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Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.

Device Description

A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending.

AI/ML Overview

The provided text describes the 510(k) summary for the Portex Ring Pessary, which is a medical device. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert adjudication, or MRMC comparative effectiveness studies.

The document primarily focuses on:

Device Identification: Applicant, name, classification, predicate device.
Device Description and Intended Use: What it is, what it's for, contraindications, and warnings.
Technical Characteristics: Mentions that "tests have been developed which are considered sufficient to ensure the efficacy and safety of the device(s) for its intended use" and lists "Visual and Dimensional" tests.
Data Submitted (Safety): States that a biological safety assessment was performed in accordance with ISO 10993, Part 1:1994.

Therefore, I cannot provide the requested table and study details as the information is not present in the given text.

Summary of what can be extracted (and what cannot):

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated. The document mentions "tests have been developed which are considered sufficient to ensure the efficacy and safety of the device" including "Visual and Dimensional" tests, and biological safety per ISO 10993. No specific quantifiable criteria or pass/fail thresholds are given.
Reported Device Performance: No specific performance metrics or results (e.g., success rate in preventing prolapse, reduction in stress incontinence) are provided.

2. Sample sized used for the test set and the data provenance:

Sample Size: Not mentioned for any performance or efficacy testing.
Data Provenance: Not mentioned.

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

Not mentioned. The document relies on pre-clinical testing and comparison to a predicate device, not clinical studies with expert-established ground truth.

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

Not applicable/Not mentioned, as there is no described test set requiring adjudication in the context of clinical performance or diagnostic accuracy.

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 device is a pessary, not an AI-assisted diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.

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

Not applicable. This device is a physical pessary, not an algorithm.

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

For biological safety, the ground truth would be established by the ISO 10993 standards and associated laboratory tests.
For physical characteristics (visual and dimensional), the ground truth would be engineering specifications and quality control measurements.
No "ground truth" equivalent to what would be used for a diagnostic device (e.g., pathology for cancer detection) is described for this product.

8. The sample size for the training set:

Not applicable/Not mentioned. There is no "training set" as this is a physical device, not a machine learning model.

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

Not applicable.

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K Number

K012068

Device Name

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S

Manufacturer

SIMS PORTEX LTD.

Date Cleared

2001-08-03

(32 days)

Product Code

MQE

Regulation Number

884.6100

Type

Traditional

Panel

Obstetrics and Gynecology (OB)

Reference & Predicate Devices

N/A

Intended Use

The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles.
The Wallace Oocyte Retrieval Sets are sterile, single-use intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.

Device Description

Wallace Oocyte Retrieval Set is a single-use device provided sterile for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The set consists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex) tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is 33cm in length and available in 16 gauge or 17 gauge, each having echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Tubing is attached to the hub of the needle and protrudes a total distance of 700mm until it passes through a silicone bung and terminates in an ABS female luer connector. FEP tubing for suction also protrudes through the bung, and at the other end terminates in a polypropylene luer lock connector.

AI/ML Overview

The Wallace Oocyte Retrieval Set is a medical device and therefore its acceptance criteria is based on safety and efficacy rather than performance metrics like sensitivity or specificity.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Performance
Visual Inspection	Sufficient to ensure efficacy and safety
Dimensional Accuracy	Sufficient to ensure efficacy and safety
Functional Performance	Sufficient to ensure efficacy and safety
Two-cell Mouse Embryo Assay	Performed and deemed sufficient to ensure efficacy and safety
Bacterial Endotoxin (Limulus Amoebocyte Pyrogen) Test	Performed and deemed sufficient to ensure efficacy and safety
Biological Safety (ISO 10993, Part 1:1994)	Assessment performed and deemed sufficient to ensure efficacy and safety

2. Sample Size and Data Provenance

The document does not specify a distinct test set or sample size for each performance test. The device is a "set" implying multiple components and likely multiple units were subjected to these tests. Given the 2001 date, it is highly probable that all testing was retrospective and conducted in the UK, where the applicant (SIMS Portex Ltd) is located.

3. Number of Experts and Qualifications

No information is provided regarding the number or qualifications of experts involved in establishing acceptance criteria or interpreting test results. The implication is that internal company experts conducted and assessed the tests.

4. Adjudication Method

No formal adjudication method is described. The acceptance appears to be based on the internal assessment of the conducted tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The Wallace Oocyte Retrieval Set is a medical device, not an AI or imaging diagnostic tool that would typically involve a multi-reader, multi-case study.

6. Standalone (Algorithm Only) Performance

Not applicable. The Wallace Oocyte Retrieval Set is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth for acceptance appears to be established by adherence to internal company-developed tests and the ISO 10993 standard for biological safety, rather than external expert consensus, pathology, or outcomes data in the context of diagnostic accuracy. The "two-cell Mouse Embryo Assay" provides a biological ground truth for embryo toxicity.

8. Sample Size for Training Set

Not applicable. The device is not an AI model, so there is no "training set."

9. How Ground Truth for Training Set Was Established

Not applicable.