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The Vest APX System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, The Vest APX System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.

The Vest APX System may be used for the pediatric population (6 months and older) to geriatric population.

The Vest APX System is a high-frequency chest wall oscillation device designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest APX System consist of a control unit, hoses, and an inflatable garment. Oscillating positive pressure air pulses are applied to the garment by the control unit. The Blower provides the baseline pressure to the system. The user will input the different intensity from 1 -10 on the Graphical User Interface (GUI) and the blower will produce different static pressure based on speed. The air pulse generator (APG) provides the air pulsations (oscillations) based on the frequency input (ranging from 5 to 20 Hertz) provided by user via the GUI. The APG is driven by the Brushless Direct Current (BLDC) motor.

The resulting pressure pulses cause the garment to inflate and deflate against the chest of the patient, creating high-frequency chest wall oscillation and mobilization of bronchial secretions. This form of airway clearance therapy is referred to as high-frequency chest wall oscillation (HFCWO).

The provided text describes a 510(k) premarket notification for a medical device called "The Vest APX System." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, "The Vest Airway Clearance Systems." The basis for this determination is a comparison of technological characteristics and performance data.

However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative table format, details about a usability study beyond mentioning it, or information about sample size for test sets or training sets, ground truth establishment, or multi-reader multi-case studies as requested in the prompt. The "performance data" section only lists compliance with certain electromagnetic compatibility and safety standards, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, sample size for test sets or training sets, data provenance, number of experts, adjudication methods, details of MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The information primarily focuses on demonstrating substantial equivalence through similar intended use, indications for use, and technological characteristics, particularly through non-clinical testing.

Here's a summary of what is available regarding testing:

Nonclinical Tests Performed:

• Comparative pressure testing for the subject and predicate garments: This test would likely compare the pressure outputs or profiles generated by both the new device (The Vest APX System) and the predicate device (The Vest Airway Clearance Systems) when used with their respective garments. The goal would be to demonstrate similar functional performance in terms of pressure application for airway clearance.
• Usability testing per IEC 62366-1:2015 + A1:2020: This indicates that a usability study was conducted following international standards for medical device usability. The purpose is to evaluate if the device can be used safely and effectively by its intended users.
• Additional comparative pressure testing for the 16"-19" Child XS Garment with the subject and predicate devices: This specific comparative pressure test focuses on a particular garment size (Child XS) to ensure equivalent performance for this pediatric population.

Performance Data / Compliance:

The Vest APX System meets the following standards:

• IEC 60601-1-2 Edition 4.1 2020-09 (Electromagnetic Disturbances)
• ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (General requirements for basic safety and essential performance)
• IEC 60601-1-11 Edition 2.1 2020-07 (Requirements for medical electrical equipment in home healthcare environment)
• ISO 10993-1:2018 (Biological evaluation of medical devices - Biocompatibility)

What is NOT provided in the text:

• A specific table of acceptance criteria (e.g., minimum pressure output, maximum deviation, specific usability scores).
• Quantitative reported device performance to compare against acceptance criteria.
• Sample sizes for any of the tests (e.g., how many garments were tested for pressure, how many users in the usability study).
• Data provenance for any test data.
• Details on ground truth for any test (e.g., what was the "gold standard" for pressure measurements).
• Any information regarding experts involved in establishing ground truth or adjudication.
• Details about a multi-reader multi-case study (this device is a physical therapy device, not an AI diagnostic tool, so such a study would not be applicable).
• Standalone performance (again, not an AI diagnostic tool).
• Information on training sets, as this is not a machine learning or AI device.

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The Baxter AK 98 dialysis machine is intended to be used for intermittant haemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or Home use.

The U9000 Ultrafilter is indication of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Ultrafilter is intended to be used in conjunction with a water treatment system.

C-705 Accessory Expansion Chamber is a single use sterile medical device intended to be used during the delivery of Hemodialysis treatment in Single Needle mode, on patients affected by chronic renal failure. The C-705 Accessory Expansion Chamber is an ancillary device used to allow the conversion from Double Needle to Single Needle administration mode of treatments, after connection to proper Blood Tubing System intended for Haemodialysis treatment in Double Needle mode and to a Dialyzer filter. C-705 Accessory Expansion Chamber shall be used in combination with Blood Tubing System suitable for AK 98 haemodialysis delivery system only. The total extracorporeal blood volume for the extracorporeal circuit including the set, dialyzer and accessories should represent less than 10% of the patient's blood volume.

The proposed device AK 98 Hemodialysis system, which is subject for this Traditional 510(k) premarket notification, consists of the following:

• AK 98 dialysis machine
• U9000 (Ultrafilter)
• C-705 (Accessory Expansion chamber)

AK 98 is a standalone, software controlled hemodialysis machine intended to be used in a chronic care dialysis or hospital care environment for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload.

The Ultrafilter product family (U9000, and its predicate device Diaclear) are ultrafilters intended for water filtration (removal of pyrogens and microorganisms), and filtration of dialysis fluid.

The C-705 Accessory Expansion Chamber is a single use sterile medical device for hemodialysis intended to be connected to compatible bloodlines for hemodialysis that allow the channeling of blood from the body through its circuits into another device that carries out the hemodialysis effect of the treatment.

This document is an FDA 510(k) premarket notification for a medical device. It does not describe an AI medical device or a study involving human experts to establish ground truth or assess AI performance. Instead, it details the substantial equivalence of new hemodialysis equipment (AK 98 Dialysis Machine, U9000 Ultrafilter, and C-705 Accessory Expansion Chamber) to previously cleared predicate devices.

Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria, involving items like sample size, expert adjudication, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from this document because it pertains to conventional medical devices, not AI/ML-based ones.

The document primarily focuses on:

• Device Identification and Intended Use: Clearly defines what the devices are and what they are used for.
• Predicate Device Comparison: Detailed tables (Table 3, Table 4, Table 5) compare the features, specifications, and performance of the proposed devices to their respective predicate devices. This is the core of a 510(k) submission, demonstrating "substantial equivalence."
• Nonclinical Testing: Summarizes the performance testing conducted to confirm the functional performance, electrical safety, electromagnetic compatibility, risk assessment, and biocompatibility of the devices, all in accordance with relevant FDA guidance and international standards (e.g., IEC 60601 series, ISO 10993-1).

No information related to AI/ML acceptance criteria, expert adjudication, or MRMC studies is present.

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The EASYGRIP FLO-41 Precision MIS Delivery System is indicated for delivering compatible hemostatic agents to bleeding sites through a 5 mm or larger trocar.

The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a sterile, single-use device that consists of two components: (1) one applicator device with a 41 cm long cannula (5 mm outer diameter) and (2) one empty 1.5 mL syringe.

The EASYGRIP FLO-41 System is used to deliver compatible hemostatic agents to bleeding sites. After preparation of compatible hemostatic agent per the instructions, the proposed device is filled by first attaching the compatible hemostatic agent syringe to the syringe port by a Luer lock connection and depressing the syringe plunger, which then fills the enclosed 5 mL reservoir syringe with the hemostatic matrix. The delivery of hemostatic agent to the bleeding site would be performed by actuating the device trigger handle, which can be performed using one hand. As an optional step, if application of the residual hemostatic agent that remains within the cannula is needed, an empty, disposable 1.5 mL syringe is provided and would be filled with non-heparinized saline. Following the same steps as with the hemostatic agent, the reservoir syringe would be filled with 1.5 mL of saline and the residual hemostatic agent would be expelled from the cannula by actuating the device trigger handle.

The provided document describes the acceptance criteria and a summary of the performance study for the EASYGRIP FLO-41 Precision MIS Delivery System. The study primarily focuses on bench tests to demonstrate the functional performance and biocompatibility of the device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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