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The Pedi-Spider strap is designed for securing a pediatric patient to a long spine board, by the use of a checker board series of straps that are placed over the patient and secure to the back board with Velcro hook and loop closures on each side of the back board. The device should be used on children from 10 to 100 pounds and 12 to 55 inches in height.

The Pedi-Spider utilizes 1 ½" nylon or polypropylene material in a cargo net fashion with Velcro on the ends for securing the strap to the backboard.

The provided text describes a 510(k) submission for a medical device called the "Pedi-Spider Strap." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through a study with acceptance criteria in the same way a novel, high-risk device might.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, including MRMC studies or standalone algorithm performance, is not applicable to this type of regulatory submission.

The "study" here is essentially the comparison to a predicate device, arguing for substantial equivalence.

Here's a breakdown based on the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense for a 510(k) submission demonstrating substantial equivalence of a low-risk device like a patient restraint. The "acceptance criteria" for a 510(k) is that the device is substantially equivalent to a legally marketed predicate device.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. There was no specific "test set" of patients or data used in a clinical study to evaluate the device's performance against predefined metrics. The assessment is based on the device's design, materials, and intended use compared to a predicate.
• Data Provenance: Not applicable. No clinical data or patient-specific data was mentioned as being used for this submission.

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

• Number of Experts: Not applicable. No "ground truth" for a test set was established by experts in the context of a performance study. The regulatory assessment is made by the FDA based on the provided submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no test set 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

• MRMC Study: Not applicable. This device is a physical restraint, not an AI-powered diagnostic or assistive technology for human readers.

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

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

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

• Type of Ground Truth: Not applicable in the context of a traditional performance study. For a 510(k), the "ground truth" is effectively the established safety and effectiveness profile of the predicate device (Pedo Cush), to which the new device (Pedi-Spider Strap) claims substantial equivalence based on similar design, materials, and intended use.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI with a training set.

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

• Ground Truth for Training Set: Not applicable. As above, this device does not involve AI or algorithms with a training set.

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The Geratherm SOS-Vacutherm is a temperature-controlled electric whole body warming system intended for use in preventing or treating the effects of incidental hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility

The Geratherm SOS-Vacutherm System is a combination product made of two primary components:

1. An electrically warmed panel. - Class II

2. A integrated vacuum mattress / stretcher - Class I (exempt from 510(k) premarket notification).

The provided text describes the Geratherm® SOS-Vacutherm, a thermal regulating system designed to prevent or reduce hypothermia. The submission focuses on demonstrating substantial equivalence to a predicate device and adherence to various standards rather than presenting extensive device performance data against specific acceptance criteria.

Therefore, the response will reflect the information available in the provided document.

Acceptance Criteria and Device Performance

The submission primarily focuses on functional equivalence to a predicate device and adherence to safety standards, rather than defining specific numerical acceptance criteria for clinical performance.

Study Information

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

   • Clinical Study: The clinical performance data references a study: Alexander Kober, MD; Thomas Scheck, BS; Béla Fülesdi, MD; Frank Lieba, BS; Wolfgang Vlach, BS; Alexander Friedman, MD; & Daniel I. Sessler, MD. "Effectiveness of Resistive Heating Compared With Passive Warming in Treating Hypothermia Associated With Minor Trauma: A Randomized Trial," Mayo Clinic Proc. 2001;76:369-375.
     • Sample Size: The document does not explicitly state the sample size (number of patients) used in this randomized trial. The provided document only references the publication.
     • Data Provenance: The study was conducted at the Mayo Clinic, implying US-based data. It is described as a "Randomized Trial," indicating it was a prospective study.
   • Non-Clinical Performance Data: The document mentions studies conducted by CE-LAB GmbH, iMG gGmbH, TREO Electrooptik GmbH, and TÜV GmbH, focusing on adherence to various technical standards. No sample sizes are applicable for these standard compliance tests.
   • Verification of Operation Under Non-Laboratory Conditions: The device was tested by several European rescue organizations (SAMU 38 - Helicopter Mountain Rescue Grenoble, France; ADAC Helicopter Rescueservice Munich, Germany; Royal Dutch Army, Helicopter Catastrophe Rescueteam Netherlands; REGA - Mountain rescue service REGA - Centre Zürich Airport Zürich, Switzerland). The document does not specify a "sample size" for these real-world verifications, nor does it detail the specific data collected, but rather states the device was "found to prevent or reduce hypothermia."

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

   • For the clinical study ("Effectiveness of Resistive Heating Compared With Passive Warming in Treating Hypothermia Associated With Minor Trauma: A Randomized Trial"), the authors listed include MDs (Alexander Kober, Béla Fülesdi, Alexander Friedman, Daniel I. Sessler) and BS (Thomas Scheck, Frank Lieba, Wolfgang Vlach). Daniel I. Sessler, MD, is a well-known expert in perioperative temperature management. The "ground truth" in this context would be the measured patient core body temperature and the diagnosis of hypothermia, which would be established by medical professionals involved in the care and monitoring of the patients receiving the treatment, as per the randomized trial protocol. The document does not specify the exact number of experts involved in establishing this clinical ground truth beyond the listed authors, nor does it give specific years of experience for each, but refers to them as medical professionals at the Mayo Clinic.

3. Adjudication method for the test set:

   • The document does not explicitly detail an adjudication method (such as 2+1 or 3+1) for the clinical study's outcomes. In a randomized controlled trial measuring physiological parameters like body temperature, the "adjudication" is typically inherent in the standardized measurement protocols and statistical analysis of the collected data. The outcome (degree of hypothermia) would be objectively measured, not subjectively adjudicated by experts beyond the initial data collection.

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 MRMC or AI-assisted comparative effectiveness study was conducted or mentioned. The device is a physical warming blanket system, not an AI-enabled diagnostic or assistance tool that would involve human readers/interpreters.

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

   • Not applicable. The device is a hardware system, not an algorithm.

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

   • For the clinical study, the ground truth was clinical outcomes data, specifically patient core body temperature measurements and the clinical determination of hypothermia based on those measurements.
   • For regulatory compliance and non-clinical testing, the "ground truth" was adherence to established international and national standards (e.g., IEC, EN, NATO, ISO, UL).

7. The sample size for the training set:

   • Not applicable as this is a hardware device where the clinical study focused on performance rather than training a machine learning model.

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

   • Not applicable for the reasons stated above.

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Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.

Baby Pod is designed to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility. Baby Pod consists of a lightweight carbon fiber outer shell, which is lined with a shock absorbent foam inner layer, and has transparent shields for viewing the baby. Baby Pod contains a patient positioning vacuum mattress, stretcher fixing straps to secure the device for transport, and safety straps to secure the baby inside the device during transport.

The provided text describes a 510(k) submission for a medical device called "Baby Pod." This document is a premarket notification for a Class I device and focuses on establishing substantial equivalence to a predicate device, rather than detailed performance studies with strict acceptance criteria often seen in Class II/III devices or AI/software as a medical device (SaMD) clearances.

Therefore, many of the requested elements (like acceptance criteria for performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance with metrics like sensitivity/specificity, or detailed ground truth methodologies) are not applicable or not provided in this type of submission.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable/Not Provided: This submission focuses on substantial equivalence based on design characteristics and material biocompatibility, not performance metrics derived from a test set of data or patient outcomes. There is no mention of a "test set" in the context of clinical or performance data.

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

• Not applicable/Not Provided: No clinical "ground truth" or expert review of a test set is mentioned. The ground truth for biocompatibility would be established by laboratory testing against ISO standards.

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

• Not applicable/Not Provided: No test set requiring adjudication by experts 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 device is a pediatric carrier-stretcher accessory, not an AI or imaging device. Therefore, no MRMC study or AI assistance is relevant.

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 or software.

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

• Biocompatibility Standards: For the specified acceptance criteria, the "ground truth" for material safety relied on ISO-10993 recognized test methods for biocompatibility.
• Predicate Device Comparison: The determination of "substantial equivalence" served as the primary "ground truth" or benchmark for this type of submission, comparing the new device's features, intended use, and indications to a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable/Not Provided: There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not Provided: No training set is involved.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" described in this 510(k) submission is primarily a comparison to a predicate device and biocompatibility testing.

• Predicate Device Comparison: The "Baby Pod" was compared to the WEEVAC 6 Infant Evacuation Stretcher (K902521). The study aimed to demonstrate that the Baby Pod has the "same intended use and similar indications for use." The minor technological differences (materials of construction and configuration) were characterized and deemed "more contemporary" but "biocompatible," ensuring they did not raise new questions of safety or effectiveness. This comparison facilitated the substantial equivalence determination by the FDA.
• Biocompatibility Testing: "Material components in contact with the baby have been evaluated in accordance with ISO-10993 recognized test methods and found to be biocompatible." This testing directly addressed the safety aspect of the materials used in the device.

In essence, for a Class I device seeking 510(k) clearance, the "study" is often an engineering and design comparison combined with relevant safety testing (like biocompatibility), rather than a clinical trial or performance evaluation using patient data.

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