Search Results

The Wallace SIS/AI Catheter is intended to be used in artificial insemination procedures intended for insertion of the catheter and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/Al Catheter is also intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection abnormalities within uterine cavities.

The Wallace Artificial Insemination Catheter (K964848) is a single-use, sterile, disposable device that was originally submitted and cleared with the intended use for insertion of catheters and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/AI Catheter for the purpose of this submission is intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection of abnormalities within uterine cavities. The catheter is also intended to be used in artificial insemination (AI) procedures.

The Catheter has two opposing smooth side eyes and a rounded smooth closed distal tip. It has an overall length of 18cm and consists of a flexible-end inner catheter and a detachable outer sheath attached to the inner catheter by a luer lock. The inner catheter is 16 gauge with a uniform lumen throughout its length. When the outer sheath luer is attached to the hub of the catheter, the inner catheter protrudes from the outer sheath by 5cm. The outer sheath has a series of 1cm graduations at the distal end, the graduations are used to assess the depth of the insertion.

An inner tube with an outer sheath that covers 2/3 segments of the inner sheath with marks of the distance from the distal part of the catheter and a cover rigid protective tube.

The provided documentation is a 510(k) summary for the Wallace SIS/AI Catheter. It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than presenting a detailed study with specific acceptance criteria and detailed performance data on the device itself. Therefore, much of the requested information cannot be extracted directly from this document.

However, I can extract the available information and highlight what is not present.

Acceptance Criteria and Study Information for Wallace SIS/AI Catheter

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The document mentions "field testing and evaluation of this product by the end-user" but does not specify the sample size of patients or procedures, the design of the test, data provenance (e.g., country of origin), or whether it was retrospective or prospective.

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

This information is not provided in the document. It mentions "evaluation by the end-user" but does not specify the number or qualifications of these end-users, nor how they established any ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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/provided. The device is a physical catheter, not an AI algorithm. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable/provided. The device is a physical catheter, not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not explicitly stated in the document. The "field testing and evaluation" implies clinical use and assessment by healthcare professionals (end-users), but the specific method of establishing ground truth (e.g., comparison to a gold standard like pathology or subsequent clinical outcomes) is not detailed.

8. The Sample Size for the Training Set

This information is not applicable/provided. As the device is a physical catheter and not an AI algorithm, there is no "training set" in the context of machine learning.

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

This information is not applicable/provided. As the device is a physical catheter and not an AI algorithm, there is no "training set" or corresponding ground truth establishment in the context of machine learning.

Ask a specific question about this device

The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.

The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided document, K964848 (Wallace Artificial Insemination Catheters), there is no detailed study information or specific acceptance criteria for performance metrics as would be expected for a diagnostic or AI-driven device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with quantitative results.

Therefore, many of the requested sections (2-9) cannot be answered from the provided text as the information is not present.

However, I can extract the closest information to "acceptance criteria" based on the substantial equivalence argument, which implies that the device is deemed acceptable if it is comparable to the predicate device in terms of materials, sterilization, and intended use.

Here's the breakdown of what can be derived from the provided input:

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

Since specific quantitative performance acceptance criteria are not explicitly stated, the "acceptance criteria" are implied by the substantial equivalence argument – that the new device should be similar to the predicate device. The "reported device performance" is essentially the comparison to the predicate.

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

• Not provided. The document describes a comparison of device characteristics, not a clinical performance study with a test set.

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. No test set or ground truth establishment process is described.

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

• Not applicable. No test set or adjudication process 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

• No. This is not an AI device, and no MRMC study is mentioned.

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

• No. This is not an AI device.

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

• Not applicable. No ground truth established for performance. The "ground truth" for the substantial equivalence claim is the characteristics of the predicate device (Edwards-Wallace Catheters).

8. The sample size for the training set

• Not applicable. This is not a device that relies on a training set in the AI sense.

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

• Not applicable.

Ask a specific question about this device