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The intended use of the Simplicity StarPlus Soft Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

Device Description

Sterling Medivations, Inc.'s ("SMI") Simplicity ™ StarPlus Soft Infusion Set is designed for use by people with diabetes to infuse insulin subcutaneously from a pump or syringe. The device consists of four main parts: (1) an infusion catheter made from polytetrafluorthylene (PTFE), (2) an infission hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a comecting tube and (4) a female Luer connector. The Simplicity StarPlus Soft Infusion Set is an infusion administration set, connecting to a pump or syringe and inserted in the subcutaneous tissue of a patient. The Sterling Medivations Simplicity StarPlus Soft Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the pump or syringe by means of a female Luer connector, and subcutaneously in the patient through an indwelling catheter made of polytetrafluorthylene (PTFE). The connecting tubing is made from a polyethylene tube. The 25 gauge-indwelling PTFE catheter is introduced into the subcutaneous tissue using an insertion needle. The insertion needle is removed and a connector housing is attached to the indwelling catheter. This connector needle part of the connector hub pierces a septum formits the infusion of medication without leakage. The connector needle is connected to the connector housing. The connector housing. The connector tubing proximal end is attached to a female Luer connector for attachment to the medicine reservoir. The connecting tube is solvent bonded to the connector housing and to the Luer connector. The quick disconnect allows the patient to temporally disconnect the pump reservoir from the indwelling catheter to better facilitate bathing and reservoir changes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Simplicity StarPlus Soft Infusion Set." This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the context of diagnostic accuracy or clinical effectiveness. Therefore, many of the requested categories for a diagnostic device study are not applicable or cannot be extracted from this documentation.

Here's a breakdown of the available information based on your request, with an emphasis on what can and cannot be provided from this particular document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be typical for a diagnostic device. Instead, the "acceptance criteria" are compliance with various standards for medical device manufacturing, materials, and sterilization, and the "reported device performance" is the statement that the device meets these standards, thus supporting substantial equivalence.

Acceptance Criteria Category	Specific Standard/Requirement Met	Reported Device Performance
Intravascular Administration Set Requirements	CDRH 21 C.F.R. section 880.54400 Intravascular administration set	Meets requirements
Sterile, Single-Use Intravascular Catheters	ISO 10555 (Part 1: General Requirements)	Meets requirements
	ISO 10555 (Part 5: Peripheral catheters)	Meets requirements
Stainless Steel Needle Tubing	ISO 9626 Stainless steel needle tubing for the manufacture of medical devices	Meets requirements
Ethylene Oxide Sterilization	ISO 11135: 1994 Medical devices -- Validation and routine control of ethylene oxide sterilization	Meets requirements
	ISO 11138-2: 1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization	Meets requirements
Conical Fittings (Luer Taper)	ISO 594-1: 1986 Conical fittings with a 6%) (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements	Meets requirements
	ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings	Meets requirements
Packaging for Sterilized Medical Devices	ISO 11607: 1997 Packaging for terminally sterilized medical devices	Meets requirements
Sterile Single Use Syringes for Insulin	ISO 8537: 1991 Sterile single use syringes, with or without needle for insulin	Meets requirements
Endotoxin Test	FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. ODE Blue Book Memorandum #K90-1.	Meets requirements
Design Control	Center of Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS (FDA 21 CGR 820.30 and Sub-clause 4.4 of ISO 9001)	Adhered to

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

This document does not describe a "test set" in the context of clinical or performance data involving patient samples. The "performance data" refers to the device meeting the specified engineering, material, and sterilization standards. Therefore, information on sample size and data provenance for a "test set" is not applicable here.

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

This information is not applicable. No ground truth establishment by experts for a clinical "test set" is described.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable. No adjudication method for a clinical "test set" is described.

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 infusion set, not a diagnostic AI tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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 infusion set, not an algorithm, so standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable. For this type of submission, "ground truth" relates to the device specifications and documented compliance with recognized standards, not clinical outcomes or diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms, which this device is not.

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

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

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