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The ATS 5000 Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including: Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations.

The ATS 5000 is a non-sterile dual-port microprocessor controlled pneumatic tourniquet instrument intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The ATS 5000 instrument is used in conjunction with available dual port tourniquet cuffs and hoses distributed/supplied by Zimmer Biomet Inc. A cuff is applied to a patient prior to the beginning of a procedure. Connective tubing is then attached to the cuff and then plugged into the ATS 5000 connector ports. The instrument is controlled via a touchscreen user interface.

The provided document is a 510(k) summary for the ATS 5000 Automatic Tourniquet Instrument. It details the device's indications for use, its substantial equivalence to a predicate device (Zimmer ® A.T.S. ® 4000 Automatic Tourniquet System, K123553), and includes non-clinical performance data.

However, the document explicitly states that clinical performance data was not needed for this device. This means there was no study conducted to assess device performance against specific clinical acceptance criteria. Instead, the submission relies on non-clinical testing and the established safety and performance of the base technology and predicate device.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from the given text in the way you've requested for typical AI/ML medical devices, as this device (a pneumatic tourniquet) underwent a different regulatory pathway that did not require such a clinical study.

I can, however, extract details about the non-clinical performance data and the rationale for not requiring clinical data, as well as the overall conclusion regarding the device's safety and performance from the provided text.

Here's a breakdown of the information that can be extracted:

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

• Acceptance Criteria: The document mentions that "All tests passed according to predetermined acceptance criteria" for the non-clinical testing. However, the specific quantitative acceptance criteria for each test are not listed in this summary.
• Reported Device Performance:

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

• Not applicable as no clinical study was performed. The non-clinical tests would have their own sample sizes (e.g., number of units tested), but these are not provided in the summary.

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

• Not applicable as no clinical study was performed and thus no "ground truth" was established with experts in a clinical context.

4. Adjudication method for the test set:

• Not applicable as no clinical study was performed.

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 device is a pneumatic tourniquet, not an AI/ML diagnostic tool.

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

• Not applicable. This device is a pneumatic tourniquet; it's an instrument, not an algorithm. Its operation involves human interaction (qualified medical professionals).

7. The type of ground truth used:

• Not applicable since no clinical study was conducted. For the non-clinical tests, "ground truth" would be defined by the technical specifications and standards (e.g., a pressure reading is accurate if it matches a calibrated reference).

8. The sample size for the training set:

• Not applicable. This device did not involve machine learning with a training set.

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

• Not applicable. This device did not involve machine learning with a training set.

Summary of why clinical data was not required:
The document states: "Clinical Performance – Clinical data was not needed for this device. Expanded functionality which falls outside the 510(k) exemption classification, does not require additional clinical data as the base technology safety and performance is well established. Existing literature, alongside the non-clinical performance data support the safety and performance of the proposed device."

This indicates that because the device is largely a modification or update to an existing, well-understood technology (pneumatic tourniquets), and the new features (Deflation Protocols, Cuff ID, EZ Method to measure LOP) were either considered minor enhancements or had their safety and performance supported by non-clinical testing and existing literature, a clinical study was not deemed necessary for substantial equivalence.

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T-Cuff is indicated for use in donor populations during apheresis procedures as an alternative method to maintain pressure on the arm and obtain venipuncture. The T-Cuff operates similar to a pneumatic tourniquet intended to partially restrict blood flow on the upper arm to result in optimal venous access during apheresis collection procedures.

The T-Cuff is a pneumatic tourniquet used as an alternative method to maintain consistent pressure on the arm and blood flow at the access site during apheresis procedures. This device is composed of 4 major components and was developed to enhance venous access during venipuncture and help donors maintain a consistent pressure on the arm during apheresis procedures. The catalog number for the T-Cuff is 71252.

T-Cuff is designed to maintain a consistent pressure when applied to the donor's bicep with consistent squeezing of the inflatable bulb. During the apheresis process, the device operates in two modes: Venipuncture and Collection. The mode of operation is changed by adjusting the pressure relief valve cap. During Venipuncture mode, application of T-Cuff to the donor's upper arm prior to obtaining venipuncture allows the T-Cuff to inflate to assist with vein selection. During Collection mode, the T-Cuff maintains a consistent pressure of 20-40 mmHg (millimeter of mercury) on the donor's upper arm to help facilitate optimal blood flow during apheresis procedures. T-Cuff is a non-sterile, non-single use device.

The T-Cuff is a pneumatic tourniquet used as an alternative method to maintain pressure on the arm and, aid in the facilitation of blood flow during apheresis procedures. It operates in two modes, Venipuncture and Collection. During Venipuncture mode, the T-Cuff is inflated to higher pressure (no greater than 120 mmHg) as venipuncture is performed. Once Venipuncture is complete, the device maintains a steady, lower, consistent pressure (20 - 40 mmHg) during Collection mode. The donor squeezes a rubber bulb in continuous intervals to distribute air through the system and, facilitate optimal blood flow during apheresis procedures. The T-Cuff does not contain an energy source. Primary mechanism of action is obtained through the influx of air into the system and, by a modulating pressure relief valve that maintains defined pressure ranges.

The provided document is a 510(k) premarket notification for a medical device called "T-Cuff," a pneumatic tourniquet. The document explicitly states that the T-Cuff is substantially equivalent to a predicate device and does not present acceptance criteria or detailed results from a clinical study designed to prove the device meets acceptance criteria in the typical sense of a novel device demonstrating its efficacy or safety against pre-defined metrics.

Instead, the clinical study mentioned (Section VII.F. Clinical Studies) was designed to determine if manual and/or automatic adjustments to the draw flow rate would decrease operator interventions and overall procedure time when using the T-Cuff in apheresis procedures. The T-Cuff itself was "utilized for all donations in this study," implying it was a tool within a larger study, rather than the primary subject of a performance validation study against specific acceptance criteria for its own function (e.g., pressure accuracy, comfort, etc.).

Therefore, I cannot extract the information required by the prompt's structured questions from the provided text, as the document does not contain:

• A table of acceptance criteria and reported device performance for the T-Cuff meeting those criteria.
• Details on sample size for a test set specifically for T-Cuff performance validation.
• Information on ground truth establishment (number/qualifications of experts, adjudication methods) for T-Cuff performance, as the study focused on apheresis procedure efficiency.
• Mention of MRMC comparative effectiveness studies or standalone algorithm performance, as the T-Cuff is a physical, non-AI device.
• Specific details of the sample size for a training set or how ground truth was established for it, as this is not an AI/ML device.

The document states:

• "The primary endpoint for this study was to determine if manual and/or automatic adjustments to the draw flow rate would decrease the number of operator interventions and overall procedure time."
• "The T-Cuff was utilized for all donations in this study, and it was demonstrated that manual and automatic adjustment to the draw flow rate decreased the number of operator interventions and did not increase the overall procedure time."
• "All products collected met the FDA regulations regarding the level of residual white blood cells (

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The A.T.S. 4000TS Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including; Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations

The Zimmer A.T.S. 4000TS Tourniquet System is a non-sterile device intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The system consists of the A.T.S. 4000TS control unit that is coupled to the patient with the applied part (inflatable pneumatic tourniquet cuff) via the connecting tubing. The tourniquet cuff is applied to the patient prior to the procedure beginning. The connecting tubing is attached to the inflatable tourniquet cuff and plugged into the A. T.S. 4000TS's connector ports.

The provided text describes a medical device, the Zimmer A.T.S. 4000TS Tourniquet System, and its regulatory submission. However, it does not contain the specific information requested about acceptance criteria for device performance and a study proving the device meets those criteria, particularly in the context of an AI/algorithm-based device.

The document states that the device is a "non-sterile device intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures". It is a pneumatic tourniquet.

Here's what can be extracted and what is missing:

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

• Missing. The document mentions "predetermined acceptance criteria" were met for various tests (Electrical safety, Environmental, Software, Usability, Hardware, and Software validation), but it does not specify what those criteria were or detail the reported performance against them. This is a pneumatic tourniquet, not an AI/algorithm-based diagnostic device, so typical metrics like sensitivity, specificity, or AUC are not applicable here.

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

• Not applicable. This device is a pneumatic tourniquet system, not a diagnostic or AI-based device that would typically involve test sets of patient data. The "testing" referred to in the document is for hardware, software, electrical safety, usability, etc., not for analyzing patient data.

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

• Not applicable. See point 2.

4. Adjudication method for the test set:

• Not applicable. See point 2.

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

• Not applicable. This is not an AI-assisted diagnostic device.

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

• Not applicable. This is a hardware and software system for controlling a pneumatic tourniquet, not a standalone AI algorithm for diagnosis or interpretation.

7. The type of ground truth used:

• Not applicable for performance validation in the AI/data sense. The "ground truth" for this device would relate to the accuracy and reliability of its mechanical and software functions (e.g., pressure regulation, alarm functionality). These are typically validated through engineering tests and simulations, not patient data ground truth.

8. The sample size for the training set:

• Not applicable. The device's software and hardware undergo development and testing, not "training" in the machine learning sense.

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

• Not applicable. See point 8.

Summary of what the document does state about performance and testing:

• Non-Clinical Performance and Conclusions:
  • During development, the following testing was completed:
    • Electrical safety and Environmental testing in accordance with IEC 60601-1, 60601-1-2, 60601-1-8.
    • Software and device development conducted in accordance with IEC 62304:2006 and AAMI/ANSI HE-75:2009.
    • Device Usability testing conducted in accordance with IEC 60601-1-6 and IEC 62366:2007.
    • Hardware and Software testing, including validation.
  • Conclusion: "All tests passed according to predetermined acceptance criteria." (Specific criteria and performance details are not provided).
• Clinical Performance and Conclusions:
  • "Clinical data and conclusions were not needed for this device." This statement is crucial and indicates that no human clinical study was conducted to demonstrate safety or effectiveness for this 510(k) submission, likely because it was deemed substantially equivalent to a predicate device based on its design and non-clinical performance.

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The EZvein™ inflatable secondary tourniquet is used in conjunction with a nonpneumatic tourniquet, to enhance the presentation of veins for access (blood draw or IV administration.)

The EZ Vein inflatable secondary tourniquet is made with soft fabric and flexible plastic to form an inflatable bladder. The integral Velcro attachment strips secure the EZVein around an appendage in the same way as would a blood pressure cuff. Dimensions have been chosen to wrap around most anyone's arm, but an extension is included to allow the EZVein to work on lower limbs or with large arms. The Vein Access Window allows the health care professional to position the EZVein over the target vein for access for IV drip, blood draw or injection. The EZVein cuff is applied after the initial conventional non-inflatable tourniquet (such as latex tubing) is applied. The initial tourniquet, as is conventional, blocks the return of venous blood through the major veins to the heart, but the application of the EZVein inflatable cuff helps move the blood in deep tissues into the veins to help them to distend for easier visualization and access. This may aid the medic desiring venous access to more accurately and rapidly achieve the desired aim.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that the device "has been tested," but it does not provide details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not mention the use of experts or the establishment of ground truth for the performance testing. The test described appears to be a direct physical measurement of the device's self-release mechanism.

4. Adjudication Method for the Test Set

As no experts or specific ground truth establishment method is mentioned, there is no information provided on any adjudication method.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The described testing focuses solely on the device's mechanical self-release property.

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

This device, the EZ Vein inflatable tourniquet, is a physical medical device, not a software algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply. The described testing is inherently a standalone performance test of the device's physical mechanism.

7. Type of Ground Truth Used

The "ground truth" for the test appears to be a direct physical measurement of the pressure at which the Velcro strip self-releases. There is no mention of expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not mention a training set, as this is a physical device with a mechanical function, not a system that relies on machine learning or algorithms requiring a training phase.

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

As no training set is mentioned, this information is not applicable.

Summary of the Study:

The study referenced in the document is a performance test to ensure the safety of the EZ Vein inflatable tourniquet. The primary safety concern addressed is the potential for over-inflation. The acceptance criterion is that the device's Velcro strip must self-release within a specified pressure range (195 mmHg to 220 mmHg). The reported device performance confirms that it meets this critical safety threshold.

The details regarding the methodology, sample size, and rigorousness of this "testing" are very limited in the provided excerpts. It is presented as a straightforward verification of a mechanical safety feature.

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This device is intended for use in MR imaging of peripheral blood yessels in the lower extremity for patients with suspected peripheral vascular disease for diagnostic purposes and pre-operative information.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter states that the device, an "MRI Compatible Thigh Tourniquet," has been determined to be substantially equivalent to legally marketed predicate devices. This determination is based on the indications for use provided by the applicant.

Therefore, I cannot extract the requested information as it is not present in the provided document.

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The A.T.S. 3000 Automatic Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including: Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations

The Zimmer A. T.S. 3000 Automatic Tourniquet System is a non-sterile device intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The system consists of the A.T.S. 3000 control unit that is coupled to the patient with the applied part (inflatable pneumatic tourniquet cuff) via the connecting tubing. The tourniquet cuff is applied to the patient prior to the procedure beginning. The connecting tubing is attached to the inflatable tourniquet cuff and plugged into the A.T.S. 3000's connector ports.

The Zimmer A.T.S. 3000 Automatic Tourniquet System is a non-sterile device designed to temporarily occlude blood flow in a patient's extremities during surgical procedures. The device was found to be substantially equivalent to other legally marketed tourniquet systems (Richards Pressure Sentry Tourniquet and Zimmer A.T.S. 2000 Tourniquet System), and its LOP feature was found substantially equivalent to the Medasonics Versatone D9 stethoscope.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not explicitly mention a "test set" in the context of clinical data for performance evaluation because it states that clinical data and conclusions were not needed for this device.
The performance assessment was based on non-clinical testing and comparison to predicate devices. Therefore, details like sample size, provenance, retrospection/prospection are not applicable for a traditional clinical "test set" in this context.

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 clinical data and a "test set" requiring expert ground truth were not used for device acceptance.

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

Not applicable, as clinical data and a "test set" requiring adjudication were not used for device acceptance.

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 device is a pneumatic tourniquet system, not an AI-assisted diagnostic or interpretative tool that would involve multi-reader multi-case studies or AI assistance for human readers.

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

This question is not applicable to a physical medical device like a pneumatic tourniquet system. There is no "algorithm only" performance to evaluate in this context.

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

For the non-clinical performance, the "ground truth" was established by compliance with recognized standards and guidance documents (e.g., "Guidance for FDA Reviewers and Industry," ANSI/AAMI/ISO 10993-1:1997), and through established engineering and safety testing protocols. The substantial equivalence to predicate devices also serves as a baseline for expected performance and safety, derived from their long-standing use and acceptance in the medical field.

8. The sample size for the training set

Not applicable. This device is a physical medical device and does not involve AI or machine learning models that would require a training set.

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

Not applicable, as no training set was used.

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The intended use of a tourniquet cuff is to restrict blood flow to a patient's limb during surgery.

Tourniquet cuffs are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to restrict the blood flow in the limb during surgery.

Here's an analysis of the provided text regarding the acceptance criteria and study for Medical Instruments Technology, Inc.'s reprocessed tourniquet cuffs:

Acceptance Criteria and Device Performance Study for Reprocessed Tourniquet Cuffs

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set. It broadly refers to "reprocessed tourniquet cuffs" and "the predicate device" during comparisons.

The data provenance is internal to Medical Instruments Technology, Inc. and is retrospective, as the testing was performed on their reprocessed devices and compared against an existing predicate device (Instrumed, Color Cuff K890014).

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

The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of clinical or diagnostic evaluation. The assessments seem to be engineering and performance-based comparisons conducted by MIT.

4. Adjudication Method

The document does not describe an adjudication method for the test set, as there is no indication of multiple reviewers or differing interpretations of results requiring resolution. The evaluation appears to be a direct comparison against pre-defined parameters by MIT staff.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic imaging or interpretation tasks where human readers make assessments. The device in question is a reprocessed medical instrument, and the evaluation focuses on its physical and performance characteristics, not human reader interpretation.

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

Yes, a standalone study was performed. The entire evaluation described is a standalone assessment of the reprocessed device's physical and performance characteristics, comparing it directly to the predicate device without human-in-the-loop performance being a factor. The "algorithm" here is the reprocessing procedure and subsequent quality checks, which are evaluated on their own merits.

7. Type of Ground Truth Used

The "ground truth" for the test set was essentially the characteristics and performance of the new predicate device (Instrumed Color Cuff K890014). The reprocessed cuffs were evaluated for "substantial equivalence" against this established benchmark.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of device evaluation. This concept is typically associated with machine learning or AI models. The evaluation here is for a physical medical device, not a software algorithm that would require training data.

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

As there is no training set mentioned or implied, the method for establishing its ground truth is not applicable.

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