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The device is intended to warming pre-set body temperature as determined by the physician. It can also be utilized to warming normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. The device has heating capability, not cooling.

This device is an external thermal regulating system consisting of blankets that are placed in contact with the patient, and a temperature controller and is to warming the patient's temperature using carbon technology between 30 and 40 ℃ (86 and 104ºF). The function of the device is heating, not cooling. The heating element and sensor are both embedded inside the blankets. Four blanket sizes are available: 11- 100 Watts, Pediatric: 1.0 by 0.65 meters (3.3 by 2.17) and 3mm high (0.12 inches) weighing 0.9 kgs (Product code WD-01-100); 2 140 Watts, Adult: 2.0 by 1.35 meters (6.6 by 4.5 ft) and 3mm high (0.12 inches) weighing 2.0 kgs (Product code WD-01-200); 3- 40 Watts, Arm Shoulder: 1.5 meters (5.0 ft) and 3mm high (0.12 inches) weighing 1.0 kg (Product code 150-AW); 4- 50 Watts, Leg Warmer: 0.95 meters (3.17 ft) and 3mm high (0.12 inches) weighing 1.2 kgs (Product code 100-DB).

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the new device.

However, based on the available information, I can extract and infer some points regarding the study and acceptance criteria as presented in a 510(k) context:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for "Inferred" Acceptance Criteria:
In a 510(k) submission, "acceptance criteria" are generally tied to demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This means the new device must perform as safely and effectively as the predicate, often by having the same technological characteristics or having different characteristics that do not raise new questions of safety or effectiveness and are demonstrated to be as safe and effective. The table above reflects the claims made in the "Summary comparing technological characteristics with other predicate device" section.

2. Sample Size for Test Set and Data Provenance:

• The document describes a comparison to a predicate device (Klimamed® Thermal Mats, 510k # K011859) rather than a clinical performance study with a distinct "test set" and a specified sample size.
• Data Provenance: Not explicitly stated. The comparison is based on the characteristics of the devices themselves, suggesting a technical and regulatory review rather than a new clinical study.
• Retrospective/Prospective: Not applicable in the context of the provided information, as it's a comparative analysis against an existing device's characteristics.

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

• This information is not provided in the document. The substantial equivalence claim is based on a comparison of technical and performance specifications, not on expert consensus or ground truth derived from clinical cases for a test set.

4. Adjudication Method for the Test Set:

• This information is not provided as there is no mention of a test set requiring adjudication.

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

• No, an MRMC comparative effectiveness study is not mentioned in the provided text. This type of study is more relevant for diagnostic imaging devices where human reader performance with and without AI assistance is being evaluated. The Klimamed® Thermal Blankets are therapeutic devices (warming blankets).

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone performance study is not mentioned. The device is a physical product (thermal blankets and a controller) for warming patients, not an algorithm, so this concept does not apply in the usual sense. The "performance" mentioned in the comparison refers to its functional performance as a warming device.

7. Type of Ground Truth Used:

• The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., pathology, outcomes data) is not directly applicable here. The "truth" in this context is the demonstrated safety and effectiveness of the predicate device, and the new device's characteristics are compared against that established benchmark.

8. Sample Size for the Training Set:

• Not applicable/Not provided. The device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" of data.

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

• Not applicable. See point 8.

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THIS DEVICE IS INDICATED TO MAINTAIN PRESET BODY TEMPERATURE AS DETERMINED By THE PHYSICIAN. IT CAN ALSO BE UTILIZED TO MAINTAIN NORMAL BODY TEMPERATURE DURING SURCICAL PROCEDURES . IT IS INDICATED FOR USE IN HOSPITAL INVASIVE AND CORONARY CARD UNITS, IN OPERATING, RECOVERY AND EMERGENCY IN BURN UNITS, Rock's AND ON MEDICAL | SURGICAL floors

This device is an external thermal regulating system consisting of a mat that is placed in contact with the patient and a temperature controller and is to regulate the patient's temperature between 30 and 37.7 ℃ (86 and 100ºF), using carbon technology. The heating element and sensor are both embedded inside the mat. Two mat sizes are available: 1- 95 Watts, Standard 0.950 by 0.495 meters (3.1 by 1.6 ft) and 9mm high (0.35 inches) weighing 5 kg (11 lbs) (Product code 75/95/12M) for adult patients 2- 55 Watts, Pediatric 0.550 by 0.495 meters (1.8 by 1.6 ft) and 9mm high (0.35 inches) weighing 3.5 kg (7.7 lbs) (Product code 55/95/12M) for pediatric patients 75/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 75/95/12M 55/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 55/95/12M

The provided 510(k) summary for the Klimamed® Thermal Mat & Controller 95 & 55 Watts does not contain detailed information about specific acceptance criteria, a study proving device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods.

Instead, the submission primarily focuses on demonstrating substantial equivalence to a predicate device (Allon 2001 by M.T.R.E Advanced Technology, Ltd, K001546) based on technological characteristics.

Here's a breakdown of the available information and what's missing:

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

The document does not explicitly define acceptance criteria as numerical targets or benchmarks that the device had to achieve. Instead, it relies on a comparative table to show that the Klimamed® device's characteristics are "Identical" or "Similar" to the predicate device.

What's missing regarding "reported device performance":
The document states "Performance: Identical" in the comparison table, but it does not provide any specific performance metrics, data, or results from tests conducted on the Klimamed® Thermal Mat & Controller itself. It implicitly claims that because its performance is "Identical" to a legally marketed predicate, it meets an unstated, accepted level of performance.

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 provided in the 510(k) summary. The submission does not describe a specific clinical or performance test set with a defined sample size. The equivalence is primarily based on a comparison of technological characteristics.

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

This information is not provided. As no specific performance study on a test set is described, there's no mention of experts establishing ground truth.

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

This information is not 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

This is not applicable to this device. The Klimamed® Thermal Mat & Controller is a thermal regulating system, not an AI-assisted diagnostic device that would involve human readers interpreting cases.

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

This is not applicable to this device. It is not an algorithm-based device.

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

This information is not provided. No specific test set or ground truth establishment is described. The "ground truth" for demonstrating substantial equivalence appears to be the established safety and effectiveness of the predicate device based on its prior market clearance.

8. The sample size for the training set

This information is not provided. This device is a physical medical device, not a machine learning model, so the concept of a "training set" in this context does not apply.

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

This is not applicable as there is no training set for this type of device.

In summary:

The 510(k) submission for the Klimamed® Thermal Mat & Controller relies on a comparison of technological characteristics to a predicate device to demonstrate substantial equivalence, rather than providing detailed acceptance criteria and the results of a specific performance study against those criteria. The argument is that since the device's characteristics (including "Performance") are "Identical" or "Similar" to a device already cleared by the FDA, it is considered safe and effective.

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