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The Arrow Antimicrobial Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

The Arrow Antimicrobial Pressure Injectable PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based antimicrobial technology.

The catheters will be packaged sterile in both nursing and radiology The canoters will be passfigurations will include components to facilitate insertion. .

The Arrow Antimicrobial Pressure Injectable PICC underwent extensive nonclinical (bench, in vitro, and in vivo animal) testing to demonstrate its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

2. Sample size and data provenance for the test set

The document does not explicitly state the exact sample sizes for each test in the provided "Summary of Verification Activities." However, it specifies confidence levels and LTPD (Lot Tolerance Percent Defective) for several tests, indicating sample-based testing.
For example:

• Air Leakage, Collapse Resistance, Liquid Leakage: "All catheters must pass to achieve a 5% LTPD with 95% confidence."
• Force at break: "There must be a 95% confidence level that 95% of the population meets the specification."
• Catheter Body Kink, Central Venous Pressure Monitoring: "This requirement shall be met with 95% assurance."
• Trim Tool: "With a sample size of n=60, zero failures are required to show a 95% confidence level and LTPD=5%."
• Luer Hub Slip/Lock: "with 95% confidence and a LTPD of 10%".
• Catheter Securement: "Demonstrate a 95% confidence level and LTPD=5%".

The data provenance is from nonclinical testing, including bench testing, in vitro testing, and in vivo animal infection studies. No specific country of origin is mentioned for the data, but the testing was performed by Arrow International, Inc. (a subsidiary of Teleflex Inc.) in the USA. These are laboratory studies, not clinical (human) studies.

3. Number of experts and qualifications for ground truth

Not applicable. This submission describes nonclinical "bench" and "in vitro/in vivo animal" testing. There is no mention of experts establishing ground truth for a test set in the context of human data or diagnoses. The "ground truth" for these tests comes from objective measurements and predefined engineering or biological criteria.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for human data (e.g., medical imaging) to establish ground truth. The tests described are objective nonclinical measurements.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No MRMC study was done. This is a 510(k) summary for a medical device (PICC catheter), focusing on nonclinical safety and performance, not diagnostic effectiveness with human readers.

6. Standalone (algorithm only without human-in-the-loop performance)

This is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable. The device's performance was evaluated inherently "standalone" in bench, in vitro, and in vivo animal tests against predefined criteria.

7. Type of ground truth used

The ground truth used for these nonclinical studies is based on:

• Objective physical measurements: Electrical resistance, force at break, optical density, flow rates, pressure measurements, mechanical integrity assessments (e.g., kink resistance, leakage).
• Standardized protocols and specifications: Adherence to ISO standards (ISO 10555-1, 10555-3), BS EN standards (BS EN 13868, BS EN 20594-1, BS EN 1707), JIS T standards (JIS T 3218), and FDA Guidance documents.
• Biological efficacy criteria: For antimicrobial tests, a "minimum 4 log reduction of adherent biomass (microbial colonization)" compared to initial inoculum concentration. This is a predefined microbiological efficacy threshold.

8. Sample size for the training set

Not applicable. This device is a physical product, not an AI/ML algorithm 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 a physical medical device.

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The Arrow ® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.

The Arrow Seldinger arterial catheterization devices are comprised of an introducer needle, a spring wire guide, and an arterial catheter assembly. The catheter assembly consists of a polyurethane arterial catheter molded to a winged catheter juncture hub. An extension tubing segment is molded to the proximal end of the winged catheter hub. The proximal end of the extension tubing segment is molded to a luer-locking hub. A slide clamp is provided on the extension segment.

The provided document is a 510(k) summary for the Arrow® Seldinger Arterial Catheterization Device. It does not describe an AI/ML medical device, but rather a traditional medical device (catheterization device). Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, ground truth establishment for training, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract the available information regarding the device's acceptance criteria and the study that supports it within the context of a traditional medical device submission.

Acceptance Criteria and Study for the Arrow® Seldinger Arterial Catheterization Device

Study Overview:
The study performed for the Arrow® Seldinger Arterial Catheterization Device was a series of in-house verification and validation tests to demonstrate the safety and efficacy of the device. The conclusion of this testing was to demonstrate substantial equivalence to a legally marketed predicate device, the Arrow Radial Artery Catheterization Set (K810675).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample sizes (number of units tested) for each of the performance tests.
• Data Provenance: The data is from in-house "Verification and validation testing." This suggests prospective testing conducted by the manufacturer, Arrow International, Inc., likely at their facilities in the USA.

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

• This is not applicable to this type of device and study. The "ground truth" for a physical device like a catheterization kit is established through engineering and quality control specifications, not expert interpretation of outputs like images. Performance is measured against predefined technical specifications.

4. Adjudication Method for the Test Set:

• This is not applicable as the tests are objective physical performance measurements against specifications, not subjective interpretations requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human reader performance is being evaluated with and without AI assistance. This device is a physical medical instrument.

6. Standalone (Algorithm Only) Performance:

• No, a standalone (algorithm only) performance study was not done. This device is not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance tests is based on engineering specifications and industry standards for similar medical devices. These specifications would dictate acceptable ranges for parameters like "needle penetration force," "leak rate," "tensile strength," etc. The comparison to the predicate device also forms a "ground truth" for equivalence in fundamental technology and expected performance.

8. Sample Size for the Training Set:

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

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

• This is not applicable as there is no training set for this type of medical device.

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Arrow Surgical Drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Arrow Surgical Drapes are sterile, disposable patient coverings for use in surgical procedures. They are composed of one or more of the following materials: Barrier, Absorbent, and Repellant materials. They may incorporate one or more fenestration openings for surgical site access and can also include medical grade patient fixation adhesive.

The provided document is a 510(k) summary for a surgical drape, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device through performance testing, rather than clinical studies involving humans or AI algorithms. Therefore, many of the requested categories are not applicable to the information contained within this 510(k) summary.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests. While it specifies the types of tests performed, it does not provide explicit numerical acceptance criteria for these tests nor does it report the specific numerical results obtained for the Arrow Surgical Drape. It broadly states that the results "demonstrate that Arrow's Surgical Drapes are safe, effective and perform favorably when compared to the predicate drapes."

| Performance Test | Acceptance Criteria | Reported Device Performance |
|-----------------------------------------------------------|------------------------------------------------------------|
| Resistance to Liquid Penetration (Synthetic Blood) | "perform favorably when compared to the predicate drapes" |
| Resistance to Liquid Penetration (Hydrostatic Pressure) | "perform favorably when compared to the predicate drapes" |
| Spray Impact | "perform favorably when compared to the predicate drapes" |
| Linting - Gelbo Flex Test | "perform favorably when compared to the predicate drapes" |
| Tear Resistance | "perform favorably when compared to the predicate drapes" |
| Puncture Penetration | "perform favorably when compared to the predicate drapes" |
| Tensile Grab | "perform favorably when compared to the predicate drapes" |
| Flammability | "perform favorably when compared to the predicate drapes" |

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

• Sample Size: The document does not specify the sample size for the "bench tests."
• Data Provenance: The tests are "bench tests" performed to demonstrate substantial equivalence against predicate devices. The country of origin of the data is not specified, but it would typically be conducted by or for the submitter (ARROW International, Inc. based in Reading, PA, USA). The study is non-clinical performance data, not a human study, so terms like "retrospective" or "prospective" are not applicable in this context.

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

• N/A. This is a physical product (surgical drape) and the evaluation is based on non-clinical performance testing (bench tests) against recognized standards (AAMI, ASTM, ISO, AATCC, CFR). There is no "ground truth" established by human experts in the context of diagnostic accuracy, as is typical for AI device evaluations.

4. Adjudication Method for the Test Set:

• N/A. As mentioned above, there are no human readers or expert consensus required for these physical and material property tests.

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

• No. This is not an AI device or a diagnostic imaging device. It's a surgical drape, and its effectiveness is determined through physical performance tests, not through human reader interpretation.

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

• N/A. This is not an algorithm or AI device.

7. Type of Ground Truth Used:

• The "ground truth" in this context refers to the defined standards and methodologies for evaluating physical and material properties (e.g., AAMI PB70, ASTM F 1670, ISO 9073-10). The performance of the device is measured against these established standards and then compared to the performance of predicate devices.
• The document explicitly states: "The results of the bench tests demonstrate that Arrow's Surgical Drapes are safe, effective and perform favorably when compared to the predicate drapes." This comparison to predicate devices acts as a form of "ground truth" for substantial equivalence.

8. Sample Size for the Training Set:

• N/A. This device does not involve machine learning or AI, so there is no training set.

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

• N/A. As there is no training set, this question is not applicable.

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The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.

The Arrow Echogenic Introducer Needle has the following characteristics:
Outside Diameter = 18Ga - 21Ga
Inside Diameter = 0.0240 - 0.042 in.
Usable lengths of 1 ½ - 2 ¾ in. (3.81 - 7cm)
Grit-blast echogenic surface treatment

Here's an analysis of the provided information regarding the Arrow Echogenic Introducer Needle, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) Summary, does not explicitly list quantitative acceptance criteria in a pass/fail format. Instead, it describes performance tests undertaken to demonstrate substantial equivalence to predicate devices. The and the reported device performance are generally stated as achieving "substantial equivalence."

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

The document does not specify the sample size used for the "Needle penetration test" or "Hub bond tensile strength test." It only mentions that these "tests were performed."

Furthermore, there is no information provided about the data provenance (e.g., country of origin, retrospective or prospective) as these are bench tests and not clinical studies.

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

This information is not applicable to the provided document. The studies performed are physical, bench-top performance tests of a medical device (needle penetration and hub bond tensile strength). These do not involve human interpretation or expert evaluation for establishing ground truth in the way, for example, a diagnostic imaging study would.

4. Adjudication Method for the Test Set

This information is not applicable. As mentioned above, the tests are physical performance tests, not studies requiring expert adjudication.

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 applicable. The device is an echogenic introducer needle, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study assessing human reader improvement with AI assistance would not be relevant.

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

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

7. The Type of Ground Truth Used

The ground truth for the "Needle penetration test" and "Hub bond tensile strength test" would have been established through objective, standardized measurements and criteria for defining "penetration" and "tensile strength" in a mechanical testing environment. These are typically based on engineering and material science principles, and reference standards for medical device testing. It is not based on expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of physical performance testing for a medical device like an introducer needle. Training sets are relevant for machine learning algorithms.

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

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

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The non-absorbable silk suture is intended for use in general soft tissue approximation, excluding use in cardiovascular, ophthalmic and neurological tissues.

The Arrow Non-Absorbable Silk Suture has the following characteristics: Black, braided silk suture thread of '000' (Metric 2) diameter, 30" (75 cm) suture thread length, Pre-attached, straight, stainless steel needle, 2-3/8" (60 mm) needle length

The provided document is a 510(k) summary for a Non-Absorbable Silk Suture. This type of device approval primarily relies on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies for a novel AI or diagnostic device. As such, many of the requested categories are not applicable or cannot be extracted from this specific document.

Here's an attempt to address the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, "performance tests" were conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the new device's performance is comparable to or "favorable" compared to the predicate devices in these tests.

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

The document does not specify the sample sizes for the tensile strength, needle attachment, suture diameter, or biocompatibility tests. It also does not mention what would typically be considered "test sets" in the context of AI or diagnostic device studies, nor does it refer to "data provenance" (country of origin, retrospective/prospective data). These are bench tests performed on the physical device.

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

This information is not applicable to a submission for a physical medical device like a suture, which relies on standardized bench testing and biocompatibility assessments, not expert-derived ground truth.

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

Not applicable. Bench tests do not involve expert adjudication in the same way as clinical or AI performance studies.

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 a physical medical device, not an AI or diagnostic tool designed to assist human readers.

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

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

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

For the performance tests, the "ground truth" is defined by the standards themselves (e.g., USP 29 and ISO 10993-1). The device's characteristics are measured against the specifications outlined in these standards and against the performance of predicate devices. For biocompatibility, it's about whether the material elicits an adverse biological response according to the ISO standard.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; there is no "training set."

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

Not applicable. There is no training set for this device.

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The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure

The Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy. The IABP provides temporary support to patients with impaired left ventricular function through the therapeutic method referred to as counterpulsation increases coronary and systemic profusion, decreasing after load (myocardial work) and decreasing preload.
The AutoCAT Series IABP System utilizes computer technology to select and maintain precise IAB inflation and deflation timing and triggering based on current physiological data from the patient. The system offers two modes of operation, the Autopilot mode, where functions are automatically selected and controlled by the IABP and the Operator mode where the user has control over settings and selections.

The provided documents are a 510(k) summary and FDA clearance letters for the Arrow AutoCAT Intra-Aortic Balloon Pump Series. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a novel AI/ML device.

However, based on the information provided, I can infer and reconstruct some aspects relevant to your request, especially regarding performance data and regulatory compliance.

Here's an analysis of the provided text in relation to your questions:

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

The document does not explicitly present a table of acceptance criteria and reported numerical device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that the device, with modified software, "meets all the same performance standards of the unmodified device." It then lists the regulatory and guidance documents it complies with, implying that performance is evaluated against these standards.

Inferred Acceptance Criteria / Performance:

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

The document does not provide specific details on the sample size for a test set (e.g., number of patients, number of cases) or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for studies involving clinical data, which is not the primary focus of this 510(k) summary for a software update to an established device. The assessment here is centered on the software modifications and adherence to engineering/safety standards rather than a new clinical trial with a "test set" of patient data in the AI/ML sense.

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 a 510(k) for an Intra-Aortic Balloon Pump software update, the "ground truth" concept as applied to AI/ML devices for diagnostic or interpretive tasks (e.g., imaging diagnosis) is not relevant here. The "ground truth" for IABP function would be physiological parameters and the device's ability to accurately sense and provide counterpulsation based on those parameters according to established medical principles. These are assessed through engineering tests and simulations rather than expert consensus on diagnostic images.

4. Adjudication method for the test set

Not applicable. There is no mention of an adjudication method, as it does not appear that a "test set" requiring expert adjudication (common in AI/ML diagnostic studies) was used. Testing would involve engineering verification and validation.

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-assisted diagnostic or interpretive device for human readers. It's an automated therapeutic device (an Intra-Aortic Balloon Pump) with software for controlling its operation. Therefore, an MRMC study is not relevant.

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

The device, an Intra-Aortic Balloon Pump, operates in both "Autopilot mode, where functions are automatically selected and controlled by the IABP" and "Operator mode where the user has control over settings and selections." While the Autopilot mode represents a form of "standalone" algorithm operation, the context is the device's performance of its therapeutic function, not an algorithm's diagnostic performance. The 510(k) submission assesses the safety and effectiveness of this standalone capability (Autopilot) as part of the overall device. The performance is assessed against engineering standards and comparison to predicate devices, not typically through metrics like sensitivity/specificity derived from a clinical dataset (unless a significant change warranted a new clinical study, which is not indicated here).

7. The type of ground truth used

For an IABP, the "ground truth" would be the actual physiological state of the patient (e.g., continuous arterial pressure waveforms, ECG signals) and the correct physiological response the device should generate (e.g., precise timing of balloon inflation/deflation relative to the cardiac cycle for optimal counterpulsation).

This "ground truth" is typically established through:

• Physiological models and simulations: Using calibrated simulators that mimic human cardiovascular dynamics.
• Animal studies: If novel physiological interactions are being investigated (less likely for a software update to an established device).
• Bench testing: Verifying that sensors accurately detect physiological signals and that the pump mechanism correctly inflates/deflates the balloon according to software commands.
• Clinical experience and medical consensus: The fundamental principles of counterpulsation and the desired physiological outcomes are well-established in cardiology.

The document implicitly refers to this type of ground truth by stating it meets "performance standards" and is "substantially equivalent" to predicate devices, which have already clinically demonstrated their ability to achieve these physiological goals.

8. The sample size for the training set

Not applicable. This is not an AI/ML device in the sense of requiring a "training set" of data for a machine learning model. The software update (V2.22) involves modifications to pre-set start-up settings, autopilot timing, calibration, signal switching, triggering, purge cycle, noise recognition, arrhythmia timing, alarm handling, and help text. These are likely based on engineering design, refinement, and bug fixes rather than a machine learning training paradigm.

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

Not applicable, as there is no "training set" in the AI/ML context for this type of software update. The "ground truth" for the software's logic and parameters would be derived from:

• Engineering specifications and requirements: Defining how the device should operate.
• Physiological data and models: Understanding cardiovascular mechanics and optimal counterpulsation strategies.
• Clinical feedback and empirical data: Data from previous device versions and clinical practice informing improvements and error correction.

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A Peripherally inserted Central Catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.

The Arrow International Peripherally Inserted Central Catheters are similar to the currently marketed Arrow Trimmable and Blue FlexTip® single and double lumen catheters. The catheter juncture has been modified to improve overall catheter strength. The hub colors and catheter labeling have changed to distinguish the new Arrow catheters. The catheter is available in lengths of 40 cm - 60 cm.

Here's an analysis of the provided information regarding the Arrow International Peripherally Inserted Central Catheters:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria (Stated or Implied)":
The document does not provide explicit numerical or qualitative acceptance criteria for these tests. Instead, it relies on the concept of "substantial equivalence" to predicate devices. This implies that the performance of the new device in these tests must be comparable to or not worse than the legally marketed predicate devices (Arrow International's Peripherally Inserted Central Catheter (K930129) and Two Lumen PICC with Blue FlexTip® Catheter with Integral Needle Protection (K003006)).

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

• Sample Size: Not specified in the provided document. The term "laboratory tests" is used, implying a controlled environment, but the number of devices tested for each performance characteristic is not detailed.
• Data Provenance: The data is generated from "laboratory tests" and is therefore likely prospective, as it was specifically conducted to demonstrate the safety and effectiveness of the new device for regulatory submission. The country of origin of the data is not explicitly stated, but given the submitter's location (Reading, PA, USA) and the submission to the FDA, it's highly probable the testing was conducted in the USA or by a facility adhering to US standards.

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

This section is not applicable to this type of device submission. The "ground truth" for the performance tests (tensile strength, flex, burst, fatigue, leakage) is established through standardized engineering and materials testing methods, not through expert consensus on medical images or clinical outcomes. These are objective physical tests with quantifiable results.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving subjective interpretation (e.g., image reading) to resolve discrepancies among multiple expert evaluations. The tests performed here are objective, mechanical evaluations.

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. These studies are typically relevant for diagnostic imaging devices where human readers interpret results, and the impact of AI algorithms on reader performance is being assessed. This submission is for a physical medical device (catheter) and focuses on engineering performance tests.

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

This section is not applicable. This device is a physical medical instrument, not a software algorithm or AI. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for these performance tests is based on objective measurement against established engineering and material science principles and comparison to the performance of predicate devices. For example, the "ground truth" for tensile strength is the maximum force a material can withstand before breaking, measured according to a standard test method. The comparison to predicate devices then establishes "substantial equivalence."

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of this device submission. Training sets are used for machine learning algorithms. The development of this medical device involves engineering design, material selection, and manufacturing processes, followed by performance testing, not algorithmic training.

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

This section is not applicable for the same reasons as point 8.

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The Arrow SharpsAway II™ Locking Disposal Cup is intended as a single use needle protection device, which covers the end of needles after use to minimize the risk of needle sticks. This device is designed for use with 15 Ga. to 30 Ga. needles for various clinical procedures.

The proposed SharpsAway II™ Locking Disposal Cup was created to help prevent needle sticks by providing a means of moving used sharps from procedure to sharps container.

The SharpsAway II™ Locking Disposal Cup is a device designed to prevent needle sticks by covering used sharps. The provided text outlines the performance tests conducted to demonstrate its substantial equivalence to a legally marketed predicate device (Devon Industries - Point-Lok® Needle Protection Device, K946289).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the performance tests were designed to demonstrate substantial equivalence to the predicate device. Therefore, the "reported device performance" is that the device met the requirements such that it was deemed substantially equivalent.

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

The provided text does not specify the sample sizes used for any of the performance tests (Simulated Use Study, Puncture Resistance, Gripping Mechanism Functionality Test, Water Leak). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

The provided text does not contain any information about experts used to establish a ground truth for the test set. The tests appear to be physical or mechanical performance tests rather than clinical studies requiring expert interpretation.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method. Given the nature of the performance tests (e.g., puncture resistance, water leak), it is unlikely that a human adjudication method like 2+1 or 3+1 would be applicable.

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

This device, the SharpsAway II™ Locking Disposal Cup, is a medical device for sharps disposal, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study comparing AI assistance with human readers was not done, and there is no mention of AI in the provided documentation.

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

As stated above, this device is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm-only performance study was not done.

7. The Type of Ground Truth Used

For a physical device like the SharpsAway II™ Locking Disposal Cup, "ground truth" would typically be established by:

• Engineering specifications and standards: For tests like Puncture Resistance, there would be predefined standards or internal specifications for resistance levels.
• Functional requirements: For tests like Simulated Use and Gripping Mechanism, the "ground truth" is whether the device successfully performs its intended function (e.g., locks a needle, grips effectively) under simulated use conditions.
• Physical properties: For the Water Leak test, the ground truth is simply the absence of a leak.

The document implicitly suggests that these tests were performed against such established criteria to determine if the device functioned as intended and was substantially equivalent to the predicate.

8. The Sample Size for the Training Set

This device is not an AI/ML product, so there is no concept of a training set in this context.

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

As there is no training set for this type of medical device, this question is not applicable.

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The Intra-Aortic Balloon (IAB) is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure

IAB's are designed to provide cardiac assist therapy. The devices are dual lumen percutaneously inserted Intra-Aortic IAB catheters, with two independent non-communicating lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. IABs are timed to inflate within the aota during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart, resulting in increased blood supply to the heart muscle and decreased work load for the left ventricle.

This appears to be a 510(k) summary for an Intra-Aortic Balloon (IAB) device. The document does not describe a study involving an AI component or a specific algorithm. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is common for medical device clearances that are not novel AI/ML devices.

Therefore, most of the requested information about acceptance criteria, study design, and AI performance metrics is not applicable to this document. The document primarily focuses on the device description, indications for use, and a list of predicate devices used to establish substantial equivalence.

Here's an attempt to answer the questions based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of the document:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics in the manner typically seen for AI/ML performance. The document implies the acceptance criterion is "substantial equivalence" to predicate devices based on technological characteristics and intended use.
   • Reported Device Performance: The document states, "The results of the laboratory tests demonstrate that the device is substantially equivalent." No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided, as this is not a study reporting on diagnostic or predictive output.

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

   • Not applicable/Not provided. The document refers to "laboratory tests" but does not detail the sample size or provenance of data used in those tests, as it's a submission for an IAB device, not an AI study.

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/Not provided. Ground truth establishment by experts is not relevant in this context, as it's about the physical and functional characteristics of an IAB device.

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

   • Not applicable/Not provided.

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, and no MRMC study is mentioned.

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 with standalone performance.

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

   • Not applicable. For a substantial equivalence claim for an IAB, ground truth would relate to its physical and functional specifications meeting design requirements and performance similar to predicate devices, rather than a diagnostic 'truth'.

8. The sample size for the training set

   • Not applicable/Not provided. There is no AI training set for this device.

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

   • Not applicable/Not provided.

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The HemoSonic™ 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability.

The probe jacket contains the acoustic gel into which the ultrasound crystals are placed. It consists of a plug rod, tip cap, hub, body, acoustic gel and tip.

This 510(k) submission describes a "Probe Jacket for the HemoSonic™ 200 Hemodynamic Monitor," which is an accessory to an existing hemodynamic monitor. Based on the provided information, the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance metrics against defined acceptance criteria for clinical diagnostic performance.

Therefore, many of the requested categories regarding clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness are not applicable or not explicitly detailed in this type of submission. This 510(k) is about a device component whose safety and effectiveness are established through physical and material property testing, rather than a diagnostic algorithm.

Here's the breakdown of what can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "Tests were performed to demonstrate substantial equivalence in the following areas: • tensile strength, • acoustic properties, • simulated insertion, and • biocompatibility." It doesn't list specific numerical acceptance criteria or performance values. The conclusion is that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices," implying successful meeting of internal criteria designed to show equivalence.

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

This information is not provided in the given 510(k) summary. The "tests" mentioned are laboratory tests, not clinical studies with patient data.

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

This information is not applicable/not provided. The ground truth for laboratory tests like tensile strength or acoustic properties is based on established engineering and materials science standards, not expert adjudication of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for clinical diagnostic studies where expert consensus on interpretations is needed. For mechanical and material properties, standardized test methods are followed.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a diagnostic device (often AI-assisted) on human reader performance, typically in interpreting medical images or data. The "Probe Jacket" is a physical accessory and not a diagnostic algorithm.

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

No, a standalone algorithm performance study was not done. This device is a physical accessory, not a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance tests (tensile strength, acoustic properties, simulated insertion, biocompatibility) would be based on engineering standards, material specifications, and established biocompatibility testing protocols. It is not clinical "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device does not involve a "training set" in the context of machine learning or AI algorithms. The "training" for such devices would involve manufacturing process controls and quality assurance, not data training.

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

This information is not applicable/not provided. As there is no training set in the AI sense, this question is not relevant to this device submission.

In summary: The K040802 submission for the "Probe Jacket for the HemoSonic™ 200 Hemodynamic Monitor" is a 510(k) for an accessory device. The evaluation of its safety and effectiveness relied on demonstrating substantial equivalence through laboratory tests of its physical and material properties, rather than clinical efficacy studies often associated with diagnostic devices or AI algorithms. Therefore, much of the requested information pertinent to clinical study design and AI validation is not applicable to this particular submission.

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