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The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with mild, moderate, and severe stress urinary incontinence

The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system to treat women with urinary incontinence. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of an intravaginal wand and a hand-held controller. The Flyte wand is placed in the vagina and, under the direction of the controller, delivers a series of mechanical vibrations while the pelvic floor muscles are contracting. This treatment is called mechanotherapy.

The Flyte controller controls the wand, guides the user through the treatment session and provides visual information to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand is designed to make optimal contact within the vaginal canal and to deliver vibrations via an eccentric weight driven by an electric motor which causes the wand to oscillate at a specific frequency as directed by the controller. The wand additionally provides a resistive surface against which the user can contract the PFM. A cable connects the wand and the controller.

Controller: The controller consists of a 3.7V Lithium-ion Polymer rechargeable battery with a capacity of 700-750 mAh and built-in safety protection. The controller also contains a PCB assembly used to control the motor speed and frequency and to provide the user with visual information. The controller housing is made of ABS plastic (Acrylonitrile-butadiene-styrene copolymer).

Wand: The wand contains an accelerometer and gyroscope which enable the Controller to generate visual information. It also houses the motor and weight used to generate mechanical vibrations. The wand is available in large and small sizes. The wand housing is cylindrical and is made of ABS plastic. The wand is the only part of the device that directly contacts the user's vaginal cavity (mucosal membrane contact,

The provided text describes a 510(k) premarket notification for the "Flyte Mechanotherapy System, MTI-1.5". This document focuses on the substantial equivalence of the new device (MTI-1.5) to a predicate device (MTI-1.0) and presents non-clinical and clinical data to support this claim.

However, the document is a regulatory submission for a physical medical device (perineometer) that uses mechanical vibrations and a mobile app. It is not for an AI/ML-driven diagnostic or prognostic device that relies on complex algorithms to interpret data or images. Therefore, the acceptance criteria and study design elements typically associated with AI/ML device evaluations (e.g., specific acceptance metrics like AUC, sensitivity, specificity, expert ground truth adjudication for image interpretation, MRMC studies) are not applicable in this context.

The study described is a clinical trial to demonstrate the effectiveness of the physical device in treating stress urinary incontinence based on a specific clinical outcome (24-hour pad weight).

Here's an attempt to answer the questions based only on the provided text, while acknowledging the inherent mismatch in the questions asked and the nature of the device:

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

The document does not explicitly state "acceptance criteria" in the format of a table with specific thresholds for performance metrics. Instead, it reports on the clinical benefits observed in a clinical trial.

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The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with stress urinary incontinence.

The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of a wand and a hand-held controller. The Flyte wand is placed in the vagina and delivers a series of mechanical vibrations while the pelvic floor muscles are contracting. The hand-held controller controls the wand, guides the user through the treatment session and provides a visual feedback function to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand provides a resistive surface against which the user can contract the PFM, and houses an electric motor containing an eccentric weight that generates mechanical oscillations when the motor is running. A cable connects the wand and the controller.

The provided document [K233362] is a special 510(k) submission for a labeling modification to the Pelvital USA, Inc. Flyte System (aka Flyte System) (MTI-1.0). This means the device itself, its technological characteristics, and its principles of operation have not changed from its already cleared predicate device (K212655 Flyte System).

Therefore, this specific submission does not contain new acceptance criteria or a new study to demonstrate device performance. The document explicitly states: "Given the changes proposed in this submission were limited to minor labeling changes, no clinical and non-clinical performance data was submitted in this submission to support the changes."

To answer your questions, we would need the documentation associated with the original K212655 Flyte System clearance, which established the acceptance criteria and presented the performance study data that supported the substantial equivalence of the original device.

Without that original document, I can only provide general information based on the typical requirements for predicate devices.

Based on the information provided in K233362, the following answers apply:

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

• No new acceptance criteria or reported device performance are presented in this submission. The submission is for a labeling modification only, indicating no changes to the device itself.

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

• Not applicable to this submission. No new performance studies were conducted or presented. The original premarket notification (K212655) would contain this information.

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

• Not applicable to this submission. No new performance studies were conducted or presented.

4. Adjudication method for the test set:

• Not applicable to this submission. No new performance studies were conducted or presented.

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 to this device. The Flyte System is a perineometer for strengthening pelvic floor muscles and does not involve AI or human readers evaluating medical images, which is typically where MRMC studies are performed.

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

• Not applicable to this device. The Flyte System is a physical medical device, not an algorithm, and is intended for user-operated rehabilitative exercise, not an automated diagnostic or treatment system in the context of standalone algorithm performance.

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

• Not applicable to this submission. No new performance studies were conducted or presented. For the original device, performance would likely have been evaluated based on outcomes data related to pelvic floor muscle strengthening and reduction in stress urinary incontinence symptoms.

8. The sample size for the training set:

• Not applicable to this submission. No new performance studies were conducted or presented. This device does not have a "training set" in the context of machine learning.

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

• Not applicable to this submission. As above, this device does not have a "training set" in the machine learning sense.

In summary, this document K233362 explicitly states that no new performance data was submitted because the submission is solely for a minor labeling modification, and the device itself is identical to its predicate (K212655). To obtain the requested information, you would need to review the original 510(k) submission for the K212655 Flyte System.

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The Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

Not Found

This is an FDA premarket notification (510(k)) letter for the Pelvital USA, Inc. Flyte™ System. The letter itself does not contain detailed information about acceptance criteria or the study that proves the device meets those criteria. It primarily states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar intended use and technological characteristics as a device already on the market.

To answer your request, I would need access to the actual 510(k) submission (K212655) or accompanying clinical study documentation, which is not provided in these FDA letters. The provided text only confirms the clearance of the device and its intended use: "The Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence."

Without the actual study data, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

For this specific FDA letter, the requested details are not present.

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The Pelvital Flyte™ System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

Not Found

The provided text is an FDA 510(k) clearance letter for the Pelvital Flyte™ System, a device intended for strengthening pelvic floor muscles to help women with stress urinary incontinence.

Unfortunately, the document does not contain any information regarding the following:

• Acceptance criteria for device performance.
• The study that proves the device meets acceptance criteria.
• Reported device performance metrics.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of AI assistance on human readers.
• Whether standalone (algorithm only) performance was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is primarily a regulatory clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices and outlining the regulatory requirements for the manufacturer. It does not delve into the specific details of performance studies or acceptance criteria.

To obtain the information requested, one would typically need to refer to the 510(k) summary or other supporting documentation submitted by the manufacturer to the FDA, which would detail the performance data and testing conducted for the device. This information is not present in the provided FDA clearance letter.

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The devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.

There are three models in the Quingo range for this subject 510(k): Quingo Flyte Power Scooter, S551 (transportable model), Quingo Classic Power Scooter, S1301 and Quingo Toura Power Scooter, S350 (pavement and higher speed models). They all have very similar characteristics which are detailed below, with the main differences being: length, widths, motor size, controller size, and wheel size. All the Quingo models scooter frames are a welded steel construction and they all include 2 rear wheels connected by a motor/ transaxle with an electromagnetic brake, batteries, and they all have 3 front wheels and a tiller to control its turning direction. When the user activates the throttle lever, the controller receives a signal to release the brakes. With the brakes released, the scooters are allowed to move forwards or backward. When the user releases the throttle lever, the scooter slows to a stop and the brakes are automatically re-engaged. The electromechanical brakes allow the user to stop by letting to of the throttle lever. All the Quingo Models have an emergency parking brake, the lever for this brake is on the tiller and the brake itself is a carbon disc brake on to the front middle wheel.

The provided document is a 510(k) summary for a medical device, specifically power scooters. It does not contain information about an AI/ML-driven medical device, nor does it detail acceptance criteria and a study proving an AI/ML device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance standards and comparisons of specifications.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves an AI/ML device meets acceptance criteria based on the provided text. The document discusses:

• Device Description: Power scooters (Quingo Classic, Flyte, Toura).
• Predicate Device: Merits Transformer, Model S941, K142162.
• Comparison Tables: Detailed comparisons of physical, electrical, and performance characteristics between the subject devices and the predicate device.
• Non-Clinical Tests: Adherence to various ISO, ANSI, BS EN, and IEC standards for wheelchairs and motorized three-wheeled vehicles (e.g., static stability, dynamic stability, brakes, energy consumption, dimensions, speed, strength, climatic tests, electromagnetic compatibility, ignition resistance).
• Clinical Tests: Stated as "Not applicable as there are no new indications for use which must be supported by a clinical data."
• Software Information: Mentions "Software validation was conducted in accordance with a major level of concern designation" but provides no details on the validation study itself.

None of this information pertains to the rigorous evaluation of an AI/ML device's performance against defined acceptance criteria, including aspects like sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies for human-AI interaction.

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The Quingo Flyte is an electric scooter designed to provide transportation to those with mobility limitations such as the disabled or elderly.

The Quingo Flyte Mobility Scooter is a battery powered indoor scooter. The vehicle uses a 5 (Five) wheel system comprised of 3 main wheels with two additional wheels to provide additional safety, stability and improved turning ability. Attached to the wheelbase are a padded seat, steering tiller, bars and electronic controls which allow the user to properly direct and control the vehicle. As the vehicle is battery powered a charging unit is included. To assist with loading into vehicles for transport an aluminium railing system which fits into most vehicles is provided along with a directly wired electronic control so that no disassembly is required and no heavy lifting by the user is needed.

The provided document, K171256 for the Quingo Flyte Mobility Scooter, is a 510(k) premarket notification and does not contain the information requested for acceptance criteria and a study proving device performance in the context of an AI/software as a medical device (SaMD).

This document demonstrates substantial equivalence to a predicate device (Kymco EQ 30) based on intended use, technological characteristics, and performance testing against ISO standards for mobility scooters, not clinical or diagnostic performance criteria as typically seen for AI/SaMD.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) from the provided text.

Here's why:

• Type of Device: The Quingo Flyte Mobility Scooter is a physical, mechanical device, not an AI/SaMD. The FDA's review process for such devices focuses on safety, mechanical performance, and substantial equivalence to existing devices through engineering tests and adherence to industry standards like ISO 7176.
• Absence of AI/SaMD-specific Information: The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This further confirms that the type of study, ground truth, expert involvement, and statistical metrics (like sensitivity, specificity, or effect size for human readers) typically associated with AI/SaMD performance validation are not present.
• "Acceptance Criteria" Context: For this device, "acceptance criteria" largely refer to meeting the requirements of the ISO 7176 standards listed, which are engineering and functional performance benchmarks (e.g., maximum speed, braking distance, weight capacity, stability, etc.), not diagnostic accuracy metrics.

In summary, the provided text does not contain the information necessary to fulfill your request regarding acceptance criteria and a study proving device performance for an AI/SaMD.

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The Stryker Steri-Shield Flyte Hybrid Togas are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material. The togas are sterile and single use only.

The Steri-Shield Flyte Hybrid Togas are single use, sterile, disposable devices that comprise part of the Steri-Shield Flyte Hybrid Personal Protection System. They are intended to be worn by healthcare personnel to protect the patient and healthcare personnel against contamination, exposure of infectious bodily fluids and the transfer of microorganisms and particulate material. The devices are prescription use.

The provided FDA 510(k) summary for the Stryker Steri-Shield Flyte Hybrid Togas describes performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria per se. The context is a "Special 510(k): Device Modifications with no change to fundamental scientific technology or intended use."

The document focuses on comparing the modified device (Stryker Steri-Shield Flyte Hybrid Togas) to its predicate device (Stryker Steri-Shield Flyte Togas, K073017) across various specifications and explicitly states that the "Results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Steri-Shield Flyte Hybrid Togas are sufficient for their intended use and support a determination of substantial equivalence."

Key points from the provided text:

1. Acceptance Criteria and Reported Device Performance:

   The document doesn't explicitly list "acceptance criteria" but rather presents a comparison table where the subject device's performance is listed against the predicate device's performance, often with "Compliant - Pass" as the reported result for both. The "Explanation of Difference" column clarifies if the subject device meets the same specifications, even if materials or test standards changed.

   Acceptance Criteria (Implied / Specification Met)	Reported Device Performance (Stryker Steri-Shield Flyte Hybrid Togas)
   Biocompatibility: Non-cytotoxic	Non-cytotoxic
   Biocompatibility: Non-sensitizing	Non-sensitizing
   Biocompatibility: Negligible irritant	Not an irritant
   Sterility Assurance Level (SAL)	10⁻⁶
   Lint Level (ISO 9073 part 10)	Compliant - Pass
   Tensile Strength (BS EN 29073-3)	Compliant - Pass
   Tear Resistance (ASTM D 5587-08)	Compliant - Pass
   Evaporative Resistance (ASTM F 1868)	Compliant - Pass
   Bacterial Filtration Efficiency (ASTM F2101-07)	Compliant - Pass
   Particulate Filtration Efficiency (ASTM F2299-03)	Compliant - Pass
   Viral Penetration (ASTM F1671) Level 4 (Critical Zone)	Front/Sleeve material: Pass requirements for Level 4 Protection. Sleeve Seam: Pass requirements for Level 4 Protection. (Note: Hood region material not designed to meet Level 4)
   Water Resistance: Impact Penetration (AATCC 42) Level 1 (Critical Zone)	Hood region material: Pass requirements for Level 1 Protection. Back material: Pass requirements for Level 1 Protection. All other protective seams: Pass requirements for Level 1 Protection.
   Flammability (16 CFR Part 1610)	No Flame Spread
   Shelf Life (initial submission)	1 year (with intent to extend upon further studies)

2. Sample Size Used for the Test Set and Data Provenance:
   The document does not specify exact sample sizes for each performance test. It only states "Results of performance testing demonstrate..." without numerical data on the number of units tested.
   The data provenance is not explicitly stated beyond being "performance testing" conducted by Stryker Instruments. It is prospective testing performed to support the 510(k) submission for the modified device. There is no mention of country of origin for the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   This information is not applicable to this type of device and study. The testing described is primarily physical, mechanical, and biological performance testing against recognized standards (e.g., ISO, ASTM, AAMI, AATCC, CFR). There is no "ground truth" established by human experts in the context of diagnostic accuracy, for example. The "truth" is whether the material or assembled device meets the specified performance metrics in the standards.

4. Adjudication Method for the Test Set:
   Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation of outputs (e.g., imaging devices with radiologists). The Stryker Steri-Shield Flyte Hybrid Togas are surgical apparel, and their effectiveness is evaluated through physical and biological barrier properties, not diagnostic accuracy or human interpretation.

6. Standalone Performance:
   Yes, a standalone performance assessment was done. The performance testing (biocompatibility, sterility, lint level, tensile strength, tear resistance, evaporative resistance, bacterial filtration, particulate filtration, viral penetration, water resistance, flammability, shelf life) evaluates the intrinsic properties and performance of the device itself, separate from human interaction or interpretation beyond fitting and use.

7. Type of Ground Truth Used:
   The "ground truth" used is defined by established international and national standards for medical devices and textiles, such as:

   • ANSI/AAMI/ISO 10993-1:2009 (Biological Evaluation of Medical Devices)
   • ANSI/AAMI/ISO 11135-1:2007 (Sterilization)
   • ISO 9073 part 10 (Lint Level)
   • BS EN 29073-3 (Tensile Strength)
   • ASTM D 5587-08 (Tear Resistance)
   • ASTM F 1868 (Evaporative Resistance)
   • ASTM F2101-07 (Bacterial Filtration Efficiency)
   • ASTM F2299-03 (Particulate Filtration Efficiency)
   • ASTM F1671 (Viral Penetration)
   • AATCC 42 (Water Resistance: Impact Penetration)
   • 16 CFR Part 1610 (Flammability)

   The device performance is compared against the requirements specified in these standards.

8. Sample Size for the Training Set:
   This information is not applicable. This device is not an AI/ML algorithm that requires a training set for model development. The modifications are material changes and dimensional adjustments for physical apparel.

9. How the Ground Truth for the Training Set Was Established:
   Not applicable, as there is no training set for this type of device.

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The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

The devices are provided sterile and for single use only.

The Stryker Flyte Hybrid Hoods are intended to be worn over a Flyte Helmet to provide protection to the user's face and head region during surgery. Hoods are worn in conjunction with surgical gowns where the hood material extends beyond the user's upper back and shoulders, while the surgical gown covers the lower portion of the hood up to the user's neck.

The Stryker Flyte Hybrid Hood is comprised of 3 main parts: Hood, Filter and Lens. Stryker Flyte Hybrid Hoods are available with either a standard or peel away lens.

The devices are prescription devices, provided sterile and single use only.

This document describes the acceptance criteria and performance data for the Stryker Flyte Hybrid Hoods.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Stryker Steri-Shield Flyte Toga, Pullover; Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens, Zippered are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

The scope of this Special 510k material modification is limited to material changes to the gown. The toga has a hood and gown section. The hood covers the user's head. A lens is attached to the front of the hood. The gown of the toga covers the user's front, back and arms. The Stryker Steri-Shield Flyte Togas are tested to meet applicable AAMI PB70:2003 standards. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hoods and lens (components of the togas) are exempt from classification under the AAMI PB70:2003 standard.

Stryker Steri-Shield Flyte Toga, Pullover: The Stryker Steri-Shield Flyte Toga, Pullover is intended to be worn over any Stryker Flyte Helmet. The Stryker Steri-Shield Flyte Pullover togas provide Level 4 and Level 1 barrier protection for the critical zones as set froth in the accompanying drafted IFUs (Attachment 8 and as classified under the AAMI (Association for the Advancement of Medical Instrumentation) guidelines for barrier performance. This garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM F1671:2003 per the AAMI Barrier Classification System and demonstrate a passing result with an AQL of 4% under Procedure A. Level 1 zones resist liquid penetration per AATCC (American Association of Textile Chemist and Colorist) 42:2000 with an AQL (acceptable quality level) of 4%. Level 4 critical zones resist liquid and viral penetration. The Stryker Steri-Shield Flyte Toga Zippered garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM (American Society for Testing and Materials) F1671:2003 with an AQL of 4% under Procedure A. The barrier material for the Stryker Steri-Shield Flyte Toga Pullover is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. The Stryker Steri-Shield Flyte Toga, Pullover will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.

Stryker Steri-Shield Flyte Toga, Zippered: Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; Stryker Steri-Shield Flyte Toga with UV Lens, Zippered. The Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens. Zippered are intended to be worn over any Stryker Flyte Helmet. The Stryker Steri-Shield Flyte Togas provide protection as specified by the AAMI (Association for the Advancement of Medical Instrumentation) Barrier Classification System. Level 1 zones resist liquid penetration per AATCC (American Association of Textile Chemist and Colorist) 42:2000 with an AQL (acceptable quality level) of 4%. Level 4 critical zones resist liquid and viral penetration. The Stryker Steri-Shield Flyte Toga Zippered garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM (American Society for Testing and Materials) F1671:2003 with an AQL of 4% under Procedure A. The Level 4 barrier material is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. The Level 1 material on the back of the zippered togas is constructed of 35 gram SMMS polypropylene. The Stryker Steri-Shield Flyte Toga. Zippered will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.

The provided text describes a 510(k) submission for Stryker Steri-Shield Flyte Togas, which are surgical gowns. The focus of the submission is on material changes to existing products and demonstrating substantial equivalence to predicate devices, rather than a study on a new device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested categories for AI/medical device studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, stand-alone performance) are not applicable to this document as it's not a clinical trial of an AI-powered diagnostic or therapeutic device.

However, I can extract information related to the performance standards and testing mentioned for the Steri-Shield Flyte Togas.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This document describes performance testing against material standards, not a clinical study with a "test set" of patient data. The AQL (Acceptable Quality Level) of 4% for certain tests refers to a sampling plan for manufacturing quality control, not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/medical device studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for these tests are the established and recognized testing methodologies and standards (AAMI, AATCC, ASTM).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a clinical test set is relevant to this document.

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 not an AI-powered device or a cognitive aid for 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 device's "standalone" performance is its ability to meet the defined material barrier standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference standards used are established industry and regulatory standards for material performance:

• AAMI PB70:2003 (Association for the Advancement of Medical Instrumentation)
• AATCC 42:2000 (American Association of Textile Chemist and Colorist) for liquid penetration
• ASTM F1671:2003 (American Society for Testing and Materials) for resistance to viral penetration (bacteriophage Phi-X174).

8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device and testing.

9. How the ground truth for the training set was established
Not applicable.

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