion Diameter: 1.9mm
• Needle Width: 21G
• Normal Needle Length: 20mm
• Maximum Needle Length: 40mm

• NA-201SX-4022:

• Working Length: 700mm
• Maximum Insertion Portion Diameter: 1.8mm
• Needle Width: 22G
• Normal Needle Length: 20mm
• Maximum Needle Length: 40mm

Both models feature an adjustable sheath length and are intended for single use.

This document is a 510(k) clearance letter for a physical medical device (Single Use Aspiration Needle), not an AI/Software-as-a-Medical-Device (SaMD). Therefore, the requested information pertaining to AI/SaMD performance evaluation criteria (such as test set size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable and is not present in the provided document.

The document discusses the substantial equivalence of the new aspiration needles to a predicate device based on their physical and functional characteristics. The performance data section refers to bench testing of physical attributes, not computational performance or diagnostic accuracy.

Therefore, I cannot provide the requested information as it relates to AI/SaMD. I can, however, extract the acceptance criteria and reported device performance for the physical device based on the provided text.

Acceptance Criteria and Reported Device Performance (Physical Device)

This section summarizes the performance data for the Single Use Aspiration Needle (NA-201SX-4021 and NA-201SX-4022), based on the provided FDA 510(k) summary. These criteria relate to the physical and functional performance of the device, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/SaMD specific questions:

As stated previously, the provided document is for a physical medical device (Single Use Aspiration Needle), not an AI/SaMD device. Therefore, the following information is not applicable and not provided in the source text:

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was physical bench testing, not data-driven AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established by engineering specifications and direct measurement, not expert review of AI outputs.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This applies to AI-assisted diagnostic or interpretive systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical needle refers to its engineered specifications and expected mechanical/biological performance, verified through bench testing.
8. The sample size for the training set: Not applicable. This applies to machine learning models.
9. How the ground truth for the training set was established: Not applicable. This applies to machine learning models.

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The OnFlex™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

The OnFlex™ Mesh is a self-expanding, non-absorbable, sterile device made from monofilament polypropylene mesh and has a lightweight large pore design. This construction allows a prompt fibroblastic response through the interstices of the mesh as observed in a preclinical model, which may not correlate to performance in humans. The OnFlex™ Mesh has an anatomical shape design to cover potential defect areas. The OnFlex™ Mesh also contains a pocket on the larger medial apex of the mesh to facilitate insertion and positioning of the device.

The OnFlex™ Mesh contains SorbaFlex™ Memory Technology comprised of an absorbable PDO monofilament which forms an interrupted ring. SorbaFlex™ Memory Technology provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament is folded and welded onto itself at the ends. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 – 8 months. The PDO monofilament is dyed violet by adding D & C Violet No. 2. The interrupted ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the interrupted recoil ring during the degradation process. The interrupted ring, contained in the mesh tube, is sewn between two layers of mesh with polytetrafluoroethylene (PTFE) monofilament.

The OnFlex™ Mesh has a blue limit line at the lateral portion of the mesh, composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant, to provide visual feedback for where the device can be tailored. The OnFlex™ Mesh can be tailored at the opening of the interrupted ring or outside of the blue limit line.

The OnFlex™ Mesh is offered in two sizes: medium (0115410) and large (0115411). The OnFlex™ Mesh is considered a tissue contacting permanent implant.

The provided FDA 510(k) clearance letter for the OnFlex™ Mesh (K251955) indicates that this is a Special 510(k) submitted to notify the FDA of changes to the device labeling only. The device itself remains identical to its predicate, OnFlex™ Mesh (K142711), cleared in 2015.

Therefore, the submission explicitly states: "No non-clinical or clinical testing was provided in support of this Special 510(k)."

This means that the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, as no new testing was performed for this specific submission. The substantial equivalence is based on the device's identity to its predicate and the conclusion that the labeling changes do not affect safety or effectiveness.

Because no new studies were conducted or presented in this document for the K251955 submission, I cannot provide the requested information. The document focuses solely on demonstrating that the labeling updates do not alter the substantial equivalence to the original predicate device (K142711).

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