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The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.

The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.

The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.

The provided text is a 510(k) summary for the Caerus Active System and Avenue8, seeking substantial equivalence to predicate devices. It describes performance data and a clinical study conducted.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that non-clinical performance testing and a clinical study were conducted to verify device performance and satisfy special controls. However, it does not explicitly state specific acceptance criteria values (e.g., "The device must achieve X% pain reduction to be considered effective") and then report the results against those criteria in a tabular format. Instead, it reports outcomes from the clinical study and compliance with standards.

We can infer "performance" from the clinical study's outcome in terms of pain reduction effect.

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

The text describes a clinical study which serves as the "test set" for demonstrating clinical performance.

• Sample Size: 120 patients enrolled.
  • 48 in the Active System (Shortwave Diathermy + Heating Therapy) group.
  • 43 in the SOC group. (Note: The sum of these two groups is 91, not 120. There's a discrepancy in the provided numbers, as 120 is the total. This could imply other groups or just a rounding/reporting discrepancy. Assuming the reported group sizes are correct for the Active System and SOC groups, the remaining 29 participants are unaccounted for in this specific breakdown).
• Data Provenance: Not specified, neither country of origin nor retrospective/prospective. However, a clinical study implies prospective data collection.

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

• This information is not provided in the document. For a clinical study measuring pain, the "ground truth" is typically the patient's self-reported pain score (Mankowski scale in this case), not an expert consensus on interpreting data like images. Therefore, expert consensus in the traditional sense (e.g., radiologists interpreting images) is not applicable here.

4. Adjudication Method for the Test Set

• This information is not applicable as the "ground truth" is patient-reported pain scores, not adjudicated data. There's no mention of an adjudication process for these scores.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This device involves direct patient treatment and pain measurement, not interpretation of data by multiple human readers (e.g., radiologists) with or without AI assistance. The study described is a clinical trial comparing the device's efficacy against standard of care.

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

• This question is not applicable. The device (Active System) is a physical medical device that delivers therapy, not a standalone AI algorithm for diagnosis or interpretation. The clinical study evaluates the device's performance as a treatment.

7. The Type of Ground Truth Used

• The "ground truth" for the clinical study was patient-reported pain assessment scores, specifically using the Mankowski scale, measuring the change from baseline at the end of 2 weeks.

8. The Sample Size for the Training Set

• This information is not applicable or not provided. This document describes a medical device for treatment, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The clinical study serves to validate the device's effectiveness, not to train an algorithm. There is no mention of an algorithm or AI component that would require a training set.

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

• This information is not applicable or not provided as there is no "training set" in the context of an AI/ML algorithm for this device.

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The Infant Heel Warmer™ Heel Snuggler® are instant warm packs intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, nontoxic, non-sterile, disposable device. The Infant Heel Warmer™, Heel Snuggle® have two configurations, the Heel Snuggler®, which is designed to conform to the shape of the infant's heel, and the standard Infant Heel Warmer™. The devices are primarily used in hospitals, Doctor's offices, and other healthcare settings.

The Infant Heel Warmer™/Heel Snuggler® is a single use, disposable pouch that is filled with a super saturated solution of food grade sodium acetate and a catalyst disk. When the catalyst disk inside the packet is flexed by the user, the catalyst disk reacts with the non-toxic solution and initiates a chemical exothermic crystallization of the sodium acetate, generating heat. When activated at 75°F, both models will reach between 104-107°F and then gradually decrease in temperature over time.

The Heel Snuggler® is a butterfly shape with two straps and the Infant Heel Warmer™ is rectangular with one strap. Straps with adhesive ends are attached to the packet for securing the heel warmer to the infant's foot, if desired. Immediately following activation of the user rests the bottom of the infant's foot on one portion of the packet and holds the other portion of the packet to the ankle. The straps with adhesive tape on the end are then fitted across the infant's foot and ankle and secured to the opposite side of the adhesive portion of the strap is affixed to the packet only, not the infant's skin. The straps on the heel warmer are perforated, which enables the user to easily tear the straps and remove the heel warmer from the infant's foot after use.

The provided text details a 510(k) summary for the Infant Heel Warmer™/Heel Snuggler®, arguing for its substantial equivalence to a predicate device. This submission primarily focuses on bench testing and comparison of technical specifications, not on an AI/ML-driven medical device that would involve a study of the type described in the request.

Therefore, many of the requested elements are not applicable to this document. The document describes a physical medical device (a warming pack), not a software or AI-based diagnostic tool.

However, I can extract the acceptance criteria and the "study" (bench testing) that was performed to demonstrate the device meets those criteria, as well as addressing the applicable parts of your request.

Here's a breakdown based on the provided text, with notes on what is not applicable:

Device: Infant Heel Warmer™; Heel Snuggler®

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the successful completion of specified tests. The performance is reported as meeting these implied criteria.

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

• Sample Size: Not explicitly stated for bench tests (e.g., how many units were tested for temperature, burst, stability). It typically refers to a statistically significant number of units for product testing, but specific numbers are not provided in this summary.
• Data Provenance: The testing was performed internally by International Biomedical. The location of the testing is not specified beyond "International Biomedical 8206 Cross Park Drive Austin, TX 78754 U.S.A." This is prospective testing of manufactured devices for performance and safety.

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

N/A. This device is a physical warming pack, not an AI/ML-driven diagnostic tool that requires expert annotation for ground truth. Its performance is measured directly through physical tests (temperature, burst strength, stability).

4. Adjudication Method for the Test Set

N/A. Not applicable to physical device bench testing.

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

N/A. This is a physical device, not an AI/ML-driven diagnostic system. No human reader study or AI assistance is involved.

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

N/A. Not an algorithm-driven device. Bench testing was performed on the physical device in a "standalone" manner (i.e., the device itself was tested, not in conjunction with a human operator as part of a performance study, though it is used by a human).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and safety standards, and direct measurement of physical properties (e.g., temperature, burst strength, material properties) against predefined acceptance thresholds and comparison to a legally marketed predicate device's characteristics. There's no "expert consensus" on imaging or pathology results here.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device, so there is no training set.

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

N/A. This is not an AI/ML device, so no ground truth for a training set was established.

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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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Adjunctive treatment of musculoskeletal pain related to: (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee.

The ActiPatch® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.

The provided document is a 510(k) premarket notification for the ActiPatch® device. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness. Therefore, the information provided focuses on comparative performance and safety rather than establishing acceptance criteria as would be seen for a new medical device. The document does not explicitly state "acceptance criteria" but rather presents clinical study results as evidence of comparable safety and effectiveness to predicate devices.

Here's an attempt to extract and organize the requested information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't define explicit "acceptance criteria" in the traditional sense of pre-defined thresholds. Instead, it presents clinical study results to demonstrate effectiveness and safety comparable to predicate devices. The "reported device performance" below summarizes these clinical findings.

• 36% of the treatment group reported a >30% decrease in VAS pain, compared to 9% for the placebo group.
• 18% of the treatment group reported a >30% decrease in total WOMAC pain, compared to 3% for the placebo group.
• 26% of the treatment group stopped pharmacological therapy, whereas 33% of the placebo group started new pharmacological therapy. |
  | Effectiveness - Plantar Fasciitis | Reduction in pain levels (daily morning VAS score) comparable to or better than placebo/no treatment for plantar fasciitis. | Plantar fasciitis study:
• Average reported pain reduction (day 1 AM to day 7 AM VAS) for the treatment group was 40%, compared to 7% for the control group. |
  | Safety | No significant adverse events related to the device. | Osteoarthritis of the knee study: No adverse events were recorded.
  Plantar fasciitis study: Primary safety endpoint was all treatment-related adverse events; the document does not explicitly state if any were recorded but implies a positive safety profile through the "safe and effective as its predicate devices" conclusion. |
  | Usability (OTC Use) | Lay users must understand how to use the device safely and effectively for pain relief in the specified indications. | Usability testing:
• 46 men and women (age >17, wide education levels) demonstrated understanding of indications for use, contraindications, how to turn on, correct placement, and duration of use. |
  | Non-Clinical Performance | Conformity to relevant electrical safety, electromagnetic compatibility, and biocompatibility standards. Performance as intended under anticipated conditions of use regarding output power, pulse characteristics, absorption rates, and electromagnetic fields. | Non-Clinical/Performance Data:
• Conformed to IEC/EN 60601-1-2:2012, IEC 60601-1:2005+A1:2012, EN 60601-1:2006.
• Biocompatibility testing (ISO 10993-10:2010 for sensitization and irritation, ISO 10993-5:2009 for cytotoxicity) showed no evidence of sensitization, irritation, or in vitro cytotoxicity.
• Special controls testing (per October 13, 2015 Final Reclassification Order) demonstrated intended performance, characterizing peak output power, pulse characteristics, duty cycle, average output power, specific absorption rates, and electrical/magnetic fields in a saline gel test load. |

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

• Osteoarthritis of the knee study:
  • Sample size: 66 intent-to-treat patients, with 60 patients completing the four-week study.
  • Data Provenance: Not explicitly stated (e.g., country of origin, specific locations), but described as "double-blind randomized controlled study" implying a prospective design.
• Plantar fasciitis study:
  • Sample size: 70 patients completed the study.
  • Data Provenance: Described as "double-blind, multicenter, randomized, placebo-controlled study," implying a prospective design. Country of origin not specified.
• Usability testing:
  • Sample size: 46 men and women.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but the description ("These subjects demonstrated use...") implies a prospective, interactive study.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of image interpretation or diagnostic accuracy studies. The clinical studies evaluated patient-reported outcomes (VAS and WOMAC scores) and adverse events, which are direct measures from the participants themselves, rather than interpretations by experts.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document describes the clinical studies as "double-blind and placebo-controlled randomized controlled trials." This implies that blinding was used for both participants and researchers/assessors regarding treatment allocation. However, it does not specify an adjudication method for outcome measures like VAS or WOMAC scores, which typically do not require such adjudication as they are direct patient responses. For adverse events, it states "No adverse events were recorded" for the knee study; the method for reviewing or adjudicating AEs in the plantar fasciitis study is not detailed beyond "primary safety endpoint was all treatment-related adverse events."

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, an MRMC comparative effectiveness study was not done. The ActiPatch® is a physical medical device for pain relief, not an AI or imaging interpretation device that would typically involve human readers.

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

Not applicable. The ActiPatch® is a physical device, not an algorithm. Its performance is inherent in its physical and electrical characteristics and its interaction with the patient's body. The clinical studies evaluate the device's effect directly on patients.

7. The Type of Ground Truth Used

For the clinical studies, the "ground truth" was primarily based on patient-reported outcomes:

• Pain levels: Measured using validated scales like the Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores.
• Adverse events: Self-reported by patients or observed during the study.

For usability testing, the "ground truth" was established by observing lay user comprehension and ability to perform tasks (turn on, place correctly, understand indications/contraindications).

For non-clinical testing, the "ground truth" was conformance to established engineering and biological standards (e.g., IEC, ISO standards for electrical safety, biocompatibility, and specific power output measurements).

8. The Sample Size for the Training Set

The document does not describe the use of a "training set" as it would for an algorithm or AI model development. The clinical studies described are for evaluating the final device's performance, not for training a model.

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

Not applicable, as no training set was explicitly mentioned or used in the context of algorithm development. The document describes clinical trials and usability studies of a physical medical device.

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An instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.

The CooperSurgical Infant Heel Warmer, which is available in both a liquid version (The Infant Heel Warmer, Model 24401) and a gel version (WarmGel® Infant Heel Warmer, Model 20418), is a non-sterile, single-use, disposable device comprised of a biaxially oriented nylon (BON)/polyethylene outer pouch filled with a supersaturated solution of food grade sodium acetate and water (liquid version), or food grade sodium acetate, water, and hydroxyethylcellulose, a common thickener (gel version). An adhesive tape is attached to the pouch, which can hold the warmer in place if desired. The pouch also contains a stainless steel disc that, when flexed, initiates an exothermic crystallization of the sodium acetate, generating heat. When activated at 75° + 1° F, the maximum peak temperature of the CooperSurgical Infant Heel Warmer is 107° F, which is reached in approximately 40 seconds and then gradually decreases over time.

The provided text describes the 510(k) premarket notification for the CooperSurgical Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418). This device is a hot or cold disposable pack and is classified as Class I. The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific numerical acceptance criteria for a novel AI/software medical device.

Therefore, many of the requested categories related to AI/software device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this traditional medical device submission.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them, adapted to the context of this manual heating device:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices, particularly regarding safety and effectiveness for its intended use. The primary performance aspect evaluated is its temperature profile and its effect on infant skin.

Study Details

The primary "study" described is a combination of non-clinical performance testing and an animal study.

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

   • Temperature Profile Testing: "For each sample, a calibrated thermocouple was attached to the center..." The exact number of samples tested for temperature profiling is not explicitly stated. It implies multiple samples were tested to establish the profile.
   • Animal Study: 6 pigs (3 light-skinned, 3 dark-skinned), aged 3 to 3.5 weeks.
   • Data Provenance: Not specified, but generally assumed to be internal laboratory testing by the manufacturer or contracted labs. The animal study involved "pigs."

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

   • Not Applicable in the context of an AI/software device. For this device, "ground truth" for temperature was measured by calibrated thermocouples. For the animal study, grading of thermal insult and erythema was done against "established criteria," implying veterinary or pathology expertise, but the number and specific qualifications of graders are not provided.

3. Adjudication method for the test set:

   • Not Applicable. This is not a human-reader-based diagnostic device.

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:

   • Not Applicable. This is not an AI/software diagnostic device that involves human readers.

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

   • Not Applicable. This is a physical heating device, not an algorithm.

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

   • Temperature Profile: Objective measurements from calibrated thermocouples.
   • Biocompatibility: Adherence to international standards (AAMI/ANSI/ISO 10993-5:2003, AAMI/ANSI/ISO 10993-10:2010), likely involving established lab tests for cytotoxicity and sensitization/irritation.
   • Animal Study (Skin Safety): Visual grading against "established criteria" for thermal insult and erythema, which would typically involve macroscopic and potentially microscopic (pathology) assessment by trained personnel/veterinarians, but the specific detail is not explicitly provided.

7. The sample size for the training set:

   • Not Applicable. This is not a device based on trained algorithms.

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

   • Not Applicable.

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Rapid Aid Infant Heel Warmer is primarily used in hospitals, doctor's offices, and other healthcare facilities. It is an instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.

The Rapid Aid Infant Heel Warmer is a self contained unit comprised of a flexible, poly/nylon outer pouch containing:

• a) A metal disc that can be flexed during activation,
• b) Liquid solution of food grade sodium acetate and water,
• c) Minute crystals of sodium acetate.
  An adhesive tape is attached to the top of the unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermnic reaction causes the unit to heat up to 104ºF. The adhesive tape strip is used to hold the warmer in place if desired.

Here's an analysis of the provided text regarding the Rapid Aid Instant Disposable Infant Heel Warmer, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The main performance characteristic tested for this device is its temperature profile.

Note: The exact numerical "specified range" for maximum temperature and dwell time is not explicitly stated as a formal acceptance criterion but is implied by the comparison to the predicate device and the statement "both within the specified range for this device."

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

• Sample Size: Not explicitly stated. The document mentions "The Infant Heel Warmer with Disc was tested against the predicate device," implying a test set, but does not provide the number of units tested.
• Data Provenance: Not explicitly stated, but it's a bench test conducted by the manufacturer, Rapid Aid Corp. (Canada). This would be prospective data generated for the 510(k) submission.

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

This information is not applicable to this type of device and study. The testing described is bench testing of physical properties (temperature, dwell time, material properties), not diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves objective physical measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not conducted. This device is a physical warmer, not an AI or diagnostic tool that would involve human readers interpreting cases.

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

This information is not applicable. This is a physical medical device, not an algorithm, so "standalone performance" in the context of AI does not apply. The performance evaluation was essentially a standalone bench test of the device's physical properties.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation appears to be the established performance characteristics of the legally marketed predicate device (Rapid Aid Instant Disposable Infant Heel Warmer, K040856) and the "specified range for this device" (though this range is not explicitly defined in the document). In essence, the new device's performance was compared to that of a previously cleared, substantially equivalent device.

For material properties, the ground truth is based on ASTM standards (for poly/nylon pouch material) and toxicological acceptability (for sodium acetate).

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

This information is not applicable for the reasons stated in point 8.

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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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For use by hospital, Ambulatory Surgery staff, Outpatient Clinics for warming of Infant's Heels prior to drawing blood for sampling or general analysis. This device is intended for Rx use only. This device is single use, non-sterile, and disposable.

Not Found

This document is a 510(k) clearance letter for a medical device called the "DeNovo Teddy Gel Infant Heel Warmer." It is not a study report and therefore does not contain information about acceptance criteria or a study proving device performance as requested in the prompt.

The document primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation number, regulatory class, and product code. It also includes an "Indications for Use Form" which specifies the intended use of the device.

Since the input document does not provide the requested information, I cannot fill out the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications.

Here's what I can extract from the provided text, noting that the core request for study data cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. This document is a clearance letter, not a study report. It does not contain acceptance criteria or reported device performance metrics.

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

• Not applicable. No study details are provided.

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

• Not applicable. No study details are provided.

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

• Not applicable. No study details are provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a non-AI medical device (a heel warmer). No MRMC study or AI component is mentioned.

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

• Not applicable. This is a non-AI medical device.

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

• Not applicable. No study details are provided.

8. The sample size for the training set:

• Not applicable. No study details are provided.

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

• Not applicable. No study details are provided.

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OrthoCor Knee System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis.

The OrthoCor Active Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The OrthoCor Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm to the tissue target via the inductive coupling with an applicator coil. The system also includes disposable, single-use, air activated OrthoPods that provide heat. The OrthoPods are snapped into medial and lateral slots on the knee wrap. Treatment may occur directly through dressings, clothing, casts, compression garments or supports.

The provided text describes a 510(k) submission for the OrthoCor Active Knee System, a medical device for pain and edema. The submission primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and adherence to safety standards, rather than conducting a detailed clinical study with acceptance criteria for device performance in a clinical context.

Therefore, many of the requested categories related to clinical performance studies, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not applicable or not provided in this document.

Here's the information that can be extracted based on the provided text:

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

Study that proves the device meets the acceptance criteria:

The document states that "Equivalence was based on bench testing that showed the device produces the same outputs as the predicate as shown in the table below." This implies a bench testing study was conducted to compare the technical specifications and outputs of the OrthoCor Active Knee System against its predicate device (Ivivi Torino II K070541).

2. Sample size used for the test set and the data provenance: Not applicable. The submission relies on bench testing for technical equivalence, not clinical data sets with "test sets" in the context of AI/diagnostic device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical studies, not technical equivalence bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI-assisted diagnostic device.

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 (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context is the technical specifications and measured outputs of the predicate device (Ivivi Torino II K070541), which the OrthoCor Active Knee System aimed to match. The assessment was based on objective physical measurements during bench testing.

8. The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.

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

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