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The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.

The °MEQU °M Warmer System consists of three components:

• a single-patient use, disposable warmer unit
• a multi-patient, reusable, rechargeable battery pack for powering the warmer
• a reusable charger for recharging the battery pack.
  The warmer contains a sterile fluid path with standard Luer lock connectors allowing it to be connected in the infusion fluid line. The fluid path includes a parylene coated aluminium heating chamber in which fluids passing through the warmer are heated. Heat is generated using resistive heating elements, using power supplied by the rechargeable battery pack.
  The warmer contains the electronics and software to control the temperature of the chamber and thus the temperature of the outgoing fluid.
  Remaining power in the battery pack is indicated to the user during use. When depleted, the battery pack can be re-charged using the charger.

The provided text does not include information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the °M Warmer System, which is a medical device designed to warm fluids for intravenous administration, not an AI or software as a medical device (SaMD).

Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document discusses performance in the context of non-clinical studies for a traditional medical device (like sterilization, electrical safety, biocompatibility, and heater safety testing) and concludes that the device is substantially equivalent to a predicate device. It explicitly states, "The claim of substantial equivalence is not based on an assessment of clinical performance data." and also "The software control the heating process and the operation of the device." which refers to the embedded software within the warmer, not an AI or diagnostic algorithm.

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The Warrior Blood and Fluid Warmer device is intended for warming blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.

The Warrior EXTREME Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.

The Warrior Lite Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.

The QinFlow Blood and Fluid Warmer (Warrior / Warrior lite) is a portable sterile fluid path, inline blood and fluid warmer intended for warming blood, blood products, and intravenous fluids prior to administration. The device is composed of the following main components:

1. Disposable Unit (DU) / Compact Disposable Unit (CDU)
2. Base Unit (BU)
3. Power source
4. Connecting Cable (CC)
5. The CDU can be connected directly onto the Warrior Lite BU or using an Extension cable accessory. The DU can be connected to the Warrior Lite using the Extension cable only.

The provided text describes a 510(k) premarket notification for a medical device, the QinFlow Blood and Fluid Warmer (Warrior, Warrior EXTREME, and Warrior Lite). This document asserts that the new device is substantially equivalent to a previously cleared predicate device (K180154).

The information provided focuses on the device's technical characteristics and performance testing to demonstrate substantial equivalence to a predicate device, rather than a study validating a new acceptance criterion for an AI/ML algorithm or a typical clinical efficacy study. Therefore, many of the requested items related to AI/ML specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, effect size of AI assistance) are not applicable in this context.

However, I can extract the relevant information regarding performance criteria and the testing performed for this medical device submision.

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

The document doesn't explicitly list "acceptance criteria" in a separate table, but rather describes the performance testing requirements and states that the device meets them. The comparison to the predicate device serves as the primary means to demonstrate substantial equivalence.

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

The document describes "Performance Data" which includes various types of engineering and laboratory testing (functional, electrical safety, EMC, software V&V, hemocompatibility, usability, shelf-life, sterilization).

• Sample Size: The specific sample sizes for each type of functional or safety test are not provided in this summary. It states "Testing to verify that the device functions as intended, and all design and functional specifications are met for all models/system configurations" and "shelf-life testing and Sterilization assessment... was conducted with acceptable results."
• Data Provenance: This is not a data-driven clinical study in the sense of patient data. The data provenance is from laboratory and engineering testing of the devices themselves. There is no mention of country of origin of data, or if it was retrospective or prospective in the context of clinical patient data, because this is about device performance characteristics, not clinical trial data.

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

• Not applicable. This submission focuses on the engineering and functional performance of a fluid warming device, not on diagnostic accuracy based on expert interpretation of medical images or data. Ground truth here refers to objective measurements against engineering specifications and industry standards, not expert medical consensus.

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

• Not applicable. See point 3.

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/ML diagnostic or assistive device.

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

• Not applicable. While the device does contain software, the submission reviews its performance as an integrated medical device for fluid warming, not as a standalone AI algorithm for analysis or decision-making without a human in the loop. The software V&V ensures the software functions correctly within the device.

7. The type of ground truth used:

• The "ground truth" for this device's performance evaluation comes from established engineering specifications, recognized industry standards (e.g., IEC 60601 series, ISO 11135, IEC 62304, IEC 62366), and direct physical/electrical measurements. For example, the "ground truth" for temperature accuracy is the target temperature, measured by calibrated instruments. For hemocompatibility, the "ground truth" is the absence of adverse interactions with blood products, demonstrated through specific testing.

8. The sample size for the training set:

• Not applicable. This refers to a traditional medical device submission, not an AI/ML algorithm development. There is no "training set" in the context of machine learning. The device's software is developed and validated through traditional software engineering V&V processes.

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

• Not applicable. See point 8.

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The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Insulated Strap is an accessory to the enFlow IV Fluid Warmer which is used to secure the warmer component of the enFlow IV Fluid Warmer System to the patient during transport. The Insulated strap consists of a silicone strap, an insulating element and a mounting plate, into which the user can secure the enFlow IV Fluid Warmer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Insulated Strap:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (510(k) Summary for K130867) does not list specific numerical acceptance criteria or performance metrics for the enFlow IV Fluid Warmer Insulated Strap. Instead, it focuses on qualitative compliance and equivalence.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document mentions "User Validation Testing" and "Design & Performance Verification Testing" but does not quantify the number of units or tests involved.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission from a US company (GE Healthcare, Totowa, NJ), the testing was likely conducted in the US, but this is not confirmed. The testing appears to be retrospective in the sense that it's evaluating a developed accessory against established standards and a predicate device, rather than a prospective clinical trial.

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

• Number of Experts: Not explicitly stated. The section mentions "User Validation Testing" but does not specify how many users were involved or if they were considered "experts" for establishing ground truth, and if so, their qualifications. The other tests (biocompatibility, design/performance verification, risk analysis) would involve qualified engineers and scientists, but these are not referred to as "experts establishing ground truth" in the context of clinical or diagnostic performance.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. For non-clinical tests like material biocompatibility, functional verification, and risk analysis, formal adjudication methods like 2+1 or 3+1 are typically not applied in the same way they would be for expert review of images in a diagnostic AI study. Decisions would be based on test results meeting predefined specifications or standards.

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

• MRMC Study Done? No. The document explicitly states: "The subject of this premarket submission, enFlow IV Fluid Warmer Insulated Strap, did not require clinical studies to support substantial equivalence." This means no comparative effectiveness study with human readers was conducted, as the device is an IV fluid warmer accessory, not a diagnostic imaging device.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as there was no MRMC study or AI component in this device.

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

• Standalone Study Done? Not applicable. This device is an IV fluid warmer accessory and does not involve an algorithm or AI for diagnostic or predictive purposes. Its performance is related to warming fluids and material properties.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus for disease presence or absence) is not directly applicable here. For this device, the "ground truth" or reference for evaluating its performance comes from:

• Defined Specifications: For functional, packaging, and labeling evaluations.
• Voluntary Standards: For overall compliance.
• ISO 10993: For biocompatibility requirements.
• Intended Use: For user validation testing.
• Predicate Device Performance: For establishing substantial equivalence.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This device is a hardware accessory and does not involve a "training set" in the context of machine learning or AI models.
• How Ground Truth for Training Set was Established: Not applicable.

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The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of KVO (Keep vein open) to a maximum of 200ml/min. The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit. The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Strap device:

Important Note: The provided document (K121775) is for a modification to an already cleared device (enFlow IV Fluid Warmer, K112902). The modification is specifically the addition of a Strap as an accessory. Therefore, the core performance of the fluid warmer itself is not being re-evaluated in this submission. The focus is on the impact of the strap.

Acceptance Criteria and Reported Device Performance

The submission states: "The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm." And "[t]here have been no changes to either the intended use of the device or the fundamental scientific technology of the device."

Given this, the acceptance criteria are implicitly that the addition of the strap does not negatively impact the safety and effectiveness of the previously cleared enFlow IV Fluid Warmer.

Study Details

Based on the provided K121775 submission:

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

   • No specific test set sample size is mentioned for the strap itself.
   • The document explicitly states: "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." This means there was no clinical test set in the traditional sense for the strap.
   • Non-clinical studies (Risk Analysis, Biocompatibility Testing, Performance Testing) were conducted, but details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests specific to the strap are not provided in this summary. These would typically be detailed in a more comprehensive testing report.

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

   • Not applicable. No clinical test set requiring expert ground truth was performed for this specific modification.

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

   • Not applicable. No clinical test set was performed.

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 device is a medical fluid warmer, not an AI-powered diagnostic or assistive technology.

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

   • Not applicable. This is not an algorithmic device.

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

   • For the non-clinical tests (Risk Analysis, Biocompatibility, Performance Testing), the ground truth would be based on engineering specifications, regulatory standards, and established laboratory testing methodologies. No human-derived ground truth (like expert consensus or pathology) is relevant here.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

Summary of the Study for this Specific Submission (K121775):

The submission K121775 is a "Special 510(k) Premarket Notification" for a minor change (adding a strap) to an already cleared device. As such, the "study" is primarily a demonstration of substantial equivalence to the predicate device (K112902) despite the modification, based on non-clinical data.

The relevant non-clinical studies mentioned are:

• Risk Analysis: To ensure the strap does not introduce new unacceptable risks.
• Biocompatibility Testing: To ensure the strap material is safe for patient contact (if applicable, though its primary function is to secure the warmer to the arm, not direct patient contact, the material's interaction with the warmer itself or incidental human contact could be considered).
• Performance Testing: To ensure the strap functions as intended (securing the warmer) and does not impede the warmer's performance.

The key finding is that these non-clinical tests supported substantial equivalence and that clinical testing was not required due to the nature of the modification. This implies that the strap was assessed to be safe and effective and did not alter the fundamental characteristics or performance of the fluid warmer.

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The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infuscate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min.

The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit.

The provided document is a 510(k) premarket notification for the enFlow IV Fluid Warmer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI/medical device might.

Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes for test and training sets, and expert involvement for ground truth establishment cannot be fully provided from this document.

Here's an explanation based on the document's content:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. Instead, it states that the device is substantially equivalent to a predicate device and lists a series of non-clinical studies for verification and validation.

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

Not applicable. The document states that clinical testing was not required to support substantial equivalence due to the nature of the modifications (minor labeling, shelf life, design, and software modifications). Therefore, there is no clinical test set for which to determine sample size or data provenance.

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

Not applicable, as no clinical test set was used for this 510(k) submission.

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

Not applicable, as no clinical test set was used for this 510(k) submission.

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. The enFlow IV Fluid Warmer is a physical medical device (an IV fluid warmer), not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

Not applicable, as no clinical ground truth was established for this submission. The "ground truth" for this device's performance would be its ability to warm fluids to a specific temperature range, which is verified through engineering specifications and performance testing, not clinical outcomes in a study. The document mentions "Performance/Functional Verification and Validation" in the non-clinical studies section, implying engineering and bench testing.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not an AI/machine learning model that requires a training set.

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

Not applicable, as no training set was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (based on the document):

The document states that "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." (Page 2, Section 9).

Instead, the substantiation for this 510(k) submission relies on a series of non-clinical studies and design control measures applied to the development of the enFlow IV Fluid Warming system. These studies confirm that the device, even with the minor modifications, continues to be substantially equivalent to its predicate device (eFlow Model 100 IV Fluid Warmer, K060537).

The "acceptance criteria" in this context are not clinical performance metrics but rather the demonstration through these non-clinical studies that the modified device functions safely and effectively within its intended use and is equivalent to the predicate. The "study" proving this consists of:

• Risk Analysis
• Requirements Development and Reviews
• Software Verification and Validation (for the device's inherent software, not an AI algorithm)
• Performance/Functional Verification and Validation (bench testing to confirm the device performs as intended, e.g., heats fluids to the specified temperature and flow rates)
• Biocompatibility Testing
• Sterilization and Shelf-Life Testing
• Electrical Safety and EMC Testing

The document specifically highlights that "There have been no changes to the fundamental scientific technology of the device" (Page 1, Section 7), further supporting the reliance on non-clinical data for substantial equivalence. The FDA ultimately found the device substantially equivalent based on this information (Pages 3-5).

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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Belmont Instrument Corporation for their device, The Belmont® buddy lite™ Fluid Warmer. This type of document does not contain the detailed information requested regarding acceptance criteria, study design parameters (sample sizes, data provenance, expert details, adjudication methods), multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/ML-based medical devices.

The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (warming blood, blood products, and intravenous solutions prior to administration to prevent hypothermia). It discusses regulatory compliance and general controls but does not present clinical study results or technical performance data in the format requested for an AI/ML device.

Therefore, I cannot extract the requested information from the provided text.

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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called "The Belmont® buddy lite™ Fluid Warmer." This document does not describe or include information about a study that proves the device meets acceptance criteria in the manner requested, which typically refers to performance studies for software, AI, or diagnostic devices.

Instead, this letter is a regulatory approval based on the device's "substantial equivalence" to a predicate device. It confirms that the device meets certain regulatory requirements for marketing.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth as those elements are not part of this type of FDA clearance document for a medical fluid warming device.

The information on this document focuses on:

• Device Name: The Belmont® buddy lite™ Fluid Warmer
• Regulation Number/Name: 21 CFR 864.9205, Blood and Plasma Warming Device
• Regulatory Class: II
• Product Code: BSB
• Indications For Use: To warm blood, blood products, and intravenous solution prior to administration by healthcare professionals in clinical environments to prevent hypothermia.
• Basis of Approval: Substantial equivalence to legally marketed predicate devices.

The questions in the prompt are more relevant to the evaluation of AI/ML-based medical devices or diagnostic tools, which involve detailed performance studies with quantitative metrics, ground truth establishment, and often human reader studies. This document pertains to a physical fluid warming 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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The Soft Sack iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.

The FloorMount iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.

The Pak 2 iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.

The Thermal Sack Pressure Infuser is a thermal maintenance device. It is intended for use as an accessory for use with iv fluid warmer devices to enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in clinical and field environments. This device has not been tested for pediatric use.

Each of the iv fluid warmer devices (Soft Pack, FloorMount and Pak 2) employs a heating plate or heating blanket to warm or maintain the temperature of iv fluids such as normal saline and ringers lactate. These devices use a standard temperature control method and operate reliably in the range of 36-38 degrees C. The Smithworks products are designed to use a 40 watt, 12 VDC with an optional 120 VAC adaptor, for enhanced safety and portability when used in the field.

The Thermal Sack Pressure Infuser is an accessory to the Smithworks iv fluid warmer components. This device is wrapped around the iv fluid bag and is used to apply even pressure to the iv fluid bag when it cannot be maintained in the standard hanging state, which applies normal gravity pressure. This device should only be used in conditions that require emergency personnel to move victims in conditions that prevent a normal gravity based suspension of the iv fluid bag, and when the rescue mission is conducted by a limited number of emergency medical personnel.

This document is a 510(k) premarket notification for "The Smithworks Company IV Fluid Warmer" product line, dated November 29, 2006. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in a robust clinical trial setting.

The document does not contain explicit acceptance criteria tables or detailed study results (like clinical trials or performance studies with statistical analysis) in the way a typical academic paper or a more recent 510(k) summary might for a novel AI device. Instead, it describes characteristics and operational parameters, and then asserts substantial equivalence based on those.

However, we can infer some "acceptance criteria" based on the described features and comparison to predicate devices. For parts of your request that cannot be directly answered from the provided text, I will state that the information is not available in the given document.

Here's an attempt to answer your questions based on the provided text:

Analysis of Acceptance Criteria and Device Performance (Inferred)

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the performance characteristics of the device and its substantial equivalence to predicate devices, particularly regarding temperature control and fluid compatibility. There are no explicit, quantifiable acceptance criteria presented as a table with associated performance metrics from a formal study.

However, based on the Device Descriptions and Comparison with Legally Marketed Devices sections, we can infer the following:

Study Information:

The provided document does not describe a detailed study in the traditional sense of a clinical trial or a performance study with a test set, ground truth, experts, or statistical analysis (like sensitivity/specificity, AUC, or MRMC studies).

Rather, it is a 510(k) Premarket Notification which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is typically done through:

• Comparison of technological characteristics.
• Comparison of indications for use.
• Risk analysis.
• Verification and validation testing (which are mentioned as being part of the product development process, but no detailed results are included in this summary).

Therefore, many of your specific questions cannot be answered directly from the text because such a study design is not presented.

Here's an attempt to address your questions given this context:

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

• Not available/Not applicable (N/A): The document does not describe a "test set" in the context of a clinical or performance study with a defined sample size (e.g., number of patients or cases). The submission focuses on device characteristics and substantial equivalence to predicate devices, implying engineering verification and validation rather than a clinical "test set" presented in the summary. Data provenance is therefore not specified for such a "test set."

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)

• N/A: There is no "test set" described that would require expert-established ground truth.

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

• N/A: There is no "test set" described that would require an adjudication method.

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

• N/A: This document is for an IV fluid warmer, not an AI or imaging device. Therefore, an MRMC study is not relevant and was not conducted.

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

• N/A: This document is for an IV fluid warmer, not an AI or algorithm-based device. "Standalone performance" in this context would refer to the device's ability to warm fluids to a specific temperature, which is implicitly stated ("operates reliably in the range of 36-38 degrees C"). No formal "standalone study" results are detailed with specific methodologies or metrics, beyond the claim of reliable operation within the specified temperature range.

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

• N/A (for clinical ground truth): For an IV fluid warmer, "ground truth" would typically refer to accurate temperature measurements by calibrated sensors during engineering testing. The document states, "The Smithworks products are individually tested to operate reliably in the range of 36-38 degrees C." This implies internal testing and validation against known temperature standards, rather than clinical "ground truth" from experts or pathology.

8. The sample size for the training set

• N/A: This is not an AI/machine learning device that would have a "training set."

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

• N/A: This is not an AI/machine learning device that would have a "training set."

Summary regarding "the study":

The provided document is a 510(k) summary, which outlines the basis for substantial equivalence to predicate devices for an IV fluid warmer. It explicitly states, "The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes." However, it does not present the detailed methodology, results, or data from specific "studies" (clinical trials, performance studies with defined test sets, etc.) within this summary document itself, beyond stating the device's operational temperature range and other features. The focus is on demonstrating that the device is as safe and effective as existing, legally marketed devices.

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buddy plus™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

The Belmont buddy plus™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module which powers the heater unit and displays alarm and status messages, and a single-use disposable heat exchanger set. The power module also contains a built-in battery pack which automatically switches over to the battery operation when the AC power is disconnected. When the power is restored, the system reverts to AC power automatically, the battery charger is activated, and the battery is charged. The heating technology used is resistive heating of two plates within the heater unit. The buddy plus™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of IV fluid flow, or empty set, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The system provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a user-supplied cannula or IV infusion set at its output. The input can come from a gravity fed IV line with roller clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.

The Belmont buddy plus™ Fluid Warmer is a nonelectromagnetic blood or fluid warming device intended for warming blood, blood products, and intravenous solutions to physiological temperature prior to administration. It is designed for use by healthcare professionals in clinical environments to prevent hypothermia, specifically for applications where the flow rate is 6 liters/hour (100 ml/min) or less.

Here's a breakdown of the acceptance criteria and the study information presented:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify a numerical sample size for the "nonclinical tests." It only states that "the following tests were carried out."
• Data Provenance: Not specified, but the testing was conducted by Belmont Instrument Corporation, presumably in-house or through a contracted laboratory to demonstrate performance. The testing is implied to be prospective, as it was done to "verify performance" for K062774.

3. Number of Experts and their Qualifications for Ground Truth of Test Set

This type of information is not applicable to this device. The Belmont buddy plus™ Fluid Warmer is a medical device for warming fluids, and its performance and safety are typically evaluated through engineering and functional tests against established physical and safety criteria, rather than through expert consensus on qualitative assessments or diagnostic interpretation. Therefore, there are no "experts" establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image analysis) where ambiguous cases require expert resolution. The nonclinical tests described for the fluid warmer are objective, measurable performance criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to assess the impact of AI assistance on human performance. The Belmont buddy plus™ Fluid Warmer is a therapeutic/supportive care device, not a diagnostic one involving human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed in the sense that the device's technical specifications and functional capabilities were tested independently to verify its performance against design requirements. The "nonclinical tests" fall under this category, evaluating the device's ability to warm fluids and its safety features directly.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective engineering specifications and safety standards. For example:

• Physiological temperature: This is a defined temperature range (e.g., 37°C ± a certain tolerance). The device's ability to achieve and maintain this temperature is measured directly.
• Alarm conditions: These are defined fault conditions, and the "ground truth" is whether the device accurately detects them and triggers the appropriate alarm.

8. Sample Size for the Training Set

This information is not applicable. The Belmont buddy plus™ Fluid Warmer is not an AI/ML-driven device that requires a training set. Its design and operation are based on conventional engineering principles of resistive heating and electronic control, not machine learning algorithms.

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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