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The B&J DVT Calf/Thigh Garments, Models 801/830 Series are designed to increase venous blood flow in at risk patients in order to help lower the risk of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

The 801/830 series of DVT calf/thigh garments are compression devices. When the devices are attached to a pump system, they provide intermittent, sequentially gradient pressure to a patient calf/thigh for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf or thigh.

The provided document is a 510(k) Premarket Notification for a medical device (B&J DVT Calf/Thigh Garments, Models 801/830 Series). It's important to understand that a 510(k) submission generally aims to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials as would be required for a PMA (Premarket Approval).

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission refer to the non-clinical tests performed to demonstrate that the new device performs at least as well as the predicate device regarding specific physical and functional characteristics.

Here's an analysis based on the provided text for the B&J DVT Calf/Thigh Garments:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "predefined acceptance criteria" but does not explicitly list them in a table format with corresponding performance metrics. Instead, it states that "All the test results demonstrate 801 series and 830 series garments meet the requirements of its predefined acceptance criteria and intended use."

The non-clinical tests conducted are listed as:

Note on Acceptance Criteria: The document implies that the acceptance criteria for these non-clinical tests were based on established standards for similar devices or performance equivalent to the predicate devices. Specific quantitative criteria (e.g., "bladder burst pressure > X mmHg", "leakage < Y ml/min", "Z cycles without failure") are not explicitly stated in this summary.

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

• Sample Size: The document does not specify the exact number of units/garments tested for each non-clinical test (biocompatibility, bladder burst, leak test, pressure cyclic test). It refers to "801 series and 830 series garments" generally.
• Data Provenance: The testing was conducted by B&J Manufacturing Ltd. (the manufacturer) in China. The data provenance is retrospective in the sense that the testing was completed prior to the 510(k) submission.

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

This information is not applicable to this type of 510(k) clearance based on non-clinical testing for substantial equivalence. "Ground truth" for these engineering tests is established by calibrated instruments and predefined engineering specifications, not by expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers or experts are interpreting outcomes (e.g., medical images). Here, the tests are objective engineering measurements.

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

No, an MRMC comparative effectiveness study was not conducted. The document explicitly states: "No clinical testing was used to support the decision of substantial equivalence." MRMC studies are clinical in nature and involve human readers assessing diagnostic performance, which was not part of this 510(k) pathway.

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

This concept is not applicable to the device (DVT Calf/Thigh Garments). This device is a mechanical compression garment, not an algorithm or AI. Standalone performance refers to the performance of an AI algorithm without human involvement.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by:

• Engineering Specifications: e.g., the expected pressure range, acceptable leakage rates, and cycle life determined through design requirements and comparison to predicate devices.
• Material Standards: For biocompatibility, it's adherence to recognized standards for medical device materials.

This is distinct from "expert consensus," "pathology," or "outcomes data" which are typically used for establishing ground truth in clinical diagnostic or prognostic studies.

8. The Sample Size for the Training Set

This information is not applicable. The device is a mechanical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

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

This information is not applicable for the same reason as above. There is no training set for a mechanical device.

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The B&I MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

The device can be used in the 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 B&J MHP800 Deep Vein Thrombosis Prevention System is an intermittent pneumatic compression system that aids in the prevention of deep vein thrombosis a potentially life-threatening condition which can lead to pulmonary embolism. The DVT compression device is a non-invasive mechanical prophylactic system that helps decrease the incidence of deep vein thrombosis. The system consists of a pair of pump and sleeve assemblies.

The DVT pump will inflate each leq cuff to a preset pressure of 45mmhg for 12 seconds, and followed by 48 seconds of deflation period once the pressure is reached. This happens once every minute. The cycles are repeated on each unit until the power is turned off.

Internal rechargeable batteries allow the MHP800 to be completely portable to prevent interruptions in treatment.

This document is a 510(k) submission for the B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance data in a format suitable for the requested table.

The provided text does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance numbers, sample sizes, or ground truth establishment methods as typically found in clinical trials or performance assessments for AI/diagnostic devices.

However, I can extract information related to general performance validation and the types of tests conducted.

Here's a breakdown of what can be inferred and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

The document states: "All the test results demonstrate MHP800 DVD [DVT] compression device meet the requirements of its predefined acceptance criteria and intended use." (Page 8)
However, the specific numerical acceptance criteria were not explicitly defined, nor were the reported device performance values presented in a comparative table. The document lists categories of tests performed.

Missing: Specific numerical values for the acceptance criteria and the device's measured performance in these non-clinical tests.

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

• Sample size: Not specified. The document refers to "non-clinical testing" (Page 8) but does not detail the number of units or test cycles performed for each test.
• Data provenance: Not specified. These are non-clinical engineering/performance tests, not human data. The tests were presumably conducted by B&J Manufacturing Ltd. Given the company's address in Shenzhen, China (Page 3), the tests were likely performed there.

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

• Not applicable. These are non-clinical mechanical/electrical performance tests for a DVT compression device, not a diagnostic device requiring expert interpretation of results for ground truth.

4. Adjudication method for the test set:

• Not applicable. This is for non-clinical performance testing.

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 DVT prevention system, not an AI-powered diagnostic tool requiring human interpretation.

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

• Not applicable. This device is a DVT prevention system, a mechanical compression device, and does not have a standalone "algorithm-only" performance in the context of AI/diagnostic tools. The performance tests mentioned (pressure accuracy, cycle time, etc.) are inherent to its mechanical function.

7. The type of ground truth used:

• Not applicable in the typical sense of expert consensus or pathology for diagnostic devices. For the non-clinical tests listed (pressure accuracy, cycle time, bladder burst, leak), the "ground truth" would be the engineering specifications and established test methodologies (e.g., measuring pressure against a calibrated standard, timing cycles, applying defined force for burst tests).

8. The sample size for the training set:

• Not applicable. This is a physical medical device (DVT compression system), not an AI algorithm that requires a training set.

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

• Not applicable. (See #8)

Summary of what is present in the document regarding validation:

The document lists "Non-clinical Testing" performed to assess the MHP800 DVT compression device, including:

• Biocompatibility
• Software validation
• Electromagnetic compatibility and electrical safety
• Reliability
• Performance (System level software, Pressure accuracy, Cycle time, Bladder burst, Leak)

The claim is that "All the test results demonstrate MHP800 DVD compression device meet the requirements of its predefined acceptance criteria and intended use." (Page 8) However, the details of these "predefined acceptance criteria" and the "test results" (i.e., the specific performance numbers achieved) are not disclosed in this document. The purpose of this 510(k) summary is to assert substantial equivalence, not to provide a detailed study report.

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The B&J Manufacturing Ltd. MHH800 and MHH800SQ Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

The Deep Vein Thrombosis (DVT) Pumps MHH800 and MHH800SQ are external pneumatic compression (EPC) devices that aid in the prevention of DVT from a potentially life threatening condition which can lead to pulmonary embolism. MHH800 and MHH800SQ are non-invasive mechanical prophylactic devices. The devices function as secondary pumps to propel venous blood for patients whose deep veins thrombosis must be prevented after surgeries in Orthopaedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.

Model variations are distinguished by characters. MHH800 is without SQ, so the device means an intermittent pneumatic compression pump. MHH800SQ is with SQ, so the device means a sequential pneumatic compression pump.

The two devices separately consist of an air pump and a soft pliable compression garment(s) for the foot, calf or thigh. For MHH800, the controller supplies compression on a preset timing cycle (12 seconds inflation and maintenance followed by 48 seconds of deflation) at a suggested pressure setting of 40 mmHg for the Leg and 120mmHg for the Foot. For MHH800SQ, the controller supplies compression on a preset timing cycle (12 seconds inflation followed by 48 seconds of deflation) at a suggested pressure setting, 45mmHg in the 1st chamber, 40 mmHg in the 2nd chamber and 30mmHg in the 3rd chamber for the Leg and 120mmHg for the Foot. The pressure in the garments is transferred to the extremity, augmenting venous blood flow when the leg is compressed, reducing stasis. This process also stimulates fibrinolysis; thus, reducing the risk of early clot formation.

The DVT pumps produce automatically timed cycles of compressed air. This compressed air forces blood out of the deep veins, helping to prevent slowed or stopped blood flow. Bursts of air are delivered to the specially designed garments wrapped around extremities. This air helps to move blood out of the deep veins and reduce the risk of developing DVT. Garments are lined with tricot fabric to help reduce heat and perspiration.

The provided text describes the 510(k) premarket notification for the B&J DVT Compression Devices MHH800/MHH800SQ. This document focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical efficacy studies with specific acceptance criteria for AI performance. As such, the information typically requested in questions related to AI-driven medical devices (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance with effect sizes) are not relevant to this submission.

However, based on the non-clinical testing section, we can infer some general "acceptance criteria" related to the device's functional and safety performance, and the "study" that proves these criteria were met is the non-clinical testing itself.

Here's a breakdown of the requested information, adapted to the context of this 510(k) submission:

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)

• Sample Size: Not specified. For non-clinical, bench testing, this would typically refer to the number of units or components tested. This information is not provided in the summary.
• Data Provenance: Not specified. This is non-clinical testing, likely performed in a lab setting, possibly at the manufacturer's facility in China, or at a contracted testing lab. The data would be prospective as the tests are conducted specifically for the submission.

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. This device is a DVT compression pump, a hardware device, not an AI or imaging diagnostic tool. "Ground truth" in the context of expert review for medical image analysis is not relevant here. The ground truth for performance tests is established by calibrated measuring equipment and established test protocols.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly for AI evaluations. This is a non-clinical, bench testing scenario.

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. An MRMC study is not applicable to this device. This device is a physical therapy device and does not involve human "readers" or AI assistance in the interpretation of medical data.

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

• Not applicable. This is not an algorithm-only device. Its performance is evaluated through direct physical measurements (pressure, cycle time) and material/electrical safety tests.

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

• The "ground truth" for the non-clinical tests would be established by:
  • Calibrated Measurement Standards: For pressure accuracy, cycle time, etc., the "truth" is determined by measurements against known, calibrated equipment.
  • Industry Standards & Regulations: For biocompatibility, EMC, and electrical safety, the "truth" is adherence to established national and international standards (e.g., ISO, IEC).

8. The sample size for the training set

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

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

• Not applicable. (See #8)

In summary, the provided document is a 510(k) premarket notification for a Class II medical device, a DVT compression pump. The "acceptance criteria" and "study" proving they are met refer to a series of non-clinical, bench-top performance and safety tests conducted on the device, rather than clinical trials or AI performance evaluations commonly associated with the detailed questions on ground truth, expert review, and training/test sets. The conclusion states that these tests demonstrate the device meets predefined acceptance criteria and is substantially equivalent to a predicate device.

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OmniNeb™: This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The OmniNeb™ INebulizer is a low flow continuous nebulizer to be used to deliver aerosolized medications for up to four hours via direct patient interface on spontaneous breathing patients. Patient population: Asthma, Pneumonia. COPD. or any other conditions in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized. The Omni-Neb™ requires 45-55 psig source gas of Oxygen or Air.

OmniMax™: This device is to be used under medical supervision in hospitals. The OmniMax™ Nebulizer is to be used to deliver aerosolized medications in conjunction with Heliox therapy to sponfaneous breathing patients. Patient population: Asthma, Pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized, and adjunctive Heliox would be beneficial. The Omni-Max® requires 45-55 psig of Oxygen source gas. 10 liters/minute of 80/20 Heliox is added via auxiliary gas port.

Nebulizer (Direct Patient Interface)

I apologize, but this document is a 510(k) clearance letter from the FDA for nebulizer devices (Omni-Neb and Omni-Max). It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document primarily focuses on the substantial equivalence determination for these nebulizers.

Therefore, I cannot provide the requested information based on the content of this document.

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Ultrasound scanner and transducers for B, M and combined mode imaging. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts (organs), Transvaginal.

2101 supports the following scanning modes and mode combinations: B-mode and B+M-mode (M=motion). An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system operates with 3 types of transducers: mechanical sector, linear array and convex array (curved linear array). The system can perform simple geometric measurements, and perform calculations in the arcas of Urology, Cardiology and OB/GYN applications.

The provided text describes a 510(k) summary for the Ultrasound Scanner Type 2101. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to clinical efficacy or diagnostic accuracy.

The document primarily focuses on:

• Device Description: Scanning modes (B-mode, M-mode, B+M-mode), optional ECG, transducer types (mechanical sector, linear array, convex array).
• Intended Use: Listing clinical applications (Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts, Transvaginal) and modes, comparing it to a predicate device (Type 2002, K943315).
• Safety and Standards Compliance: Discussion of controls affecting radiated fields (global maximum M/I and Ispta values within allowable limits for Track 3 non-ophthalmic devices), patient contact materials complying with ISO10993-1, maximum Thermal Index (TI ≤ 6.0), electrical/thermal/mechanical safety tested to IEC 60601-1, and acoustic output reporting according to FDA and NEMA standards.
• 510(k) Clearance Letter: A letter from the FDA confirming substantial equivalence to the predicate device (K943315) for the stated indications for use, and an "ADD-TO-FILE" request for a special report on acoustic output.

Therefore, I cannot provide the requested information, which pertains to clinical performance and validation studies, as it is not present in the given text. The text suggests that the device's accuracy for clinical measurements is described in the User Guide, but it does not report those accuracies or the studies conducted to verify them.

Summary of missing information from the provided text:

1. Acceptance criteria and reported device performance related to diagnostic accuracy: Not provided. The document focuses on technical and safety compliance.
2. Sample size for test set and data provenance: Not mentioned.
3. Number and qualifications of experts for ground truth: Not mentioned.
4. Adjudication method for test set: Not mentioned.
5. MRMC comparative effectiveness study results (AI vs. human): Not applicable, as this is a traditional ultrasound scanner, not an AI diagnostic device.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not mentioned.
8. Sample size for training set: Not applicable (no AI training data discussed).
9. How ground truth for training set was established: Not applicable.

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This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The HOPE nebulizer is a high output nebulizer to be used by patients who require aerosolized medications. It provides additional hydration to help loosen secretions for patients whose condition is such that superior sympathomines, parasympathetic amines, or other appropriate medications would be nebulized. It is intended for use with bronchodilators, corticosteroids, antibiotics, mucolytics, and diagnostic formulations.

HOPE Nebulizer

The provided document is a 510(k) premarket notification letter from the FDA for the "Hope Nebulizer II". It indicates that the device has been found substantially equivalent to a predicate device marketed before May 28, 1976. However, this document does not contain any information regarding acceptance criteria, device performance studies, or details about such studies. It is a regulatory approval letter, not a study report or technical specification document.

Therefore, I cannot provide the requested information based solely on the text provided.

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B&D Activated Clotting Time (ACT) test tubes are intended for use in monitoring anticoagulation effects of heparin. Heparin is commonly used during coronary bypass surgery, coronary angioplasty and several other medical/surgical procedures in order to prevent thrombus formation. B&D Kaolin ACT test tubes (BD-K101) are not sensitive to provinin, and are the appropriate ACT test tubes to monitor heparin in patients treated with the moderate levels of protease inhibitor, aprotinin (up to 180 KIU/mL). B&D ACT test tubes are for whole blood, in-vitro diagnostic use only. B&D ACT test tubes are to be used with several whole blood ACT analyzers currently available, such as Hemochron® ACT analyzers Model numbers: 400, 401, 800, 801 and 8000.

Activated coagulation time (ACT) test tubes are used for monitoring heparin and aprotinin anticoagulation during coronary bypass surgery, coronary angioplasty and other medical/surgical procedures. These test tubes contain a clotting activator (either diatomaceous earth or kaolin), flip-top cap and a plastic insert that retains the magnet at the bottom of the test tube. Fresh whole blood is added to the test tube, it is mixed and placed into an instrument that is designed to display the activated clotting time (ACT) when the clotting is formed. This activated clotting time (ACT) timing indicates to physicians if the patient needs any anticoagulation adjustments.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary does not explicitly state numerical acceptance criteria in terms of a threshold value for correlation coefficients or a range for quality control plasma results before the studies were conducted. Instead, the reporting describes the achieved performance and concludes equivalence based on these results.

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

• Sample Size: The document does not specify the exact number of samples (e.g., number of fresh whole blood samples or QC plasma samples) used in the testing. It mentions "four different heparin concentrations, as well as a baseline" for fresh whole blood, implying multiple tests per concentration. For QC plasma, it mentions "Normal and Abnormal levels," again implying multiple tests.
• Data Provenance: The document does not specify the country of origin. The studies appear to be prospective as they were conducted to establish equivalence for the new devices, rather than analyzing existing data.

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

This information is not provided in the summary. The studies involve measuring clotting times, which are instrument-derived values rather than interpreted by human experts in the typical "ground truth" sense for diagnostic imaging.

4. Adjudication Method for the Test Set

This is not applicable as the test results are direct measurements from an instrument (Hemochron® 8000) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the equivalence of the device to a predicate device, not on the improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in spirit. The studies described are standalone performance evaluations of the device (test tubes) when used with an existing ACT analyzer (Hemochron® 8000). The device itself, in conjunction with the analyzer, provides the activated clotting time without human interpretation being the primary output being evaluated for accuracy.

7. The Type of Ground Truth Used

The ground truth implicitly used is the measurement provided by the predicate device (FTCA510 or KACT) when run on the same instrument (Hemochron® 8000). The goal was to show that the new devices' measurements correlated highly and produced similar results, especially with QC plasma that has predetermined "midrange" values. Essentially, the predicate device's performance, which is already accepted, serves as the standard.

8. The Sample Size for the Training Set

This product is a medical device (test tube) and not an AI/Machine Learning algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.

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

Since there is no training set as this is not an AI/ML device, this question is not applicable.

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