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The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable.

Indications for use for the Medi-Therm thermal regulating system include:
a. To maintain pre-set body temperature as determined by the physician
b. To maintain normal body temperature during surgical procedures
c. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors
d. This system can be used with adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket/s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system.

The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.

The provided document is a 510(k) summary for the Gaymar Medi-Therm Hyper/Hypothermia System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the technological characteristics, intended use, and general safety and effectiveness.

Based on the provided text, there is no information available regarding a study that assesses device performance against specific acceptance criteria in the format you requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or reader improvement with AI).

The document mentions "Bench testing was conducted to confirm the MTA6900 and MTA7900 and their disposable accessories operate as described in this submission and therefore are as safe and effective as the predicate devices to which it claims substantial equivalence." The types of bench testing listed are:

• Temperature Control Performance
• Temperature Stability and Flow
• Biocompatibility (ISO 10993-5; ISO10993-10; 16 CFR 1500)
• Ship Testing (ISTA 1A)

However, the document does not provide:

• Specific acceptance criteria for these tests (e.g., "temperature control performance must maintain patient temperature within +/- 0.5°C").
• Reported device performance against such criteria in a quantitative table.
• Details about sample sizes, data provenance, ground truth establishment, expert involvement, or MRMC studies. The context of this device (a thermal regulating system) does not typically involve the kinds of diagnostic accuracy studies (MRMC, standalone, human-in-the-loop) that would require such detailed information on ground truth, expert consensus, and reader performance.

Therefore, I cannot populate the table or answer most of your specific questions as the necessary information is not present in the provided 510(k) summary. The document focuses on demonstrating that the device meets safety and performance standards generally expected for its product classification and is substantially equivalent to existing devices through engineering and functional comparisons, not clinical performance metrics in the way a diagnostic AI device would be evaluated.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Study Information (Based on the document):

1. Sample size used for the test set and the data provenance: Not applicable/not provided. The document refers to "Bench testing," which implies laboratory-based tests rather than patient data test sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth establishment with experts is typically for diagnostic devices assessing images or other complex data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not mentioned and is not typically relevant for a thermal regulating system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This refers to diagnostic algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided. For bench testing, the "ground truth" would be the expected physical or electrical output/behavior based on design specifications or industry standards.
7. The sample size for the training set: Not applicable/not provided. This device is not described as involving machine learning or algorithms that require a "training set" in the context of data analysis. Its "microprocessor control" refers to conventional programming.
8. How the ground truth for the training set was established: Not applicable/not provided.

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The T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or cold water at controlled temperatures via water circulating pad for the application of localized therapy in situations where a physician determines that temperature therapy is necessary or desirable.

Localized temperature therapy is of particular benefit in treating the following; orthopedic conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin trauma such as abscesses, boils, bruises, burns and contusions; other medical conditions such as chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration: and symptoms such as infection and localized pain.

The T-Pump Localized Temperature Therapy Pump is a small electronically controlled water heater that supplies warm or cold water at controlled temperatures to a water circulating pad for the application of localized temperature therapy. The control unit is an cloctrical device that uses a heating element to increase the temperature of water to controlled temperature set points, which the user selects from the digital display face. The temperature is controlled by a dual microprocessor control circuit and a thermostat to prevent overheating. To utilize the cold therapy option, the user adds ice water to the device, which will heat the water to a set point of 50 degrees Fahrenheit. The temperature range of the device ranges from 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point).

The T-Pump Localized Temperature Therapy Purnp attaches to a connector hose that connects to the water-circulating pad; the temperature-controlled water flows from the pump to the pad. The pads are applied to the part of the body requiring temperature therapy, thereby providing the interface for the therapy.

The T-Pump Localized Temperature Therapy Pump measures, in inches, 11.5 x 8 x 8. The device weighs under 10 pounds with the unit filled with water reservoir has a maximum capacity of 2750ml. The housing is composed of ABS Plastic and Polycarbonate.

The leakage current is 100 microamperes maximum, and the flow rate is 9 gph (34 lph) minimum, with the water circulating pad attached.

The provided text describes the T-Pump Localized Temperature Therapy Pump (K073675) and its regulatory submission, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document is a 510(k) summary and approval letter from the FDA. Its primary purpose is to demonstrate "substantial equivalence" to previously cleared predicate devices, not to present a detailed performance study with acceptance criteria.

The information sought in your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set size and ground truth establishment) is typically found in design validation reports or clinical study reports, which are part of the detailed submission to the FDA but are not usually included in the publicly available 510(k) summary.

Therefore, I cannot provide the requested table and details based solely on the provided text.

Here's a breakdown of why the information is not present and what is mentioned:

• Acceptance Criteria & Reported Performance: Not explicitly stated. The document focuses on comparing the new device's features and intended use to predicate devices to establish equivalence.
• Sample Size (Test Set) & Data Provenance: Not mentioned for any specific performance test.
• Number of Experts, Qualifications, Adjudication Method: Not applicable as no specific test set or ground truth establishment process is described beyond the general device description.
• MRMC Comparative Effectiveness Study: Not mentioned. The 510(k) pathway for this device typically relies on demonstrating equivalence rather than conducting a full comparative effectiveness study with human readers/users.
• Standalone Performance Study: Not mentioned in terms of quantitative performance metrics, sensitivity, specificity, accuracy, etc. The document describes the device's technical specifications and intended function.
• Type of Ground Truth: Not mentioned.
• Sample Size (Training Set): Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires training data in the same way.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does provide in relation to product performance and characteristics:

• Temperature Range: "From 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point)."
• Physical Dimensions: "11.5 x 8 x 8 inches."
• Weight: "Under 10 pounds with the unit filled with water."
• Reservoir Capacity: "Maximum capacity of 2750ml."
• Leakage Current: "100 microamperes maximum."
• Flow Rate: "9 gph (34 lph) minimum, with the water circulating pad attached."

These are specifications, not "acceptance criteria" against which a clinical or performance study's results are measured and reported for the purpose of demonstrating efficacy or safety in the way an AI algorithm's performance would be.

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The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.

The CLINI-DYNE Rotational Therapy System consists of an electromechanical inflation pump control unit which is connected to a mattress with cells (air filled bladders) through hose assemblies connected to the inflation pump. The system affords programmed patient position changes by gently turning the patient from supine to left side or right side and back to supine position when staff is unable to do so or needs assistance.

The provided text describes a Premarket Notification [510(K)] Summary for the GAYMAR INDUSTRIES, INC. CLINI-DYNE Rotational Therapy System. This document focuses on demonstrating substantial equivalence to a predicate device (CLA 1400 System) rather than reporting on a study demonstrating the device meets pre-defined acceptance criteria in the way a clinical trial for a novel AI device would.

Therefore, the requested information elements related to AI device performance studies (like sample size for test sets, expert consensus, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document. This is a regulatory submission for a medical device that predates the common application of AI in medical imaging or diagnosis.

However, I can extract information related to the device's technical specifications and safety testing, which serve as a form of "acceptance criteria" for demonstrating substantial equivalence.

Here's the information that can be extracted from the provided text, adapted to the requested format where possible:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of 510(k) submission, "acceptance criteria" are typically defined by demonstrating that the new device is as safe and effective as the predicate device. The performance is compared feature-by-feature for substantial equivalence.

NOTE 1: The document notes "See Substantial Equivalence" for these differences, implying that despite the direct difference, the total package of features and safety data still allows for a claim of substantial equivalence for the intended use.

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

• Not Applicable. This document describes a Traditional 510(k) for a physical medical device (Rotational Therapy System). The "test set" and "data provenance" as understood in AI/ML performance studies (e.g., patient data, image sets) are not relevant here. The "testing" involved physical and electrical safety standards (e.g., biocompatibility on materials, flammability, UL standards).

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

• Not Applicable. Ground truth in the context of expert consensus on data interpretation is not relevant for this device's regulatory submission. Safety and performance were assessed against established technical standards and by comparison to a predicate device.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple experts interpreting data, which is not applicable to the type of testing described here.

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. MRMC studies are used for evaluating diagnostic performance, often in conjunction with AI. This document is for a physical patient support system.

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used

• For Biocompatibility, Tissue Interface Testing, and Flammability: The "ground truth" was established by standardized laboratory testing procedures against pass/fail criteria for physical and chemical properties.
• For UL Approvals: "Ground truth" is compliance with Underwriters Laboratories (UL) standards.
• For comparative features: "Ground truth" is the demonstrated performance and characteristics of the predicate device (CLA-1400).

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of AI/ML.

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

• Not Applicable. This device does not involve a "training set."

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To aid in the reduction and management of peripheral edema such as lymphedema and ulceration associated with vascular insufficiency.

The Sof.Press EPC 51 System is an external pneumatic compression device that consists of a pump, an inflatable three cell sleeve, and connection tubing. Each cell of the sleeve is inflated sequentially with the highest pressure applied distally and with successively lesser pressures applied proximally.

The provided text is a Premarket Notification [510(K)] Summary for a medical device called the "Sof.Press EPC 51 System." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report with the specific information requested.

Therefore, many of the requested details cannot be extracted directly from this document. The document primarily covers regulatory information, device description, and a high-level safety summary comparing the new device to existing ones.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not present in the provided text. The document includes a "Safety Summary Chart" that lists some tests (Biocompatibility, Flammability, UL Approvals, Pressure Relief Valve) and reports "pass" for the Sof.Press device. However, these are not clearly defined "acceptance criteria" with specific thresholds or metrics for performance, nor is there a detailed "reported device performance" section with quantitative results. It primarily states whether the device passed certain safety evaluations.

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

This information is not present in the provided text. No details about sample sizes, data provenance, or study design (retrospective/prospective) are mentioned.

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

This information is not present in the provided text. The document does not describe any studies involving experts establishing ground truth.

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

This information is not present in the provided text. No adjudication methods are mentioned, as detailed efficacy or diagnostic studies are not 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:

This information is not present in the provided text. The Sof.Press EPC 51 System is a pneumatic compression device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not discussed.

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

This information is not present in the provided text. The device is a physical pneumatic compression system, not a software algorithm.

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

This information is not present in the provided text. No specific ground truth methodology is described as the document focuses on substantial equivalence based on technological characteristics and safety.

8. The sample size for the training set:

This information is not present in the provided text. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

This information is not present in the provided text, as there is no training set described.

Summary of available information related to "acceptance criteria" and "study":

The document presents a "Safety Summary Chart" which can be interpreted as a limited set of safety acceptance criteria for the device itself, rather than performance criteria related to its intended use in reducing edema.

Table of "Acceptance Criteria" (Safety-focused) and Reported "Performance":

Study/Evidence:

The "study" that proves the device meets these safety aspects is implied to be the underlying testing that resulted in the "pass" statements. However, the document does not provide details of these studies, such as methodology, sample sizes, or specific results beyond the pass/fail outcome. The entire submission is a "Premarket Notification" aiming to demonstrate substantial equivalence to predicate devices (Jobst Extremity Pump System 7500 and Huntleigh Flowpress AC300) based on similar technological characteristics and the safety data summarized in the chart. This is a regulatory filing, not a detailed clinical study report.

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The SPR+II overlay system is a pressure relieving support system intended to reduce the potential for development of pressure ulcers on at risk patients or to be used in the treatment of existing pressure ulcers.

The SPR+II System consists of an electromechanical inflation pump control unit which is connected to an overlay through a hose assembly connected to the inflation pump.

This is a premarket notification [510(k)] summary for the SPR+II System, a low air loss system designed to prevent and treat pressure ulcers. It primarily establishes substantial equivalence to a predicate device, the CLA 1500 System, rather than presenting a performance study with acceptance criteria and a detailed statistical analysis against those criteria. Therefore, most of the information requested cannot be extracted directly from the provided text.

Here is an attempt to address the request based on the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of a target performance metric (e.g., accuracy, sensitivity, specificity) for a diagnostic or AI-driven device. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and nonclinical performance data.

The "acceptance criteria" here are implicitly that the SPR+II System performs similarly to or better than the CLA 1500 System in the listed characteristics, especially regarding safety and intended use.

Table of Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence):

Study Details (Based on the provided document)

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

   • The document describes a submission for substantial equivalence based on a comparison of technological characteristics and nonclinical performance data between the SPR+II System and the predicate device (CLA 1500). It does not describe a clinical "test set" in the context of an algorithm or diagnostic device. The "performance data" referred to are related to the device's physical and functional properties, not data derived from patient testing or a specific dataset for algorithm evaluation.
   • Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a test set is not applicable here.

2. 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):

   • As this is a submission for a medical device (a low air loss system) and not an AI or diagnostic algorithm that requires "ground truth" derived from expert interpretation, this information is not applicable. The "ground truth" here is the established function and performance of the predicate device against which the new device is compared.

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

   • This is not applicable as there is no "test set" in the context of expert adjudication for an algorithm.

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:

   • This is not applicable. The device is an electromechanical low air loss system, not an AI or diagnostic tool that would be used in an MRMC study to compare human reader performance.

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

   • This is not applicable. The device is a physical medical support system, not an algorithm.

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

   • For this type of device, "ground truth" refers to established engineering specifications, functional requirements, and safety standards, as well as the documented performance of the predicate device (CLA 1500). The "truth" is that the device meets these specifications and performs equivalently to a legally marketed predicate.

7. The sample size for the training set:

   • This is not applicable as the device is not an AI or machine learning algorithm requiring a "training set."

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

   • This is not applicable as the device is not an AI or machine learning algorithm.

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