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The Noddle™ is indicated for use by patients who have physical limitations, weaknesses and/or limited communication abilities in order to assist them with summoning and communicating with their caregiver by controlling other devices such as the nurse call and speech generation devices. To use the noddle™ patients should be sufficiently cognitively intact so that they can produce intentional gestures and intend to communicate with caregivers.

The Voxello noddle™ is a patient assistive communication device that accepts signals from a sensor to determine when a disabled patient is attempting to intentionally gesture for control of a device or system. The Voxello noddle™ interprets the signals from the sensor to allow the user to control up to three output switches. These outputs may be connected via hardwire or Bluetooth connection to control or access devices such as nurse call stations, and/or speech generation devices.

Based on the provided text, the Noddle™ device is a powered communication system intended to assist patients with physical limitations in communicating with caregivers by controlling other devices (e.g., nurse call, speech generation devices). The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific study design (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance), and detailed ground truth establishment is not available in this document. The document describes a comparison to a predicate device rather than a de novo clinical performance study against defined acceptance criteria.

However, I can extract and infer some information:

1. Table of acceptance criteria and reported device performance:
   The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it relies on demonstrating compliance with safety standards and substantial equivalence to a predicate device.

   Acceptance Criteria	Reported Device Performance
   Compatibility with predicate device characteristics	"The Voxello noddle™is substantially equivalent to the commercially available Comfort Keyboard. These devices assist the patient in communicating and have similar characteristics."
   Meeting relevant safety standards	The Voxello noddle™ complies with all relevant EN/IEC 60601-1 Safety Standards, Particular and Collateral Standards, including:

• AAMI ES60601-1 *BEI Issued: 2006/03/09 (R2012) Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; Amd. C1: 2009, Amd. 2:2010
• CSA C22.2#60601-1 *DEI Issued: 2014/03/01 Ed: 3 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
• IEC 60601-1:2005 Ed.3+A1;C1:2014 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
• IEC 60601-1-2 Issued 2007/03/02 Ed: 3.0 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance; - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
• ISO 14971 Issued: 2007/10/01 Ed:2 Medical Devices - Application of Risk Management to Medical Devices |
  | Not introducing new safety hazards and effectiveness | "The Voxello noddle does not introduce any new indications for use, nor does the use of the systems result in any new potential hazard. Voxello believes the noddle to be substantially equivalent with the predicate device with respect to safety and effectiveness." |

2. Sample size for the test set and data provenance:
   Not explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence through engineering and design comparisons, and compliance with safety standards, rather than a clinical performance study using a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
   Not applicable (N/A) as no clinical "test set" and associated ground truth determination by experts are described in this 510(k) summary.

4. Adjudication method for the test set:
   N/A.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
   N/A. This 510(k) summary does not describe a clinical comparative effectiveness study, especially one involving human readers and AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) study was done:
   N/A. This device is a powered communication system that accepts signals from a sensor to allow a user to control other devices. Its evaluation appears to be technical and safety-focused, rather than algorithm performance in a standalone AI context.

7. The type of ground truth used:
   The "ground truth" implicitly used for this type of submission is:

   • Predicate device characteristics and performance: The Comfort Keyboard (K930044) serves as the benchmark for functionality and safety.
   • Safety and performance standards: Compliance with international and national medical electrical equipment and risk management standards (e.g., IEC 60601-1 series, ISO 14971).
   • Engineering and design documentation: Verification and validation activities demonstrating that the device design meets its specifications and doesn't introduce new risks.
     No clinical 'ground truth' based on expert consensus, pathology, or outcomes data from a patient cohort is mentioned for a new study.

8. The sample size for the training set:
   N/A. The document does not describe a machine learning algorithm that requires a training set. The device interprets signals from a sensor based on its design, not a learned model from a training dataset.

9. How the ground truth for the training set was established:
   N/A, as no training set for a machine learning component is described.

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