Search Results

KleenSpec® Single Use Vaginal Speculum: The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal speculum can be used with or without the illuminator. KleenSpec® 790 Series Cordless Illuminator: When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery. The illuminator can be used independent of the speculum as a general-purpose light source.

The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures such as: Pap smears, dilation and curettage (D&C), biopsy, & electrosurgery. Models with a smoke tube assembled to the upper blade can be connected to a separate smoke evacuator during electrosurgical procedures. The vaginal speculum can be used with or without the illuminator. When used with the vaginal speculum, the cordless illurninator provides illumination during pelvic examinations. The illuminator can be used independent of the speculum as a general-purpose light source.

This 510(k) Premarket Notification for the Welch Allyn KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System does not contain the level of detail requested for acceptance criteria and a comprehensive study description as it applies to an AI/ML device.

This document is a submission for a traditional medical device (vaginal speculum and illuminator) under the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use, rather than detailed performance metrics derived from clinical studies with ground truth establishment in the way an AI/ML device would need. The FDA letter confirms the device is substantially equivalent to a predicate device.

Therefore, many of the requested fields cannot be filled from the provided text.

Here is what can be inferred or explicitly stated from the document, along with explanations for the missing information:

Acceptance Criteria and Device Performance for Welch Allyn KleenSpec® Single Use Vaginal Speculum and 790 Series Cordless Illumination System (K070964)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for Missing Information:
For a traditional medical device like this, acceptance criteria primarily revolve around demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The 510(k) summary does not include specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) derived from controlled studies, which are typically required for AI/ML devices.

Study Information Pertaining to K070964

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

• Sample Size: Not applicable. The submission is for a physical medical device, not an AI/ML algorithm. There is no "test set" in the context of an algorithm's classification or prediction performance. The "test" for substantial equivalence often involves comparing design specifications, materials, and intended use to a predicate device.
• Data Provenance: Not applicable. There is no data provenance in the context of clinical data used for AI/ML model evaluation.

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

• Number of Experts: Not applicable. Ground truth establishment is not relevant for this type of device submission.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There is no test set in the context of AI/ML evaluation, and thus no adjudication method for ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This is not an AI/ML device; therefore, no MRMC study comparing human readers with and without AI assistance would have been performed or would be relevant.

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

• Standalone Performance: Not applicable. This is not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not applicable. Ground truth, in the context of AI/ML, refers to the verified correct answer against which an algorithm's output is compared. This concept does not apply to a physical device like a speculum or illuminator. The "truth" for this device relates to its physical properties, biocompatibility, and functional performance matching its intended use and predicate device.

8. The sample size for the training set

• Sample Size: Not applicable. There is no AI/ML model to train.

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

• Ground Truth Establishment: Not applicable.

Summary of Device and 510(k) Context:

This 510(k) submission (K070964) is for a physical medical device: a vaginal speculum and a cordless illumination system. The submission's purpose is to demonstrate substantial equivalence to an existing legally marketed device (the KleenSpec Disposable Vaginal Speculum 580 series, K941272).

For such devices, the "acceptance criteria" are primarily related to:

• Meeting the same intended use as the predicate device.
• Having similar technological characteristics (e.g., materials, design principles).
• Raising no new questions of safety or effectiveness.
• Conforming to relevant performance standards (though not explicitly detailed in this summary).

The 510(k) mechanism is a premarket notification process for medical devices that do not require a Premarket Approval (PMA) application. It is fundamentally different from the regulatory pathway for AI/ML-driven devices, which would necessitate extensive data sets, ground truth establishment, and performance metrics like sensitivity, specificity, AUC, and studies evaluating human-AI interaction.

Ask a specific question about this device

The RI MOS. s.r.l. Cuscovag, Specuvag and Specuvag AS devices are used to expose the interior of the vagina. The Cuscovag is indicated as an aid for routine examination in adolescent and geriatric women, the Specuvag as an aid for routine examination and the Specuvag AS as an aid for routine examination and procedures where smoke must be evacuated from the vaginal canal.

The RI. MOS. s.r.l. speculae line are sterile, single-use, disposable devices.

This document describes a 510(k) submission for gynecological specula (GINRAM® Cuscovag, Specuvag, and Specuvag AS). The submission aims to demonstrate substantial equivalence to a predicate device, the KleenSpec® Specula marketed by Welch Allyn (K941272).

Here's an analysis of the provided text in relation to your questions:

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

The provided text does not contain a table of acceptance criteria or specific device performance metrics in the way one would expect for an AI/CADe device. This submission is for a physical medical device (specula), not a software-based diagnostic tool. The "acceptance criteria" here are based on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and safety testing.

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 applicable or not provided in the context of this 510(k) summary for a physical medical device. There is no "test set" of patient data in the typical sense for evaluating an AI algorithm's diagnostic performance. The evaluation is focused on the device's physical and material properties and its intended use.

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 applicable or not provided. Since there's no diagnostic AI algorithm being described, there's no "ground truth" derived from expert consensus on medical images or data.

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

This information is not applicable or not provided. No "adjudication method" for a test set is mentioned because there's no diagnostic performance being evaluated in this manner.

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. The device is a speculum, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance would be relevant or performed.

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

This information is not applicable. The device is a physical instrument, not an algorithm.

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

This information is not applicable. No "ground truth" for diagnostic purposes is discussed or needed for a speculum 510(k) submission. The "truth" here relates to the device meeting safety standards and performing its intended mechanical function.

8. The sample size for the training set

This information is not applicable. There is no "training set" for a physical medical device like a speculum.

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

This information is not applicable. As there is no training set, there is no ground truth establishment for it.

In summary: The provided document is a 510(k) summary for a physical medical device (gynecological specula). It focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with safety standards (ISO 10993). The questions you've posed are primarily relevant to the evaluation of AI/CADe (Computer-Aided Detection/Diagnosis) systems, which process and interpret data, and therefore, most of the answers are "not applicable" in this context.

Ask a specific question about this device