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Nirvana D is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

The Nirvana D Personal Lubricant is an anhydrous, non-sterile, clear silicone-based personal lubricant composed of dimethicone, dimethiconol, vanillyl butyl ether ("VBE") and hexyl nicotinate. Nirvana D Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not a spermicide or a contraceptive. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, flip top polypropylene (PP) closure constituting the device's primary packaging. One bottle is packaged into a cardboard carton, which constitutes the device outer packaging

The provided document describes the 510(k) submission for the Nirvana D Personal Lubricant. The information requested pertains to studies typically performed for AI/ML-driven medical devices, which involve performance metrics like sensitivity, specificity, and reader studies. However, the Nirvana D Personal Lubricant is not an AI/ML-driven device. It is a silicone-based personal lubricant, and its evaluation focuses on biocompatibility, condom compatibility, and shelf-life, rather than statistical performance metrics like those used for diagnostic algorithms.

Therefore, the requested information cannot be fully provided in the context of this device. I will extract the relevant information that is present in the document.

Here's a breakdown of the relevant information from the document:

1. Table of acceptance criteria and the reported device performance:

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

• Biocompatibility Testing: The specific sample sizes for the in vivo animal tests (Rabbit Vaginal/Penile Irritation, Acute Systemic Toxicity, Guinea Pig Maximization, Primary Rabbit Skin Irritation) are not explicitly stated in the provided text. Cell cultures would be used for cytotoxicity. The data provenance is not specified beyond "testing was performed in accordance with ISO 10993."
• Condom Compatibility Testing: "Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested." This refers to the types of condoms, not necessarily the number of individual condoms tested. The provenance is not specified.
• Shelf-life Testing: The sample size for the accelerated aging study is not specified.

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

This is not applicable as the device is not an AI/ML diagnostic tool. Performance is based on standardized biological and physical testing, not expert consensus or interpretation of images/data. The "ground truth" would be established by the results of the scientific tests themselves, according to established protocols like ISO 10993 and ASTM D7761-10.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring adjudication of expert interpretations.

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

Not applicable. This device is a personal lubricant, not an AI/ML system, so no MRMC study was performed.

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

Not applicable. This device is a personal lubricant, not an algorithm.

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

The "ground truth" for this device's evaluation is primarily based on:

• Biological responses: Observed reactions in established in vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) models, conforming to recognized standards (ISO 10993).
• Physical performance standards: Compatibility with condoms assessed against an ASTM standard (ASTM D7761-10, modified).
• Physicochemical stability: Evaluation of viscosity, odor, color, appearance, and microbial counts over time.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" as this is not an AI/ML device.

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The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

The predicate LENSAR Laser System is an ophthalmic surgical laser that has been cleared by the Agency for use in anterior capsulotomy and laser phaco fragmentation in cataract surgery performed individually or consecutively during the same surgery under K120214 (LENSAR Laser System - fs 3D). In K122829, the laser expands the Indication for Use to single-plane and multi-plane clear corneal cuts/incisions. This expansion of the Indication for Use is for partial as well as full thickness single-plane and multi-plane arc cuts/incisions in the cornea.

The current LLS-fs 3D uses the same laser and the same beam guidance system to deliver laser pulses to the eye as the predicate LENSAR device cleared via 510(k) K120214 and K 122829. Also, the patient interface device (PID), controlled force docking mechanism and moveable optical head to dock the laser to the stationary patient are unchanged from that 510(k) K120214 and K122829.

The LLS-fs 3D biometric system, which measures and constructs a three dimensional model of the optical surfaces within the eye, is unchanged from the predicate device except for software modifications to allow the system to analyze the shape and position of the peripheral cornea. To improve the accuracy of incision placement in the cornea, a new functionality called "Localized Imaging" has been added to the system. Localized Imaging is a process whereby the biometric camera is positioned to observe the corneal incision site and a very small laser mark (at low energy) is made at the center of the stroma. By imaging and measuring the position of the mark relative to the cornea anterior and posterior surfaces, the system mitigates any potential of incorrect laser beam placement due to eve movement. The corneal incision surgery is performed immediately after Localized Imaging and results in accurate incision depth in the cornea (

Acceptance Criteria for LENSAR Laser System - fs 3D (LLS-fs 3D)

Based on the provided 510(k) summary, the acceptance criteria for the LLS-fs 3D, specifically regarding the new indication of partial thickness corneal incisions, revolve around demonstrating comparable or superior accuracy and safety compared to conventional manual techniques and the previously cleared predicate devices.

The primary performance metric evaluated for the new indication of partial thickness corneal incisions appears to be accuracy of incision depth. The goal was to show that laser-created partial thickness incisions (PTIs) achieved depths much closer to the target than manually-created PTIs, and that there was no significant difference in accuracy or variance between human and porcine eyes, and no detrimental effect on endothelial cells.

Here's a breakdown of the acceptance criteria and reported device performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Porcine ex vivo eyes: "The accuracy of the depth of conventional manual versus laser-generated partial thickness corneal incisions (PTIs) was tested using a porcine ex vivo eye model." (Specific number of eyes not quantified, but tested).
  • Human donor globes: "The laser PTIs in porcine eyes were compared to a smaller number of laser PTIs in human donor globes." (Specific number of globes not quantified, but referred to as "smaller number").
  • Endothelial cell study: "Evaluation of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes..." (Source of ex vivo eyes not specified, but likely porcine or human donor as implied by other tests. Specific number not quantified).
• Data Provenance:
  • The studies were "ex vivo," meaning performed on excised tissues, not live subjects.
  • The origin (e.g., country) of the porcine or human donor eyes is not specified.
  • The studies were likely retrospective in nature, as they utilize ex vivo samples for controlled measurements. They are presented as performance tests supporting a 510(k) submission, typical of pre-market validation.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish ground truth for the test set.
• It also does not specify the qualifications of any experts involved in defining or adjudicating the ground truth. The ground truth ("measured depths") was established using an "optical coherence tomographer" which implies objective measurement, rather than expert interpretation of images.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method for the test set. The ground truth for incision depth was established through objective measurement using "an optical coherence tomographer," which typically involves automated or semi-automated measurement, reducing the need for human adjudication of subjective interpretations.

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

• No, an MRMC comparative effectiveness study was not done. The studies described were primarily technical performance evaluations (e.g., measuring incision depth accuracy), and safety assessments (e.g., endothelial cell integrity), rather than studies evaluating the impact of AI assistance on human reader performance. This device is not an AI-assisted diagnostic tool that would typically warrant such a study.

6. Standalone Performance Study (Algorithm Only)

• Yes, in essence, standalone performance was assessed for the laser's ability to create incisions. The studies evaluated the LLS-fs 3D's performance in creating incisions (accuracy of depth, effect on tissue) in ex vivo eyes, independent of a human surgeon's real-time interaction beyond initiating the procedure. The "Localized Imaging" functionality, which uses the biometric system to image and analyze laser marks to guide subsequent incisions, represents the device's internal "algorithm" controlling the laser's output. The accuracy reported for laser PTIs and the "Localized Imaging" feature ("

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Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.

Synovis Collagen Matrix is an implantable biologic patch comprised of non-crosslinked bovine pericardium.

The Synovis Collagen Matrix is an implantable biologic patch made from non-crosslinked bovine pericardium, intended for the reconstruction and repair of the pericardium. This device received 510(k) clearance (K122306) based on substantial equivalence to predicate devices, primarily Veritas® Collagen Matrix.

The device's safety and performance were evaluated through non-clinical testing, including bench testing and animal studies.

Acceptance Criteria and Device Performance:

Details of the Studies:

1. Sample size used for the Test Set and Data Provenance:

   • Bench Testing: The document does not specify the exact sample sizes for each bench test (suture retention, thickness, amine index, tensile, burst, sterilization validation, packaging, shelf-life, biocompatibility). These tests are typically conducted in a laboratory setting. Data provenance is implied to be from the manufacturer's internal testing.
   • Animal Studies:
     • Swine Model: Used for systemic toxicology and histological examination. The exact number of swine is not specified.
     • Canine Model: Used for pneumonectomy stump repair and chest wall defect repair. The exact number of canines is not specified.
     • Rat Model: Used for adhesion formation evaluation. The exact number of rats is not specified.
   • All animal studies were conducted prospectively as part of the device evaluation process. The country of origin for the data is not specified but is assumed to be part of the manufacturer's regulatory submission process.

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

   • The studies described are non-clinical (bench and animal studies). Ground truth for these studies is established through objective measurements (e.g., mechanical properties, chemical analysis) and histopathological examination by qualified veterinarians and pathologists, typically employed by contract research organizations or the device manufacturer. The specific number and qualifications of these experts are not provided in the summary.

3. Adjudication Method for the Test Set:

   • Not applicable as these were non-clinical bench and animal studies, not human clinical trials involving expert review and adjudication of patient data for diagnostic accuracy.

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

   • No. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Synovis Collagen Matrix is an implantable surgical patch, not an imaging device.

5. Standalone Algorithm Performance:

   • Not applicable. This device is a biocompatible surgical implant, not a standalone algorithm.

6. Type of Ground Truth Used:

   • For bench testing: Objective measurements of physical and chemical properties.
   • For animal studies: Histopathology (histological examination), clinical observation (e.g., absence of air leaks, hernia-free), and systemic toxicology (laboratory analysis).

7. Sample Size for the Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is used for machine learning models, not for traditional medical devices like surgical implants. The animal studies served as preclinical evaluation, not "training."

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

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

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The LensAR Laser System - fs 3D (LLS-fs 3D) is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.

The LensAR Laser System - fs 3D (LLS-fs 3D) employs a mode-locked Yb:YAG laser which generates a high frequency series of femtosecond, low energy pulses at a wavelength of 1030 nm. The system is technologically the same as the predicate device defined in K112098, i.e., designed to cut the lens and lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted tissue at the beam focus. The precision capsulotomy and lens fragmentation incision patterns are generated by computer-controlled scanning of the position of the laser beam focus in three dimensions at the target location. The laser energy is delivered to the eye through a disposable, proprietary patient interface device (PID) that consists of a Suction Ring which is affixed to the eye, and a precision fused silica window, which when mounted onto a PID Arm, fixates the eye and allows the laser light to be coupled into the eye through a refractive index matching cell. The index matched light coupling allows the focused laser pulses to be accurately delivered to target locations within the patient's crystalline lens.

The provided text describes a 510(k) summary for the LensAR Laser System - fs 3D (LLS-fs 3D). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study with defined performance metrics, ground truth establishment, or expert consensus.

Therefore, much of the requested information, such as a table of acceptance criteria with reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types for a performance study, is not explicitly detailed in this 510(k) summary.

However, based on the provided text, I can extract the following relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. The performance data presented focuses on verifying that the new device performs similarly or equivalently to the predicate devices and that any changes do not adversely affect safety or effectiveness. Specific quantitative acceptance criteria with reported performance values, as would be found in a clinical trial report, are not present.

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

• Test Set Description: The "testing" referenced in the summary seems to involve various engineering and preclinical assessments rather than a single clinical "test set" in the traditional sense of a diagnostic device.
• Sample Size:
  • Ex vivo eyes & artificial eyes: No specific number provided, only "ex vivo porcine and human donor eyes and custom built artificial eyes."
  • Clinical observation for adjunctive ultrasound use: The study "Consistent with the predicate devices Indication for Use (K102727 and K112098), the LensAR Laser System - fs 3D was studied for the indication of anterior capsulotomy and laser phaco fragmentation during cataract surgery." refers to a patient cohort. However, the exact sample size for the LLS-fs 3D laser cohort is not specified. It is compared to "the LensAR Laser cohort" (from K112098) and the "Control Cohort in K102727" (conventional procedures), which implies patient data.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The mention of "ex vivo porcine and human donor eyes" suggests laboratory/pre-clinical setting. The clinical observation on adjunctive ultrasound implies prospective patient data, likely conducted as part of the predicate device studies or a limited follow-up for this 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 in the summary. The studies described are primarily engineering validations and comparisons to existing predicate device performance, not assessments against expert-established ground truth for diagnostic accuracy. Clinical observations on adjunctive ultrasound use would implicitly rely on surgical outcomes and clinician assessment, but no formal ground truth establishment by a panel of experts is mentioned.

4. Adjudication method for the test set:

This information is not provided in the summary.

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 to this device. The LensAR Laser System - fs 3D is a surgical laser system for cataract surgery, not an AI-assisted diagnostic or imaging system for human readers. Therefore, an MRMC study and effects on human reader improvement are not relevant.

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

The device itself is a standalone surgical instrument that performs specific laser procedures (anterior capsulotomy and laser phaco fragmentation). Its performance is evaluated on its ability to execute these procedures precisely and safely. The summary details tests on the system's accuracy, precision, safety, and physical characteristics. Therefore, in a sense, the device's technical performance without human intervention (beyond initiating the procedure) is what's being assessed by the engineering and preclinical tests.

7. The type of ground truth used:

• Engineering/Physical Ground Truth: For tests on accuracy and precision, the ground truth would be precise measurements of shot placement in artificial materials (acrylic plastic) or ex vivo tissues. For biometric system accuracy, the ground truth would be known dimensions or established imaging standards.
• Clinical/Surgical Outcome Ground Truth: For the observation related to adjunctive ultrasound use and capsule complications, the "ground truth" would be the observed surgical metrics (e.g., CDE – Cumulative Dissipated Energy, which is a common metric in phacoemulsification, and documentation of complication causes). This is an outcomes-based assessment rather than an expert consensus on an image.

8. The sample size for the training set:

This information is not provided. The device uses "computer-controlled scanning of the position of the laser beam focus" and "software used to generate the custom incision patterns." It also has a "biometric system to measure and construct a three dimensional model of the optical surfaces within the eye." These systems would likely involve algorithms and models that were developed and validated, but the summary does not detail a specific "training set" of data as would be described for a machine learning algorithm.

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

This information is not provided. As above, the summary doesn't detail a specific "training set" or its ground truth establishment. The biometric system's ability to measure optical surfaces and the software's pattern generation are likely based on known physics, ophthalmological principles, and engineering validation rather than a distinct labeled "training set" as understood in modern AI/ML contexts.

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The LensAR-fs Laser System is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.

The predicate LensAR Laser System is an ophthalmic surgical laser that has been cleared for use in anterior capsulotomy in cataract surgery (K090633) and anterior capsulotomy and laser phaco fragmentation performed individually or consecutively during the same surgery (K102727). In new laser device with modification to the pulse width of the laser (LensAR-fs Laser System) is intended for use in the same indication as cleared in K102727. The system employs a mode-locked Yb:YAG laser which generates a high frequency series of ultrashort (1500 femtosecond), low energy pulses at a wavelength of 1030, my The system is technologically the same as defined for the predicate device, i.e., designed to cut the lens and lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted itssue at the beam focus. The precision capsulotomy and lens fragmentation is generated by computercontrolled scanning of the position of the laser beam focus in three dimensions at the target location. The laser energy is delivered to the eye through a disposable, patient interface device that consists of two separately packaged parts: a commercially wailable Suction Ring with Spring Loaded Syringe to fixate the eye and an Index Matching Eye Docking (IMED) device designed to match the refractive index of the comea to optimize beam targeting accuracy.

The LensAR-fs Laser System is an ophthalmic surgical laser indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The acceptance criteria and the study proving the device meets these criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance

The study aimed to demonstrate substantial equivalence to predicate devices (LensAR Laser System K090633 and K102727, and LenSx 550 Laser System K094052 and K082947) by showing similar performance characteristics and no new safety or effectiveness concerns despite changes in pulse width and minor hardware/software modifications.

2. Sample Size and Data Provenance for the Test Set

• Ex vivo porcine eyes: The exact number is not specified, but the testing was done on "ex vivo porcine eyes."
• Human donor ocular globes: The exact number is not specified, but evaluations were done in "human donor ocular globes."
• Data Provenance: The studies were preclinical and conducted on ex vivo biological material (porcine eyes, human donor globes). The country of origin is not specified, nor is whether the data was retrospective or prospective, though preclinical studies of this nature are typically prospective in design.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" for the test set in the traditional sense of clinical studies with expert image interpretation. The evaluation was primarily based on objective measurements and observations of the laser's physical effects.

• For Ocular Safety: An optical radiation hazard analysis was performed by Dr. Sliney. His specific qualifications are not detailed beyond "Dry Sliney confirms."

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned, as the studies were preclinical and focused on physical and technical performance rather than subjective interpretation by multiple human readers.

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

No MRMC comparative effectiveness study was done for this device. The submission explicitly states that "thus no new clinical evaluations were required," relying instead on pre-clinical data and comparison to predicate devices. Therefore, no effect size for human readers improving with AI vs. without AI assistance is provided or relevant to this submission.

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

The device is a laser system, not an AI algorithm. Its performance is inherent to its physical operation, and it is designed for use by a human surgeon. Therefore, a "standalone algorithm only" performance study is not applicable. The device's performance was evaluated based on the physical outcomes of its laser application.

7. Type of Ground Truth Used

The ground truth was established through:

• Objective Measurements/Observations: For capsulotomy incisions (e.g., accuracy, predictability in size and shape) and phaco fragmentation patterns (e.g., division into radial and concentric sections).
• Technical Comparability: Comparison of the device's technical characteristics (e.g., pulse width, laser-tissue interaction) with established predicate devices.
• Optical Radiation Hazard Analysis: Expert assessment of ocular safety.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical laser system, not an artificial intelligence or machine learning model that requires a "training set" in the computational sense.

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

This information is not applicable, as there is no training set for this type of device.

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Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

The Medtronic GTX Guidewire are steerable guide wires available in a variety of stiffnesses with available hydrophilic and hydrophobic coatings, which allow for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature. The Medtronic Vascular GTX Guidewire consists of a corewire covered with spring coils and terminated in a hemispherical tip, which impart various characteristics to the distal tip of the wire, such as tip stiffness. Wire coatings provide sufficient lubricity to reach and cross target lesions. Markers on the proximal portion of the corewire aid in gauging guide wire position relative to the guiding catheter tip.

The provided text is a 510(k) summary for a medical device (GTX Guidewire). It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

Specifically, the "Summary of Nonclinical Data" states: "The Medtronic GTX Gudiewire has successfully passed all verification testing." However, it does not detail what those verification tests were, what their acceptance criteria were, or what the reported performance was.

Furthermore, the "Summary of Clinical Data" explicitly states: "No clinical investigation has been performed for this device." This means there is no human-in-the-loop study, standalone algorithm study, or MRMC study described.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document focuses on regulatory submission and substantial equivalence to predicate devices, not on the detailed performance characteristics against specific acceptance criteria.

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The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments.

The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

The Nasal-Aire II Pediatric has been modified from the Nasal-Aire II to meet the requirements of the pediatric population and adults requiring smaller sizes to achieve the proper fit and comfort. The Nasal-Aire II Pediatric provides therapy through the nose only.

The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in hospital, clinic, or home environments.

For homecare applications, the Nasal-Aire II Pediatric may be reused multiple times by a single patient. For institutional applications (i.e. sleep lab, other clinical settings), the interface may be reused multiple times by multiple patients.

The Nasal-Aire II Pediatric interface has a soft nasal cannula to form a seal with the nasal openings. The nasal cannula has two nasal inserts and has integrated exhalation ports. The interface also has tubing, connectors to attach the tubing to the nasal cannula, and a swivel coupling that allows the interface to connect to the ventilation device. Headgear is attached to the device to secure the interface on the patient.

There are five nasal cannula sizes available, ranging from A (largest) to E (smallest).

The device is available by prescription only.

This document is a 510(k) summary for the Nasal-Aire II Pediatric device, which is an accessory to positive pressure ventilation devices. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested items related to acceptance criteria and specific study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not present in the provided text for the Nasal-Aire II Pediatric device.

The document states that "functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices." However, it does not detail what specific functional tests were performed, what the acceptance criteria for those tests were, or what the reported performance was.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot provide. The document does not specify quantitative acceptance criteria or report specific performance metrics for the Nasal-Aire II Pediatric. It broadly claims "functional testing" shows it is "as safe and effective as the predicate devices," but no details are given.

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

• Cannot provide. No information about a specific test set, its sample size, or data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot provide. No ground truth establishment for a test set is discussed.

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

• Cannot provide. No information on adjudication methods is present.

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

• Cannot provide. This is a medical device (nasal cannula), not an AI/imaging device that would typically involve human readers or MRMC studies.

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

• Cannot provide. This device is a passive accessory and does not involve an algorithm.

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

• Cannot provide. No ground truth is discussed beyond the general assertion that functional testing supports safety and effectiveness.

8. The sample size for the training set

• Cannot provide. No training set is mentioned as this is not an AI/machine learning device.

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

• Cannot provide. No training set or ground truth establishment for a training set is mentioned.

Summary of available information related to equivalence:

• Device Trade Name: Nasal-Aire II Pediatric
• Common/Usual Name: Accessory to Non-Continuous Ventilator
• Predicate Devices:
  • K060105: Kidsta Mask System (ResMed)
  • K022465: Nasal-Aire II (Innomed Technologies Inc. - likely the original version from which this pediatric version was modified)
  • K002001: Breeze Sleepgear with Nasal Pillows (Puritan Bennett Corp.)
  • K072993: Reusable Headrest® with Nasal Seal (AEIOMed, Inc.)
  • Unknown K number: Infant Nasal CPAP Set (Hudson RCI)
• Conclusion on Equivalence (from the submission): The Nasal-Aire II Pediatric device is substantially equivalent to the predicate devices in intended use, environment of use, patient population, and frequency of use. Its basic method of operation and design are also substantially equivalent to the predicates. Materials information and functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices.
• Intended Use (as stated by FDA in the letter): The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments. Intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

This 510(k) summary focuses on demonstrating that the new pediatric version of the Nasal-Aire II maintains the same safety and effectiveness as already cleared predicate devices through design similarity and general functional testing, rather than presenting a performance study against specific, novel acceptance criteria.

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ETHICON Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The proposed ETHICON Mesh is a sterile partially absorbable mesh implant, designed for repair of fascial structure of the pelvic floor in vaginal wall prolapse. The mesh implant is constructed of knitted filaments of equal parts of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber.

The provided text, K082216, is a 510(k) premarket notification for a medical device (ETHICON Mesh) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for AI/ML-driven devices or diagnostics.

Instead, this submission focuses on establishing substantial equivalence to previously marketed predicate devices for a surgical mesh. The "Performance Data" section is brief and refers to material biocompatibility and functional requirements, not clinical or diagnostic performance criteria as one would find for an AI algorithm.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth information, expert details, or MRMC study results because this document does not contain that type of information.

The relevant information from the document related to "performance" is:

• Performance Data Mentioned: "Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing indicate that the proposed device meets or exceeds all functional requirements."
• Conclusion Basis: Substantial equivalence to predicate devices (GYNECARE GYNEMESH® PS PROLENE® Soft Mesh and GYNECARE PROLIFT+M™ Pelvic Floor Repair Systems) based on similar technological characteristics.

This type of 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through material characterization, mechanical testing, and comparison of technological characteristics, rather than extensive clinical performance studies with specific statistical endpoints that would be required for a novel device or a device making diagnostic claims.

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The Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.

(Applies to the standard version):

For homecare applications, the Hybrid NE Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.

(Applies to the Disposable version): The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.

A specialized interface for Non-Invasive Ventilation. It will be modeled after the RespCare Face Mask (K052227), with intentional exhalation features removed for use with ventilators equipped with an active safety valve.

This K062019 submission describes a medical device, the RespCare Hybrid NE Mask, and its substantial equivalence to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria. Therefore, the information typically requested for a performance study (acceptance criteria, sample sizes, expert ground truth, etc.) is not present in this document.

The document is a 510(k) summary for a new medical device submission to the FDA. The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is done by comparing the new device's intended use, technological characteristics, and safety and effectiveness information to those of the predicate. It does not typically involve a clinical study with detailed performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) submission might.

Here's an breakdown of why the requested information isn't available based on the provided text, and what is available:

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

• Not Applicable. The document explicitly states, "Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices." This is a summary statement of the testing performed to demonstrate substantial equivalence, but it does not specify quantitative acceptance criteria or detailed performance results in the format requested. The detailed functional testing data and acceptance criteria would have been included in the full 510(k) submission, but are not part of this publicly available summary.

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

• Not Applicable. No human clinical study or "test set" in the context of an algorithm's performance is described. The "functional testing" mentioned would likely refer to bench testing (e.g., flow resistance, sealing capabilities) rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. No "ground truth" establishment by experts is mentioned, as there is no diagnostic or interpretive task being performed by the device that would require such validation.

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

• Not Applicable. No test set or expert adjudication is described.

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

• Not Applicable. The device is a face mask for ventilation, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This is a physical medical device (a mask), not an algorithm.

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

• Not Applicable. As a face mask, the concept of "ground truth" as it applies to diagnostic devices or algorithms is not relevant. The "ground truth" for a mask would be its physical properties and performance against engineering standards (e.g., seal integrity, pressure drop).

8. The sample size for the training set:

• Not Applicable. The device is a physical product and does not involve machine learning or a "training set."

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

• Not Applicable. No training set is used.

Summary of what is presented in the provided document:

The provided document, K062019, is a 510(k) summary for the RespCare Hybrid NE Mask. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria.

Key information from the document:

• Device Name: RespCare Hybrid NE Mask
• Intended Use: "The Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation."
• Predicate Devices:
  • K030515 – Hans Rudolph 7500 Vmask
  • K023135 - Respironics Image3 SE
• Basis for Substantial Equivalence: The document states the device is "essentially similar to the legally marketed predicate interfaces listed above in function, intended use, materials, and features." The essential difference is identified as "the shape of the interface." It further clarifies equivalence in "intended use, environment of use, patient population, and frequency of use," and that its "basic method of operation and design is also equivalent to the predicates."
• Evidence of Safety and Effectiveness: "Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices." (Note: specific details of this testing, including acceptance criteria, are not provided in this summary but would be in the full submission).

This submission is purely for regulatory clearance based on substantial equivalence to existing devices, meaning it relies on the safety and effectiveness established for the predicate devices.

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The SmartSite® Vented Vial Access Device is intended for use by healthcarc professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The SmartSite® Vented Vial Access Device (Vented VAD) is a stand-alone, single use, multiple-dose device with a SmartSite® Needle Free Valve and a 0.2 micron hydrophobic air-venting filter for use with rubber-stopper vials. The device is intended for use when reconstituting Ivophilized drugs and/or when dispensing medications, particularly hazardous drugs such as chemotherapeuties.

I am sorry, but the provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. The document is a 510(k) summary for the SmartSite® Vented Vial Access Device, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies with detailed acceptance criteria.

While it mentions "performance data indicate that the SmartSite® Vented Vial Access Device meets specified requirements and is substantially equivalent to the predicate devices," it does not elaborate on what those specific requirements or the performance data entail. Therefore, I cannot extract the information required for your request.

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