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The Venera 608 Series system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

The Venera™ 608 Series deep vein thrombosis prevention system is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life-threatening condition. The Venera™ 608 Series system consists of a device and a pair of soft compression cuff(s) (sleeves) and the extension tubing set for the calf, calf-thigh, and foot. The device will alternatively inflate the two cuffs and mimic the natural walking pace in order to enhance circulation. The device-supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mmHg is used for the calf, calf-thigh, and 120mmHg for foot treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

This document is a 510(k) summary for the Venera 608 Deep Vein Thrombosis (DVT) Prevention System. This device is an intermittent pneumatic compression device.

Here's an analysis of the acceptance criteria and the study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the functional and performance tests (e.g., Pressure Accuracy Test, Cycle Time Test). It generically states "samples of the device underwent function and mechanical testing."

The data provenance is from tests conducted by the manufacturer, Suzhou Minhua Medical Apparatus Supplies Co. Ltd. (China). The document does not specify if the testing was performed retrospectively or prospectively, but standard device verification and validation testing is typically prospective.

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

This information is not provided in the document. The device performance tests are primarily engineering and technical validations against defined specifications, not expert-adjudicated clinical outcomes.

4. Adjudication method for the test set

This information is not applicable/not provided as the performance tests listed are objective engineering and technical validations, not clinical studies requiring adjudication of results by experts.

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

No MRMC study was conducted. The document explicitly states: "No animal study or clinical study was conducted." This device is a mechanical DVT prevention system, not an AI diagnostic tool that would typically involve human readers.

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

This question is not applicable in the context of this device. The Venera 608 is a physical medical device (intermittent pneumatic compression device) with embedded software for control, not a standalone algorithm used for diagnostic or predictive purposes without human intervention as implied by the question. The software verification and validation section confirms the software's performance, but not in a "standalone algorithm" context for clinical decision-making.

7. The type of ground truth used

For the functional and performance tests (e.g., pressure accuracy, cycle time, alarm function), the "ground truth" would be the established engineering specifications and regulatory standards for the device's operational parameters. For biocompatibility, the ground truth is established by the specified ISO standards. For electrical safety and EMC, the ground truth is established by the specified IEC standards.

8. The sample size for the training set

Not applicable. This document describes a physical medical device (pneumatic compression system), not an AI/ML-based system that requires a "training set" in the conventional sense. The "software verification and validation" mentioned refers to traditional software testing, not machine learning model training.

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

Not applicable for the same reasons as #8.

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The Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in adult size.

The proposed device is an accessory used in conjunction with non-invasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.

The provided text is a 510(k) summary for a Reusable Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific acceptance criteria for an AI/ML medical device.

Therefore, the document does not contain the information required to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance: The document lists standards the device complies with (IEC 80601-2-30, ISO 81060-1, ISO 10993-5, ISO 10993-10), but these are general safety and performance standards for a mechanical device, not AI/ML acceptance criteria like sensitivity, specificity, or AUC. No specific performance metrics are reported against quantitative acceptance criteria.
• Sample size and data provenance for a test set: No mention of a test set, data provenance, or sample size for evaluating AI/ML algorithm performance.
• Number and qualification of experts for ground truth: Not applicable, as this is not an AI/ML device requiring expert-established ground truth.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The document states:

• "6. Non-Clinical Test Conclusion" and "6.1 Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 80601-2-30: 2018..., ISO 81060-1:2007..., ISO 10993-5: 2009..., ISO 10993-10: 2010..."
• "6.2 Human Factors / Usability Testing Usability testing is not required per the risk profile of this product."
• "7. Clinical Test Conclusion No clinical study is included in this submission."

This unambiguously indicates that the submission is for a physical medical device (a blood pressure cuff), assessed through non-clinical bench testing for compliance with manufacturing and biocompatibility standards, and not an AI/ML driven diagnostic or assistive device that would require the specified performance evaluations.

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The Venera 508 Deep Vein Thrombosis (DVT) Prevention Therapy System is a portable treatment to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This system can be applied in either home or clinical settings to:

• . Aid in the prevention of DVT
• . Enhance blood circulation
• . Diminish post-operative pain and swelling
• . Reduce wound healing time
• . Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
• . As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

The Venera™ 508 Deep Vein Thrombosis Prevention System is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by simulating blood flow in the extremities (simulating muscle contractions). The Venera 508 system consists of a pair of pump and cuff assemblies. The device will alternatively inflate and deflate the garment (cuff) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by 50 seconds of deflation period once it reaches the desired pressure.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., specific metrics like sensitivity, specificity, or reader performance improvement for an AI/device). Instead, it describes a medical device (Venera 508 Deep Vein Thrombosis Prevention System) and its 510(k) submission for substantial equivalence to a predicate device.

The "Performance Tests" section lists several tests conducted, but it does not provide the acceptance criteria for these tests or the reported performance data in a quantitative way. It only states, "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is safe and effective."

Therefore, I cannot populate the table or provide the detailed information requested regarding acceptance criteria and study particulars for a comparative effectiveness study or standalone performance. The document explicitly states: "No animal study or clinical study was conducted." This means there is no human subject study to evaluate the device's efficacy for its intended medical purpose (DVT prevention) that would typically involve a ground truth, expert readers, or statistical comparisons of performance.

Here's a breakdown of what can be extracted or inferred based on the provided text, and where gaps exist:

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 for Test Set: Not specified. The document mentions "samples of the device" were used for function and mechanical testing, but the number of devices or test repetitions is not stated.
• Data Provenance: Not specified. The tests were conducted internally by the manufacturer, Suzhou Minhua Medical Apparatus Supplies Co. Ltd. (China). The document does not indicate if external data sources or patient data were used for these performance tests. Given this is a physical medical device and not an AI/diagnostic software, the concept of "data provenance" as typically applied to image datasets is not relevant here.

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

• Not applicable. The performance tests described (Pressure Accuracy, Cycle Time, etc.) relate to the device's mechanical and functional specifications, not its diagnostic or therapeutic efficacy based on patient outcomes or expert interpretation of medical data. Therefore, no "ground truth" in the clinical sense was established by experts for these engineering tests.

4. Adjudication method for the test set

• Not applicable. Since no expert-based ground truth was established, there was no need for 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

• No. The document explicitly states: "No animal study or clinical study was conducted." Therefore, no MRMC study, AI assistance evaluation, or effect size calculation was performed or reported.

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

• This device is not an AI algorithm. It is a physical medical device for DVT prevention. Therefore, the concept of a "standalone" algorithm performance study is not applicable.

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

• Not applicable in the clinical sense. The "ground truth" for the engineering performance tests would be the established engineering specifications and measurement standards (e.g., a calibrated pressure gauge for the "Pressure Accuracy Test").

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" as it is not an AI/machine learning system.

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

• Not applicable for the same reason as above.

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The Reusable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and reusable in infant, pediatric but not neonatal, and adult sizes.

The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.

The given text is a 510(k) Summary for a Reusable Blood Pressure Cuff, which is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices. This document focuses on proving that the new device is as safe and effective as existing products, primarily through non-clinical testing and comparison to predicate devices, rather than an extensive study proving new performance criteria for a novel device or an AI algorithm.

Therefore, many of the requested details, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "sample size for training set," are not applicable to this type of regulatory submission and product. The device is a physical medical accessory, not an AI algorithm.

I will extract the available and relevant information.

Acceptance Criteria and Device Performance for Reusable Blood Pressure Cuff (K171889)

The acceptance criteria for the Reusable Blood Pressure Cuff (K171889) are established by demonstrating compliance with recognized international standards and substantial equivalence to predicate devices. The study conducted was primarily non-clinical testing to verify design specifications and biological compatibility.

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 specify sample sizes for the non-clinical tests (e.g., how many cuffs were tested for biocompatibility or performance). The data provenance is not detailed beyond the manufacturer being Suzhou Minhua Medical Apparatus Supplies Co., LTD in China, implying testing was likely conducted in China. The study refers to "non-clinical tests" and "test results" and "laboratory tests," which are inherently prospective for the specific devices being tested.

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 applicable. The device is a physical medical accessory, and the "ground truth" for its performance is established by compliance with international engineering and biocompatibility standards, not by expert consensus on diagnostic interpretations.

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

This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation (e.g., imaging reads) where there can be differing opinions among experts. This product's evaluation is based on objective measurements against engineering and biological 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

This information is not applicable. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of data/images, often with AI assistance. This device is a blood pressure cuff and does not involve "readers" or "AI assistance" in that context.

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

This information is not applicable. The device is a physical blood pressure cuff, not an algorithm.

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

The "ground truth" for the Reusable Blood Pressure Cuff is compliance with:

• Engineering Standards: IEC 80601-2-30: 2013 (Medical Electrical Equipment - Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers).
• Biocompatibility Standards: ISO 10993-5: 2009 (Tests For In Vitro Cytotoxicity) and ISO 10993-10: 2010 (Tests For Irritation And Skin Sensitization).
• Substantial Equivalence: Comparison to legally marketed predicate devices (K133117 and K152468) regarding intended use, principles of operation, materials, and performance specifications.

8. The sample size for the training set

This information is not applicable. "Training set" refers to data used to train algorithms, primarily in machine learning or AI. This device is a physical medical accessory.

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

This information is not applicable as there is no "training set" for this physical device.

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