Input 10F/11F are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input 10F/11F are recommended for initial percutaneous introduction of a closed end catheter, temporary pacing electrode catheter or probe, or a balloon catheter. They may also be used as an instrument to exchange catheters during a procedure.

Device Description

Input 10F/11F consists of an introducer sheath (uncoated), a locking dilator (may contain a single or double dilator), and a guide wire.

AI/ML Overview

This document, K961135, is a 510(k) Summary of Safety and Effectiveness for a medical device: the USCI Input 10F/11F Percutaneous Arterial/Venous Catheter Introducer Set. It is not a study reporting on the performance of a device against acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, this submission aims to demonstrate substantial equivalence to a predicate device (USCI Input™ Introducer Set, K940092) and therefore does not contain the specific type of acceptance criteria and study details for device performance that you've requested for an AI/algorithm-based device.

Here's why many of your requested points cannot be directly answered from this document:

This is a traditional medical device submission, not an AI/algorithm submission. The device (a catheter introducer set) is a physical, mechanical product. It does not involve AI, algorithms, or software performance in the sense of image analysis, diagnostics, or predictive modeling. Therefore, concepts like "algorithm only performance," "human readers," "AI assistance," "training set," "test set," and "ground truth for AI" are not applicable.
The document focuses on substantial equivalence. The primary goal of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device. This is typically done through comparisons of materials, design, intended use, and performance testing for physical attributes (e.g., tensile strength, biocompatibility), rather than clinical efficacy studies establishing a specific performance metric against acceptance criteria in the way you're asking.
Performance data is implicitly related to the predicate. The "study" proving the device meets criteria is largely a demonstration that it is equivalent to the predicate, which itself was approved based on its safety and effectiveness.

However, I will extract relevant information where possible and explain why other points are not applicable or cannot be found in the provided text.

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

This document does not present a table of specific acceptance criteria (e.g., "sensitivity > 90%") for the overall device's clinical performance, nor does it report device performance in that manner. Instead, it describes mechanical components and materials. The "performance" is implicitly tied to its equivalence to the predicate device and the materials used.

Acceptance Criteria Type (Implied)	Reported Device "Performance" / Justification
Material Composition	FEP sheath and black PE materials used. These are "not new to USCI" and are used in other approved USCI introducers (Hemaquet K781954, Hemaflex K897041).
Design/Components	Consists of an introducer sheath (uncoated), a locking dilator (single or double), and a guide wire. Similar to predicate (K940092) but without a locking obturator and an uncoated sheath.
Intended Use	"Percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery." Identical to predicate K940092.
"Sit-Up" Claim	Does NOT include the "sit-up" option (patient sitting up at 60° post-PTCA) that the predicate device (Input SC, K940092) has. This is a difference from the predicate, implying this feature was either removed or not validated for this specific model, rather than a performance metric.
Equivalent to Predicate	Declared "equivalent to those mentioned in the USCI Input Introducer with Sit-Up Claim (termed Input SC in this submission for identification purposes), 510(k) #K940092."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a submission for a physical medical device. There is no "test set" in the context of an algorithm or diagnostic study. Performance is established through material verification, design comparisons, and potentially bench testing (not detailed here, but typical for such devices) to demonstrate substantial equivalence to a predicate. Clinical trial data with patient samples, if any, would be for safety and efficacy for the predicate device, which this device aims to be equivalent to.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There is no "ground truth" to be established by experts for a "test set" in the context of this device. The evaluation of its safety and effectiveness is based on engineering principles, material science, and comparison to existing, approved devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or adjudication method as described for an algorithm validation.

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

Not Applicable. This is a physical, non-AI device. No human readers, AI assistance, or MRMC studies are relevant.

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

Not Applicable. This is a physical device, not an algorithm.

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

Not Applicable / Implied by Predicate Device Approval. For this specific device, the "ground truth" for its safety and effectiveness is largely the demonstrated safety and effectiveness of the legally marketed predicate device (K940092) and the inherent properties of the materials used in both (FEP, PE). The regulatory approval process for the predicate would have relied on appropriate data (e.g., bench testing, biocompatibility, potentially limited clinical data, and long-term clinical experience).

8. The sample size for the training set

Not Applicable. No training set for an algorithm.

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

Not Applicable. No training set or ground truth in this context.

Summary

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K961135

USCI Division C.R. Bard, Inc. Clinical and Regulatory Affairs 1200 Technology Park Drive P.O. Box 7025 Billerica, MA 01821 (508) 667-1300 FAX: (508) 670-4326

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SECTION 6.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.

General Information 6.1

� Name and Address of Submitter:

USCI Division of C.R. Bard, Inc. 1200 Technology Park Drive Billerica, MA 01821

� Contact:

Robert T. Miragliuolo Director, Regulatory Affairs

� Date of Summary:

March 20, 1996

Name of Device: �

USCI® Input® 10F/11F Percutaneous Arterial/Venous Catheter Introducer Set

� Common/Usual Name of Device:

Catheter Introducer

� Device Classification:

Cardiopulmonary Bypass Adapter, Stopcock, Manifold or Fitting

◆ Predicate Devices:

USCI® Input™ Introducer Set (K940092, concurrence received August 10, 1995); referred to as Input SC in this submission for identification purposes. Daig 11F Introducer

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Description and Intended Use of Device: �

Input 10F/11F consists of an introducer sheath (uncoated), a locking dilator (may contain a single or double dilator), and a guide wire. These components are presented in Exhibit 3.1 of this section with the exception of the guide wire since there are no changes to this sub-assembly. Refer to Exhibit 3.3 in this section for a photograph of the Input 10F/11F introducer.

The components described in this submission are equivalent to those mentioned in the USCI Input Introducer with Sit-Up Claim (termed Input SC in this submission for identification purposes), 510(k) #K940092. The FEP sheath and black PE materials, although new to the Input Introducer line of products, are not new to USCI. These materials are used in various other USCI introducers such as the Hemaquet Introducer (K781954/concurrence received November 29, 1978) and the Hemaflex Introducer (K897041/concurrence received March 16, 1990). Both the Hemaquet and Hemaflex Introducers have a black PE dilator. The Hemaquet Introducer also contains the FEP sheath with the polyurethane strain relief.

The Input SC (K940092), the predicate device, consists of an introducer sheath (hydrophilic coated), a locking dilator (that may contain a single or double dilator), and a guide wire. Certain model numbers also contain a locking obturator. The Input 10F/11F, covered under this 510(k), will not include a locking obturator.

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The current Input SC (as described in K940092, concurrence received August 10, 1995) allows the patient to sit up in bed at a 60° angle, post-PTCA procedure. A statement and illustration was added to the Instructions for Use (IFU) that advises physicians that patients may sit up-right (up to a 60° angle) post-procedure. However, the IFU for the Input 10F/11F introducer will not include the option of allowing the patient to sit up in bed at a 60° angle, post-PTCA procedure

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).