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The AVF sets are intended to be used for intravenous injection and connection with dialysis blood lines to transport blood from the artery of the patient to the dialyzer and transport blood after dialysis to the vein of the patient.

Device Description

Arterial Venous Fistula Needles are described in blood access device and accessories (nonimplanted) 21 CFR 876.5540 The Disposable Arterial Venous Fistula Needles that we intend to market include 1 type of design: fixed wing. It is offered with or without a clamp. The device consists of a winged needle (14 - 17 gauge) connected to polyvinylchoride AVF tubing which is connected to a AVF luer connector. Needles with a hole (back eye type) and without a hole are available as well and are both 1 inch and 1¼ inches in length. Tubing is available in lengths of 300 mm. The materials used for the components include: polyvinylchloride (PVC), stainless steel (SS), polyoxymethylene (POM), polycarbonate (PC) and polypropylene (PP).

AI/ML Overview

The provided text is a 510(k) summary for the Nipro Arterial Venous Fistula Needle. This type of document is for a medical device cleared by the FDA through the substantial equivalence pathway, not an AI/ML powered device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable and will not be found in this document.

The document describes the device, its intended use, and states that it is substantially equivalent to a legally marketed predicate device (K955182). Substantial equivalence means that the device is as safe and effective as the predicate device.

To answer your request, I must state that the document does not contain the information you are looking for regarding acceptance criteria and studies in the context of AI/ML devices.

Here's a breakdown of why each specific point you asked for cannot be answered from this text:

A table of acceptance criteria and the reported device performance: This document asserts substantial equivalence based on technical characteristics being "identical" to a predicate device. It does not set forth specific performance acceptance criteria or report performance data.
Sample sized used for the test set and the data provenance: Not applicable. This is a medical device, not an AI algorithm evaluated with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a traditional medical device and its 510(k) clearance, which is a regulatory pathway demonstrating equivalence to another marketed device. It does not involve the type of performance studies or validation processes used for AI/ML based devices, which would include the metrics you listed.

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K Number

K954676

Device Name

NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS

Manufacturer

NISSHO CORP.

Date Cleared

1997-03-04

(511 days)

Product Code

KOC

Regulation Number

876.5820

Type

Traditional

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Intended Use

The blood tubing sets are used to transport blood or fluids to a patient's vascular access device from a hemodialyzer. The reverse is also true in that the tubing set is used as to transport blood or fluids from a patient's vascular access device to a hemodialyzer.

Device Description

The tubing sets that we intend to market include arterial and venous dialysis blood tubing (nonimplanted blood access device) as described in 21 CFR 876.5540. Various models of blood tubing sets are being manufactured for application with different dialysis machines. Twenty-seven arterial line models (A001 - A021, A026, A029-A032, and A035) and 14 venous line models are described (V600 -V607, V609 - V613, and V616). All components of blood tubing, including drip chambers, infusion tubing, monitor lines, ports and segments which are used to pump blood, retain and capture air and blood debris, infuse medications or fluids, sample blood, monitor pressure, and make connections to other devices are included. The materials used for the components include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polycarbonate (PC) and polyethylene high density (PEHD).

AI/ML Overview

This document describes the safety and effectiveness of the Nipro branded disposable blood tubing set for hemodialysis, asserting its substantial equivalence to legally marketed predicate devices. The information provided heavily focuses on performance and biocompatibility testing comparing the Nipro device to existing products (Kawasumi and gambro® blood tubing sets).

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Performance Tests
Priming Volume Test	Within acceptable range (compared to predicate devices)	Observations found to be within acceptable range and test results were similar to values obtained for Kawasumi and gambro® blood tubing sets.
Pull Force at Connecting Joints	Specification not explicitly defined beyond "after disengagement of the test tubing..."	The subject and the legally marketed devices conformed to "the specification," but the numerical value of that specification isn't explicitly stated here, only that the disengagement result is recorded. It implies similarity to predicate devices.
Torque Force	Not explicitly defined	No explicit performance data given, only that it was measured. Implies similarity to predicate devices.
Endurance Test of the Pump Segment	±10% variance from nominal values mean of outer diameter of the pump segment	The subject and the legally marketed devices conformed to this specification.
Air Leakage above Atmospheric Pressure	Leaks should occur at pressures > 2.0 kgf/cm² G	Results were similar to those obtained with legally marketed devices. Leaks occurred at pressures more than 2.0 kgf/cm² G. No clogging was noted.
Air Leakage below Atmospheric Pressure	No air bubbles in the pathway	No air bubbles occurred in samples tested and results were similar in legally marketed devices for comparison.
Biocompatibility Tests
Pyrogenicity	Nonpyrogenic	Results indicate that the blood tubing sets conform to the specifications set forth. Predicate devices for comparison show similar results when tested using these methods.
Cytotoxicity (Elution Test)	No biological reactivity	Results indication conformity and similarity to predicate devices.
Acute Toxicity (systemic injection)	No biological reactivity/death	Results indication conformity and similarity to predicate devices.
Intracutaneous reactivity	No erythema, edema, or necrosis	Results indication conformity and similarity to predicate devices.
Sensitization	Not a sensitizer	Results indication conformity and similarity to predicate devices.
Hemolysis	Not to exceed 10%	Results indication conformity and similarity to predicate devices.
Ames Mutagenicity	Not mutagenic	Results indication conformity and similarity to predicate devices.
Implantation	No hemorrhage, film, or encapsulation	Results indication conformity and similarity to predicate devices.

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

The document does not explicitly state the numerical sample size for the test set or the provenance of the data (e.g., country of origin, retrospective/prospective). It only mentions "samples tested" and "subject device" implying that a certain number of the Nipro blood tubing sets were tested alongside the predicate devices. The study appears to be a benchtop (in-vitro) and laboratory animal study for performance and biocompatibility, respectively, rather than a clinical trial with human subjects.

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

Not applicable. This is not a study assessing an AI device where "ground truth" would be established by human experts in a clinical context. The "ground truth" for these tests are objective measurements and established biological assays with pre-defined specifications.

4. Adjudication Method for the Test Set

Not applicable. As this is not a study involving human interpretation of data for "ground truth," no adjudication method is relevant. The tests performed are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document describes the testing of a physical medical device (blood tubing set), not an AI algorithm for diagnostic or prognostic purposes. Therefore, an MRMC study is not relevant.

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

No. This document is not about an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests are objective measurements (e.g., volume, force, diameter, pressure, presence/absence of bubbles) and established biological assay results (e.g., pyrogenicity, cytotoxicity, hemolysis) against pre-defined specifications or in comparison to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm, so there is no "training set."

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant.