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The S-Wire Guidewire System is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used in trans-catheter aortic valve implantation (TAVI) procedures.

The S-Wire Guidewire System is a sterile, single-use guidewire used for the placement of interventional devices within the aorta and the chambers of the heart. The S-Wire has a 0.035" diameter, and an overall length of 260 cm. The S-Wire construction consists of a nickel-titanium alloy core wire that is PTFE coated, ground and thermally formed. The S-Wire distal coil is made of 304V stainless steel: the distal and proximal ends of the stainless steel coil is bonded to the core wire. The distal portion of the S-Wire has silicone coating. The distal end of the S-Wire has a pre-formed double curve shape consisting of an approximately 360° bend with an outer diameter of approximately 3 cm, and a small S-curve at the distal tip of the wire that is fully contained within the 3 cm curved area. The S-Wire Guidewire System includes a disposable plastic 9 Fr introducer (6 inches long) that is used as an aid in loading the S-Wire into an intravascular catheter.

The provided text describes a medical device, the S-Wire Guidewire System, and its substantial equivalence determination by the FDA. However, the document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML algorithm or similar diagnostic tool where performance metrics like sensitivity, specificity, or accuracy would be relevant.

Instead, this document focuses on the regulatory clearance of a physical medical device (a guidewire) based on its comparability to a predicate device. The "performance testing" described refers to engineering and biocompatibility tests for the guidewire itself, not the performance of a diagnostic algorithm.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance for an AI/ML study, nor details about sample sizes for test/training sets, expert qualifications, or adjudication methods related to diagnostic performance.

The "Performance Testing" section on page 5 details the types of tests conducted:

Performance Testing for the S-Wire Guidewire System (Physical Device):

• Measurement of physical characteristics and device integrity in accordance with FDA's Coronary and Cerebrovascular Guidewire Guidance and ISO 11070.
• Specific tests included:
  • Dimensional inspection
  • Tensile strength (guidewire and introducer)
  • Distal loop compression force
  • Distal tip shape retention
  • Tip stiffness
  • Coating integrity
  • Particulate evaluation
  • Catheter compatibility
  • Guidewire flex testing
  • Guidewire fracture testing
  • Corrosion resistance
• Additional testing included:
  • ISO 10993 biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, and pyrogen)
  • Sterile package integrity testing (pouch seal tensile strength and dye penetration)

Acceptance Criteria and Reported Device Performance (as described for this physical device):

The document states: "The Concert Medical S-Wire Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device." However, the specific numerical acceptance criteria (e.g., "tensile strength must be > X N") and the actual measured results for these tests are not provided in this summary. The comparison is made against a predicate device, but again, the detailed comparative results are not present in this document beyond the general statement of "compared favorably."

In summary, assuming the request pertains to the kind of "device" described in the input and not an AI/ML diagnostic algorithm, the answer would be:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the document. The document states that "The Concert Medical S-Wire Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device," but does not list the specific numerical criteria or results for each test (e.g., tensile strength values, corrosion resistance levels).
2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. For physical device testing, the sample size for each specific engineering test would be determined by the testing protocol, but this is not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not a diagnostic device or a study involving human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical guidewire would be defined by engineering standards and material properties, against which the manufactured guidewire's performance is measured.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.

Integra® Jarit® Heparin Cannulas, Injectors, and Needles are manual, stainless steel catheter cannulas provided in various sizes, shapes, and lengths for use during cardiovascular surgical procedures such as coronary artery bypass surgery. The cannulas are intended to be connected to a syringe filled with heparinized saline to confirm there is no leakage as well as ensure patency of harvested and/or grafted veins. The syringes are not being supplied with the cannulas nor are the syringes offered by Integra; therefore they are not part of this submission. These reusable devices are packaged non-sterile and are steam sterilizable.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Integra® Jarit® Heparin Cannulas, Injectors, and Needles:

Context: The provided text is a 510(k) Summary for a medical device seeking substantial equivalence to predicate devices, not an AI/ML medical device. Therefore, many of the typical acceptance criteria and study components associated with AI devices (like ground truth, expert consensus, MRMC studies, training/test sets, etc.) are not applicable here. This document focuses on demonstrating physical and material properties, and reusability.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The tests conducted are typically on a sample of the devices designed to be representative of production, but the specific number is not disclosed in this summary.
• Data Provenance: The tests are controlled bench tests performed on the physical devices manufactured by Integra York PA, Inc. The data is prospective for the purpose of this submission; it's generated specifically to demonstrate compliance for the 510(k). Country of origin for data generation is not specified beyond "Integra York PA, Inc." (USA).

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

This question is not directly applicable to this type of device submission. The "ground truth" for these tests is established by recognized industry standards (e.g., AAMI, ASTM, ISO) and the scientific principles behind them (e.g., measuring protein residue, assessing material integrity, verifying sterilization efficacy). These standards themselves are developed by committees of experts, but specific individual experts are not cited for establishing the ground truth for this particular test of this device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human interpretation or consensus. The tests performed yield objective, measurable results (e.g., "Pass" or "Fail" based on whether predefined thresholds from the standards are met).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a manual surgical instrument, not an AI/ML-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a physical, manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used is defined by adherence to established national and international performance standards and test methods (e.g., ANSI/AAMI ST79, ASTM TIR 30, ISO 13402, ASTM F1089-02, ISO 7153-1). These standards specify acceptable levels for cleanliness, sterilization, corrosion resistance, and mechanical strength. In the case of biocompatibility, the ground truth is based on the recognized biocompatibility profiles of the specified stainless steel materials as per relevant material standards (ASTM F899-11 and ISO 7153-1) and their long history of safe use in medical devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

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 OriGen Reinforced Dual Lumen cannula is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

The OriGen Reinforced Dual Lumen catheter (RDLC) is the same design as the OriGen Dual Lumen Catheter (the predicate device), but with the addition of a wire reinforcement layer on the tip of the device. Both are dual lumen catheters with unequal lumen areas for drainage and reinfusion. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. Other characteristics of the catheter are the same.

This is not an AI/ML medical device. It is a dual-lumen catheter used for extracorporeal life support. Therefore, the questions related to AI/ML device studies are not applicable.

However, I can extract the acceptance criteria and the summary of the study performed for this device:

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

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

• Sample Size: Not explicitly stated. The document mentions "applicable tests were carried out," but does not specify the number of units tested for each in vitro test.
• Data Provenance: The tests were conducted "in accordance with the requirements of ISO 10993-1 and the FDA 1995 memorandum." These are non-clinical, in-vitro tests, not involving human data (retrospective or prospective).

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

• Not applicable. This is a medical device (catheter), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or other patient data. The "ground truth" for this device's performance is established by objective engineering and material science standards as per ISO 10993-1 and FDA guidelines.

4. Adjudication method for the test set:

• Not applicable. As this is not an AI/ML device assessing patient data, no adjudication method for a test set by human experts is relevant.

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/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For this device, the "ground truth" can be considered the established engineering and performance specifications and safety standards defined by ISO 10993-1 and FDA guidance for medical device biocompatibility, structural integrity, and functional performance (e.g., flow rates). These are objective, measurable criteria.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not applicable. This is a physical medical device, not an AI/ML model.

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The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor (Model 90217A) is a small, lightweight unit designed to take non-invasive blood pressure (NIBP) and heart rate (HR) measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Model 90217A allows the use of an automated or manual inflation system, and utilizes the oscillometric NIBP measurement method. The pressure sensor signal is amplified, digitized by an analog to digital converter (ADC), and supplied to a microprocessor which has control of the pump and vent valve. Measurements are made during the stepwise deflation of the cuff. The Model 90217A NIBP and HR algorithms are identical to that of the predicate. Additionally, the NIBP patient cuffs used with the Model 90217A are the same as those used with the predicate. A block diagram of the Model 90217A is presented in Figure 2.

The Model 90217A is powered by three (3) "AA" alkaline or rechargeable NiCad batteries; there is no capability to connect the Model 90217A to AC mains power. A lithium battery is used to provide backup power for the Model 90217A memory. Both battery types need to be periodically replaced.

The Model 90217A is carried in a pouch that is strapped and/or belted to the side of the patient. NIPB and HR measurements are taken using a blood pressure cuff attached to the patients arm. This information is recorded in the monitor, and can be transferred over a modem link, or by direct connection, between the Model 90217A and one of the ABP analysis systems.

The provided text describes the Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor and its 510(k) premarket notification. However, it does not contain the specific details required to fully address all components of your request, particularly regarding acceptance criteria, the study design (sample sizes, ground truth establishment, expert qualifications), or comparative effectiveness studies.

The document indicates that "Performance Testing" was conducted in accordance with applicable standards and that the device "complies with its predetermined specification." This implies that acceptance criteria were met, but the specific criteria and the detailed performance results are not provided in the summary.

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

1. Table of Acceptance Criteria and Reported Device Performance

Information Missing: The document states that performance testing was done and that the device "complies with its predetermined specification." However, it does not provide a table specifying the acceptance criteria (e.g., accuracy, precision targets) or the detailed reported device performance against these criteria.

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

Information Missing: The document states that "Performance Testing" was conducted, but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).

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

Information Missing: This device is a blood pressure monitor, and the ground truth for blood pressure measurements is typically established by another, often invasive or highly calibrated, measurement method, not usually by "experts" in the sense of image interpretation. The document does not specify how ground truth was established for performance testing, nor does it mention any experts involved in defining ground truth.

4. Adjudication Method for the Test Set

Information Missing: As there is no mention of "experts" or a consensus process for ground truth establishment for a blood pressure monitor, an adjudication method is not applicable and is not mentioned.

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

No: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices where human interpretation is a primary component. The device is an automated blood pressure monitor.

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

Yes (Implied): The device is an "Ambulatory Blood Pressure (ABP) Monitor" that "takes non-invasive blood pressure (NIBP) and heart rate (HR) measurements" and records them. It utilizes "oscillometric NIBP measurement method" and its "NIBP and HR algorithms are identical to that of the predicate." This description strongly suggests that the device operates in a standalone manner, with the algorithm performing the measurements without human intervention during the measurement process. The "Performance Testing" mentioned would assess this standalone performance.

7. Type of Ground Truth Used

Information Missing (Specifics): While not explicitly stated, for a non-invasive blood pressure measurement device, the implied ground truth for performance testing would typically be simultaneous measurements from a highly accurate reference standard, such as an intra-arterial blood pressure monitor or another highly validated non-invasive reference device. The document does not explicitly state the specific type of ground truth used.

8. Sample Size for the Training Set

Information Missing: The document states that the "NIBP and HR algorithms are identical to that of the predicate." This suggests that the algorithms themselves might not have undergone new "training" for this specific device, but rather are adopted from the predicate. If any new training was done, the sample size for the training set is not mentioned.

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

Information Missing: Given the statement that the algorithms are identical to the predicate, detailed information on how ground truth was established for the original training of those algorithms (if applicable) is not provided. If new training was performed for this device, then the method for establishing ground truth for the training set is not mentioned.

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The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for

Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures.

The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula.

The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.

The provided 510(k) summary for the Edwards Lifesciences Arterial Perfusion Cannula II does not contain the kind of detailed information about acceptance criteria, study design, expert ground truth, or statistical analyses that would typically be found in a submission for a device that uses AI or machine learning.

This submission is for a medical device that is a physical product (an arterial perfusion cannula), and its safety and efficacy are demonstrated through comparative analysis and functional/safety testing against a predicate device, not through studies involving AI or complex data analysis with expert consensus.

Therefore, I cannot extract the requested information as it is not present in the provided document.

Here's why and what kind of information is available instead:

• Acceptance Criteria & Device Performance: The document states that the "functional data indicate that the subject devices perform in a substantially equivalent manner when compared with the predicate device." This implies the acceptance criteria were met if the new device's functional performance was deemed equivalent to the predicate. Specific numerical targets or performance metrics are not provided, as this is a traditional medical device submission focused on physical characteristics and performance.
• Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Functional/Safety Testing" and "Comparative Analysis." These studies demonstrate that the new APC II cannulae are "comparable to the predicate devices in intended use, fundamental scientific technology, material type, principles of operation and functional performance evaluations."
• Points 2-9 (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, training set, etc.): These points are specific to studies involving algorithms, data analysis, and expert interpretation (common in AI/ML submissions). They are entirely absent because this submission is for a physical medical device. The "ground truth" for a physical device like a cannula would be its physical integrity, material properties, flow rates, pressure resistance, etc., which are assessed through engineering and bench testing, not expert consensus on interpretations of data.

In summary, the provided text describes a 510(k) submission for a physical medical device, not an AI/ML-powered device. Therefore, the questions related to AI/ML study design and ground truth are not applicable and cannot be answered from the given information.

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The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain information regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications. It only states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot fulfill your request for the specific information outlined.

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The KD-622 Fully Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches.

KD-622 Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, presented in the requested format:

The provided text for K030358, the KD-622 Fully Automatic Electronic Blood Pressure Monitor, is a 510(k) summary and FDA clearance letter. It primarily describes the device, its intended use, and claims substantial equivalence to a predicate device. While it mentions "Clinical Tests" and "accuracy requirements of ANSI/AAMISP10-1992", it does not provide detailed information about the acceptance criteria or the study methodology, sample sizes, expert qualifications, or ground truth establishment for that study.

Therefore, most of the requested information cannot be extracted directly from the provided text.

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 in the provided document.
• Data Provenance: Not specified in the provided document. The clinical tests were performed to comply with ANSI/AAMI SP10-1992. The submitter is a Chinese company, so the tests were likely conducted in China, but this is not explicitly stated. It is standard for these types of studies to be prospective, but this is not confirmed in the text.

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)

• Number of Experts: Not specified in the provided document.
• Qualifications of Experts: Not specified in the provided document. For blood pressure monitors, "experts" typically refers to trained observers following a standardized protocol (e.g., using a reference sphygmomanometer) as outlined by standards like ANSI/AAMI SP10.

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

• Adjudication Method: Not specified in the provided document. ANSI/AAMI SP10 typically involves a comparison against a reference method by independent observers, with predefined criteria for acceptable differences between readings.

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

• MRMC Comparative Effectiveness Study: Not applicable. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance Study: Yes, as the device is an automatic blood pressure monitor, its performance is considered standalone. The "Clinical Tests" mentioned assess its ability to accurately measure blood pressure on its own.

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

• Type of Ground Truth: The ground truth for blood pressure measurement studies typically involves simultaneous measurements by trained observers using a highly accurate, calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a standardized protocol as outlined in ANSI/AAMI SP10. The readings from the reference device are considered the "true" blood pressure against which the device under test is compared.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. As a traditional medical device (non-AI/ML), there isn't a "training set" in the machine learning sense. The device is based on established oscillometric principles and calibrated during manufacturing. The "clinical tests" are for validation, not training.

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

• Ground Truth for Training Set: Not applicable for the reasons stated above (non-AI/ML device).

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The CardiacAssist Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire.

The 21 Fr. Transseptal Cannula (Figure 1) allows for drainage of the left atrium during ventricular bypass. It has 14 side holes in addition to the tip opening for inflow at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Transseptal Cannula also includes a Suture Wing and 2 Suture Rings to provide a means for securing it to the patient.

The 13 Fr. Obturator (Figure 2) is used to advance the Cannula to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a luer hub and aspiration side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to facilitate final positioning of the Cannula. It also contains a radiopaque marker band proximal to the Cannula drainage holes when the Obturator is inserted in the Cannula.

The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.

The provided text describes a 510(k) submission for the "CardiacAssist-Transseptal Cannula Set". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the device performance data provided is primarily based on bench testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes bench testing rather than human clinical trials. Therefore, information about human "test sets" or "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable in the context of this 510(k) submission for bench testing. The "test set" would consist of multiple units of the manufactured device subjected to various engineering and materials tests. The document does not specify the exact number of units tested for each criterion, but it implies a sufficient number were tested to draw conclusions.

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

This is not applicable as the data presented is from bench testing, not from human studies requiring expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for these tests are objective measurements against established engineering specifications and international standards (e.g., ISO 10993-1).

4. Adjudication Method for the Test Set:

This is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts provide interpretations that need to be reconciled. Bench tests rely on objective measurements and established protocols.

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 is not applicable. The device is a physical medical instrument (a cannula set), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness is irrelevant to this submission.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the bench tests described:

• Functional Performance (Flow vs. Pressure Drop, Kink Radius): The ground truth would be established by comparing the device's performance against the predicate device (Elecath cannula) and/or predetermined engineering specifications. The statement "substantially better than that of the Elecath cannula" indicates the predicate's performance served as a baseline or "ground truth" for comparison.
• Mechanical Strength (Tensile Strength) and Integrity (Leak Testing): The ground truth would be predefined engineering design requirements and specifications.
• Biocompatibility: The ground truth is compliance with recognized international standards and FDA guidance documents (FDA Blue Book Memorandum #G95-1 and ISO 10993-1).

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical instrument, and the testing described is bench testing, not machine learning or AI where "training sets" are used.

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

This is not applicable for the same reasons as #8.

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The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.

The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter will be available in 8, 10 and 12 fr sizes. The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.

This document is a 510(k) summary for a medical device (Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray), which focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain the kind of information requested in your prompt (acceptance criteria, device performance metrics, study design, expert evaluation, etc.).

The information you are looking for is typically found in clinical studies, validation reports, or performance testing summaries, which are distinct from a 510(k) summary. A 510(k) summary primarily addresses the device's intended use, technological characteristics, and comparison to a predicate device to establish that it is as safe and effective.

Therefore, I cannot fulfill your request using the provided input because it does not contain the necessary details about acceptance criteria or a study proving device performance.

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