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The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx.

The device can be used with cuffed and non-cuffed nasal endotracheal tubes.

The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to ease the passage of a nasal endotracheal tube from the nares to the oropharynx. The Rhinoguard device is constructed primarily of polyvinylchloride and consists of a tube with a hollow proximal end, a tapered cylindrical body and a closed, rounded distal end. The device has markings to indicate the approximate mating location for corresponding sizes of nasal endotracheal tubes. The device is provided in a small and large size. The small Rhinoguard is intended to mate with 3.0 to 4.5 mm nasal endotracheal tubes and the large Rhinoguard is intended to mate with 5.0 to 8.0 mm nasal endotracheal tubes. The device can be used with cuffed and non-cuffed nasal endotracheal tubes. Prior to using the device, the desired size of the nasal endotracheal tube must be selected and then matched to corresponding Rhinoguard size (large or small). The device is then cut just above the indices (marks) corresponding to the selected endotracheal tube size and connected with the endotracheal tube. Once mated, the distal end of the device is introduced into the naris of choice and gently pushed forward into the oropharynx. Lastly, the distal end of Rhinoguard is grasped and removed from the mouth with the aid of a laryngoscope and McGill forceps.

The provided text describes a 510(k) premarket notification for a medical device called "Rhinoguard," which is a nasal endotracheal tube introducer/dilator. The document details the device, its intended use, comparison to predicate devices, and the non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All performance testing met acceptance criteria defined in protocols." However, it does not explicitly list the quantitative acceptance criteria for each test. It only provides the purpose of each test. Below is a table summarizing the tests, their stated purpose (which implies the performance objective), and the reported outcome.

The document states, "In conclusion, the proposed device performed equivalent to or better than the predicate device. All performance testing met acceptance criteria defined in protocols."

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

• Sample Size for Test Set: The document does not specify the sample size used for any of the non-clinical (bench) tests.
• Data Provenance: The tests are described as "nonclinical (bench) test results." The document does not provide details on the location or nature of laboratories, nor does it specify if the data is retrospective or prospective. Given the nature of bench testing, it is typically prospective and controlled laboratory testing.

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

• The document does not mention using experts to establish ground truth for the performance tests. The evaluation is based on objective bench testing against pre-defined protocols and comparison to predicate devices, not expert consensus on interpretations.
• For the "Design (Usability) Validation Testing," it states it was tested "under a simulated use environment," which implies human interaction, but it does not specify the number or qualifications of users/experts involved in this validation.

4. Adjudication method for the test set

• The document does not describe any adjudication method as typically understood for medical image analysis or diagnostic studies (e.g., 2+1, 3+1). The tests are bench tests with objective outcomes (e.g., meeting a strength threshold, absence of kink, sterility level), not subjective interpretations requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is a physical medical instrument (an introducer/dilator for endotracheal tubes), not an AI/software device intended for diagnostic interpretation or to assist human "readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• This question is not applicable as the Rhinoguard is a physical medical device, not an algorithm or AI system.

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

• For the non-clinical tests, the "ground truth" or reference standard for performance is the pre-defined acceptance criteria specified in the test protocols and, for some tests (kink, disconnection, perforation), comparison to the performance of the predicate device. For biocompatibility, it's ISO standards. For sterility, it's an SAL. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these tests.

8. The sample size for the training set

• This question is not applicable as the Rhinoguard is a physical medical device, not an AI/software device that requires a training set.

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

• This question is not applicable as the Rhinoguard is a physical medical device, not an AI/software device that requires a training set or ground truth for training.

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The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting.

The HT-Wedge is an inflatable wedge with square headrest and two intake appendages, one for the head and one for the chest. An inflation/deflation valve is found in each appendage. There is also a tongue attached to the wedge that lies under the patient's buttocks. The inflatable portion of the product is 22" wide and 31 1/4" long. There are four attachment straps, two located on each side of the wedge in order for it to be secured to the OR table. The tongue adds an additional 20" in length. The wedge is constructed of polyurethane coated nylon with 2 one-way, inflation/deflation valves.

This document is a 510(k) summary for a medical device (HT-Wedge), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific quantitative acceptance criteria typically seen for diagnostic AI/ML devices.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.

The document indicates that "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications," but it does not provide the specific specifications or the results of these tests. It relies on citing compliance with voluntary standards (ISO 10993) for biocompatibility rather than performance metrics related to lifting and positioning.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Provided. This summary is for a physical patient lift, not an AI/ML device relying on a test set of data (e.g., images). The "testing" referred to is likely engineering and safety testing on the device itself, not a dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable / Not Provided. Ground truth establishment by experts is relevant for diagnostic AI/ML algorithms. For this physical device, "ground truth" would relate to its engineering specifications and safety, verified through manufacturing processes and compliance with standards. "Design review has been conducted by a cross-functional team, including but not limited to regulatory, quality, engineering and manufacturing," but detailed qualifications or number of individuals are not specified.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided. This applies to expert review of data, not physical device testing.

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

• No. This is a physical patient lift, not a diagnostic AI assistance system. MRMC studies are used to evaluate human reader performance with and without AI assistance in diagnostic tasks.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not Applicable. This is not an algorithm. Performance relates to its mechanical and functional specifications.

7. The Type of Ground Truth Used:

• For this device, "ground truth" would be internal engineering specifications, safety standards (e.g., biocompatibility standards like ISO 10993), and the performance characteristics of the legally marketed predicate device. The document implies that the device performs as designed and meets safety standards, and that its performance is equivalent to the predicate.
• The document explicitly mentions "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications." These specifications are the "ground truth" the device was tested against, but the detailed specifications themselves are not provided in this 510(k) summary.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. 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 / Not Provided. (See point 8)

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The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.

The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.

The provided text describes a 510(k) summary for the HoverTech International® Transformer, a battery-powered patient transport device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets them.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: The document states that "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications." However, it does not list what those specific specifications or acceptance criteria are, nor does it provide the results or reported performance of the device against them. It only mentions compliance with voluntary standards like IEC and UL for safety and biocompatibility. These are general standards, not specific performance metrics for this particular device.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set: All of these data points are typical for studies evaluating diagnostic or predictive algorithms/devices, especially in fields like medical imaging. Since the HoverTech International® Transformer is a physical patient transport device (a powered wheeled stretcher), these types of studies (MRMC, standalone algorithm performance, training/test sets for AI, ground truth establishment by experts/pathology) are not applicable to this device's regulatory submission as described.

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not provided. The document generally states "compliance with specifications" and "safety testing," but no specific metrics or results are reported.
2. Sample size used for the test set and data provenance: Not applicable in the context of this physical device.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What is present in the document is a declaration of compliance with general safety and electrical standards:

• Voluntary Standards the device will comply with:
  • IEC 60601-1 (General Requirements for Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • IEC 60601-2-38 (Safety of Electrically Operated Hospital Beds - applicable parts only for loading and pinch points)
  • UL 2601-1 (Standard for Medical Electrical Equipment)
  • CAN/CSA C22.2 No. 601.1-M90 (Standard for Medical Equipment)
  • ISO 10993-5 (Biocompatibility - In Vitro cytotoxicity)
  • ISO 10933-10 (Biocompatibility - irritation and sensitization, delayed type hypersensitivity)

The document concludes that the device is "substantially equivalent" to a predicate device (Transmotion Medical Model TMM6 Power Drive Chair) based on "intended use, basic technology, and performance characteristics." The "performance characteristics" are implied to be met through the safety testing and compliance with the listed voluntary standards, but no specific performance data is disclosed in this summary.

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The Power Standing Dani stand-up wheelchair is a sit to stand mobility device equipped with power driven rear mounted wheels intended for the pediatric population with disabilities which limits their ability to ambulate without assistance. The product is designed for indoor/outdoor use on normal pedestrian terrain such as asphalt, grass, and gravel and not indicated for slopes exceeding 6° in a downhill, uphill or lateral orientation. The device is not intended for use while being transported in a moving vehicle.

The Power Standing Dani stand-up wheelchair (wheelstand) is a sit to stand mobility device equipped a removable prone board and standing platform with a joystick controlled power driven rear mounted wheels, providing the pediatric population with disabilities the providing the pocking to independently ambulate in the standing position. Types of disability diagnosis include spina bifida, cerebral palsy, muscular dystrophy, spinal muscular atrophy, spinal cord injury, and various other neurological disorders.

The Power Standing Dani stand-up wheelchair (wheelstand) is equipped with a vertical positioning prone board with an attached standing platform, inclined slightly forward, to which the pediatric is supported with lateral, anterior and posterior components in the upright position. The prone board and standing platform are comprised of positioning components that are interchangeable and whose location can be adjusted to accommodate the precise needs for each individual. The prone board and attached standing platform are securely mounted to an adjustable steel base frame, to which the power driven rear wheels and front suspension caster wheels are mounted.

The drive power is provided through a rear mounted wheel system, branded as the e-fix® is supplied by Ulrich Alber. Gmbh. Each of the two drive wheels contains a 110 Watt motor, brake and gear box in its hub. The wheels sizes are available in 12" or 24" diameter. The wheel motors are powered with 2x12V (12Ah or 17Ah) batteries, which are secured in a solid mounting rack. Front suspension castor wheels support the front of the frame and allow indirect steering by applying differential power to the rear drive wheels through the joystick controller.

The provided text describes a 510(k) submission for a power stand-up wheelchair called "Power Standing Dani." However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on:

• Device identification: Proprietary name, classification, and predicate devices.
• Intended Use: Description of the target population (pediatric with disabilities limiting ambulation), use environment (indoor/outdoor, normal pedestrian terrain, not for slopes exceeding 6° or transport in moving vehicles), and the device's function as a sit-to-stand mobility aid.
• Device Description: Details on its components, power system (e-fix® add-on), and battery.
• Safety and Effectiveness claims: Based on prior experience with the Manual Standing Dani and the incorporation of an FDA-cleared power add-on. It states that the power add-on provides the same psychological and physiological benefits to those unable to manually self-propel.
• FDA Communication: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices, outlining regulatory requirements, but not discussing specific performance tests or acceptance criteria.

Therefore, I cannot provide the requested table and study details because the information is not present in the provided text.

To answer your request, the original 510(k) submission or a related document outlining the specific performance testing and results would be needed.

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The HoverJack™ lifts a patient in a supine position, from the floor to the approximate height of a bed for a subsequent lateral patient transfer.

The HoverJack™ is made of four connected nylon air chambers, each measuring 32" x 70". When inflated, each chamber is 7" high. Each chamber has a dump valve for safety purposes. Each of these chambers has an air entry valve through which an external air supply is used to inflate the chamber against the floor is to be inflated first, then the other three chambers are inflated, in an upward succession, until the device is fully inflated. When fully inflated, the HoverJack™ feels hard and substantially supports the patient atop it, also providing a surface upon which emergency patient procedures can be performed, if necessary. Also in an emergency, dump valves are available to use for quick deflation. The HoverJack™ is constructed using 200 denier Nylon Oxford. Seams are RF welded (heat-sealed) to limit infection control issues. The bottom of the HoverJack™ has strips of a non-skid material attached for safety purposes. Fill-valves are self-sealing AND have caps that also screw on for additional closure. The HoverJack™ has two patient safety straps to buckle over the patient. The HoverJack™ does require the use of the Air Supply that is available as a separate unit. The Air Supply is CSA approved, meeting UL Standard #544. This Air Supply is also used to inflate other equipment such as the HoverMatt® which is an optional accessory to the HoverJack™.

While the provided text describes the HoverJack™ Air Patient Lift Device, its intended use, and a comparison to a predicate device, it does not contain the information needed to answer your specific questions regarding acceptance criteria and a study proving those criteria.

The document refers to "Non-Clinical, Volunteer, Safety Testing" and states that "Findings and feedback from all scenarios have resulted in safety and comfort improvements ultimately ending in the final design of the product." However, it does not provide details of this testing in a structured way that would allow for the extraction of acceptance criteria, reported performance against those criteria, or the methodology of a formal study.

Therefore, I cannot provide the requested information based on the input text. The information required for your questions (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in the provided document.

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study reports or comprehensive performance data as you might find in an IDE or PMA submission.

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Match Master low fusing porcelain is to be used in conjunction with metal or pressable ceramic framework in the construction of crowns and/or bridgework.

Not Found

This document is a letter from the FDA to Davis Schottlander & Davis Limited regarding their device, Schottlander MATCH MASTER Low Fusing Porcelain. The letter states that the FDA has reviewed the company's premarket notification (510(k)) and determined that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the FDA's regulatory decision regarding market clearance based on substantial equivalence. Therefore, I cannot provide the requested information from the given text.

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Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Not Found

This document is a 510(k) premarket notification approval letter for a dental device. It does not contain information about acceptance criteria, device performance metrics, or study details as requested. The content is an FDA regulatory approval, not a scientific study report.

Therefore, I cannot provide the requested information based on the given text.

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ENIGMA denture base is to be used in conjunction with denture teeth in the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Schottlander ENIGMA HI-BASE Denture base material

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, training set details), or the type of ground truth used.

The document is an FDA 510(k) clearance letter for a dental device (Enigma Hi Base Denture-Base Material), indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements. Attachment #4 provides the "INDICATIONS FOR USE" for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.

Silk Non-Absorbable Surgical Sutures are composed of the organic protein fibroin which is derived from the domesticated species Bombyx mori (B.mori) of the family Bombycidae. Silk sutures are braided or twisted and available in white or dyed (black or blue). Braided sutures (except for size 8/0) are coated with silicone. Silk sutures are also available in various lengths, diameters and quantities with or without surgical needles. SILK sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in-vivo may result in gradual loss of all the suture's tensile strength over time. The proposed Silk suture needle will be manufactured using an automated end stiffening process of applying the medical grade adhesive to a portion of the silk strand which is then cured and cut to length.

The provided text describes a 510(k) submission for a Silk Non-Absorbable Surgical Suture with UV-10 adhesive, focusing on the substantial equivalence to a previously cleared device. The key change is an automated needle-end stiffening process compared to a manual one.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of a typical clinical study or a performance study with a defined sample size for the evaluation of the automated needle-end stiffening process. The primary evidence presented is biocompatibility testing.

• Sample size: Not explicitly stated for biocompatibility tests. It's usually a small number of samples required to demonstrate biological compatibility according to standards.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, biocompatibility testing is typically conducted in a laboratory setting.

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

Not applicable. This device submission primarily relies on biocompatibility testing and demonstrating substantial equivalence to a predicate device. There is no "ground truth" derived from expert review of cases in the way that might apply to a diagnostic imaging AI algorithm. The "ground truth" for biocompatibility is established by adherence to recognized standards (ANSI/AAMI 10993 and USP guidelines) and passing the specified tests.

4. Adjudication method for the test set

Not applicable. There is no "test set" that requires adjudication (e.g., clinical cases reviewed by experts).

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 surgical suture, not a diagnostic device with an AI component.

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

Not applicable. This is a surgical suture, not a diagnostic device with an AI component.

7. The type of ground truth used

For the safety assessment, the "ground truth" is based on:

• Biological standards: Adherence to ANSI/AAMI 10993 and USP guidelines for biocompatibility.
• Predicate device characteristics: The known safety and performance profile of the legally marketed predicate Silk Non-Absorbable Surgical Suture (K930590). The new device is considered "substantially equivalent" if it shares the same safety and effectiveness profile.

8. The sample size for the training set

Not applicable. This is a physical medical device (suture), not a machine learning model.

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

Not applicable. This is a physical medical device (suture), not a machine learning model.

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