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The Bard® 3DMAX™ Light Mesh will be indicated for use in the reinforcement of soft tissue where weakness exists, such as the repair of hernia defects.

The Proposed Bard® 3DMAX™ Light Mesh, is designed to fit the inguinal anatomy. The device is anatomically shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 0.0048 inches in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an "M" shape to designate the medial edge of the mesh and an arrow pointing to the medial aspect. Both the arrow and "M" will aid the user during positioning and placement of the device. The orientation marker is composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant.

Here's a breakdown of the acceptance criteria and the study details for the Bard® 3DMAX™ Light Mesh, based on the provided document:

This device (Bard® 3DMAX™ Light Mesh) is a surgical mesh and not an AI/ML powered device. Therefore, many of the typical questions related to AI/ML device testing (e.g., number of experts, adjudication methods, multi-reader multi-case studies, separate training/test sets, or ground truth establishment for AI) are not applicable to this submission. The device is evaluated through physical and performance testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail table format with specific ranges. Instead, it describes a comparative study showing that the Proposed Bard® 3DMAX™ Light Mesh performs similarly to predicate devices across various physical and performance characteristics. The acceptance criterion implicitly is "demonstrates substantial equivalence to predicate devices."

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

• Sample Size for Test Set: The document does not specify exact numerical sample sizes for each laboratory test. It generally states that "Laboratory bench testing was performed."
• Data Provenance: The tests were conducted internally by Davol Inc. (a subsidiary of C.R. Bard, Inc.). The data is from laboratory bench testing, presumably conducted prospectively for this submission. The country of origin of the data is not specified but implicitly is the USA, given the submission to the FDA.

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

• N/A. This is not an AI/ML device relying on expert interpretation for ground truth. Performance is assessed through objective, quantifiable laboratory bench tests.

4. Adjudication Method for the Test Set

• N/A. Adjudication methods are typically used for subjective assessments or when multiple experts are involved in establishing ground truth, which is not the case for material and mechanical property testing of a surgical mesh.

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

• No. This is not an AI/ML device that interacts with human readers for diagnostic or interpretive tasks. MRMC studies are not relevant for evaluating the physical and performance characteristics of a surgical mesh.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• N/A. This is not an algorithm. The device's performance is inherently "standalone" in that its physical and mechanical properties are measured directly.

7. The Type of Ground Truth Used

• Objective Laboratory Measurements: The "ground truth" for this device's performance relies on established engineering and materials testing standards. For example, tensile strength is measured against a standard procedure, and the result is an objective numerical value. Biocompatibility is assessed against recognized biological evaluation standards (e.g., ISO 10993 series). The comparison is then made against the measured performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device; there is no "training set."

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

• N/A. There is no training set as it is not an AI/ML device.

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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 CAPIOX® 308 Hollow Fiber Oxygenator is used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool the blood or perfusion fluid flowing through the device. The device is intended for use during extracorporeal circulation for up to 6 hours. This device is for use with neonatal and pediatric patients.

CAPIOX® 308 Hollow Fiber Oxygenator (CAPIOX 308) contains an integrated heat exchanger. The CAPIOX 308 oxygenator is a membrane oxygenator consisting of microporous polypropylene hollow fibers. Blood flows internal to the hollow fibers while gases flow outside the fibers. The heat exchanger consists of stainless steel pipes with blood flowing inside the pipes and water flowing outside the pipes. A thermistor probe is located near the outlet port of the oxygenator which can be connected to accessory temperature monitoring equipment if desired.

The CAPIOX® 308 Hollow Fiber Oxygenator with integral heat exchanger is a new device that was found to be substantially equivalent to the Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger. The substantial equivalence was established based on intended use, design and materials, technology/principles of operation, specifications, and performance.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria (Specifications) and Reported Device Performance:

The acceptance criteria for the CAPIOX® 308 were established by demonstrating substantial equivalence to the predicate device, the Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger. The "acceptance criteria" are effectively the specifications of the predicate device that the new device needed to match or surpass for critical parameters to be considered substantially equivalent.

Important Note: The document explicitly states: "Although some design dissimilarities exist, the performance s and and the the the there that these differences do not Although some design arsements that these differences do not testing results demonstrate that chose in the function and intended uses of the devices." This indicates that while some specifications varied, the overall functional performance was deemed equivalent. For instance, the lower blood flow rate for the CAPIOX® 308 is likely acceptable given its intended use for neonatal and pediatric patients, who require lower flow rates than adults. Similarly, a smaller priming volume is often an advantage.

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

The document does not specify a separate "test set" in the context of clinical trial data or patient samples. The "test results" refer to engineering and performance tests conducted to compare the CAPIOX® 308 with the predicate device. These tests would involve physical measurements and simulations, not patient data in the typical sense of a clinical trial.

• Sample Size: Not applicable in the context of human subjects or clinical data. The tests would involve multiple units of the device and the predicate device for various performance metrics. The exact number of units tested for each specific parameter (e.g., gas exchange, heat transfer, leak testing) is not provided in the summary.
• Data Provenance: The tests were likely conducted in a laboratory or manufacturing setting. The document does not specify the country of origin for the testing, but it was submitted by Terumo Medical Corporation, located in New Jersey, USA, and Elkton, Maryland, USA. The data would be considered prospective as it involves new testing of the device.

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

Not applicable. The ground truth for this medical device submission is established through engineering specifications, direct comparative performance testing against a legally marketed predicate device, and compliance with recognized standards. There is no mention of expert consensus derived from reviewing diagnostic outputs or images.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation of data where adjudication methods (like 2+1 for reaching consensus among experts) would be used. The "adjudication" in this context is the FDA's regulatory review process, which determined substantial equivalence based on the provided engineering and performance test data.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., AI algorithms for medical imaging) to assess the impact of AI assistance on human reader performance. The CAPIOX® 308 is a therapeutic device (oxygenator with heat exchanger) used during cardiopulmonary bypass, not a diagnostic imaging tool.

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

Yes, the "performance" section implicitly refers to standalone performance studies. The document states, "The test results indicated the CAPIOX 308 performs in a substantially equivalent manner to the Avecor 0800 2A and Omnitherm Heat Exchanger." These tests were conducted on the device itself, measuring its physical and functional characteristics (e.g., gas exchange efficiency, heat transfer rate, priming volume, pressure resistance) without human intervention in its primary function during the test.

7. Type of Ground Truth Used:

The ground truth used for demonstrating substantial equivalence was a combination of:

• Engineering specifications and performance data of the legally marketed predicate device (Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger).
• Direct comparative performance testing of the CAPIOX® 308 against the predicate device to show that the new device's performance aligned with, or was acceptably different from, the predicate's performance.
• Compliance with recognized standards for medical device safety and biocompatibility (e.g., pyrogen testing, sterilization validation to SAL of 10⁻⁵, ethylene oxide residuals, 100% performance and leak testing, ISO-10993 for blood-contacting materials).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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