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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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The American TeleCare, Inc. Personal Telemedicine System (PTS) is intended to be used to transmit medical information between a patient at one location, typically in their home, and a medical practitioner at another location, typically a home care nurse at a central nursing station. Information is transmitted over normal residential telephone lines and utilizes two-way video and voice communication.

The PTS is typically used in home health care situations as an augment to home care nursing.

In essence, the PTS allows a medical practitioner to make a "video-visit" TM to the patient rather than a physical visit. In this "video-visit," the medical practitioner can conduct many of the same diagnostic tests that would be performed in a physical visit.

The Personal Telemedicine System (PTS) is an assembly of medical products, each of which was previously cleared by the FDA for commercial distribution to patients for their in home use. These products are assembled into a housing which incorporates a videophone and speakerphone and thereby allows a medical practitioner to communicate directly with a patient in a remote location, both verbally and visually, to perform an examination.
Use of the PTS begins by either the medical practitioner placing a call to the patient's videophone or the patient pushing the "CALL" button on the PTS unit to notify the medical practitioner to call them. The medical practitioner then determines the patient's status through questions and answers, through visual examination via the videophone, and through use of the medical products. Visual examination is enhanced by the patient placing themselves in relation to the camera portion of the videophone and by use of a specially made magnifying lens placed in front of the camera portion of the videophone. The medical practitioner walks the patient through use of the medical products and the results of each test are presented verbally to the medical practitioner.

The medical products in the PTS unit are being used for the same purposes for which they received 510(k) clearance. The unit as a whole, however, has never been submitted to the FDA for clearance.

Here's an analysis of the provided text regarding the Personal Telemedicine System (PTS), focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain specific acceptance criteria or quantitative performance data in a format that lends itself to this table. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than a stand-alone performance study with defined criteria and results.

Instead, the document asserts:

• The constituent medical devices within the PTS "were previously cleared by the FDA for commercial distribution to patients for their in home use."
• "The medical products in the PTS unit are being used for the same purposes for which they received 510(k) clearance."
• The PTS, as an assembly, allows "a medical practitioner to communicate directly with a patient in a remote location, both verbally and visually, to perform an examination."
• This enables the medical practitioner to "conduct many of the same diagnostic tests that would be performed in a physical visit."

Therefore, the "acceptance criteria" are implicitly that the integrated system functions as intended for telemedicine, leveraging the existing clearances and functionalities of its components. The "reported device performance" is the assertion that it achieves this without new safety or effectiveness concerns.

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

The 510(k) summary does not describe a specific test set, sample size, or data provenance (country of origin, retrospective/prospective) for a clinical study to evaluate the PTS as a whole. The submission relies on the prior clearances of its individual components.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No specific study requiring expert-established ground truth for the PTS as an integrated system is described in this summary.

4. Adjudication Method

Not applicable. No study or ground truth establishment process requiring adjudication is described.

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

No. The summary does not mention an MRMC study comparing human readers with and without AI assistance. The PTS is a communication system, not an AI diagnostic tool.

6. Standalone Performance (Algorithm Only)

Not applicable. The PTS is an integrated communication and medical device system involving human interaction, not a standalone algorithm. Its performance is tied to its functional components and the human practitioner's use.

7. Type of Ground Truth Used

Not applicable in the context of a new efficacy study for the PTS. The "ground truth" for the individual components of the PTS would have been established during their initial 510(k) clearances, likely through a combination of performance testing, clinical data, and comparison to predicate devices. For the PTS itself, the ground truth is its ability to facilitate remote medical consultation using these pre-cleared components as intended.

8. Sample Size for the Training Set

Not applicable. The PTS is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, no training set is mentioned or implied for this device.

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