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The ASTOPAD® Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The ASTOPAD Patient Warming System is indicated for use in all areas of healthcare facilities for preventing or treating hypothermia or maintaining normothermia. The warming blankets can be used over or under the patient (pediatric and adult) by appropriately trained healthcare professionals.

The ASTOPAD Patient Warming System is a thermal regulating system which includes a connection cable that attaches to reusable conductive warming blankets for patient warming in clinical environments. The system consists of a control unit (DUO310-NA) and one or optionally two applied parts (warming blankets/COVXXX-NA) with different sizes to fit different applications.

The provided text describes the Stihler Electronic GmbH's ASTOPAD Patient Warming System. However, it does not contain information about acceptance criteria for device performance related to diagnostic accuracy, a study proving the device meets said criteria, or any details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically associated with artificial intelligence/machine learning diagnostic devices.

The document is a 510(k) summary for a medical device (a patient warming system) and focuses on establishing substantial equivalence to a predicate device through performance data for safety and effectiveness related to its function as a warming device.

Therefore, most of the requested information is not applicable or cannot be extracted from this document.

Here's an attempt to answer based on the available information:

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

The document primarily references compliance with various international standards for safety and effectiveness, rather than specific performance metrics directly related to diagnostic accuracy. The "acceptance criteria" are implied by meeting the requirements of these standards.

2. Sample size 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 document as it is not an AI/ML diagnostic device study. The performance data listed (biocompatibility, electrical safety, etc.) are standard engineering and laboratory tests, not clinical studies with patient data in the typical sense.

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 and is not applicable to the type of device and testing described in the document.

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

This information is not provided and is not applicable to the type of device and testing described in the document.

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 provided and is not applicable. The device is a patient warming system, not a diagnostic imaging device with human readers and AI assistance.

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

This information is not provided and is not applicable. The ASTOPAD Patient Warming System does not involve an algorithm for standalone diagnostic performance.

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

The "ground truth" for the various performance tests (biocompatibility, electrical safety, etc.) is the adherence to the specifications and limits defined within the referenced international standards (e.g., IEC 60601 series, ISO 10993-1). This is verified through laboratory testing and validation protocols rather than clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set:

This information is not provided and is not applicable. The device does not use an AI/ML model that requires a training set.

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

This information is not provided and is not applicable. The device does not use an AI/ML model that requires a training set with established ground truth.

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The PRISMAFLO II is for warming dialysis fluid and returning blood flow.

The PRISMAFLO II is a modified version of the PRISMAFLO covered by K020103. The PRISMAFLO uses water in the heat transfer process. PRISMAFLO II is the same as PRISMAFLO except it is water free.

The PRISMAFLO II dialysis fluid and blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Barkey Prismacomfort 510(K) Number K071909. The PRISMAFLO II blood warmer is used to warm the return blood flow line in order to replace heat lost to the atmosphere and effluent flow during a Prismaflex or PRISMA treatment. The PRISMAFLO II blood warmer consists of one control unit and one sleeve warmer. The control unit (Stihler PRISMAFLO II) controls the sleeve warmer and displays alarm and status messages.

The PRISMAFLO II blood warmer warns the returning blood flow line by means of a silicon tube heat exchanger which covers the blood return flow line of the Gambro Prismaflex or Prisma system completely. The heat is transferred by the contact of the resistance heating system to the inscried blood return line. The complete enclosure of the returning blood flow line to be warmed ensures that there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the return blood flow at maximum efficiency.

The sleeve warmer is powered with 22 VDC which is derived from 115 VAC (or where required 230 VAC). 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Stihler PRISMAFLO II. Above the on-off switch is a display temperature monitor showing actual and set temperature. The temperature of the sleeve warmer and other performance characteristics of the sleeve warmer are controlled electronically, visual and audible alarms as well as cut-offs are hardware realized. Like the blood warmer Barkey Prismacomfort, the sleeve warmer PRISMAFLO II is constructed as a slotted enclosed silicon tube, which can completely enclose inserted blood return flow lines of up to 7.00 mm diameter. The PRISMAFLO II woighs approx 3.9 kg and is equipped with a holder at the rear side of the control unit, which allows mounting on hemodialysis system Gambro Prismatlex and Prisma system. Both products, the PRISMAFLO II and the Barkev Prismacomfort use sleeve warmers made of silicon. The flexibility of this material ensures a nearly complete enclosure of the blood return flow line on Gambro Prismallex and Prisma system.

Only the water free operation of the PRISMAFLO II differs to the PRISMAFLO.

This document describes the PRISMAFLO II blood warmer, a medical device. The information provided heavily emphasizes that the device is a modified version of an existing device (PRISMAFLO) and is substantially equivalent to a predicate device (Barkey Prismacomfort). The "study" described is a nonclinical performance verification.

Here's an analysis of the provided text in relation to your requested categories:

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

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

• Sample size used for the test set: Not explicitly stated. The document refers to "the following tests were carried out successfully" but does not give specific numbers of units tested or duration of tests. This is a non-clinical device so "samples" would refer to devices tested, not patient data.
• Data provenance: The tests were "carried out" by the manufacturer (Stihler Electronic GmbH), presumably in Germany given their address. The data is retrospective in the sense that the tests were completed before submission.

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

Not applicable. This is a non-clinical device safety and performance verification. "Ground truth" in this context would refer to engineering specifications and regulatory standards, not expert medical opinion on patient data. The tests verify compliance with these objective standards.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication, as there are no human readers or subjective interpretations of results described. The tests are presented as objective measurements against predefined standards.

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 medical device (blood warmer), not an AI-powered diagnostic or interpretive tool. There are no human readers involved in its direct operation that would be improved or assisted by AI within the scope of this device.

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

Not applicable. This is a physical medical device. The "standalone" performance refers to the device's ability to perform its function (warming blood) independently, which is what the non-clinical tests would have assessed. However, the term "algorithm only" is not relevant here as it's not a software-only device.

7. The type of ground truth used

The "ground truth" for the non-clinical tests was adherence to:

• Engineering specifications and design requirements for preventing blood cooling and ensuring safe operation (e.g., set temperature, alarm triggers, cut-off mechanisms).
• Mandatory and voluntary consensus standards for medical device safety and performance (e.g., DIN EN 60601-1, ASTM F 2172-02).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a physical medical device.

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1. Warming transfusions, infusions, fluids.
2. Warming blood transfusions and return blood flow.

The ASTOFLO PLUS is a modified version of the ASTOFLO covered by K020060. The ASTOFLO uses the closed water circuit where the temperature of the closed water circuit is controlled by sensors. ASTOFLO PI.US uses dry heat warming and the control the sleeve temperature with integrated sensors.

The ASTOFLO PLUS blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Stihler ASTOFLO 510(K) Number 020060 and Barkey Prismacomfort 510(K) Number K071909. The ASTOFLO PLUS blood warmer is used to warm the transfusions, infusions, fluids and also return blood flow in the medical field. The ASTOFLO PLUS warmer consists of one control unit and one sleeve warmer. The control unit (ASTOFLO PLUS) controls the sleeve warmer made by Stihler and displays alarm and status messages.

The ASTOFLO PLUS warmer warms blood, infusions, fluids and return blood flow by means of a silicon tube heat exchanger, which covers the fluid lines used in the medical field nearly complete. The heat is transferred by the contact of the resistance heating system to the inserted disposable lines need in the medical field. The nearly complete enclosure of the disposable lines used in the medical field to be warmed ensures that there is good warmth conduction to the fluids and there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the disposable lines used in the medical field and may be used with any therapy choices. when heat loss may cause undesirable cooling of the patient.

The sleeve warmer is powered with 22 VDC which is derived from 115 VAC (or where required 230 VAC), 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Stihler ASTOFLO PLUS. Above the on-off switch is a display temperature monitor. The temperature of the sleeve warmer visual and audible alarms and other performance characteristic of the sleeve warmer are controlled electronically. Like the blood warmer Stihler ASTOFLO and the Barkey Prismacomfort, the sleeve warmer Stihler ASTOFLO PLUS is constructed as a slotted enclosed silicon tube, which can completely enclose inserted bluod return flow lines of up to 7.00 mm diameter. The ASTOFLO Plus weighs approx 3.0 kg and is equipped with a holder at the rear side of the control unit, which allows mounting on i.v. poles and medical rails. All three products, the Stihler ASTOFLO PLUS, Barkey Prismacomfort and the Sticker ASTOFI.O use sleeve warmers made of silicon. The flexibility of this material ensures a nearly complete enclosure of the disposable lines used in the medical field.

The provided text describes a 510(k) summary for a medical device called ASTOFLO PLUS, a blood and infusion warmer. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics for the new device.

Therefore, many of the requested categories cannot be fully addressed from the given document as it does not contain the specific information about detailed acceptance criteria, numerical performance results, sample sizes for test sets, expert involvement for ground truth, MRMC studies, or training set details that would typically be found in a detailed study report.

Here's an analysis based on the provided text, highlighting what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Numerical acceptance thresholds for temperature, heating rates, alarm activation points, or other quantitative performance metrics are not provided in this summary.

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

• Sample Size: Not specified. The document states "the following tests were carried out successfully," but does not provide any information about the number of units tested, duration, or specific fluid volumes.
• Data Provenance: Not specified. No information about the country of origin of the data or whether the studies were retrospective or prospective is present.

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

• This information is not provided. The document outlines verification and validation activities related to engineering and safety standards, but not clinical studies involving expert interpretation or ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. There's no indication of a test set requiring adjudication in the context of clinical performance or interpretation.

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

• No. The document presents nonclinical tests and design control activities for substantial equivalence. It does not mention any MRMC studies comparing human readers with AI assistance. The device in question is a medical warmer, not an AI-assisted diagnostic tool.

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

• Yes, in a sense. The "tests were carried out successfully" to verify the system's ability to warm fluids and protect the patient. These are likely engineering and bench tests performed on the device itself without direct human interaction as part of the primary performance evaluation. However, the study details are not provided.

7. The Type of Ground Truth Used

• For the non-clinical tests mentioned, the "ground truth" would be established by engineering specifications, regulatory standards (e.g., DIN EN, ASTM, IEC), and predefined performance metrics for warming capabilities and safety mechanisms. For instance, a temperature sensor would provide the objective "ground truth" of the fluid temperature, measured against a specified target range. The document doesn't mention pathology, outcomes data, or expert consensus in relation to these tests.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device is an electromechanical warmer, not an AI/ML algorithm that requires a training set.

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

• Not applicable/Not specified, as it's not an AI/ML device requiring a training set.

Summary of Limitations from the Document:

The provided text is a 510(k) summary, which is designed to demonstrate "substantial equivalence" of a new device to existing legally marketed devices. It focuses on predicate device comparisons, safety standards compliance, and general functional verification, rather than detailed performance studies with granular data, statistical analyses, or human reader studies typically associated with AI/ML or complex diagnostic devices. Therefore, much of the requested information about specific acceptance criteria numerically, sample sizes, expert involvement, and reader studies is either not present or not applicable to this type of device and submission.

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For warming dialysis fluids and returning blood flow.

Prismaflo™ Blood and Dialysate Warmer (Model PF122NA) designed for the Prisma System

This looks like a 510(k) clearance letter for the Prismaflo Blood and Dialysate Warmer (Model PF122NA). Unfortunately, this document does not contain the detailed information necessary to answer your questions about acceptance criteria and the study that proves the device meets them.

A 510(k) clearance letter primarily states that the FDA has reviewed the device and determined it to be "substantially equivalent" to a legally marketed predicate device. This process generally does not require the submission of detailed clinical study reports or performance acceptance criteria in the same way a Premarket Approval (PMA) would.

To answer your questions, I would need to see the actual 510(k) submission document or a summary of its data, which is typically much more extensive than this clearance letter.

Therefore, since the provided text does not contain the information requested, I must state:

The provided document (FDA 510(k) clearance letter K020103 for PRISMAFLO) does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

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Warm return blood flow

Not Found

I'm sorry, but this document does not contain the information requested. The document appears to be an FDA 510(k) clearance letter for a device called "Prismatherm II." It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. These details would typically be found in the 510(k) submission itself, not directly in the clearance letter provided here.

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Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow

Astotherm Plus, Astotubes, Astoline

I am sorry, but the provided text from the FDA 510(k) notification for the "Astotherm Plus, Astotubes, Astoline" devices does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document is a general clearance letter stating that the device is "substantially equivalent" to previously marketed devices and lists its "Indications for Use." It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information on any multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details about a standalone (algorithm only) performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in detailed premarket submission documents, clinical trial reports, or performance testing summaries, which are not present in this specific clearance letter.

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