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The TransMotion Medical Model TMM6 Power Drive Chair is intended to provide a method of transporting patients within health care facilities.
The TransMotion Medical TMM6 Power Drive Chair is designed for use in short term (≤ 23 hours) health care facilities. Its' intended use is to provide a method of transporting patients within the facility.

The TransMotion Medical, Inc. TMM6 Power Drive Chair (TMM6) is a battery powered device designed for use in short term (≤ 23 hours) patient care facilities. Its intended function and use is to transport patients within the confines of the facility, where patient function and use is to transport patient used to support the patient during examinations, care is boing administer clinical activity which may take place in the facility.
The TMM6 is unique in that it can support and transport patients in either a supine The TMMO is unique in that it can supportures 1 and 2 below). This enhances patient (laying) poregivers and also provides for greater patient comfort.

The provided 510(k) Premarket Notification for the TransMotion Medical TMM6 Power Drive Chair does not contain the detailed information necessary to complete most of the requested table and study details. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria and specific test results from a clinical trial.

Here's an analysis of what information can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Missing from the document concerning acceptance criteria and performance:

• Quantitative performance metrics: The document lacks specific, measurable acceptance criteria for aspects like battery life, weight capacity, maneuverability, braking effectiveness, stability, patient comfort scores, or reliability data.
• Actual test results: While it states "compliance" with standards, detailed results demonstrating this compliance (e.g., EMC emission levels, safety test outcomes) are not provided.

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

• Sample size for test set: Not applicable/not provided. This 510(k) submission primarily relies on demonstrating compliance with voluntary standards and substantial equivalence to a predicate device, not on clinical performance data from a specific test set of patients or users.
• Data provenance: Not applicable/not provided. There is no mention of country of origin or whether data would be retrospective or prospective because a clinical study with a test set as commonly understood for AI/diagnostic devices was not performed.

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

• Not applicable. There is no mention of a test set requiring ground truth established by experts.

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

• Not applicable. No test set requiring adjudication is 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

• No. This device is a powered patient transport chair, not an AI-assisted diagnostic or operative device that would involve human "readers" or an MRMC study.

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. This device does not generate diagnostic output that requires ground truth validation. The "truth" in this context is the chair's ability to safely and effectively perform its stated functions, which would be assessed through engineering and safety testing against defined specifications.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable.

Summary of Device and Approval Process:

The TransMotion Medical TMM6 Power Drive Chair is a battery-powered device designed for transporting patients within healthcare facilities for short durations (≤ 23 hours). It can support patients in both supine and seated positions. The 510(k) submission primarily establishes substantial equivalence to a predicate device, the Stryker Powered Wheeled Stretcher (K022309), and states compliance with IEC 60601-1 (General Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) standards. The FDA's letter confirms that based on the provided information, the device is substantially equivalent, permitting its marketing. The approval process for such a device would heavily rely on engineering testing to confirm safety, electrical performance, mechanical integrity, and functional performance against its design specifications and relevant voluntary standards. Clinical trials or performance studies with patient outcomes data, as might be seen for novel diagnostic or therapeutic devices, are not typically required for this type of device seeking 510(k) clearance based on substantial equivalence.

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Intended use: In conjunction with a motorized handle (c.g. Power Stick M5/3), the POWER DRIVE ART1 2304 serves as a drive unit for Richard Wolf rotary blades/abraders for the removal of tissue during endoscopic intervention. Simultaneous evacuation (suction) allows continuous removal of the ablated tissue. In conjunction with Power Drill M1, bones can be severed or machined.
Indications and field of use: The product is used in conjunction with endoscopic accessories for the following purposes:

• . In arthroscopy, e.g. resection of the meniscus, for removing soft tissue as well as intraarticular severing or abrasion of bone tissue (e.g. ACL or shoulder applications).
• In theracte surgery, e.g. for the removal of hematomas. .
• In sinus surgery, e.g. for the removal of polyps.
• . In spinal surgery (arthroscopic microdiskectomy (AMD) for removing degenerated tissue.

The POWER DRIVE ART1 2304 is an enhanced version of our POWER CONTROL 2303, cleared in K030082. The new device has new electronics, new software, additional motor handles, tools and tool holders such as rotary blades/ abraders, saws, sagittal and reciprocal saw attachments, drill chucks, drills and surgical wires.
The POWER DRIVE ART1 2304, consisting of: generator, motor handles, tools (such as rotary blades/ abraders, sagittal and reciprocal saws, drills and surgical wires) and tool holders (such as sagittal and reciprocal saw attachments and drill chucks).
Additional features are new motor handles, some with integrated keypad as well as automatic tool recognition with the new rotary blades and abraders (via RFID technology) and a touch screen for user control.
Multiple use devices are not provided sterile; they must be startlized per their instruction before each use. Single use devices are provided sterife and designed for only one use on or in-a single patient.
Via the integrated CAN-BUS interface, the POWER CONTROL 2304 can be integrated into the R. Wolf RIWO NET SYSTEM with remote control, speech control, and touch-screen monitor.

The provided document is a 510(k) premarket notification for a medical device called "POWER DRIVE ART1 2304 with motor handles, tools and Accessories".

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for performance metrics) or report device performance in a quantitative manner.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices. The core argument is that:

• The new device has same indications, equivalent design, functions, and materials as previous devices.
• New technological characteristics (electronics, software, additional handles, automatic tool recognition, touch screen) have not diminished safety or effectiveness.
• The device is designed and tested to guarantee safety and effectiveness when used according to instructions.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text as none were provided.

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

• Sample Size for Test Set: Not applicable. No clinical tests or performance studies with a specific test set are mentioned in the document. The submission states, "No clinical tests performed."
• Data Provenance: Not applicable. As no clinical tests were performed, there is no associated data provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable. Since no clinical tests were performed and no ground truth determination process is described, this information is not available.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical tests or ground truth adjudication methods are mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document explicitly states "No clinical tests performed." Therefore, no MRMC study was conducted or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No. This device is a surgical instrument (drive unit for rotary blades/abraders, drills, etc.) and not an AI algorithm. Its performance is intrinsically tied to human operation. Therefore, a standalone performance study in the context of an algorithm is not relevant or reported.

7. Type of Ground Truth Used:

• Not applicable. As no clinical tests were performed, no ground truth was established or used in the context of device performance evaluation as would be seen in an AI/diagnostic device submission. The substantial equivalence argument relies on the inherent safety and effectiveness established for the predicate devices and the manufacturing/design process of the new device.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical medical instrument, not an AI model or software requiring a training set in the conventional sense.

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

• Not applicable. (See point 8 above).

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The Power drive System is a small battery-powered device, light-weight, low speed motor handpiece, for use in light general dental works where low speed and low torque is required.

The Power drive System is a small battery-powered device, light-weight, low speed motor handpiece, for use in light general dental works where low speed and low torque is required.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth for a medical device.

The document is a 510(k) summary for a device called "Power drive," which is a dental handpiece. It primarily focuses on the administrative aspects of the 510(k) submission, such as:

• Submitter details
• Date of summary
• Reason for submission
• Trade name and classification
• FDA's response letter
• Indications for Use statement

The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. The "Indications for Use" describes the device's intended purpose as "a small battery-powered device, light-weight, low speed roto-motor handpiece, for use in light general dental works where low speed and low torque is required."

Without information directly related to performance metrics, a study design, or validation results, it is impossible to complete the requested table or answer the specific questions about acceptance criteria and study details.

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