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The VMT™ System is designed for the evaluation of visuo-motor performance disturbances.

The VMT™ System is provided as follows:
a. Trade Name VMT™ System
b. Common and Descriptive Name - Ataxiagraph

The provided document for K971549, the VMT™ System - Ataxiagraph, contains limited information regarding the specific acceptance criteria and detailed study outcomes. It primarily serves as a 510(k) summary and FDA clearance letter, rather than a comprehensive clinical study report.

Here is an analysis based on the information provided, with details explicitly stated as "Not provided" where the document does not offer the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not provided.
• Data Provenance: Not provided. The document mentions "clinical studies have been performed," but does not specify where the data originated (e.g., country of origin, specific institutions) or if it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: Not provided. The document does not describe any study comparing human readers with and without AI assistance, as the VMT™ System is presented as a device for "evaluation of visuo-motor performance disturbances," implying a diagnostic or assessment tool rather than an AI-assisted diagnostic aid for human readers.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• The VMT™ System is described as a device for evaluation, implying it provides output that a human clinician would interpret to assess visuo-motor performance. The document does not specify a "standalone" performance study in the context of an AI algorithm, but rather a clinical evaluation of the device's overall safety and effectiveness. The nature of the device (an "Ataxiagraph") suggests it mechanically measures or quantifies performance, and a human then interprets these measurements.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not provided. Given the nature of a device for "visuo-motor performance disturbances," ground truth might refer to a clinical diagnosis of a condition affecting visuo-motor performance (e.g., balance disorders, neurological deficits), or established clinical scales/assessments. However, the document does not specify.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not provided. The document refers to "clinical studies" for evaluation but does not distinguish between training and test sets or provide sample sizes for either.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not provided. Given that specific training sets are not mentioned, neither is the method for establishing their ground truth.

General Summary of the Study Presented in the 510(k) Document:

The provided 510(k) summary, K971549 for the VMT™ System - Ataxiagraph, states that "Clinical studies have been performed and have concluded that the device was safe and effective for its intended use." This statement is the primary evidence presented to demonstrate that the device meets its acceptance criteria (which are implicitly those required for 510(k) clearance, i.e., substantial equivalence to predicate devices and demonstration of safety and effectiveness). The document does not provide details of these clinical studies, such as specific methodologies, sample sizes, performance metrics, ground truth definitions, or expert involvement. The safety and effectiveness conclusion is a high-level summary of the study outcomes without the supporting data or detailed statistical analysis typically found in a full study report. The predicate devices mentioned are the Equitest System (K851744) and The Pro & Smart Balance Master Systems (K946229), both from NeuroCom International, Inc., implying the VMT™ System's performance was compared to or demonstrated to be similar to these established devices in terms of function and intended use.

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SKAR-KARE™ is indicated for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.

SKAR-KARE™ is a device composed of an outer shell consisting of medical grade silicone sheets adherent to each other with a sealed internal component filled with medical grade silicone oil. It is a soft, semi-transparent rubbery device.

This document appears to be a 510(k) Premarket Notification for a medical device called SKAR-KARE™. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics typically seen in clinical trials for new technologies.

As such, the information requested for a comprehensive study description, including detailed acceptance criteria, sample sizes for test and training sets, expert qualifications, and specific performance metrics like effect sizes, is largely not present in the provided text.

Here's an analysis of what can and cannot be extracted from the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance criteria for a 510(k) submission are generally "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
• Reported Device Performance: No specific performance metrics (e.g., reduction in scar size, improvement in appearance, patient satisfaction scores) are reported in this document. The document confirms that the device is "intended for use in the topical management of hypertrophic and keloid scars" and that the FDA found it substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned. (e.g., country of origin, retrospective/prospective). This type of detail is not typically included in a 510(k) summary focused on substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned.

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

• MRMC Study: Not mentioned. This type of study is more common for diagnostic imaging AI devices, which is not the case here.
• Effect Size: Not mentioned.

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

• Standalone Performance: Not applicable. SKAR-KARE™ is a physical medical device (topical dressing), not an algorithm or AI.

7. The Type of Ground Truth Used

• Ground Truth: Not explicitly defined or used in the context of a "test set" as this is not a study reporting on diagnostic accuracy or AI performance. The basis for substantial equivalence is comparison to a predicate device, REJUVENESS™ (K953420), regarding intended use and technological characteristics.

8. The Sample Size for the Training Set

• Sample Size: Not applicable/not mentioned. There's no "training set" in the context of this device being a physical topical dressing.

9. How the Ground Truth for the Training Set was Established

• Ground Truth Establishment: Not applicable/not mentioned.

Summary of what is available from the provided text:

• Device Name: SKAR-KARE™
• Intended Use: Topical management of hypertrophic and keloid scars (do not use on open wounds).
• Predicate Device: REJUVENESS™ (K953420) by RichMark International Corporation.
• Device Description: An outer shell of medical grade silicone sheets with a sealed internal component filled with medical grade silicone oil; a soft, semi-transparent rubbery device.
• Regulatory Outcome: FDA found the device substantially equivalent (K973271) to the predicate device.
• Over-The-Counter Use: Permitted.
• No detailed clinical study data, performance metrics, or information on specific acceptance criteria beyond "substantial equivalence" is provided in this 510(k) summary.

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For the management of hypertrophic or keloid scars.

SCAR CARE™ is intended for use in the management of hypertrophic and keloid scars.

SCAR CARE™ is a device composed of an outer shell consisting of medical grade silicone sheets adherent to each other with a sealed internal component filled with medical grade silicone oil. It is a soft, semi-transparent rubbery device.

This document is a 510(k) summary for the SCAR CARE™ device and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The provided text focuses on:

• The FDA's 510(k) clearance letter for SCAR CARE™.
• General information about the regulatory process for medical devices.
• A 510(k) summary for SCAR CARE™ detailing its trade name, common name, predicate device (TopiGel™ Gel Sheeting), description, and intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as it is not present in the given text.

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