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The Concert Medical Hands-Free Syringe (HFS) is indicated for general fluid irrigation/infiltration.

The Concert Medical Hands-Free Syringe (HFS) is an infiltration pump used to infuse fluids (such as regional anesthetics) into the body. The HFS consists of a sterile, single-use plastic syringe (20 mL capacity) fitted with a custom plunger, a reusable motor housing, and a reusable foot pedal. The user fills the syringe with the fluid of choice, then locks the filled syringe into the motor housing, where the specially designed syringe plunger rack mates with the custom plunger housing gear. The male luer fitting of a sterile, single-use needle set (not supplied by Concert Medical) is attached to the standard female luer fitting on the HFS syringe. The foot pedal connector is plugged into the receptacle on the motor housing, then the foot pedal is placed in a convenient location on the floor. The motor housing contains non-replaceable AAA batteries, which power a small DC motor which in turn controls the movement of the syringe plunger. The foot pedal consists of a color-coded rubber bar; when the user applies light foot pressure to the appropriate half of the foot pedal (green = infuse; yellow = aspirate), the motor activates the plunger movement mechanism to move the plunger forward (infuse) or backward (aspirate). The motor control is designed to deliver fluid at a maximum flow rate of 0.5 mL/sec. The motor is designed with an overpressure safety feature, which causes the plunger movement to stop if the pressure in the syringe exceeds 15 psi regardless of whether the "infuse" portion of the foot pedal is depressed. The motor housing has three LED indicator lights for real-time display of the syringe plunger action: a green light illuminates when the syringe is infusing, a yellow light illuminates when the syringe is aspirating, and a red light illuminates if the plunger movement has stopped because the 15 psi pressure limit has been reached. The foot pedal control provides the user with two-handed control of the needle placement without the need for a second person to manipulate the syringe plunger for infusion or aspiration.

Here's an analysis of the acceptance criteria and study information for the Concert Medical Hands-Free Syringe (HFS) based on the provided document:

This document does not describe an AI/ML device, therefore many of the requested fields (multi-reader multi-case study, standalone performance, training set details, ground truth for training) are not applicable. The device is a physical medical device (an infiltration pump).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table with specific acceptance criteria values alongside their corresponding reported performance values for each test. Instead, it offers a general statement that the device "met pre-determined acceptance criteria."

However, we can infer some criteria and performance from the "Device Description" and "Non-Clinical Performance Testing" sections:

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

The document does not specify the sample size for the non-clinical performance testing. It also does not mention data provenance in terms of country of origin or whether the study was retrospective or prospective, as these are typically considerations for clinical data, which is not described here.

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

This question is not applicable as the "test set" here refers to physical performance testing of a medical device, not a diagnostic or AI/ML algorithm requiring expert-established ground truth from data. No experts were involved in establishing "ground truth" for pressure, flow rate, or electrical safety tests.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Adjudication methods are typically used for reconciling disagreements among human readers or for establishing consensus ground truth in studies involving human interpretation, not for physical device performance tests.

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. This type of study is relevant for AI/ML diagnostic tools that impact human reader performance. The Concert Medical HFS is a physical medical device (an infiltration pump), not a diagnostic algorithm.

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

No, a standalone study was not done. This concept applies to AI/ML algorithms, not physical devices. The device's performance is inherently linked to its physical operation, which is what was tested.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" would be established by:

• Measurement against objective physical standards: For flow rate, pressure, and electrical safety, the "ground truth" is derived from direct measurements using calibrated instruments and comparison to predefined engineering specifications and regulatory limits (e.g., 15 psi pressure limit, 0.5 mL/sec flow rate).
• Functional verification: For foot pedal and syringe plunger control, the "ground truth" is simply whether the device functions as designed (e.g., foot pedal depression leads to infusion/aspiration).

8. The Sample Size for the Training Set

This question is not applicable. The Concert Medical Hands-Free Syringe is a physical device, not an AI/ML system. Therefore, there is no "training set" in the context of machine learning.

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

This question is not applicable for the same reason as point 8.

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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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For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.

The Concert Medical Conductor coronary guidewire consists of a flexible wire that is available with silicone or hydrophilic coating. The wire is intended to guide the placement of intravasculable will with compatible lumens during PTCA or other therapeutic or diagnostic procedures.

The provided text is a 510(k) Premarket Notification for a coronary guidewire, which is a medical device. It does not contain information about an AI/ML device or a study proving its performance against specific acceptance criteria in the context of AI/ML.

Therefore, many of the requested fields cannot be filled.

However, I can extract information related to the device's performance testing in a general sense:

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

The study that proves the device meets the acceptance criteria:

The study proving the device meets its acceptance criteria is a series of "Performance Testing" and "Biocompatibility Testing" as described in the 510(k) summary. These are bench tests and material compatibility tests, not clinical studies involving human patients or AI/ML evaluation.

Regarding the specific AI/ML related questions, the information is NOT available in the provided text:

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, as this is not an AI/ML device study. The performance testing refers to bench tests and biocompatibility tests.
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. "Ground truth" in the context of expert consensus is for diagnostic AI/ML devices. This device is a physical guidewire validated through engineering and biocompatibility tests.
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): The "ground truth" for this device's performance would be the objective measurements from bench testing (e.g., tensile strength, torque transmission, guidewire trackability) and the results of biocompatibility assessments against established standards.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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