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The Instylla Delivery Kit is intended to be used for the intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link).

The Instylla Delivery Kit with modified packaging is a sterile, single patient use device intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions. The device consists of a double-barreled syringe holder which holds and couples two (2) commercially available needleless syringes with calibrated hollow barrels and movable plungers. A single plunger clip is attached to both syringe plungers to facilitate the simultaneous injection of two distinct fluids when depressed.

The syringes of the Instylla Delivery Kit are composed of polycarbonate. The plunger clip and holder are composed of Acrylonitrile Butadiene Styrene (ABS).

I am sorry, but the provided text does not contain the detailed information needed to construct the complete response regarding acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter and summary for a delivery kit, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with specific acceptance criteria and detailed study parameters as requested.

While the document mentions "Performance testing... met the predetermined acceptance criteria," it does not explicitly list these criteria in a table or describe the study in the comprehensive manner you've outlined (e.g., sample size, data provenance, expert details, adjudication, MRMC studies, standalone performance details, ground truth specifics, training set details).

Based on the available text, I can only provide the following:

Device: Instylla Delivery Kit

Regulatory Class: Class II

Product Code: FMF (Piston Syringe)

Intended Use: For the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

Performance Data Summary (from the text):

• Performance testing of the final, sterilized Instylla Delivery Kit with modified packaging included bench testing and functional testing.
• Tests Conducted:
  • Syringe Force Performance
  • Fluids Compatibility
  • Delivery Integrity
• Outcome: "The Instylla Delivery Kit with modified packaging met the predetermined acceptance criteria ensuring substantial equivalence to the predicate devices. No new safety or performance issues were raised during testing."
• Standards Compliance: The syringes are compliant with FDA recognized standards ISO 7886-1 and ISO 594-2.
• Biocompatibility: Evaluation conducted per FDA Guidance Document Use of International Standard ISO 10993-1. No new testing was performed on the subject device as contact materials and manufacturing processes were identical to predicate devices.
• Sterility: Sterilized via validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10^-6, per ISO 11135. EO and ECH levels acceptable per ISO 10993-7. Bacterial endotoxin test (BET) validated for

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The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link).

The provided document describes the Instylla Delivery Kit (K202544), which is a medical device intended for the administration of radiographic contrast media, saline, and other aqueous solutions. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device (K191659). This particular submission focuses on a modified version of the Instylla Delivery Kit with 3mL syringes, whereas the predicate device used 1mL syringes.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not provide a formal table of specific, quantitative acceptance criteria. Instead, it states that "The Instylla Delivery Kit with 3mL syringes met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device."

Here's a summary of the performance tests conducted and the general outcome:

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for the bench and functional testing. It mentions "Performance testing of the final, sterilized Instylla Delivery Kit with 3mL syringes included bench testing and functional testing." Without specific numbers, the sample size remains unknown.

Data provenance: All testing appears to be retrospective bench and functional testing conducted by the manufacturer, Instylla, Inc. There is no information provided regarding the country of origin of the data beyond the company's location (Bedford, Massachusetts).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes a 510(k) submission for a piston syringe device, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation. The "ground truth" here is defined by engineering specifications, material properties, and regulatory standards.

4. Adjudication method for the test set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert interpretations, which is not relevant for the type of testing described here.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic devices, which is not the subject of this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

There was no standalone (algorithm-only) performance study conducted. This device is a physical medical device (syringe kit), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance specifications (e.g., disconnection force, glide force, particulate matter), the "ground truth" is based on predetermined engineering specifications, validated test methods, and compliance with recognized industry standards like ISO 7886-1, ISO 594-2, USP , ISO 11135, and ISO 10993-7. For biocompatibility, the ground truth was established by prior testing of the predicate device against ISO 10993-1.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

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The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

The Instylla Delivery Kit is comprised of two 1mL delivery syringes, a syringe holder, and a plunger clip (link).

This document describes a 510(k) premarket notification for the "Instylla Delivery Kit," a piston syringe for administering medical solutions. The document does not contain any information about acceptance criteria or a study proving the device meets said criteria in the context of performance metrics like sensitivity, specificity, accuracy, or any AI/algorithm performance. The provided text details bench and functional testing for mechanical and material properties, rather than clinical performance or AI evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data in the context of an AI device.

However, I can extract information related to the device's non-AI performance testing, as detailed in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance testing that was conducted, but it does not explicitly state specific acceptance criteria values or detailed quantitative reported performance metrics. It generally states that these tests were performed "to verify specifications fundamental to the device" and that the syringes are "compliant against FDA recognized standards ISO 7886-1 and ISO 594-2."

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