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Medi-Tech International Corporations Easy-View Mitts are intended to be utilized as a patient safety device when patients are assessed at risk of disrupting life-saving treatments or could cause self-injury.

The Medi-Tech International Corp. Protective Restraint is a protective restraint device which is intended for medical purposes to control the movement of a patient's hand or finger movements thereby enabling examination or protection of the patient or others. Device Design Materials Used/Physical Properties: The Medi-Tech Protective Restraint is designed similar to those marketed by other manufacturers. Primarily comprised of cotton and polyester material and polyester fiber filling.

The Medi-Tech International Corp. Protective Restraint (Easy-View Mitts, Model #MTRM281) is a protective restraint device intended to control the movement of a patient's hand or finger movements to enable examination or protection of the patient or others, particularly when patients are at risk of disrupting life-saving treatments or causing self-injury.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Non-Clinical Data: One individual, Marilyn Geiger, Medi-Tech International Corporation's Product Manager, was used for the "Non-Clinical Data" tests (Safety, Effectiveness, Function).
  • Bench Testing: The document does not specify the number of units or samples tested for each of the bench tests (e.g., how many fabric swatches for tearing resistance, how many mitts for seam failure). The tests were performed by Intertek testing facility.
• Data Provenance: Retrospective, as these tests were conducted to demonstrate substantial equivalence to an already marketed device (J.T. Posey Company Protective Restraint K963413). The document doesn't specify country of origin for the data beyond the testing facility (Intertek) being utilized.

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

• Non-Clinical Data: One "expert" (Marilyn Geiger, Product Manager) conducted the tests and reported the results. Her specific qualifications beyond being the company's Product Manager are not detailed in the provided text. No independent expert consensus was explicitly stated.
• Bench Testing: The testing was performed by Intertek, a third-party testing facility. While not explicitly stated as "experts," Intertek is a recognized testing institution, implying their personnel are qualified to conduct the specified ASTM and AATCC tests. No ground truth was established by human consensus for these physical tests; they are objective measurements against established standards.

4. Adjudication method for the test set

• Non-Clinical Data: No explicit adjudication method (like 2+1 or 3+1) is mentioned. The testing appears to have been observed and reported by a single individual (Marilyn Geiger).
• Bench Testing: The concept of "adjudication" as typically applied to clinical or image-based studies doesn't apply directly here. The bench tests involve objective measurements and visual inspections against defined criteria and standards. The results would be objectively determined by the testing equipment and qualified technicians at Intertek.

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 protective restraint and not an AI-assisted diagnostic or therapeutic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

• No standalone algorithm performance study was done, as this is a physical medical device, not a software algorithm or AI.

7. The type of ground truth used

• Non-Clinical Data (Safety, Effectiveness, Function): The ground truth was based on observational assessment and comparison to the predicate device by the Product Manager. The "ground truth" was essentially the subjective judgment that the device performed "as intended" and "similar" to the predicate.
• Bench Testing: The ground truth was based on objective physical measurements against established industry standards (e.g., ASTM, AATCC) and visual inspections for compliance with design specifications (e.g., labeling, workmanship, sharp edges). The predicate device served as a comparative benchmark for several functional and material properties (e.g., strap strength, material composition).

8. The sample size for the training set

• No specific training set in the context of machine learning or AI is mentioned, as this is a physical medical device. The "training" for such a device would typically involve design, engineering, and manufacturing processes, not data-driven algorithm training.

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

• Not applicable, as there is no training set in the context of AI/ML for this device. The design and development of the device would have been guided by engineering principles, material science, and regulatory requirements, and benchmarked against existing devices.

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The intended use of this (single patient use) safety strap set is to act as a positioning aid and to prevent accidental falls of the pre-term (

The STATStrap™ Neonatal Incubator Safety Strap is a soft closed cell foam material covered with a laminate of soft fabric that allows Hook (Velcro® style) fabric to attach to it along the straps entire length. The end of each strap incorporates a hook fabric wing tab or a wire spring hook, so as to attach each strap to the infant incubator tray. These 13 inch straps are positioned in four positions altation our carp to the menthess tray so as to fit the patient's size. Once the straps are in place and securely fastened to the mattress tray, the straps cross over the neonate ( infant's ) body in a "X" pattern and attach to each other so as to provide positioning aid, prevent gross body movement or falls of the patient. A hook "tie strap" is included on both models to secure the two main straps together into a single unit. These straps are single patient use disposable items. Labeling states the disposable nature of the strap, precautions and the use instructions.

The provided text describes a 510(k) premarket notification for the STATStrap™ Neonatal Incubator Safety Strap. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove safety and effectiveness.

Therefore, many of the typical acceptance criteria and study components usually associated with a novel device's performance evaluation (like specific accuracy metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance studies) are not applicable in this context. The focus here is on comparing the new device's characteristics and intended use to an existing, approved device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for the device itself. Instead, the "acceptance criteria" are implied by the demonstration that the STATStrap™ shares the same fundamental design, materials, chemical composition, intended purpose, and attachment mechanism as the identified predicate devices, with only minor differences such as single-patient use labeling. The reported "performance" is that it functions in the same manner as existing safety straps.

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

• Not applicable. No test set in the traditional sense of a performance study was conducted. The equivalence was based on a comparison of device characteristics to predicate devices.
• The "study" is a comparison to legally marketed predicate devices, not a clinical trial with a test set of patients.

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

• Not applicable. There was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or expert adjudication was performed.

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

• No. This type of study is not typically required for a 510(k) substantial equivalence submission for a physical accessory device like this.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

• Not applicable. This device is a passive physical accessory, not an algorithm or software. Its function inherently involves human interaction (placement by a user).

7. The Type of Ground Truth Used:

• Not applicable. No ground truth in the sense of clinical outcomes or pathology was established for the STATStrap™ as part of this submission. The "truth" considered by the FDA in a 510(k) is whether the new device is "substantially equivalent" to an existing, approved predicate device in terms of safety and effectiveness.

8. The Sample Size for the Training Set:

• Not applicable. No training set for an algorithm was used.

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

• Not applicable. No training set or ground truth for a training set was established.

Summary of the "Study" and Its Findings:

The "study" or evidence provided is a comparison to predicate devices (K031096/K850496A by International Bio Medical / Airborne Life Support, and K001019/K941106 by Hill-ROM Airshield / Draeger Medical Inc.).

• Conclusion from Testing: The submission explicitly states "Clinical Data: Not applicable" and "Summary / Conclusion from Testing: Not applicable." This indicates that no new clinical or performance testing was conducted or submitted with this 510(k).
• Proof of Meeting Acceptance Criteria: The device met the "acceptance criteria" by demonstrating that its characteristics (design, materials, intended use, function) are substantially equivalent to those of the legally marketed predicate devices. The minor differences (single-patient use labeling, specific attachment mechanisms for different incubator types, and being labeled with the company name) were deemed not to raise new questions of safety or effectiveness. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

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The Centurion® Protective Restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting.

The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.

The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyester foam core, and nylon tricot backing.

The provided text describes a 510(k) premarket notification for the Centurion® Protective Restraint. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety or effectiveness through extensive clinical trials. Therefore, the study described is a comparative bench performance test.

Here’s an analysis of the provided information, framed by your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text only mentions "Comparative bench performance testing was performed."
• Data Provenance: The study was a "bench performance testing," implying it was conducted in a laboratory setting, likely by the manufacturer (Tri-State Hospital Supply Corporation). There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies.

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

• This information is not provided as this was a bench performance test, not a clinical study involving human judgment on clinical outcomes. Ground truth for a bench test would be based on engineering specifications and direct measurements against those specifications.

4. Adjudication Method for the Test Set

• This is not applicable/not provided as no human expert adjudication of clinical performance was involved in this bench test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

• No, an MRMC comparative effectiveness study was not done. The submission describes a 510(k) for a Class I device, which relies on demonstrating substantial equivalence through bench testing, not clinical studies like MRMC.

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

• This question is not applicable as the device is a physical protective restraint, not an AI algorithm or software.

7. The Type of Ground Truth Used

• The ground truth for this bench testing would have been based on pre-defined engineering specifications, material properties, and functional requirements for protective restraints, derived from regulatory standards, internal product design specifications, and the characteristics of the predicate device. It's not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This section describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, this device does not utilize AI/ML and therefore does not have a "training set" or ground truth established for one.

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ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actors associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable anatomical areas and for recovery from minor physical injuries.

ComfortCare Absortek fabric construction provides for absorption and venting of perspiration thereby minimizing potential for skin irritation.

ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents moisture and minimizes damp layer conducive to bacterial and fungal growth.

(a) Elasticized material to support and compress a part of the body. (b) Insole provides magnetic Magnets encased in breathable fabric reader comers (a) (ents moisture to keep feet dry.

This document describes a Special 510(k) Pre-Market Notification for modifications to an existing device, not a new device requiring a comprehensive performance study with acceptance criteria. Therefore, much of the requested information regarding performance metrics, sample sizes, and expert adjudication for a study proving acceptance criteria will not be present.

Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, despite the addition of magnets.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is largely not applicable in the traditional sense for this type of 510(k) submission. The "acceptance criteria" here relate to the regulatory standards for substantial equivalence, rather than specific performance metrics of the device itself that would require a study to "prove".

The fundamental "acceptance criteria" for this Special 510(k) were to demonstrate that the modifications (adding magnets) did not alter the fundamental technology, safety, or intended use of the predicate devices. The "reported device performance" is the claim of substantial equivalence.

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

• Not applicable. This submission does not describe a clinical performance study with a test set. The evidence provided is primarily based on regulatory comparison and literature review regarding magnet safety.

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

• Not applicable. No test set or expert ground truth was established for the device's efficacy in this submission. The FDA's review process inherently involves regulatory experts (e.g., those in the Division of Dental, Infection Control and General Hospital Devices) evaluating the substantial equivalence claim.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication was performed.

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-enabled device or a diagnostic device where MRMC studies would typically be conducted.

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

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

7. The Type of Ground Truth Used

• The "ground truth" in this context is the established regulatory framework for similar existing devices (predicate devices) and scientific consensus/literature regarding the safety of static magnets.
  • For the compression component: Established regulatory classifications (Section 880.5075) for elastic bandages and common use/characteristics of legally marketed products (e.g., Ace, Decam).
  • For the insole component: Established regulatory classifications (Section 880.6280) for medical insoles and common use/characteristics of legally marketed products.
  • For the magnet component: World Health Organization reports and "numerous studies" supporting the safety limits of 20,000 Gauss, and the historical use of magnets.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that would have a "training set." The product's development would likely incorporate design verification and validation testing, but these are not described as "training" in the context of this 510(k) summary.

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

• Not applicable. As above, there is no "training set" for this type of device.

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BioThane Patient Restraints are intended for medical purposes only. They are intended to limit the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

Not Found

This document is an FDA 510(k) clearance letter for the BioThane™ Patient Restraint. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for diagnostic or AI-driven medical devices.

The letter is the outcome of a regulatory review stating that the device is "substantially equivalent" to legally marketed predicate devices. This means that, based on the information provided in the 510(k) submission (which is not included here), the FDA determined the device is as safe and effective as a predicate device.

Therefore, I cannot extract the requested information from the provided text. This document is a regulatory clearance, not a performance study report.

Specifically, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This document doesn't define specific performance metrics or acceptance criteria for the restraint device itself. It's a regulatory approval.
2. Sample size used for the test set and the data provenance: No test set information is present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic test set.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical patient restraint, not an AI or diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Yagabond for Neonatal Transport: This soft restraint system is indicated for transport of neonates from one hospital to another when isolets are necessary for perservation of life. The Vagabond Neonate Transport System safely insures the well being in the event of sudden jarring or accident. The neonate is proteced withi this special device from lateral or vertical movement due to collision or rough ride.

Vagabond for EMS Transport: This application is used for adults and pediatric patients when they are picked up in the field by Emergency Medical Service personnel and an EMS board is used for transport. Instead of using single straps the Vagabond provides eight points of secure side release locks along iwth a combination of webbing and netting to safely secure the patient to the baord for transport.

Vagabond for Panoose Application: The papose application is necessary for the pediatric patients who require emergency room procedures sucha as suturing or other Minor procedures where they need to remain tionary. The Vagabond board and restrain system comfortabily holds the child in place and can serve as an and for transport whent he child might need to be transferred to another dept. of a hospital. This is accomplished by merely lifting the patient and the board onto a cot or rolling bed.

Yagabond for bed restraint: This restraint is used when patients are sedated or disoriented and there is concern over thier falling out of bed. The Vagabond restraint helps to insure the and there is concent by providing a comfortable restraint that serves to keep them in bed.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device called the "Vagabond Soft Restraint System." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical trial or performance evaluation.

However, based on the nature of the document, we can infer some aspects and highlight what information is missing.

What the document tells us (and what it doesn't):

The document grants substantial equivalence to a predicate device, which means the FDA has determined the new device is as safe and effective as a legally marketed device. This process typically relies on comparing the new device's design, materials, and intended use to an existing, approved device, rather than requiring extensive new performance studies against specific acceptance criteria.

Response to your questions based on the provided document:

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

   • Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or mechanical stress limits). The acceptance criterion implicitly met is "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as a legally marketed device.
   • Reported Device Performance: The document does not report specific device performance metrics resulting from a study. It only describes the "Indications For Use" for which the device is considered substantially equivalent. These indications describe how it's meant to be used, implying it performs adequately for these uses, but without quantitative data.

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

   • The document does not mention any specific test set sample size or data provenance for a study demonstrating performance. The 510(k) process primarily involves comparing the new device to a predicate, and often relies on bench testing, previous clinical data for the predicate, or design specifications rather than a new large-scale clinical trial for every submission.

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):

   • This information is not provided. As no specific test set or clinical study is detailed, the establishment of ground truth by experts is not discussed.

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

   • This information is not provided. There is no mention of a test set or an adjudication method.

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. The "Vagabond Soft Restraint System" is a physical restraint device, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers or AI assistance in interpretation.

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

   • This is not applicable as the device is a physical restraint system, not an algorithm.

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

   • Since there's no mention of a specific performance study in this document, there's no information on the type of ground truth used. The "ground truth" for a physical restraint device would typically relate to its mechanical integrity, durability, and effectiveness in securing patients according to established safety standards, which are usually assessed through engineering tests and comparison to predicate devices, not clinical outcomes data in the same way as a diagnostic device.

8. The sample size for the training set:

   • This is not applicable. The device is a physical restraint system, not an AI model requiring a training set.

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

   • This is not applicable. The device is a physical restraint system.

In summary: The provided document is a regulatory clearance letter, not a scientific study report. It confirms the "Vagabond Soft Restraint System" is substantially equivalent to a legally marketed predicate device for various indications, but it does not detail the specific performance studies, acceptance criteria, or methodological aspects that would be present in a research paper. These types of details are usually contained in the 510(k) submission itself, which is a much larger and more technical document.

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The Heelbo Waist and Chest Vest is intended to 1) help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair and 2) help prevent a patient from falling out of bed or climbing over slide rails.

The Heelbo Waist and Chest Vest is a poncho style safety vest that has two sets of two straps that are secured to a wheelchair to support the upper torso. When all the straps are connected per the instructions the Heelbo Waist and Chest Vest is intended to help prevent the patient from slumping or sliding forward while seated in a wheelchair and helps to prevent a patient from falling out of bed. The Waist and Chest Vest is available in a polyester/cotton blend (9340) or a polyester mesh material (9340B).

The provided text is a 510(k) summary for the Heelbo Waist and Chest Vest. It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) based on intended use and technological characteristics, which is the primary requirement for a 510(k) premarket notification. This type of submission typically does not include extensive clinical trial data with specific performance metrics and acceptance criteria in the way a new, non-substantially equivalent device might.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from the provided text.

Here's what can be gathered:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics. The underlying "acceptance criteria" for a 510(k) submission are generally that the device is safe and effective for its intended use and is substantially equivalent to predicate devices.
• Reported Device Performance: The document claims the device is "safe and effective for its intended use and is substantially equivalent to the predicate device." However, no specific performance data (e.g., how effectively it prevents falls, or slumping) is provided.

Table (based on substantial equivalence comparison, not performance metrics):

2. help prevent a patient from falling out of bed or climbing over slide rails. |
   | Materials | Generally safe materials for patient contact (as evidenced by predicate) | Polyester Cotton Blend, Polyester Mesh (materials identical to previously cleared Heelbo devices K963099 and K963041) |
   | Number of straps | Same as predicate (2 straps) | 2 |
   | Where used | Same as predicate (wheelchair, geriatric chair, bed) | wheelchair, geriatric chair, bed |

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The submission relies on a comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.

4. Adjudication method for the test set: Not applicable. No test set requiring 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. This document describes a medical device for physical support, not an AI-assisted diagnostic or imaging device 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 or software device.

7. The type of ground truth used: Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate devices as safe and effective.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an algorithm development.

9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

Summary of available information regarding the "study":

The "study" in this context is the 510(k) submission itself, which primarily demonstrates substantial equivalence to predicate devices. The arguments presented are:

• Comparison Chart: A direct comparison of the proposed device's characteristics (intended use, materials, number of straps, where used) to a predicate device (Posey® Waist and Chest Vest) and other cleared Heelbo devices.
• Biocompatibility: The materials used are identical to those cleared in previous Heelbo devices (K963099, K963041). The suppliers have a history of safe use in clothing/garment, and Heelbo Inc. reports no adverse biological incidents over 15 years with these materials.

In essence, the document implies that because the device is technologically similar and has the same intended use as already legally marketed devices, it can be considered safe and effective without requiring new clinical performance studies.

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Pedo Cush Pedo Cuddle is to be used under the direction and/or the supervision of a dentist only, as a tool to help manage an uncontrollable child for the purpose of protection of the child from injury while receiving dental treatment. It is not to be used as a punishment tool. The Health Professional must be in control of his/hers emotions while using the Pedo Cush if at any time he/she feels the overwhelming of the exnotions he/she must take a break, deliver the child back to the parent's arms. After the emotions are under control then helshe may continue to work. Remember that the option of referring out to another dentist is a possibility.

A combination restraint and cushion for securing a pediatric patient in a dental chair, said combination comprising; a restraint comprising a main body portion which has a plurality of flaps attached thereto, each of said flaps having hook and loop fasteners affixed thereto, such that said flaps can be positioned and fastened around said patient to hold said patients torso in position a plurality of strings (straps) for tying said restraint around said dental chair and a headpiece which fits around the top of said dental chair, said restraint having adhesive material affixed to the back thereof to hold said restraint in position on said dental chair, and a cushion having an arcuste indentation at its top end to hold said petient's buttooks in position, said cushion being enclosed in a pillowcase having an adhesive material affixed to the underside thereof in order to maintain said cushion in position on said dental chair, said pillowcase having a plurality of flaps attached thereto, said flaps each having hook and loop fasteners affixed thereto such that said flaps can be positioned and fastened around said patient's legs to hold them in position. Pedo Cush Pedo Cuddle is covered by U.S. Patent N. 5,425, 381 and is described in more detail therein.

The provided text describes a 510(k) premarket notification for a medical device called "Pedo Cush Pedo Cuddle." This document is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study designed to prove the device meets specific acceptance criteria in the way a clinical trial or performance study would. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth, and expert involvement is not present in this type of regulatory document.

However, based on the information provided, we can infer some aspects and extract others.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantifiable manner as would typically be seen in a performance study. Instead, the device's performance is described qualitatively in comparison to the predicate device. The primary "acceptance" is the FDA's determination of substantial equivalence, which is based on similar technological characteristics and performance for the stated intended use.

Study Details

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

   • Sample Size: "over 1,000 child patients" were reportedly tested.
   • Data Provenance: Not specified, but given the submitter's address (St. Paul, MN), it can be inferred the testing was likely conducted in the USA, at the submitter's facility or associated clinics. The data appears to be retrospective observation of clinical use rather than a controlled prospective study, as it describes a range of patient behaviors encountered in practice.

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

   • This information is not provided. The "testing" appears to be based on the experience of "Cavity Free Kids," likely dentists or dental professionals at their practice, observing the device's effectiveness. No independent experts or specific qualifications beyond being the users are mentioned for establishing a formal "ground truth."

3. Adjudication method for the test set:

   • No formal adjudication method is described. The performance claim is based on the general observation of "successfully managed the patients to allow dental procedures to be performed."

4. 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, an MRMC study was not done. The device is a physical pediatric restraint, not an AI or imaging device that would involve "readers" or AI assistance.

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

   • No, this is a physical device, not an algorithm. Its performance is inherently tied to human (clinician) interaction and application.

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

   • The "ground truth" is implicitly the successful completion of dental procedures on uncooperative children, as observed by the clinicians using the device. This is a form of outcomes data based on clinical observation, though not formally structured as a study with predefined endpoints and expert consensus. The "management" of the patients to allow procedures is the key outcome.

7. The sample size for the training set:

   • Not applicable/Not provided. This is not a machine learning model, so there is no training set in that sense. The "testing" on "over 1,000 child patients" appears to be the only data mentioned for performance evaluation.

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

   • Not applicable, as there is no training set mentioned in the context of an AI/machine learning model.

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