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The BIOPORT System is designed for closed, needle-free access of arterial blood from pressure monitoring catheters.

The BIOPORT System is designed for needle-free access of undiluted blood from arterial catheters (typically 16 or 18 Ga.) not longer than 6.4 cm (2 - ½ "). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to permit needle-free withdrawal of undiluted blood from the BIOPORT using a blood sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the undijuted sample is drawn, the heparinized, diluted blood in the Reservoir Syringe is reinfused into the patient to reduce fluid loss.

The BIOPORT System is composed of a 3-way stopcock; BIOPORT (a pre-slit latex rubber septum housed in a clear, rigid, plastic housing); a 3 cc Reservoir Syringe with protective dust cover over the plunger shaft to minimize contamination of Syringe contents by dust particles; and high-pressure Extension Tubing. The BIOPORT and stopcock are bonded 12 and 14 inches, respectively, from the distal male Luer lock connector of the pressure monitoring tubing. The 3-cc Luer lock Reservoir Syringe is pre-attached to the 3-way stopcock. The stopcock, BIOPORT, and Reservoir Syringe are located on a rigid plastic support equipped with a Velcro-type fastener for mounting on a patient's arm.

A Blunt Cannula Adapter (BPN)- terminating in a female Luer lock connector at one end for attachment to the male Luer of a sampling syringe, and a hollow, blunt plastic cone at the other end for insertion into the pre-slit septum of the BIOPORT- is provided separately to effect needle-free blood access via the BIOPORT.

This looks like a 510(k) premarket notification for a medical device called the BIOPORT™ Closed Blood Sampling System. As such, the information provided is a summary of the device's characteristics and its equivalence to predicate devices, rather than a detailed clinical study report with specific acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.

Therefore, many of the requested points (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance) are not applicable or cannot be determined from the provided text, as this type of submission focuses on demonstrating substantial equivalence to existing devices and adherence to recognized standards, rather than proving a specific performance level of a novel algorithm or diagnostic output.

However, I can extract the information that is present and explain why other points are not.

BIOPORT™ Closed Blood Sampling System Premarket Notification (K983372)

This submission describes a Class II medical device, the BIOPORT™ Closed Blood Sampling System, which is intended for closed, needle-free access of arterial blood from pressure monitoring catheters. The primary goal of the submission is to demonstrate substantial equivalence to predicate devices and compliance with applicable standards, rather than to present a performance study with specific acceptance criteria as you might see for a diagnostic AI.

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: Not specified. The document references "Performance data" and "Tests," but does not provide details on the number of units tested, the number of measurements taken, or specific sample sizes.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies appear to be internal testing conducted by Biosensors International.

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

• Not applicable / Not provided. This device submission does not involve expert-established ground truth in the context of diagnostic interpretation. The "ground truth" here is adherence to engineering standards and functional performance metrics.

4. Adjudication method for the test set

• Not applicable / Not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies with subjective interpretations, which is not relevant for this device's performance assessment.

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 medical accessory (blood sampling system), not an AI-driven or diagnostic imaging system that would involve human readers or AI assistance.

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

• Not applicable. This device does not involve an algorithm. Its performance is assessed through physical and functional testing against established engineering and biocompatibility standards.

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

• For this device, the "ground truth" is based on objective engineering and biological standards and requirements. These include:
  • International Standard ISO 10993 (Biocompatibility)
  • FDA G95-1 Memorandum (Biocompatibility)
  • International Standard ISO 8536-4 (Tensile strength, leakage resistance)
  • BP 22, American National Standard for Blood Pressure Transducers (Frequency response/bandwidth)
  • Functional testing to ensure syringe plunger retention under pressure.
  • Demonstration of substantial equivalence to already cleared predicate devices.

8. The sample size for the training set

• Not applicable. This device does not utilize machine learning or AI, and therefore does not have a "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm, there is no corresponding ground truth to be established for it.

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The Biosensors Embolectomy Catheter is indicated for use in the removal of emboli and thrombi from the arterial system. The catheter should be used only by a physician with surgical skill in the vascular system.

Biosensors International (BI) has developed an embolectomy catheter that is equivalent in design and performance to embolectomy catheters currently marketed by Baxter. BSI's embolectorny catheters are configured as single lumen, balloon-tipped catheters.

The catheters vary in length and diameter to accommodate various thrombotic obstruction and vessel lumen sizes. They are supplied in 3, 4, 5, 6, and 7 French diameters, with inflated balloon diameters of 6, 9, 11, 13, and 14 mm, respectively.

The catheters are color coded, and have black distance markings at 10 cm intervals (with "0" cm located at the distal catheter tip.)

The proximal end of the flexible catheters terminate in a rigid, winged adapter with female luer lock port to permit attachment to a stylet for stiffening the catheter during insertion, or sterile syringe during balloon inflation. The distal end of the catheters terminate in a latex-coated tip immediately distal to the latex balloons. The latex balloons lie flat against the catheters during insertion through the vasculature and lesion, and are inflated with sterile isotonic saline or other appropriate sterile solution during embolectomy procedures.

The catheters are supplied with a stainless steel stylet inserted in their lumens. The stylets terminate proximally in a rigid male luer adapter that mates with the female luer of the catheters. The stylets can be used, when appropriate, to add rigidity to the catheters to aid in their insertion.

The Biosensors Embolectomy Catheter received 510(k) clearance based on its substantial equivalence to the Baxter Healthcare's Fogarty® Arterial Embolectomy Catheter. The device's performance was assessed through a series of tests to demonstrate it met the acceptance criteria implied by its substantial equivalence to the predicate device.

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 sizes used for each specific test (burst strength, pull strength, etc.). The study appears to be a retrospective comparison based on laboratory testing of the Biosensors Embolectomy Catheter against the characteristics of the predicate device. There is no indication of country of origin for the data provided, as it is a premarket notification for a US market.

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

This information is not provided in the document. For a medical device like an embolectomy catheter, the "ground truth" for performance evaluations typically comes from engineering testing against established standards and benchmarks of predicate devices, rather than expert consensus on a test set of clinical images or cases.

4. Adjudication Method for the Test Set:

This information is not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers are interpreting data or making diagnoses, often for image-based diagnostic devices. This premarket notification focuses on the physical and material performance of the catheter.

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

No MRMC comparative effectiveness study was done. This type of study involves human readers and is not relevant for the assessment of a physical medical device like an embolectomy catheter.

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

A standalone performance assessment was conducted in the sense that the device's physical and material properties were tested in a laboratory setting. This is an "algorithm only" equivalent in that the device's performance characteristics were evaluated as an isolated entity. The device's performance in terms of burst strength, pull strength, inflation volume accuracy, tensile strength, and leak resistance were evaluated independently.

7. Type of Ground Truth Used:

The "ground truth" for this study was based on engineering and performance specifications established for similar medical devices, specifically the predicate Baxter Healthcare's Fogarty® Arterial Embolectomy Catheter. It relies on the understanding that if the new device performs equivalently to a legally marketed predicate device on these objective measures, it is deemed safe and effective.

8. Sample Size for the Training Set:

This information is not applicable as this is a physical medical device, not an AI/algorithm-driven device requiring a training set in the conventional machine learning sense. The "training" for such a device would be the design and manufacturing process, optimized through engineering principles.

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

This information is not applicable for the same reasons as #8. The "ground truth" relevant to the device's development would be established through industry standards, regulatory requirements, and the functional specifications of existing, successful embolectomy catheters.

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The BSI BIOTRANS Pressure Monitoring Kits are designed for use with BIOTRANS Sensor Bases. Kits containing integral 3- and 40 cc/hr flush device are designed for use in physiologic pressure measurements where continuous flow is required to maintain catheter patency. The 40 cchr flush devices are included in Kits designed for neonatal applications in conjunction with a properly calibrated fluid delivery purnp.

The BIOTRANS Pressure Monitoring Systems consist of the sterile, single-use BIOTRANS Pressure Monitoring Kits and reusable BIOTRANS Reusable Sensor Bases and Monitor Adapter Cables. The single-use BIOTRANS Pressure Monitoring Kits provide the sterile fluid pathway components that deliver IV solution to maintain catheter patency via the administration set components. transducer dome assembly and extension set, and convey the hemodynamic waveform from the patient's catheter to the reusable sensor (provided separately). The pressure waveform is conveyed to the sensor via two compliant diaphragms which are brought into intimate contact during set up of the device by the end-user. All fluid contact occurs within the sterile single-use kit components.

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 sizes used for testing each individual criterion (e.g., number of domes tested for pressure performance, number of materials tested for biocompatibility, number of bonded joints tested for tensile/leak).

• Provenance: The document implies that parts of the testing were conducted to meet US (ANSI/AAMI) and international (ISO) standards. The administration sets' performance history is cited for "Asia and Europe." The testing appears to be retrospective in the sense that it evaluates the manufactured device against established standards.

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

Not applicable. The performance data is based on engineering testing against established performance and safety standards (ANSI/AAMI, ISO) for medical devices, rather than expert interpretation of a test set.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation is based on meeting predefined technical specifications and standards, not on expert consensus or adjudication of interpretations.

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 document describes a technical evaluation of the device's performance against established industry standards.

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

Yes, the study describes a standalone evaluation of the device's physical and functional performance (e.g., meeting pressure requirements, biocompatibility, leak tests) without human interaction influencing the core performance metrics.

7. The Type of Ground Truth Used:

The ground truth used consists of established performance and safety standards for medical devices, specifically:

• American National Standard for Blood Pressure Transducers (ANSI/AAMI BP22-1994)
• FDA and ISO biocompatibility requirements (ISO-10993-1 and G95-1)
• International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical monitoring kit, not an AI/algorithm-based device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The BSI BIOTRANS is used to convert hemodynamic pressure waveforms into electrical signals which can be displayed using separate monitoring equipment. As such, its Indications for Use are identical to those for Medex's MX 860 and MX 960. BIOTRANS cables are used to make an electrical connection between the sensor and monitor. Their use is identical to that of cables manufactured by Utah Medical Products, Inc.

The BSI BIOTRANS Sensor Base is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can be displayed using separate monitoring equipment.

The BIOTRANS Pressure Monitoring System consists of the sterile, single-use BIOTRANS Pressure Monitoring Kit (subject of a separate 510k) and BIOTRANS Reusable Sensor Base and Monitor Adapter Cables. The Base consists of a rugged silicon-based piezoresistive pressure sensor mounted on a rigid plastic support. A standard Wheatstone Bridge circuit etched into the sensor is used to detect pressure changes applied to the sensor and convert them to electronic signals for display on standard monitoring equipment.

The sensor is electrically isolated from the patient by a dielectric gel and two elastomeric diaphragms. The physiologic pressure waveform is conveyed from the patient catheter via a fluid-filled pathway to the single-use dome diaphragm. The dome diaphragm is mechanically coupled to the reusable pressure sensor diaphragm for pressure monitoring. The diaphragms make intimate contact during use permitting transfer of the pressure waveform to the transducer, with fluid contact occurring on the patient side of the disposable dome diaphragm. A 25 cm (10") Sensor cable permanently wired to the sensor transmits the electronic signal from the transducer to the patient monitor via the appropriate Monitor Adapter Cable.

The integral Sensor cables terminate in 5 different electrical adapters compatible with 5 common brands of Monitor Cables (Utah Medical, Baxter International, Medex, Abbott, and Ohmeda.) Monitor Adapter Cables designed for specific use with all major monitor suppliers are available from BSI.

The Base features built-in organizer/mounting systems compatible with standard manifold clamps for pole-mount applications.

Here's a breakdown of the acceptance criteria and the study details for the BSI BIOTRANS™ Reusable Sensor Base:

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 a specific sample size for a "test set" in the context of human subjects or cases. The performance evaluation appears to be based on meeting the requirements of the ANSI/AAMI BP22-1994 standard. The data provenance is not specified beyond this.

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

Not applicable. The performance is assessed against a technical standard (ANSI/AAMI BP22-1994), not against expert interpretations of cases.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication process for a test set, as the evaluation is based on compliance with a technical standard.

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

No. An MRMC study was not done. The device is a physical transducer, and the evaluation focuses on its technical performance against a standard, not human interpretational accuracy.

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

Yes, in essence. The evaluation provided focuses on the device's inherent technical performance (e.g., electrical requirements, conversion of pressure waveforms) in a standalone capacity, without human intervention in its core function as a transducer.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptance is based on adherence to the American National Standard for Blood Pressure Transducers, ANSI/AAMI BP22-1994. This is a technical standard that defines performance requirements for such devices.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware component (pressure transducer), not an AI/machine learning algorithm. Therefore, there is no "training set" in the conventional sense.

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

Not applicable, as there is no training set for this hardware device.

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