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The InfaTherm™ Disposable Infant Warming Mattress is an instant warm pack intended to provide warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants. It is a single use, nontoxic, non-sterile, disposable device.

The InfaTherm™ Disposable Infant Warming Mattress is a single use, disposable pouch that is filled with a super saturated solution of food grade sodium acetate and water and a catalyst disk. When the catalyst disk inside the packet is flexed by the user, the catalyst disk reacts with the nontoxic solution and initiates a chemical exothermic crystallization of the sodium acetate, generating heat. When activated at 75°F, the Infant warming mattress will reach between 100-102°F and then gradually decrease in temperature over time. The InfaTherm™ Disposable Infant Warming Mattress is rectangular in shape. Immediately following activation of the mattress, the user places the infant on the mattress.

This document describes the InfaTherm™ Disposable Infant Warming Mattress and its substantial equivalence to a predicate device, as submitted for FDA 510(k) clearance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for performance. Instead, it compares the subject device's characteristics and performance to those of a predicate device to demonstrate substantial equivalence. The implication is that if the subject device's performance is similar to or equivalent to the predicate device, it meets the "acceptance criteria" for safety and effectiveness.

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The Rapid Aid Infant Transport Mattress Warmer with Disc provides warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants.

The Rapid Aid Infant Transport Mattress Warmer with Disc (Infant Transport Mattress) is a rectangular pad that is intended to provide warmth during transport of an infant within a hospital or between hospitals. The single-use disposable device consists of an outer pouch with a liquid solution activated by bending an activator disc; an exothermic reaction warms the Infant Transport Mattress to no higher than 104°F (range 101°F to 104°F) for a dwell time of ≥10 minutes.

This document describes the premarket notification (510(k)) for the Rapid Aid Infant Transport Mattress Warmer with Disc. It's important to note that this device is a medical warming device, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study designs associated with AI/SaMD (like those involving human readers, ground truth establishment by experts, MRMC studies, or training sets) are not applicable to this physical device.

Based on the provided document, here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The acceptance criteria are primarily focused on the physical and performance characteristics of the warming mattress, demonstrating its substantial equivalence to a predicate device.

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

The document does not specify the exact sample sizes (number of units tested) for each performance test. It states "all tests were a pass," implying multiple units were tested to demonstrate consistency and meet specifications.

The data provenance is from performance testing conducted by Rapid Aid Corp. The studies are inherently prospective as they are tests performed on manufactured devices to demonstrate compliance with specifications. The location of the testing is not explicitly stated but would likely be internal to the manufacturer or a contracted lab. Given the manufacturer is based in Canada (Mississauga, ON, Canada), the tests would have been performed there or an affiliated laboratory.

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

This question is not applicable to this type of medical device. "Ground truth" in the context of AI/SaMD for diagnostic tasks involves expert consensus on medical images or patient records. For a physical warming device, the "ground truth" is measured physical properties like temperature, pressure resistance, and material compatibility, established through validated testing methodologies by engineers and laboratory technicians, not medical experts for diagnostic purposes.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers provide subjective assessments (e.g., categorizing medical images). For physical performance tests, the results are objective measurements against defined specifications. There is no subjective human interpretation 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

This question is not applicable as this is not an AI/SaMD device. MRMC studies are used to evaluate the impact of AI assistance on human reader performance in diagnostic tasks.

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

This question is not applicable as this is not an AI/SaMD device. Standalone performance refers to the accuracy of an automated AI algorithm without human intervention in diagnostic or analytical tasks.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective engineering and laboratory measurements against predefined physical and chemical specifications. This includes:

• Direct temperature readings.
• Timers for dwell time.
• Pressure gauges for seal strength.
• Weight scales for weight.
• Microscopes/visual inspection for seal integrity and material assessment.
• Standardized biocompatibility tests (e.g., ISO 10993-1).
• Accelerated aging tests.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This question is not applicable as there is no training set for a physical device.

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Provision of warmth during transport of infant within the hospital or between hospitals. Recommended for full term infants.

Neo Nest Infant Transport Mattress

This document is a 510(k) clearance letter from the FDA for a medical device called the "DeNovo Products Neo Nest Gel Infant Transport Mattress". It does not contain any information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter is a regulatory approval, not a scientific study report. It indicates that the device has been deemed "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market.

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

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The EyeFeel ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.

The EyeFeel Ophthalmic Warmer also may relieve accommodative fatigue and may help recover baseline visual acuity levels after prolonged work on visual display terminals.

The EyeFeel Warmer consists of a front layer, two oval shaped sacks that hold the iron powder mixture, and a back inner layer that is placed on the face. The iron powder mixture consists of iron powder, sodium chloride, filtrated water, powdered activated carbon, granular activated carbon, sodium polyacrylate powder, and exfoliated vermiculite.

The information provided describes the indications for use and technological characteristics of the EyeFeel Ophthalmic Warmer, along with a statement about a clinical study. However, it does not provide specific acceptance criteria or the detailed results of a study designed to meet those criteria in a quantitative manner.

Here's the breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that a clinical study was conducted to "assess the effect" and that its "results...support the expanded indications." However, it does not explicitly define what constitutes "relief," "recovery," or any quantitative threshold for these effects, which would typically be included in acceptance criteria.

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

• Sample Size: "A small clinical study" – specific number not provided.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The phrasing "was conducted" suggests it was a prospective study.

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

• Not Applicable / Not Provided: The nature of the study (assessing the effect on fatigue and visual acuity) suggests that ground truth would likely be established through objective measurements (e.g., visual acuity charts, objective measures of accommodative response) rather than expert consensus on diagnostic images. Therefore, expert consensus for "ground truth" in the diagnostic sense is not relevant here, and no information about experts is provided for this purpose.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: As the study likely involved objective physiological measurements rather than subjective diagnostic interpretations requiring adjudication, this information is not relevant or provided.

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

• No: The document describes a "small clinical study" assessing the device's effect, not a comparative effectiveness study comparing human readers with and without AI assistance. The device itself is a physical warmer, not an AI diagnostic tool.

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

• No: This question is not applicable. The device is a physical warmer and does not involve an algorithm or AI. The study assessed the device's direct therapeutic effect on human subjects.

7. The Type of Ground Truth Used:

• Likely Objective Clinical Measurements: While not explicitly stated, for a study assessing "accommodative fatigue" and "visual acuity," the ground truth would typically be established by:
  • Visual Acuity: Standardized visual acuity charts (e.g., Snellen chart, ETDRS chart).
  • Accommodative Fatigue: Objective measurements of accommodation (e.g., using an autorefractor, accommodometer, or dynamic retinoscopy before and after prolonged visual display terminal work and after device use).
    The document does not detail the specific methods used.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided: This device is a physical warmer and does not involve a "training set" in the context of machine learning or AI algorithms.

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

• Not Applicable / Not Provided: This question is not relevant for the described device.

Summary of what is missing in the provided text regarding acceptance criteria and study details:

• Quantitative Acceptance Criteria: No specific numerical thresholds or target values for improvement in visual acuity or reduction in fatigue are stated.
• Detailed Study Protocol: No information on the study design, specific endpoints, measurement methods, statistical analysis plan, or blinding.
• Exact Sample Size: "Small clinical study" is vague.
• Demographics/Baseline Characteristics of the study participants.
• Detailed Results: Only a general statement that "results...support the expanded indications" is provided, without sharing actual data, p-values, confidence intervals, or effect sizes.

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Is intended for over-the-counter (non-prescription) use by the consumer.

Provides moist heat therapy to temporarily relieve minor muscle and joint aches and pain associated with over-exertion, strains, sprains, arthritis, stiffness, and muscle spasm.

Temporarily relieves minor menstrual pain.

Temporarily increases local blood circulation.

BENGAY™ Heat Therapy is a disposable, single-use, airactivated pain relieving patch which adheres to the skin by means of a hydrogel adhesive and generates heat by the oxidation of iron powder.

The device consists of 6 components:

• Oxygen-impermeable, primary packaging; .
• . Breathable fabric sachet containing the heating element mixture;
• Heating element mixture; .
• Backing sheet which separates the heating element . mixture from the hydrogel layer;
• . Hydrogel layer to provide adhesion to the skin surface; and,
• Release liner to protect the adhesive hydrogel laver . prior to consumer use

When the air-tight, protective packaging is opened, the heating element mixture reacts with oxygen in the air, and the patch begins to warm up. It takes up to 30 minutes for the patch to reach its target temperature range. The patch stays warm for at least 8 hours.

BENGA Y™ Heat Therapy reaches its target temperature range in 30 minutes or less, and remains in this temperature range for a minimum of 8 hours.

BENGAY™ Heat Therapy provides moist heat as demonstrated by user perception and laboratory experiments.

The provided document is a 510(k) summary for a medical device (BENGAY™ Heat Therapy heat patch) and an FDA clearance letter. It is not a study report or clinical trial document that would typically include detailed acceptance criteria tables and performance metrics for an AI/algorithmic device. The information requested (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is standard for AI/ML device evaluations, but is not present in this type of regulatory submission for a heat therapy patch.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will answer based on the information that is present, noting where information is missing or not applicable to this type of device.

Acceptance Criteria and Device Performance for BENGAY™ Heat Therapy

This submission is for a heating patch, not an AI/ML device. Therefore, the "acceptance criteria" and "device performance" are focused on the physical characteristics, safety, and functionality of the heat patch itself, rather than diagnostic accuracy or algorithmic performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated for any of the studies mentioned (clinical safety study, biocompatibility tests, or moist heat demonstration studies).
• Data Provenance: Not explicitly stated (e.g., country of origin). The document implies the studies were conducted by Johnson & Johnson Consumer Products Company, likely in the US, but this is not confirmed.
• Retrospective or Prospective: The clinical safety study suggests a prospective design (comparing BENGAY™ Heat Therapy with the predicate device). Biocompatibility and laboratory experiments are typically prospective.

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

• Not applicable/mentioned. This device is not an AI/ML diagnostic system where expert-established ground truth is typically required for evaluation. The "ground truth" for this device relates to physical properties (temperature, duration) and biological responses (skin irritation, circulation), which are measured objectively or through clinical observation.

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

• Not applicable/mentioned. Adjudication methods are typically relevant for resolving disagreements among multiple human readers/experts in diagnostic imaging or clinical assessment, which is not the context for this device.

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. This is not an AI-assisted device, so MRMC studies are not applicable.

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

• Not applicable. This is a physical heat patch, not an algorithm.

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

• Moist heat: User perception and laboratory experiments.
• Biocompatibility: Results from standardized in vitro and dermal irritation studies.
• Clinical Safety (irritation, thermal injury, skin temperature): Direct clinical observation, measurements of skin temperature, and assessment of skin reactions by medical professionals involved in the clinical study.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for a machine learning model.

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The EyeFeel™ Ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eye lids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.

The EyeFeel Ophthalmic Warmer is a simple device for application of heat therapy to the eye. It is shaped as a kind of "mask" to fit over the eyes, and consists of layers of synthetic paper, which surround a "sac" containing an iron powder mixture. Oxidation of the iron powder mixture generates heat.

Here's a breakdown of the acceptance criteria and study information for the EyeFeel™ Ophthalmic Warmer, based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in the traditional sense of a predetermined threshold that the device must meet. Instead, it presents performance data from a study and concludes that the device is "substantially equivalent to its claimed predicates under conditions of intended use." The P values for the clinical outcomes (0.028) suggest statistical significance, implying the observed improvements are unlikely due to chance.

However, we can infer the "acceptance criteria" were implied by the chosen clinical endpoints and the statistically significant improvement shown in these metrics.

Table of Acceptance Criteria (Inferred) and Reported Device Performance:

Study Information

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

   • Sample Size: Six patients with non-inflamed obstructive MGD for efficacy testing. Three patients with healthy eyes for safety testing.
   • Data Provenance: Not explicitly stated (e.g., country of origin, specific institution, retrospective/prospective). However, the language "Six patients... tested the EyeFeel Product" suggests a prospective clinical observation or trial.

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

   • The document does not mention the use of experts to establish ground truth for the test set. The measurements (tear evaporation, BUT, MG lipid expressibility) are objective clinical assessments. The MG lipid expressibility score, while potentially involving a subjective grading, is based on a defined scale (Grade 0-3). It does not specify who performed these assessments or their qualifications.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned. The study involved objective measurements and a subjective scoring system without an explicit mention of adjudication by multiple parties for the test set.

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

   • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study focuses on the device's direct impact on physiological parameters and clinical scores, not on human reader performance with or without AI assistance.

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

   • Not applicable. The EyeFeel™ Ophthalmic Warmer is a physical device, not an algorithm or AI product. The study evaluates the device's direct therapeutic effect.

6. Type of Ground Truth Used:

   • The "ground truth" for the efficacy study was established through objective physiological measurements (tear evaporation rate, tear breakup time) and a clinical scoring system (meibomian gland lipid expressibility score) assessed by investigators. For the safety study, it involved direct temperature measurements of the eyelids and cornea.

7. Sample Size for the Training Set:

   • Not applicable. The EyeFeel™ Ophthalmic Warmer is not an AI/ML algorithm requiring a training set.

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

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

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Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.

The Porta-Warm™ Mattress consists of a heat source housed in a plastic pouch. The heat source pouch consists of a supercooled solution of sodium thiosulfate, dextrose and water. The sodium thiosulfate, dextrose and water "bubble" is housed in a separate plastic pouch inside the outer pouch. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, thus creating a physical exothermic reaction.

The provided document (K98657) is a 510(k) submission for the Allegiance Porta-Warm™ Mattress, a hot therapy pack. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a detailed study format. Therefore, several aspects of your request, such as a formal table of acceptance criteria with reported performance values, specific sample sizes for test sets, expert-established ground truths, and MRMC studies, are not explicitly provided in this type of regulatory document.

However, I can extract the information that is available within the document regarding testing and how equivalence was established.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance

Due to the nature of a 510(k) submission for a predicate device, explicit acceptance criteria with numerical performance targets are not detailed. Instead, the document establishes substantial equivalence based on material composition, performance attributes, and intended use.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Additional Information on Testing and Ground Truth:

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

   • Test Set Sample Size: Not specified. The document states that various tests (skin sensitization, intracutaneous reactivity, cytotoxicity, temperature performance, tensile strength, primary skin irritation) were performed, but it does not provide the number of samples or units tested for each.
   • Data Provenance: The tests were conducted by the manufacturer, Allegiance Healthcare Corporation. The specific country of origin of the raw data/testing is not explicitly stated beyond the manufacturer's address in Moberly, Missouri, USA and McGaw Park, Illinois, USA. The testing appears to be "prospective" in the sense that it was conducted specifically for this submission to demonstrate safety and equivalence.

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

   • Not applicable/Not specified. For biocompatibility and physical performance tests, the "ground truth" is typically defined by accepted laboratory standards (e.g., ISO, Food Chemicals Codex) and interpreted by qualified laboratory personnel, not by a panel of medical experts establishing a diagnostic ground truth. The document does not detail the specific experts or their qualifications involved in these lab tests, beyond implicitly assuming adequately qualified personnel.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data. The tests described are laboratory and material science-based, not reliant on human reader interpretation in that context. Results are presumed to be objective measurements against predefined standards.

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 study was conducted or described. This device is a simple, non-AI medical product.

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

   • Not applicable. This device is not an algorithm or AI.

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

   • The "ground truth" for this submission relies on established scientific and regulatory standards:
     • Chemical Composition: Conformance to Food Chemicals Codex specifications (e.g., Sodium Thiosulfate on page 1).
     • Biocompatibility: Conformance to ISO Standard 10993 Part 1 (skin sensitization, intracutaneous reactivity, cytotoxicity, primary skin irritation).
     • Physical Performance: Conformance to internal specifications for "temperature performance and tensile strength tests" (no numerical details provided).
     • Substantial Equivalence: Direct comparison to already legally marketed predicate devices for chemical composition, performance attributes, method of activation, and intended use.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI, so there is no "training set" in the context of machine learning. The "training" could conceptually be considered the development and refinement of the manufacturing process and material selection.

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

   • Not applicable, as there is no training set for an AI/algorithm. For the development of the product, the "ground truth" for design and manufacturing would have been established through internal engineering specifications, material science principles, and regulatory requirements (e.g., Good Manufacturing Practices).

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The DeRoyal Industries Inc. Infant Transport Mattress is to be used to assist in maintaining infant body temperature.

The DeRoyal Industries, Inc. Infant Transport Mattress is a device intended for medical purposes to provide warm therapy that helps maintain infant body temperature. Device Design/Materials UsedPhysical Properties: The DeRoyal Infant Transport Mattress is designed similar to those marketed by other manufacturers. The pouch is comprised of a low-density polyethylene (LDPE) film bag which contains the activation ingredient, sodium acetate (food grade).

The provided text describes a 510(k) summary for the DeRoyal Industries, Inc. Infant Transport Mattress, a medical device for providing warm therapy to infants. However, it does not include detailed information about acceptance criteria, specific studies, sample sizes, expert involvement, or ground truth establishment for a device performance study.

The document is a premarket notification (510(k)) indicating that the device is "substantially equivalent" to legally marketed predicate devices. The primary focus of a 510(k) submission is to demonstrate this substantial equivalence through a comparison of technological characteristics and intended use.

Here's a breakdown of what can be inferred from the provided text and why the requested information is largely absent:

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

The document implicitly uses the performance of the predicate device as an acceptance criterion for the DeRoyal device's key characteristic: temperature achieved at activation.

Explanation: The comparison table explicitly states that the predicate device achieves "104° F" for approximate temperature at activation. The DeRoyal device reports achieving "105° F". This indicates that the DeRoyal device meets or exceeds the temperature performance of the predicate. Other characteristics are primarily comparisons of materials and dimensions, not performance metrics with explicit acceptance criteria.

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

Not provided. The document does not mention any specific test sets, sample sizes, or data provenance from a performance study. The "test" here refers to a comparison against a predicate, not a clinical trial or extensive standalone performance study with a dedicated test set as you might see for a more complex device.

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

Not applicable/Not provided. No "ground truth" in the sense of expert consensus on clinical findings is discussed. The assessment is primarily based on comparing the physical and functional characteristics of the DeRoyal mattress to a known, legally marketed predicate device.

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

Not applicable/None mentioned. There's no indication of an adjudication process for a test set. The review process is by the FDA, determining substantial equivalence.

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 an infant transport mattress, not an AI-powered diagnostic tool. MRMC studies are used for assessing diagnostic performance, typically for imaging devices with human reader involvement.

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

Not applicable. This device is a physical product for warmth, not an algorithm.

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

Implicitly, the performance of the legally marketed predicate device. For a 510(k) submission like this, "ground truth" for demonstrating safety and effectiveness often comes from the established performance and safety record of the predicate device. The DeRoyal device aims to show it is at least as safe and effective as the predicate, not necessarily to establish new clinical efficacy against a "true" medical condition outcome.

8. The sample size for the training set:

Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device. The design and materials are based on existing technology and knowledge.

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

Not applicable/Not provided. No training set exists for this type of device and submission.

In summary:

The provided document details a 510(k) submission for a simple medical device. The "study" referenced is the comparison of the DeRoyal Infant Transport Mattress to a legally marketed predicate device (Prism Technologies). The "acceptance criteria" are implicitly that the DeRoyal device must be substantially equivalent to the predicate in terms of materials, design, intended use, and performance characteristics (like achieving a similar therapeutic temperature). Since this is a comparison for substantial equivalence, formal clinical trials with extensive test sets, expert ground truth establishment, or AI-specific studies are not typically part of such a submission. The FDA's letter confirms that based on the provided information, the device was deemed substantially equivalent.

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The CP&S Disposable Ice Pack Limb Kit Transporter provides an environment above freezing for a severed body part while being transported to the hospital emergency room or replantation surgery.

The CP&S Disposable Instant Ice Pack Limb Kit Transporter is an instant ice pack with an added pouch for the insertion of a severed body part for transport to the hospital emergency room or replantation surgery. The Instant Cold Pack Limb Kit Transporter is activated in the same manner as the Disposable Instant Cold Pack and provides cooling for the severed limb within the gauze lined zip lock top bag. A cool environment above freezing is maintained for approximately 30 minutes. The additional pouch does not affect the safety or efficacy of the disposable Instant Cold Pack.

This submission describes a medical device, the "Instant Cold Pack Limb Kit Transporter," which is essentially an instant cold pack with an added pouch for transporting severed body parts. The key claim is that it maintains a cool, above-freezing environment for approximately 30 minutes, which is crucial for limb preservation.

Here's an analysis of the acceptance criteria and the study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a test set or data provenance. The "study" mentioned appears to be an internal verification (Attachment C) and a reference to general medical studies (Attachment D) rather than a formal pre-market clinical study on this specific device with a defined test set.

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

The provided text does not mention using experts to establish ground truth for a test set related to the device's performance. The "ground truth" for the medical necessity of above-freezing temperatures for severed limbs is based on general medical knowledge, as implied by "studies showing that the severed limb should be stored at above freezing temperatures" (Attachment D).

4. Adjudication Method for the Test Set

No test set for expert adjudication is mentioned, therefore, no adjudication method is described.

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

No MRMC study was conducted. This device is a physical product designed for basic physiological effect (cooling), not a diagnostic algorithm where human-in-the-loop performance would typically be evaluated.

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

This device is a physical product, not an algorithm. Therefore, no standalone algorithm performance study was conducted or is applicable. The "standalone" performance here refers to the physical cold pack's ability to maintain temperature, which is described in the Acceptance Criteria table.

7. Type of Ground Truth Used

The "ground truth" referred to in the context of this submission is:

• Performance of the predicate device: The instant cold pack component's efficacy is assumed to be similar to the predicate Disposable Instant Cold Pack (K890553).
• General Medical Knowledge/Literature: Expert consensus and outcome data from existing medical literature regarding the optimal storage temperature for severed limbs, as indicated by "studies showing that the severed limb should be stored at above freezing temperatures and that proper techniques for preservation of the amputated part are important for survival" (Attachment D).

8. Sample Size for the Training Set

No training set is mentioned as this is a physical medical device, not an AI/ML algorithm.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary of the "Study" that Proves Acceptance Criteria:

The "study" referenced in the 510(k) submission to demonstrate the device meets acceptance criteria is primarily based on:

1. Assertion of Equivalence: The manufacturer asserts that the "Instant Cold Pack Limb Kit Transporter" is activated in the same manner as their existing "Disposable Instant Cold Pack" (predicate device K890553) and provides cooling.
2. Internal Testing/Verification (Attachment C): The text states, "A cool environment above freezing is maintained for approximately 30 minutes. (Attachment C)". This indicates some form of internal testing or verification was conducted to determine the duration of cooling and temperature maintenance. Details of this testing (methodology, number of units tested, conditions, etc.) are not provided in the summary.
3. Assertion of Non-Interference: The manufacturer states, "The additional pouch does not affect the safety or efficacy of the disposable Instant Cold Pack." This is likely based on design analysis and potentially additional testing similar to the above.
4. Reference to Established Medical Practice (Attachment D): The submission leverages existing medical knowledge, stating, "studies showing that the severed limb should be stored at above freezing temperatures and that proper techniques for preservation of the amputated part are important for survival. (Attachment D)." This supports the rationale for the device's design (maintaining above-freezing temperatures) rather than directly proving the device's performance through a clinical trial.

In essence, this 510(k) submission relies heavily on the substantial equivalence to a predicate device and internal performance claims, rather than a large-scale clinical study with a defined test set, expert adjudication, or comparative effectiveness. The "study" mentioned for performance focuses on the physical properties of the cold pack.

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Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces. Also used as a heat therapy pack with an absorbent perineal pad; for use post delivery to absorb lochea while relieving edema and inflammation associated with an an episiotomy.

The Allegiance Kwik Heat™ Perineal Warm Pack is comprised of an outer pouch which is secured to a perineal pad and then wrapped in a polyester material. The heat source pouch consists of a supercooled solution of sodium thiosulfate, dextrose and water. The sodium thiosulfate, dextrose and water "bubble" is housed in a separate plastic pouch inside the outer pouch. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, and kneading the unit, thus creating a physical exothermic reaction.

The document describes the Allegiance Kwik Heat™ Perineal Warm Pack, a hot therapy pack intended for medical purposes, including post-delivery use to absorb lochia and provide therapeutic heat to relieve pain associated with an episiotomy incision.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify sample sizes for the test sets related to the biological and physical testing. It only states that "All materials used in the composition of this hot pack were identified, evaluated and tested."

The data provenance is also not specified. Given the context of a 510(k) submission in 1997, it's highly likely that testing was done by or for the manufacturer (Allegiance Healthcare Corporation) and would be considered prospective data for the purpose of demonstrating device safety and effectiveness. There is no information about country of origin of the data.

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

The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the test data. The types of tests (biocompatibility, chemical composition, temperature performance) would typically rely on standardized laboratory protocols and measurements rather than expert consensus on a 'ground truth' in the way it's understood for diagnostic AI.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. This is not relevant for the type of safety and performance testing described (e.g., cytotoxicity, temperature measurement) which relies on objective laboratory results rather than subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often aided by AI. The Allegiance Kwik Heat™ Perineal Warm Pack is a physical medical device (a hot pack), not a diagnostic tool, and therefore, an MRMC study is not applicable.

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

No, a standalone study (in the context of an algorithm) was not done. The device itself is a physical product and does not involve any algorithms or artificial intelligence. Therefore, this question is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" for the device's safety and performance was established through a combination of:

• Standardized laboratory testing results: For biocompatibility (skin sensitization, intracutaneous reactivity, cytotoxicity, primary skin irritation) and physical temperature performance.
• Compliance with established specifications and standards: For the chemical composition (e.g., Food Chemicals Codex for Sodium Thiosulfate) and general safety standards (ISO Standard 10993 Part 1).
• Toxicological assessment: Determining that the chemical mixture was "toxicologically acceptable."

8. The Sample Size for the Training Set:

The concept of a "training set" is applicable to machine learning and AI algorithms. Since this device is a physical product and does not involve AI, there is no training set in this context.

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

As there is no training set for an AI algorithm, this question is not applicable.

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