Search Results

The intended uses are interconnection of devices for transmission of light, hold suction tubes and instruments.

The devices are made of injected molded parts. Does not require assembly (simple product). Has vents to allow heat to escape. No contact with body surfaces. Has interlocking cone for device attachment. The device is for single use only.

The provided text describes a medical device called "Glo-Spec I, II and III," which are connectors for medical devices, primarily used for transmitting light and holding suction tubes and instruments. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested elements for a rigorous device performance study are not explicitly stated or applicable in this 510(k) summary. The document does not describe a performance study with numerical acceptance criteria and results in the way a clinical trial might. Instead, it relies on a comparison to a predicate device.

Here's an analysis based on the provided text, addressing the points where information is available or inferable, and explicitly stating when information is not provided.

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

The document does not provide a table of numerical acceptance criteria. Instead, the acceptance criteria are implicitly based on demonstrating substantial equivalence to a predicate device, the Welch Allyn Kleenspec, and other devices. The "performance" is summarized as being "constructurally equivalent" and complying with "all acceptance criteria listed above" (referring to the characteristics listed under "Physical/Technical Comparison").

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. The submission relies on a comparison to "millions of applications" of predicate devices, implying a general understanding of the predicate's performance rather than a specific test set for the Glo-Spec.

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. As no specific test set or clinical study is detailed, the concept of expert-established ground truth for a test set is not applicable here.

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

This information is not provided. There is no described test set or adjudication process.

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

An MRMC study was not done. This device is a passive connector, not an AI-assisted diagnostic tool or an imaging device for which MRMC studies would be relevant.

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

A standalone performance study was not done or described. This device is a physical connector, not an algorithm.

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

The concept of "ground truth" as typically used in diagnostic device studies is not applicable here. The performance is assessed based on functional equivalence to predicate devices, which are assumed to be safe and effective based on their established market history ("millions of applications").

8. The sample size for the training set

This information is not provided. There is no training set mentioned as this is a physical device, not a machine learning model.

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

This information is not provided. As there is no training set, this is not applicable.

Ask a specific question about this device

The intended use is interconnection of devices for transmission of light.
The intended use is to illuminate area of view.
The intended use is the interconnection of devices for transmission of light.

Not Found

The information provided is insufficient to describe acceptance criteria and study details as it appears to be a 510(k) summary for a medical device (Glo-Spec™ Connector, Vaginal Speculum) seeking substantial equivalence to a predicate device, rather than a performance study report with specific acceptance criteria and detailed study methodology.

The document primarily focuses on establishing equivalence based on intended use, physical/technical characteristics, and materials. It mentions the device "complies with all acceptance criteria listed above" but these criteria are not a quantitative set of performance metrics for proving efficacy or safety in a controlled study. Instead, they are statements of similarity to a predicate device.

However, based on the provided text, I can extract the following information which relates to acceptance but isn't a direct performance study:

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

None of the following information can be extracted from the provided text as it is not a performance study report:

2. Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set 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: Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for performance is described.
8. The sample size for the training set: Not applicable. This device does not use a training set in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable. This device does not use a training set.

Summary of the study/submission:

The provided document is a 510(k) Premarket Notification for the Glo-Spec™ Connector, Vaginal Speculum. The "study" concept here is not a clinical performance study with statistical metrics, but rather a demonstration of substantial equivalence to a predicate device (Welch Allyn's Kleenspec). The acceptance criteria are primarily based on qualitative and objective comparisons of intended use, materials, manufacturing processes, and design features with the predicate device. The "performance summary" states that the device is "constructurally equivalent" to existing predicate devices that have undergone millions of applications, implying its safety and effectiveness are established through the history of its predicate.

Ask a specific question about this device

• The intended use is to expose the interior of the vagina
• The intended use is to maintain a clear and protected area of view
  This device is to be used for exposing the interior of the vagina.

• The device is made of injected molded parts .
• The device assembly includes a window trap for pins to snap together ●
• The instrument has levels in the windows to lock positions as desired . by the expanding vertical blades
• The lateral blade protectors act to prevent lateral walls from cascading ● into view area.
• Lateral protector blades are same thickness of vertical blades thus act as rigid barriers
• Lateral protector blades conform with the design of vertical blade that . provide rigid conforming structures that allows smooth unchanged entrance
  The device once snapped together do not require any further assembly
• The device is for single use only

The provided text describes a 510(k) summary for the Nu-Spec D Vaginal Speculum. It does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in the way that would typically be associated with an AI/ML device or a device requiring new performance data.

Instead, the document focuses on substantial equivalence to a predicate device. This means the manufacturer is asserting their device is as safe and effective as a legally marketed device that FDA has previously cleared.

Here's a breakdown based on the information provided, explaining why some sections of your request cannot be fully answered due to the nature of this particular 510(k):

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: In a 510(k) based on substantial equivalence for a physical device like a speculum, "acceptance criteria" are generally derived from the features and performance of the predicate device. The device is deemed "accepted" if it is shown to be substantially equivalent in design, materials, and intended use, and does not raise new questions of safety or effectiveness. The Nu-Spec D highlights its differentiating features (lateral wall protectors) as improvements without compromising equivalence in core functions.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This 510(k) summary relies on a claim of "constructural equivalence" to a predicate device that has undergone "millions of applications," rather than a specific test set of data for the Nu-Spec D itself. No new clinical or performance study data with a distinct test set is provided or referenced for the Nu-Spec D.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. No new test set requiring expert ground truth establishment is referenced.

4. Adjudication Method for the Test Set:
Not applicable. No new test set requiring adjudication is referenced.

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 manual medical instrument (vaginal speculum), not an AI/ML device, and no MRMC study was conducted or is relevant to its clearance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (the Cooper Speculum) through its extensive use in millions of applications, as well as the comparison of physical and technical characteristics.

8. The Sample Size for the Training Set:
Not applicable. No "training set" in the context of AI/ML or statistical modeling is relevant to this device submission.

9. How the Ground Truth for the Training Set was Established:
Not applicable. As above, no training set or ground truth in that context is relevant.

In summary: The submission for the Nu-Spec D Vaginal Speculum leverages the established safety and effectiveness of a predicate device (the Cooper Speculum) through a claim of "substantial equivalence." The "study" proving it meets acceptance criteria is primarily an analysis of its design, materials, and intended use in direct comparison to the predicate, with additional claims that its new features enhance safety without altering core utilization. It is a traditional 510(k) submission for a physical, manual instrument, not a data-driven or AI-enabled device.

Ask a specific question about this device