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The Easycess Aspiration Pump is intended for general suction use in hospitals or clinics.

The Easycess Aspiration Pump is mainly composed of negative pressure suction pump host and Easycess Canister(Model: DC1000). The Easycess Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Aspiration Pump operates using AC power and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 29 inHg. The pump is available in 110V and 220Vac versions. The pump is used with the available 1000ml canister / tubing set. The Easycess Aspiration Pump is provided in non-sterile; it is reusable and should be managed as a prescription device. The Easycess Canister is for single use only.

The Easycess Aspiration Pump is a medical device intended for general suction use in hospitals or clinics. The study provided in the document focuses on bench testing to demonstrate its substantial equivalence to a predicate device, the Penumbra Pump MAX (K122756).

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes bench testing, which typically does not involve patient data. The tests were performed on the Easycess Aspiration Pump itself to verify its physical and mechanical performance. Therefore, there is no specific "sample size" of patient data for a test set in the traditional sense, nor data provenance related to country of origin or retrospective/prospective collection as one would find in clinical studies.

The testing was conducted according to the FDA special control guidance document: Guidance Document for Powered Suction Pump 510(k)s, and the ISO 10079-1:2022 Medical suction equipment - Part 1: Electrically powered suction equipment.

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

There is no mention of experts or their qualifications being used to establish a ground truth. Since this was bench testing of a hardware device's performance characteristics, the "ground truth" was the objective measurement of the device against established engineering and safety standards (e.g., ISO, IEC, FDA guidance).

4. Adjudication Method for the Test Set

As there were no human readers or interpretations involved in establishing a ground truth for a test set (it was objective bench testing), there was no adjudication method applied.

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

No, an MRMC comparative effectiveness study was not done. The study presented here is focused on the device's adherence to technical standards and its substantial equivalence based on bench testing.

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

The Easycess Aspiration Pump is a hardware medical device; it is not an algorithm-based device or an AI system. Therefore, the concept of a "standalone" algorithm performance study is not applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the bench testing was established by objective engineering specifications, regulatory standards (ISO 10079-1:2022, IEC 60601-1, IEC 60601-1-2), and FDA guidance documents for powered suction pumps. These are physical and mechanical performance metrics rather than clinical outcomes or expert interpretations.

8. The Sample Size for the Training Set

As this is a hardware medical device and not an AI/ML algorithm, there is no concept of a "training set" for an algorithm.

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

Again, since there is no training set, this question is not applicable.

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The Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.

The Distal Access Catheter consists of a catheter and accessories (hemostatic valve, introducer sheath, and a shaping mandrel). The catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steamshapeable, and a hydrophilic coating is applied for navigation of the catheter through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.

The catheter body is constructed with a stainless-steel coil (less 2 cm of the catheter length) over the inner lumen liner comprised of polytetrafluoroethylene (PTFE). To provide additional shaft support, a stainless-steel wire braiding has been added over the stainless-steel coil from the proximal end to distal end. A platinum/iridium alloy radiopaque marker band is located at the distal tip of the catheter. An outer layer of varying durometers and lengths of polyamide (PA), polyether block amide (Pebax) and polyurethane (PU) covers the entire catheter body from proximal to distal end, respectively.

A hub (PC) is attached to the proximal end of the catheter. A strain relief made from polyether block amide (Pebax) is placed at the proximal end of the catheter and distal end of the hub. The hub-strain relief provides for the kink resistance for the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories.

The outer surface of the catheter (distal 60 cm) is coated with a hydrophilic coating to reduce friction during navigation in the vasculature.

A shaping mandrel (stainless steel, 80 mm in length) is provided with the catheter to be used by the physician for tip shaping. An introducer sheath (PTFE) is included to facilitate the introduction of the catheter into guide catheters during clinical use. A hemostatic valve is used to connect to the proximal section of the catheter.

The Distal Access Catheter is provided sterile and for single use only. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (HDPE) that is provided in a sterile barrier PET/PE film and Tyvek pouch and placed in a carton box.

This document describes the regulatory clearance for a medical device called a "Distal Access Catheter," not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, expert ground truth, MRMC studies, and human-in-the-loop performance, are not applicable.

The acceptance criteria and the study that proves the device meets them are based on bench testing (physical and mechanical properties) and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device met its acceptance criteria through a series of bench tests and biocompatibility evaluations.

Bench Test Study:

• Study Design: The bench testing of the Distal Access Catheter was performed using the applicable sections of the ISO 10555-1 international standard for sterile, single-use intravascular catheters. This standard specifies requirements for sterile, single-use intravascular catheters. The tests covered various physical and mechanical properties crucial for safe and effective device function.
• Methodology: The document lists 24 distinct bench tests (e.g., Surface Inspection, Dimensional Verification, Corrosion Resistance, Peak Tensile Force, Fluid Leakage, Kink Resistance, Simulated Use, Dynamic Burst, Flow Rate, etc.). Each test had specific acceptance criteria derived from the ISO standard or established engineering specifications for the device. The results consistently concluded that the device was "suitable for intended clinical use," "met requirements," or was "equivalent to the predicate device."
• Conclusion: The bench testing demonstrated that "the in vitro behavior of the device is well characterized within design specifications."

Biocompatibility Study:

• Study Design: The biocompatibility evaluation was conducted in accordance with FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."
• Methodology: The biological tests were conducted in compliance with the Good Laboratory Practice (GLP) Regulation 21 CFR 58. These tests included Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolytic Properties, Partial Thromboplastin Time (PTT), In Vivo Thrombogenicity, Pyrogen, and Complement Activity tests. Each test had specific criteria for acceptable biological response. The conclusions for these tests consistently indicated that the device was non-cytotoxic, non-sensitizing, non-irritant, non-systemically toxic, had no effect on hemolytic properties or PTT, was equivalent to control/predicate for thrombogenicity and complement activity, and was non-pyrogenic.
• Conclusion: The biocompatibility testing confirmed the device material safety for its intended biological contact.

The following information is not applicable (N/A) as this is a traditional medical device (catheter) and not an AI/ML powered device.

2. Sample size used for the test set and the data provenance: N/A (for AI/ML test sets). These are physical and biological tests, not data-driven evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (for AI/ML expert annotation). Ground truth for physical/biological tests is based on objective measurements against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (for AI/ML 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: N/A (not an AI-assisted device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI algorithm).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" or acceptance standard is derived from established international medical device standards (e.g., ISO 10555-1, ISO 80369-7, ISO 10993 series, USP ) and internal design specifications, verified through objective bench and biological testing.
8. The sample size for the training set: N/A (not an AI/ML device; no training set in this context).
9. How the ground truth for the training set was established: N/A (not an AI/ML device).

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