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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.

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.

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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The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

The provided text is a 510(k) Premarket Notification for the Snuggle Warm® 4000 Convective Warming System. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology.

Therefore, the information required to populate the requested table regarding acceptance criteria and device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the Snuggle Warm® 4000 Convective Warming System is not present within the provided text.

The document explicitly states: "There are no significant changes in technological characteristics or intended use that impact the safety or effectiveness of these warming devices." This indicates that the submission relies on the established safety and effectiveness of the predicate device (Temp Marq™/ Snuggle Warm Convective Warming System, K904690) rather than new performance studies for the modifications made to the Snuggle Warm® 4000.

Here's a breakdown of what can be extracted and what is missing based on your request:

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

• Not provided. The document focuses on demonstrating "substantial equivalence" to a predicate device, implying that the performance is expected to be similar, but it does not specify new acceptance criteria or report specific performance metrics for the modified device.

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

• Not provided. No new test data is presented for the Snuggle Warm® 4000.

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 / Not provided. Since no new test set is described, there's no mention of experts or ground truth establishment for such a test.

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

• Not applicable / Not provided.

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 convective warming system, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not applicable. This device is hardware, not an algorithm.

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

• Not applicable / Not provided.

8. The sample size for the training set:

• Not applicable / Not provided. This document is for a hardware device, not an AI model requiring a training set.

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

• Not applicable / Not provided.

In summary, the provided 510(k) notification focuses on the regulatory process of demonstrating substantial equivalence to a predicate device rather than presenting new performance data or detailed studies as would be expected for a novel device or AI algorithm.

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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.

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.

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

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.

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This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The Needle-Pro® device is not designed for use with a luer lock syringe.

This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device is an integral component of the device as it comes pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the needle bevel by swiveling the orange arm to the desired position. After the procedure is completed, the needle is pressed into the sheath using a onehanded technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately be disposed into a sharps container. This device is not designed for use with a luer lock syringe. The device is supplied with 25G, 26G, 27G needles both with and without a syringe.

The provided text, a 510(k) summary for the "Hypodermic Needle-Pro® Needle with Needle Protection Device" and "Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device," does not include specific acceptance criteria or an analytical study detailing device performance against such criteria.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (K923127 Needle-Pro™ Cartridge) through non-clinical bench testing.

Here's an analysis of the information available in the document:

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

The document does not explicitly state numerical acceptance criteria for specific performance metrics. It makes a general claim:

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

• Sample size: Not specified.
• Data provenance: Bench test (non-clinical) data. The country of origin is not specified, but the applicant company, SIMS Portex Inc., is based in Keene, NH, USA. The data is prospective in the sense that it was generated for the purpose of this submission, but it's not clinical data.

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

This is not applicable as the study was non-clinical bench testing comparing the device to a predicate, not assessing a diagnostic or predictive performance against a "ground truth" established by experts.

4. Adjudication method for the test set:

This is not applicable as the study was non-clinical bench testing, not involving human interpretation or adjudication.

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 not applicable. The device is a medical product (hypodermic needle and syringe), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This is not applicable. The device is a physical medical product, not an algorithm.

7. The type of ground truth used:

This is not applicable in the traditional sense of diagnostic accuracy. The "ground truth" for the non-clinical testing would be the established performance characteristics of the predicate device regarding its resistance to forces and needle disengagement. The goal was to prove the new device performed at least as well.

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of this 510(k) submission as it concerns a physical medical device, not a machine learning algorithm.

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

This is not applicable for the reasons stated above.

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Ask a specific question about this device