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The SELEC-3 I.V. Administration Set is used to provide a pathway to deliver fluid into the vascular system. This product is targeted for use by nurses and paramedics in pre-hospital, emergency room and field settings.

The Biomedix SELEC-3 I.V. Administration Set is a single- use, sterile device used for the administration of solutions and fully soluble drugs into the vascular system of a patient.

The provided document is a 510(k) summary for the Biomedix SELEC-3 I.V. Administration Set. It describes a medical device, its intended use, and confirms that it met acceptance criteria. However, it does not describe a study involving an AI/Machine Learning device or its performance.

Therefore, I cannot answer your request to describe the acceptance criteria and study proving an AI device's performance based on this document. The document pertains to a traditional medical device (an I.V. administration set) and its testing for safety and effectiveness, not an AI system.

The "Testing Summary" section of the document states:
"The SELEC-3 I.V. Administration Set has met Biomedix testing and acceptance criteria related to flow rate verification, leakage, microbial ingress, and pull force testing."

And the "Conclusion" states:
"The SELEC-3 I.V. Administration Set met all established acceptance criteria for design verification testing. Testing demonstrated that the device is safe and effective when used as intended."

This indicates that internal testing was conducted to verify the design and safety of the device against predefined criteria for physical characteristics. However, these are not the types of performance metrics or study designs relevant to an AI/ML device in the context of your original query (e.g., sample sizes for test/training sets, ground truth, expert adjudication, MRMC studies, standalone performance).

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The BioMedix PADnet 2.0 is a non-invasive device used to assess the lower and upper extremity arterial and venous circulatory systems in order to assist in the identification of vascular disease. To assess the arterial system, PADnet 2.0 uses pulse volume recording, arterial pulse contour analysis, and segmental systolic & diastolic blood pressure measurements. To assess the venous valvular system, PADnet 2.0 measures venous refilling time. For identification of venous obstruction in the deep venous (below knee) system, PADnet 2.0 measures venous outflow rate. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.

The primary goal of the PADnet 2.0 system is to assess the blood vascular system and assist on the diagnosis of arterial and venous vascular disease. The currently released PADnet+ system already provides this type of functionality. With focus on the venous system, PADnet+ permits the assessment of venous reflux in the venous valvular system of the lower extremity. Its native functionality also permits the assessment of venous obstruction in the deep venous system. It accomplishes these ends using photo-plethysmography. Photo-plethysmography refers to a technique whereby localized volume changes due to an optically scattering/absorbant substance (e.g. blood) are measured. PADnet 2.0 adds the air plethysmography modality to the pre-existing venous test suite. Thus, only the methodology used for testing has been augmented. Indications for use are unchanged. With focus on the arterial system, PADnet+ permits the assessment of arterial insufficiency. It accomplishes this end using pneumo-plethysmography (air plethysmography). Pneumo-plethysmography refers to a technique whereby localized volume changes as measured by pressure changes in an inflated blood pressure cuff are recorded. This signal is assessed for waveform morphology and amplitude. Additional information regarding arterial insufficiency may be obtained by measurement of peak arterial systolic blood pressure. . PADnet 2.0 uses oscillometry to assess limb blood pressure.

This 510(k) summary does not contain sufficient information to describe specific acceptance criteria and detailed study data in the way typically required for AI/ML device submissions. This document is a 510(k) for a medical device (PADnet 2.0) that primarily describes hardware and software modifications of an existing plethysmograph, and its safety and effectiveness are established through technological comparison to a predicate device and compliance with general safety and EMC standards. It does not describe a study involving specific performance metrics for an AI/ML algorithm or human reader performance.

Therefore, many of the requested data points (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of submission.

However, I can extract the information that is present and indicate where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable way for specific disease identification performance in the context of an AI/ML model compared to a gold standard. Instead, it relies on the device meeting established standards and being "as safe, as effective, and performs as well as or better than the non-modified device" (the predicate).

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

• Sample Size: Not specified. This document refers to compliance with standards (IEC, EN) and performance comparison to a predicate device, rather than a clinical study with a defined test set for a new algorithm's diagnostic performance.
• Data Provenance: Not applicable/not specified for a clinical performance test set in this context. The testing mentioned relates to electrical safety and EMC.

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

• Not applicable. There is no mention of a test set with expert-established ground truth for diagnostic accuracy in this submission.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set requiring adjudication is described.

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. This is not an AI/ML device submission that would typically involve an MRMC study comparing human reader performance with and without AI assistance. The device is a plethysmograph, an instrument for physiological measurements.

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

• Not applicable. This is not an AI/ML algorithm submission. The device is a measurement system.

7. The Type of Ground Truth Used:

• Not applicable for diagnostic accuracy in this context. The "ground truth" for the device's acceptable performance is its adherence to recognized electrical safety and EMC standards and demonstrating equivalence in functionality to its predicate device.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" as this is not an AI/ML algorithm submission.

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

• Not applicable. See point 8.

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The BioMedix PADnet+ is a non invasive device used to gage the lower extremity arterial and venous system, using pulse volume recording, oscillometric segmental systolic blood pressure and photo plethysmograph, to assist in the identification of vascular disease. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non intact skin.

The BioMedix PADnet+ is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere or in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab+.

The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements:

• Windows 2000 Operating System or Higher .
• 128 MB RAM .
• 20 GB Free Hard Disk Space .
• 600 MHZ Processor or Higher .

This 510(k) summary does not contain sufficient information to describe the acceptance criteria, the study proving the device meets the acceptance criteria, or most of the requested details about the study. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through descriptive comparisons of features and intended use, rather than a detailed performance study with acceptance criteria.

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

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

This information is not provided in the document. The document primarily describes the device and its similarities/differences to predicate devices, but does not state specific performance metrics (e.g., accuracy, sensitivity, specificity) for the PADnet+ or the acceptance criteria it was evaluated against.

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

This information is not provided. The document makes no mention of a specific test set or clinical data used to evaluate the PADnet+ performance.

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

This information is not provided. No test set and thus no ground truth establishment by experts is described.

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

This information is not provided. No test set is described.

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

This information is not provided. The device is described as a "non invasive cardiovascular blood flow monitor" and not as an AI-powered diagnostic tool intended to assist human readers. Therefore, an MRMC study related to AI assistance is unlikely and not mentioned.

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

This information is not provided. While the PADnet+ is a diagnostic device, the document does not present any standalone performance metrics or studies.

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

This information is not provided. No performance study with ground truth is mentioned.

8. The sample size for the training set

This information is not provided. As this document doesn't describe the development or evaluation of an AI/machine learning model, there is no mention of a training set.

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

This information is not provided. No training set is mentioned.

Summary of available information related to the device and its acceptance/clearance:

The document is a 510(k) Summary, which is typically used to demonstrate substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria through a de novo study.

• Predicate Devices: Flostat Vascular Lab (K973644, cleared Dec 23, 1997) and PADnet Lab (K042616, cleared Oct 12, 2004).
• Basis for Substantial Equivalence: The BioMedix PADnet+ is considered substantially equivalent because:
  • It has the same intended use as the predicate devices.
  • It has the same technical characteristics as the predicate devices and does not raise any new types of safety or effectiveness concerns.
  • It combines features (PPG from Flowstat Vascular Lab) with the original design of the PADnet Lab.
• Intended Use (from the Indications for Use statement): "The BioMedix PADnet+ is a non invasive device used to gage the lower extremity arterial and venous system, using pulse volume recording, oscillometric segmental systolic blood pressure and photo plethysmograph, to assist in the identification of vascular disease. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non intact skin."
• Standards Met (indicating safety and some functionality):
  • EN60601-1 Electrical Safety
  • EN60601-1-2 EMC
  • ISO 10993-1 Biological Evaluation

In essence, the "acceptance criteria" in this context are more about demonstrating that the new device is as safe and effective as the predicate devices, rather than meeting specific quantifiable performance thresholds outlined in a novel clinical study. The FDA's clearance (NOV 21 2007) signifies their agreement with this substantial equivalence claim.

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The Q.STEPS Biometer G/C Dual Monitoring System is intended for use with Q.STEPS Glucose and Cholesterol Test Strips with Q.STEPS Biometer G/C System by healthcare professionals and home users. Q.STEPS Biometer G/C System provides a quantitative measurement of Glucose and Cholesterol in whole blood from the fingertips. The Glucose measurements are used in helping the management of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors. Cholesterol measurements are used in the management of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.

The Q. STEPS™ Biometer G/C Dual Monitoring System uses enzymatic electrochemical biosensor technology for a quick and easy measurement of the whole blood glucose and cholesterol levels. When finger stick blood is applied to the test spot of the biosensor (test strip), a reduction oxidation reaction of D-Glucose or Cholesterol occurs, which is catalyzed by Glucose Oxidase and Cholesterol Oxidase respectively, and therefore, the magnitude of the electron transfer at the electrode is proportional to the glucose or cholesterol concentration in the blood. The monitor will quantify the glucose and the cholesterol levels in the blood, and then display on the readout of the monitor.

The provided 510(k) summary for the Q.STEPS™ Biometer G/C Dual Monitoring System does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The summary focuses primarily on device description, classification, predicate devices, and intended use, rather than a detailed performance study report.

However, based on the available information regarding the device's function (measuring glucose and cholesterol), and common practices for such devices, we can infer some general acceptance criteria and discuss the provided information.

Here's an attempt to structure the answer based on the prompt and the limited information:

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

The provided document does not explicitly state specific acceptance criteria in terms of numerical accuracy targets (e.g., +/- 15% for glucose, specific bias, precision values). It also does not report detailed device performance data from a specific study.

For a glucose and cholesterol meter, typical acceptance criteria, often outlined in standards like ISO 15197 for blood glucose monitoring systems, would include:

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The BioMedix PADnet Lab is a non invasive device used to record physiological data from the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures for use by the Physician in the identification of vascular pathology. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.

The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use in the early detection of peripheral vascular disease. The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere nor in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab. The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements: Windows 2000 Operating System or higher, 128 MB RAM, 20 GB Free Hard Disk Space, 600 MHz Processor or higher.

The provided document is a 510(k) premarket notification for the BioMedix PADnet Lab, which aims to demonstrate substantial equivalence to a predicate device, the Flostat Vascular Lab. This type of submission focuses on comparing the new device's characteristics and intended use to an already legally marketed device, rather than providing extensive clinical study data a standalone performance device. The document primarily highlights similarities and differences between the new device and the predicate device, emphasizing that the PADnet Lab's differences do not raise new safety or effectiveness concerns.

Therefore, many of the requested criteria, particularly those pertaining to acceptance criteria with reported performance, detailed study design, ground truth establishment, a human-in-the-loop study, or a multi-reader multi-case study are not typically part of a 510(k) submission for this type of device. The acceptance criteria in this context are primarily about demonstrating equivalence to the predicate device in terms of technology, safety standards compliance, and intended use.

Here's the information that can be extracted from the provided document:

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

The acceptance criteria for this 510(k) are implicitly based on demonstrating substantial equivalence to the predicate device (Flostat Vascular Lab) in various technical and operational aspects, and adherence to relevant safety standards. The document doesn't present a table of numerical performance targets with corresponding measured values for the PADnet Lab's diagnostic capabilities. Instead, it compares features.

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 detail a specific "test set" in the context of clinical performance evaluation studies for the PADnet Lab. The submission is a 510(k) for substantial equivalence based on technical and functional comparison to a predicate device, along with adherence to recognized safety and EMC standards. Clinical data (e.g., from a test set of patients) for this specific device's diagnostic performance is not provided as the primary method to demonstrate substantial equivalence in this filing. The term "Clinical Reports" under the comparison table refers to the device's ability to generate such reports, not the submission of clinical study data for FDA review.

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. No clinical test set with ground truth established by experts is described in this 510(k) submission.

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

Not applicable. No clinical test set and adjudication method are described in 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. This device is a "Blood Flow Monitor" and a "Plethysmograph", likely providing physiological measurements rather than interpretive "AI assistance" to human readers. No MRMC or human-in-the-loop study is mentioned.

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

Not applicable. The PADnet Lab is a measurement device, not an "algorithm-only" or AI-driven diagnostic system in the sense of an imaging analysis tool. Its performance is based on the accuracy of its physiological measurements, for which a specific standalone performance study is not detailed here beyond compliance with general electrical and biological safety standards.

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

Not applicable. No ground truth is specified as no clinical performance study for diagnostic accuracy is detailed in this 510(k). The basis for "ground truth" in this context would implicitly be the validated performance of the predicate device and the accepted physiological principles behind plethysmography and oscillometric measurements.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device requiring such.

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

Not applicable. No training set is discussed.

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The Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for all ages (excluding neonates.) It is intended for use outside the body (for in vitro diagnostic use) by health care professionals in settings such as clinical laboratories and physician offices laboratories (POLs) as an aid to monitor the effectiveness of diabetes control.

The Q.STEPS™ Biometer G Blood Glucose Monitoring System is an in vitro device designed for measuring the concentration of glucose in capillary whole blood from the fingertip. The system uses electrochemical methodology. The system quantifies glucose amperometrically by measuring the current that is produced when glucose oxidase catalyzes the oxidation of glucose to gluconic acid. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and is converted to a readout displayed on the monitor.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Q.STEPS™ Biometer G Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

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The BioMedix, Inc. Flostat Vascular Report Generator is a device for the use to display the outputs from three strip chart recorder based peripheral vascular diagnostic instruments on a PC printer. In essence, this is changing one printer for another. This generic device can bu used to input a signal from any device into a is intended soley for use in conjunction with computer but Blood pressures, displayed peripheral diagnostic instruments. digitally, may be recorded with the original cuffs provided by the original manufacturer. No change in equipment or technique is warranted.

The three target devices are the Imex Corp. 3000 Series, 301 The Life Sciences Corp./HealthWatch PVR Series Series, and All these incorporate analog or digital pen diagnostic devices. strip chart recorders to display the output waveforms. The sole use of the VRG is to display the waveforms on the PC printer. une lowest resolution dot matrix printer with 90x90 dots per inch(and certainly much higher resolution laser printers) has a much higher resolution than the relatively meager 100 Hz bandwidth that an analog pen recorder can provide. No alterations in the clinical instructions, indications, methodologies, or outcomes will occur. The VRG is simply connected to an analog output path on the target The VRG is then connected(via a high ESD rated RS-232 device. driver) to the computer. The waveforms are brought into the computer and the opportunity is provided for printing to a printer. The intended use of the VRG-Vascular Diagnostic Unit tandem is the the original intended use of the original vascular same diagnostic unit(ie. peripheral vascular studies).

The BMX Vascular Report Generator passes the output information of a peripheral vascular deviceto a computer and then onto a printer. All ourputs of a peripheral vascular device, throuhg the VRG, can displayed, including data that can be shown as a spectrum analysis. The Vascular Report Generator does not change the output of a peripheral vascular devicebut only allows the computer to display the informan: in various forms .

The BioMedix, Inc. Flostat Vascular Report Generator is a device for the use to display the outputs from three strip chart recorder based peripheral vascular diagnostic instruments on a PC printer.

The provided documentation, a 510(k) submission for the Flostat Vascular Report Generator (VRG), focuses on demonstrating substantial equivalence to existing devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the typical sense of a clinical trial for diagnostic accuracy.

The core argument for the VRG's acceptance revolves around its function as a printer substitute and its ability to display outputs from existing peripheral vascular diagnostic instruments. The "acceptance criteria" can therefore be inferred as the VRG's ability to accurately and without degradation convert and display the data from the listed diagnostic devices on a PC printer, mirroring the output of the original strip chart recorders.

Here's an attempt to extract the requested information based on the provided text, recognizing that much of it is not explicitly stated in a typical study report format:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The submission refers to "the three target devices are the Imex Corp. 3000 Series, 301 The Life Sciences Corp./HealthWatch PVR Series Series, and All these incorporate analog or digital pen diagnostic devices." This implies testing (or at least compatibility assessment) across these three models. However, the number of cases or patients tested with the VRG is not provided.
• Data Provenance: Not specified. It's likely an internal company assessment given the nature of a 510(k) submission, not a broad clinical study. The location of BioMedix, Inc. is Camden, N.J., USA, so the underlying data would presumably be from the US, but this is not explicitly stated for the "test set" (if one even existed in a formal sense). It is retrospective in the sense that it relies on the established performance of existing devices.

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

• This information is not provided. Given the nature of the device (a report generator/printer interface), the "ground truth" would likely be the direct, original output from the strip chart recorders of the peripheral vascular diagnostic instruments themselves. It's unlikely that external medical experts were formally used to establish ground truth for the display accuracy of the VRG.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. There's no indication of independent adjudication or a formal adjudication process. The assessment appears to be a technical verification that the VRG can correctly transmit and display the data.

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

• No, an MRMC study was not done. The VRG is not an AI diagnostic tool and does not involve human readers interpreting its output in a comparative effectiveness study against a baseline. Its function is to display data, not interpret it.

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

• Yes, in a conceptual sense. The "performance" of the VRG is its ability to transmit and print data accurately, independently of human interpretation of that data. The statement "The Vascular Report Generator does not change the output of a peripheral vascular device but only allows the computer to display the information" indicates a standalone function of data conveyance. The device is not making diagnostic decisions; it is reflecting the output of other diagnostic devices.

7. Type of Ground Truth Used

• The "ground truth" implicitly referred to is the output waveform/data directly from the original manufacturer's peripheral vascular diagnostic instruments operating via their original strip chart recorders. The VRG's performance is gauged against its ability to faithfully reproduce this known output on a different medium (PC printer).

8. Sample Size for the Training Set

• Not applicable/Not provided. The VRG is described as a "generic device" that can "input a signal from any device." This strongly suggests it's a hardware/software interface designed to work with any analog output pathway or specific digital signals, not a machine learning model that requires a "training set" in the conventional sense. Its "training" would be its engineering design to correctly interpret and display signals, not a data-driven learning process.

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

• Not applicable/Not provided, as there is no "training set" for an AI or machine learning model. The ground truth for its engineering design would be the specifications and expected output characteristics of the analog and digital signals from the target peripheral vascular devices.

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The BioMedix, Inc. Flostat Vascular Lab is a device for the use in the diagnosis of the etiology and extent of vascular pathology primarily in the peripheral vasculature and, in a more restricted sense, in the central vasculature(periorbital region ONLY). These tasks are accomplished via three separate modalities, each of which can be use to test either the arterial or venous system. The three modalities are 1) Pneumoplethysmography (blood pressure cuff air inflation), 2) Photoplethysmography (change in infrared light reflectance on skin as a relection of larger branches) and 31 wave doppler ultrasound velocity waveform Simple continuous measurement. NONE of these testing modalities are intended for FETAL USE and the devices and instruction manuals are so labelled.

The air pump Pneumoplethysmograph and infrared Photoplethysmograph are for use in studying the PERIPHERAL VASCULATURE ONLY.

The 5 MHz. continuous wave doppler ultrasound velocity meter and the 8 MHz. continuous wave doppler ultrasound velocity meter are for use in studying the PERIPHERAL VASCULATURE ONLY.

There is a separate control setting labelled clearly on the FLOSTAT vascular LaB - 'Ophthalmic-8 MHz.' doppler which is intended for an 8 MHz. continuous wave doppler ultrasound velocity meter exactly the same as the 8 MHz. continuous wave doppler velocity meter except that the 'Ophthalmic-8 MHz.' doppler has substantially lower acoustic output which conforms to the safety standards For periorbital studies specified by the Food and Drug Administration (FDA) . Through medical studies performed by the scientists at the it has been determined that ultrasound acoustic levels EDA, rated by various figures of merit (eg. ISPTA; etc.) are safe for different areas of the body :

For this reason, DO NOT EVER PERFORM PERIORBITAL STUDIES WITH THE. DOPPLER IN ANY MODE OTHER THAN THE 'Ophthalmic-8 MIZ.' MODE . Labels will also be placed on the doppler transducer that they are NOT FOR FETAL USE and specifying the correct frequency(5 MHz or 8 MHz) -

The doppler section is intended to generate velocity waveforms and values for study and audio output for physician analysis of the arterial and venous system.

The Ultrasonic Doppler device at 5 MHz. and 8 MHz . applies ultrasound energy through the extremities of the subject to assess blood velocity, blood velocity waveform morphology, spectrum analysis, pressure, and patency of PERIPHERAL VESSELS.

The Ultrasonic Ophthalmic- 8 MHz. device applies ultrasound energy to the periorbital region to assess blood velocity, blood velocity waveform morphology, and spectrum analysis in this area.

The Pneumoplethysmograph is used to gauge the arterial system the recording studies recording studies and is used to gauge the venous system through maximum venous outflow studies.

The Photoplethysmograph is used to gauge the arterial system through pulse waveform analysis and is used to gauge the venous system through venous reflux time tests. Full clinical information is provided in the Operators Instruction Manual(enclosed herein).

The BioMedix, Inc. Flostat Vascular Lab is a device for the use in the diagnosis of the etiology and extent of vascular pathology primarily in the peripheral vasculature and, in a more restricted sense, in the central vasculature(periorbital region ONLY). These tasks are accomplished via three separate modalities, each of which can be use to test either the arterial or venous system. The three modalities are 1) Pneumoplethysmography (blood pressure cuff air inflation), 2) Photoplethysmography (change in infrared light reflectance on skin as a relection of larger branches) and 31 wave doppler ultrasound velocity waveform Simple continuous measurement.

The provided document is an FDA 510(k) clearance letter for the FLOSTAT VASCULAR LAB (Doppler Ultrasound/Plethysmograph) from 1997. This type of document declares substantial equivalence to a predicate device, allowing the manufacturer to market the device. It does not typically contain detailed information about the acceptance criteria or a specific study proving the device meets said criteria in the format requested.

The letter focuses on the regulatory clearance process, specifying the device's classification, applicable regulations, and conditions for continued marketing (e.g., submission of a post-clearance special report with acoustic output measurements). It also lists the transducers included in the clearance.

Therefore, the requested information, such as a table of acceptance criteria, device performance, sample sizes, expert qualifications, and details of specific studies (MRMC, standalone), cannot be extracted from this document. The document states that the determination of substantial equivalence assumes compliance with good manufacturing practices and refers to general controls provisions of the Act for regulatory requirements.

The "Indications For Use" section (page 3 and 4) describes how the device is intended to be used for diagnosis, outlining the modalities (Pneumoplethysmography, Photoplethysmography, continuous wave doppler ultrasound) and the body regions they are applied to (peripheral vasculature, periorbital region). It also mentions safety standards for periorbital studies regarding acoustic output. However, this is descriptive of intended use and safety considerations, not a report of specific validation study results against acceptance criteria.

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This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations.

The I.V. Extension Line Assembly with Stopcock is attached to the Primary I.V. to facilitate two advantages. One, is to add extra length between the I.V. Supply and the Patient. A second, is to provide additional supply ports for the administration of alternate solutions and special drugs that are adminstered intraveneously. A four-way stopcock offers selection of the fluid types and sources. Biomedix is offering two models, one with a standard Needle-Type Injection Site at the Outlet and a second with a Blunt Cannula (Needleless) Type Injection Site at the outlet.

The provided document, K961928, is a 510(k) Summary for an "I.V. Extension with Stopcock" device by Biomedix, Inc. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a diagnostic or AI-powered medical device.

Instead, this document is a submission for substantial equivalence to predicate devices already on the market. It aims to demonstrate that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, and human reader performance are not applicable to this type of submission.

Here's how to interpret the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an IV extension and stopcock, the "acceptance criteria" are implicitly about the physical characteristics and intended use being similar to predicate devices, and the "reported device performance" is a description of the device's features compared to those predicate devices. There are no performance metrics like sensitivity, specificity, or accuracy that would be found in a study for a diagnostic device.

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

• Not Applicable. This document describes a comparison of device specifications, not a clinical trial with a test set of data. The "sample" here refers to the design features of the device and its predicate devices.

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

• Not Applicable. There is no "ground truth" establishment in the context of a clinical study for this type of 510(k) submission. The "truth" is established by the specifications and existing regulatory clearance of the predicate devices.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication process as described for a clinical study.

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 or diagnostic imaging device.

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

• Not Applicable. This is not an AI or algorithm-driven device.

7. The type of ground truth used

• Not Applicable. For this type of device, "ground truth" is essentially the established performance and safety of legally marketed predicate devices, against which the new device's design and intended use are compared.

8. The sample size for the training set

• Not Applicable. There is no training set for a machine learning model.

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

• Not Applicable. There is no training set for a machine learning model.

Summary for K961928:

This 510(k) submission is for a medical device (I.V. Extension with Stopcock) that is substantially equivalent to existing devices already on the market. The "study" here is a design comparison and intended use comparison against predicate devices (Baxter PHARMASEAL K52 NOVEX, Medex Extension Set, McGaw I.V. Extension Set series). The acceptance criteria are implicitly that the new device's features, materials, and intended use do not raise new questions of safety or effectiveness compared to the predicates. No clinical trials with patient data, expert reviews, or AI performance metrics are presented as part of this type of submission.

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