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The ABBI (Air Bubble Based Infuser) is indicated for the following:

• Instillation of a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (SonoHSG).

• Instillation of saline as a continuous stream of contrast media into the used in conjunction with an intrauterine catheter for performance of saline infusion sonography (SIS).

The Air Bubble-Based Infuser (ABBI™) is a dual-barrel syringe that can be connected to an intrauterine infusion catheter to instill a saline-air mixture as contrast media during sono-hysterosalpingogram (Sono HSG) procedures and saline only during hysterosonography (SIS) procedures. The device has a selector valve that allows the user to select infusion of a saline-air mixture for a Sono HSG procedure or saline alone for a SIS procedure. These procedures are used for the evaluation of the fallopian tube(s) selectively and/or the uterus.

The ABBI™ is labeled for use with the H/S Elliptosphere Catheter Set (K013972).

The device is a single use only and provided sterile using an ethylene oxide sterilization method. The device is intended to be used in a healthcare facility or hospital.

The provided text describes the Air Bubble-Based Infuser (ABBI™) and its substantial equivalence to a predicate device, focusing on non-clinical performance data. It does not contain information about the use of AI, so I cannot provide details on AI-related aspects.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence. The "performance" is implicitly stated as "demonstrates that the ABBI™ is substantially equivalent to the proposed predicate device."

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

The document does not specify the sample sizes used for any of the non-clinical tests or the cadaver study. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

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):

This information is not provided. The studies mentioned are primarily non-clinical device performance and biocompatibility tests, which typically do not involve establishing ground truth by human experts in the same way clinical diagnostic studies would. The "Summative Usability Assessment" might have involved human participants evaluating the device, but the number and qualifications of evaluators are not detailed.

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

This information is not provided. Adjudication methods are typically associated with clinical studies involving interpretation of results, which is not 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:

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance and substantial equivalence to a predicate device, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI in the document.

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

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an algorithm or AI.

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

Given the nature of the tests (filling, volume, pressure, torque, deformation, biocompatibility), the "ground truth" would be established by physical measurements, chemical analyses, and biological responses according to established engineering and ISO standards, rather than expert consensus on diagnostic images or pathology. For the cadaver study, the ground truth would be the direct observation of the device's function within the cadaver.

8. The sample size for the training set:

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an AI model that requires a training set.

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

This is irrelevant as the provided text describes a medical device (an infuser) and its non-clinical performance, not an AI model that requires a training set.

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Injection of fluid into the uterine cavity during Saline Infusion sonogram (SIS) & hysterosalpinogram (HSG). Following are some Clinical Indications:

1. Infertility.
2. Menorrahagia.
3. Dysmenorrhea.
4. Suspected Endometrial Polyp.
5. Uterine Fibroid.
6. Amenorrhea due to Uterine Synechea (Asherman Syndrome).
7. Congenital Uterine Anomaly.

Foam Seal Catheter is a single channel catheter intended for use during Foam Seal Cadieter is a single endinsion sonogram. Foam Seal Catheter is a simplified version of double-channel balloon HSG catheter. This device has a single channel version of 1.6mm to 3mm in diameter and has a length of 370mm. Both ends of this catheter are open. The outer end has a luerlock device. A two way lock is attached to this end. The inner end is used to introduce fluid into the cavity of uterus. An introducer this cho. The finiter ens of agent is placed on its mid-segment. Both catherer and of an external caminate of plastic material. A cone-shaped foam component is attached close Calliula are made of placed in the cervical canal during the procedure. The foum to himel end so it can be placed find seal and to keep the catheter in place.

Fluid media is injected into the cavity of uterus using this catheter with a syringe. Thich media is injected into ax carry of on the injected fluid. Radiology procedures of ultrasound examination is performed at this time and images of the cavity of the uterus is taken. There are several advantages to this device. This is a single chamel device and is taken. There are several advantages to the cervical canal and keeps the catheter in place without the need of an assistant.

The provided text is a 510(k) summary for the Foam Seal Catheter, which is a medical device. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics. Therefore, it does not contain the information needed to fill out most of the requested table and sections.

However, I can extract the following relevant details:

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

The document does not explicitly define acceptance criteria or report specific performance metrics for the Foam Seal Catheter. Instead, it claims substantial equivalence to a predicate device (H/S Elliptosphere Catheter set with 510K number K013972) based on "same technological characteristics," "identical intended use and operating principles." Therefore, the implicit acceptance criterion is that the device is substantially equivalent to the predicate. No quantitative performance data is provided for the Foam Seal Catheter itself.

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

This information is not provided in the document. The 510(k) summary does not describe a clinical 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)

This information is not provided in the document, as no test set or ground truth establishment process is described.

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

This information is not provided in the document, as 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

This information is not provided in the document. The device is a catheter, not an AI-assisted diagnostic tool, so an MRMC study related to AI performance would not be relevant.

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

This information is not provided in the document. This is a medical device, not an algorithm.

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

This information is not provided in the document, as no ground truth is described.

8. The sample size for the training set

This information is not provided in the document, as no training set is described for this type of device.

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

This information is not provided in the document, for the same reason as above.

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