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Brella-Spec™ Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations.

Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.

The Brella-Spec™ Vaginal Speculum is a sterile, single-use device with built-in LED illumination system to provide optimal visualization and access during gynecological and obstetrical procedures. This speculum was designed to provide visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. The device is ergonomically designed to maximize the view window using two side blades that are opened by a manually operated ratchet mechanism. The device incorporates a fully enclosed LED illumination system. It is composed of medical grade, biocompatible plastic materials.

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving the device meets them:

The document (K133857) describes the Brella-Spec™ Vaginal Speculum and its substantial equivalence to a predicate device (Depalt Vaginal Speculum 2000 Series and Depalt Lighting System, K072762).

Key Finding: The submission explicitly states: "No clinical studies have been done for the purpose of obtaining safety and effectiveness data." This means the device's acceptance criteria are NOT proven through clinical trials or comparative effectiveness studies with human readers or AI assistance. Instead, acceptance is based on bench testing, biocompatibility testing, sterilization validation, packaging validation, and electrical safety testing to demonstrate substantial equivalence to a predicate device.

Given this, many of the specifics requested (like effect size of AI assistance, number of experts for ground truth, sample sizes for test/training sets, etc.) are not applicable to this submission, as it relies on non-clinical data for clearance.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device in terms of technological characteristics, intended use, and performance, supported by non-clinical testing.

• Dimension: Minimal difference, no safety/effectiveness concerns.
• Blade Configuration: Triple blades (subject) vs. dual blades (predicate). Claimed to be "more effective because it provides larger vagina-contacting surface and view window," without impact on safety.
• Blade Movement: 2 articulating blades move horizontally (subject) vs. 1 articulating blade moves vertically (predicate). Claimed to be "more effective because it provides larger view window," without influencing safety.
• Thumb Paddle: 2 thumb paddles (subject) vs. 1 (predicate). Claimed to have "better control" without safety/effectiveness concerns.
• View Window: Adjustable area (5.8-31 cm²) (subject) vs. fixed (18 cm²) (predicate). Claimed to be "more flexible and effective without safety concerns."
• Illumination System: Same as predicate (built-in LED).
• Materials: Different (Polypropylene and Acrylic Polycarbonate for subject vs. Polystyrene for predicate), but biocompatibility testing ensures safety.
• Sterility: Sterile (subject) vs. non-sterile (predicate). Claimed to make the subject device "safer." |

Study Details (Based on Non-Clinical Data)

1. Sample size used for the test set and the data provenance:
   This information is not specified in the provided text for the bench, biocompatibility, sterilization, packaging, and electrical safety tests. The provenance is internal Proa Medical, Inc. testing, not external patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is not applicable. Ground truth for non-clinical tests (like material properties, sterilization efficacy, electrical output) is established by adherence to recognized standards (ISO, IEC, FDA Blue Book Memo) and engineering specifications, not by expert consensus in a clinical context.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This is not applicable as it pertains to clinical study adjudication, not non-clinical testing.

4. 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, a clinical MRMC study was not done. The document explicitly states: "No clinical studies have been done for the purpose of obtaining safety and effectiveness data." Therefore, there is no information on the effect size of human readers improving with or without AI assistance.

5. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
   No, a standalone algorithm performance study was not done. This device is a manual medical instrument, not an AI or algorithmic device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests, the "ground truth" is defined by regulatory standards, engineering specifications, and validated test methods. For example:

   • Biocompatibility: Compliance with ISO 10993.
   • Sterilization: Compliance with ISO 11137.
   • Electrical Safety: Compliance with IEC 60601-1.
   • Performance: Conformity to Proa Medical's internal design specifications.

7. The sample size for the training set:
   This is not applicable. No training set was used as this is a physical medical device, not a machine learning model.

8. How the ground truth for the training set was established:
   This is not applicable as there was no training set.

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The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.

The IOB disposable vaginal speculum consists of up and under plastic blades and handle with three different sizes (smail, medium and large). The speculum is used by medical professionals to visualize interior of vagina and cervix during patient examination.

The provided 510(k) summary does not contain the level of detail typically found in a clinical study report for AI/CADe devices. This device is a disposable speculum, a physical medical instrument, not an AI/CADe system. Therefore, the information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not directly applicable in the same way it would be for a software-based diagnostic tool.

However, I can extract the relevant information regarding performance and acceptance based on the content available for this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, acceptance criteria relate to its physical properties, manufacturing, and biological safety, rather than diagnostic accuracy metrics like sensitivity or specificity. Performance is primarily about functionality and equivalence to a 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)

This information is not applicable and not provided in the document. The device is a physical speculum; its testing involved "bench testing" and "stability study" simulating usage, not a clinical "test set" with patient data in the typical sense of a diagnostic algorithm.

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 is not applicable and not provided. "Ground truth" in the context of this device's testing would relate to physical performance metrics (e.g., structural integrity, ease of use), not diagnostic interpretation by medical experts.

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

This is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations of diagnostic data, which is not what was performed for this physical device.

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. An MRMC study is relevant for evaluating the impact of AI/CADe systems on human reader performance for diagnostic tasks. This device is a physical instrument, not an AI/CADe system.

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

This is not applicable. This device is a physical speculum and does not involve an algorithm.

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

For this device, the "ground truth" for performance would likely be based on:

• Biocompatibility Standards: Adherence to ISO 10993 standards.
• Engineering Specifications: Meeting pre-defined physical strength, flexibility, and dimensional requirements.
• Predicate Device Comparison: Functional equivalence observed during simulated usage against the predicate device.

8. The sample size for the training set

This is not applicable. The concept of a "training set" refers to data used to train an AI algorithm. This device is a physical instrument.

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

This is not applicable, as there is no training set for a physical device.

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The ClearSpec Single-Use 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 ClearSpec Single Use Vaginal Speculum is a disposable vaginal speculum constructed of polystyrene, used to dilate the vagina and expose the interior of the vagina and exterior of the cervix, and employs a unique flexible polyurethane sheath that is designed to assist in keeping the lateral walls of the vagina clear of the viewing area. The vaginal speculum can be used with or without an illuminator. The ClearSpec® Single Use Vaginal Speculum is made available in various sizes from extra small to large to accommodate vagina cavity size.

The provided text describes the 510(k) submission for the ClearSpec® Single-Use Vaginal Speculum. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI or diagnostic device. Therefore, many of the requested elements are not applicable to this type of regulatory submission.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample size: Not explicitly stated. The text mentions "bench testing has been conducted using simulated actual use conditions" but does not quantify the number of tests or devices used.
• Data provenance: Not explicitly stated, but based on the nature of bench testing, it would be internal lab data from ClearSpec LLC. It is prospective testing designed to evaluate the new device. Country of origin not specified, but the company is based in Boca Raton, FL, USA.

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

Not applicable. This was bench testing, not a clinical study involving expert interpretation of medical data. The "ground truth" was based on established engineering and materials science principles, and the performance of the device itself under simulated conditions.

4. Adjudication method for the test set

Not applicable. Bench testing typically involves objective measurements and comparisons to predefined engineering specifications or predicate device performance, not expert adjudication in the manner of diagnostic performance studies.

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 is a medical device (vaginal speculum) and not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.

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

Not applicable. This device does not involve an algorithm.

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

The ground truth for the bench testing was based on:

• Engineering specifications and material properties (e.g., strength, durability, bond integrity).
• Established regulatory standards for biocompatibility (FDA GPM G95-1 and ISO 10993-1).
• Comparison to the performance of predicate devices which are already deemed safe and effective.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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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.

This product is available for sale only upon the order of a physician or licensed health care professional.

The subject device has the same technological characteristics and indications for use as the predicate KleenSpec® Single Use Vaginal Speculum. The addition of the extra small size vaginal speculum does not introduce any new concerns regarding safety or efficacy. The designs have been demonstrated as substantial equivalent using bench test data.

Both the new size and the previously cleared KleenSpec® Single Use Vaginal Speculums are made of the same materials, which have biocompatibility testing according to FDA Blue Book Memo, G95-1, Use of International Standard ISO-10993 requirements for limited contact duration, surface contacting, mucosal membrane device and are demonstrated to be suitable for the intended use of this product.

The provided text is a 510(k) Summary for a medical device: the KleenSpec® Single Use Vaginal Speculum. It describes a modification to an existing device (the addition of an extra small size) and explicitly states that no clinical studies were necessary or utilized for the purpose of obtaining safety or effectiveness data.

Therefore, the device's acceptance criteria are not based on clinical performance metrics, but rather on its substantial equivalence to a predicate device. The study that proves the device meets acceptance criteria is non-clinical bench testing and adherence to design control procedures.

Here's a breakdown of the requested information based on the provided document:

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

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

• Sample size for test set: Not applicable (N/A) – No clinical test set was used. The evaluation was based on non-clinical bench testing.
• Data provenance: Not applicable (N/A) – No clinical data (from a country of origin, retrospective or prospective) was used. Testing was conducted internally by Welch Allyn.

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 (N/A) – No clinical test set requiring expert ground truth was utilized. The assessment was based on engineering design validation and verification.

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

• Not applicable (N/A) – No clinical test set requiring adjudication was utilized.

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 (N/A) – This device is a physical medical instrument (vaginal speculum), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

• Not applicable (N/A) – This device is a physical medical instrument, not an algorithm.

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

• Not applicable (N/A) – No clinical ground truth (expert consensus, pathology, outcomes data) was used. The "ground truth" for this regulatory submission was established through engineering design specifications, material specifications, and performance testing against those specifications, implicitly confirming the device's functional integrity and safety characteristics are equivalent to the predicate.

8. The sample size for the training set

• Not applicable (N/A) – No training set was used. This is not an AI/machine learning device.

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

• Not applicable (N/A) – No training set or associated ground truth was established for this device.

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The KOLPLUX System when used with a vaginal speculum provides illumination during pelvic examination and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.

The KOLPLUX System consists of a power source adapter, 2 meter long electrical cord, and the illumination system body and a carrying case. The Illumination System Body accommodates the LED and provides a keyhole female opening for the insertion of the optic fiber tube (found on the vaginal speculum).

The KOLPLUX System is a vaginal speculum illumination system. The device's substantial equivalence to a predicate device, the Welch Allyn Kleenspec Single Use Vaginal Speculum & 790 Series Cordless Illumination System, was established through a comparison of technical characteristics and compliance with international safety standards. There is no study for this 510(k) summary that provided the acceptance criteria and device performance table, the sample size for the test set, the number of experts used to establish ground truth, the adjudication method, details of a multi-reader multi-case (MRMC) comparative effectiveness study, or details of standalone algorithm performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• This 510(k) summary does not describe a clinical study or a test set for assessing device performance against acceptance criteria. The evaluation is focused on technical characteristics and compliance with standards rather than clinical performance against specific metrics.

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

• Not applicable, as no test set requiring ground truth established by experts is described.

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

• Not applicable, as no test set requiring adjudication 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 MRMC comparative effectiveness study was performed or described. This device is an illumination system, not an AI-powered diagnostic tool involving human readers.

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

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

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

• Not applicable, as no ground truth was established for performance evaluation in this 510(k) summary. The comparison is against technical specifications and indications for use of a predicate device.

8. The sample size for the training set:

• Not applicable, as there is no training set for an algorithm described.

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

• Not applicable, as there is no training set for an algorithm described.

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The disposable vaginal speculum is a non-sterile product and is to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.

The disposable vaginal speculum consists of up-foliage, under-foliage and handle with the specification of large, medium and small, which is used by medical department for examining female patients.

This is a 510(k) summary for a Disposable Vaginal Speculum, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, sample sizes, and expert qualifications for AI/ML performance is not applicable.

The document describes a traditional medical device and its substantial equivalence to a predicate device based on material, intended use, and mechanical/biocompatibility safety testing.

Here's a breakdown of the relevant information provided for this device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This is a physical medical device, and the evaluation relies on compliance with established consensus standards for mechanical properties and biocompatibility, rather than a "test set" of data in the context of AI/ML.
• The document implies that the tests were performed by, or on behalf of, Kunshan Deyi Plastic Co., Ltd., which is a manufacturer in China.

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

• Not applicable. Ground truth in the AI/ML sense is not relevant for this type of device submission. The "ground truth" here is compliance with material, design, and performance standards as determined through laboratory testing.

4. Adjudication method for the test set:

• Not applicable. There is no "adjudication method" described as would be for an AI/ML system's output. Compliance is determined by the results of the specified tests against the criteria in the standards.

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 is not an AI-assisted device.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• For mechanical and environmental safety: Compliance with the specified performance requirements within the standard YY0336-2002 (Disposable Vaginal Speculum).
• For biocompatibility: Absence of cytotoxicity, irritation, or delayed type hypersensitivity reactions as determined by the methods and criteria in ISO 10993-5 and ISO 10993-10.

8. The sample size for the training set:

• Not applicable. There is no training set for a physical, non-AI medical device.

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

• Not applicable.

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The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.

The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to OBP Corporation regarding their "OBP Office-Spec Disposable Side Speculum."

It primarily communicates the FDA's determination of substantial equivalence for the device to legally marketed predicate devices and outlines the regulatory requirements the company must comply with. The "Indications for Use" section describes what the device is intended for, but it does not include performance metrics, study details, or acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the provided input.

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Depalt Vaginal Speculum is used for the purposes of visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations.

Depalt Lighting System provides the light necessary to illuminate the field during procedures/examinations.

Depalt Vaginal Speculum is a nonmetal, single use (disposable) medical device used to expose the interior of the vagina. The vaginal speculum may be used with or without the Depalt Lighting System.

Depalt Lighting System provides the light necessary to illuminate during procedures and examinations.

This submission K072762 is for a medical device (Depalt Vaginal Speculum and Depalt Lighting System), not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, AUC) does not apply.

The FDA 510(k) submission for this device focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of:

• Intended Use: Visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations.
• Technological Characteristics:
  • Speculum: Nonmetal, single-use (disposable), made of Polystyrene.
  • Lighting System: Provides illumination during procedures and examinations.
• Material: Polystyrene for the speculum.

The substantiation for this type of device typically involves:

• Bench Testing: To ensure mechanical integrity, material compatibility, and light output specifications (for the lighting system). This is often compared against industry standards or the performance of predicate devices.
• Biocompatibility Testing: To ensure the materials used are safe for patient contact.
• Sterilization Validation: If the device is supplied sterile.
• Labeling Review: To ensure appropriate instructions for use and warnings.

Since this is not an AI/ML device, the following points from your request are not applicable:

• A table of acceptance criteria and the reported device performance (in the context of AI metrics).
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The FDA's review for this 510(k) focuses on safety and effectiveness through substantial equivalence, primarily based on the listed technical characteristics and intended use, rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy.

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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.

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