Search Results

The NX System is intended to be used as a monitoring device when time-critical care is not required. The peripheral devices compatible with the NX System are blood pressure, pulse, weight, oxygen saturation, glucose and PT/INR. The NX System enables the home-bound patient to retrieve data taken by the peripheral devices and forward them to an off-site central location for access by a health care professional.

The NX System is a Telemedicine Communications Module. It uses a custom PC platform for its patient station (NX Monitoring Station) and has more interface options to stand-alone medical device peripherals. The NX system uses wireless technology to connect to the stand-alone medical devices. It obtains readings from medical device peripherals and forwards those data to the system's Server. The NX System has no internal medical devices.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the American TeleCare NX System, detailing its intended use, classification, predicate devices, and a substantial equivalence determination by the FDA.

Therefore, I cannot provide the requested information in a table or describe a study based on this document. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting performance data against specific acceptance criteria for a new study.

Ask a specific question about this device

Ask a specific question about this device

The Aviva SLX System is intended for use as a monitoring device, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds.

The Aviva SLX System and the predicate device (Aviva System) listed above have the same intended use and very similar principles of operation and technological characteristics. Specifically, both devices consist primarily of a blood pressure meter, a telephonic stethoscope, and a communications circuit. These devices are intended for use as monitoring devices, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds. Neither device is intended to be used for diagnostic purposes.

In general, basic operation of the devices consists of: (1) establishing voice/video communication; (2) establishing communication between the sending and receiving units of a telephonic stethoscope to obtain heart and lung sounds; and (3) obtaining blood pressure and pulse readings.

The only difference from the predicate Aviva System is that the Aviva SLX System has the capability to 1) transmit the blood pressure/pulse readings from the Patient Station to the Central Station and clear the readings from the blood pressure/pulse meter; and 2) obtain glucose readings from an off-the-shelf glucose meter plugged into the data port of the Patient Station and transmit those readings to the Central Station, as well as to clear the readings from the glucose meter. The Aviva SLX Systems use the same blood pressure meter and the same telephonic stethoscope as the predicate device.

The provided text does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a typical medical device study would.

Instead, the document is a 510(k) summary for the Aviva SLX Systems, which focuses on demonstrating substantial equivalence to a predicate device, not on proving new performance characteristics through independent studies with defined acceptance criteria.

Here's why the requested information cannot be extracted from this document:

• No acceptance criteria or performance study reported: The document states that the new device has "minor modifications" and "does not raise new questions of safety or effectiveness." This implies that extensive new performance studies (like those requiring acceptance criteria, sample sizes, ground truth, etc.) were not deemed necessary because the device is substantially equivalent to an already approved device.
• Focus on substantial equivalence: The core of this 510(k) filing is to show that the Aviva SLX System has the "same intended use and very similar principles of operation and technological characteristics" as the predicate device.
• Device purpose: The device is a "Telemedicine Communications Module" intended for monitoring and gathering basic physiological data (blood pressure, pulse, heart/lung sounds, glucose readings), not for diagnostic purposes. This type of device relies more on the accuracy and reliability of its integrated components (like blood pressure meters and stethoscopes which are often already cleared) and its communication capabilities, rather than a novel diagnostic algorithm that would require extensive clinical validation against a gold standard.

Therefore, I cannot populate the table or provide answers to most of your questions because the information is not present in the provided 510(k) summary.

Disclaimer: Without a formal performance study detailed in a 510(k) summary, specific acceptance criteria as you've outlined for diagnostic AI devices are not typically presented. Regulatory clearance for devices like the Aviva SLX often relies on demonstrating that the modifications do not negatively impact safety or effectiveness compared to a legally marketed predicate device.

Ask a specific question about this device

The PIM Systems are intended for use as a monitoring device, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds.

The Aviva Systems and the predicate devices listed above have the same intended use and very similar principles of operation and technological characteristics. Specifically, all three devices consist primarily of a blood pressure meter, a telephonic stethoscope, and a communications circuit. These devices are intended for use as monitoring devices, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds. None of the devices are intended to be used for diagnostic purposes.

In general, operation of the devices consists of: (1) establishing voice/video communication: (2) establishing communication between the sending and receiving units of a telephonic stethoscope; (3) obtaining and conveying a blood pressure and pulse reading; and (4) obtaining and transmitting heart or lung sounds.

The only difference from the Personal Telemedicine System is that the Aviva Systems contain a standards based (H.324) video phone instead of an older proprietary video phone. The difference from the PTM and Digital PTM is that the Aviva Systems include a video phone to be used with the PTM and Digital PTM. The Aviva Systems use the same blood pressure meter and the same telephonic stethoscopes as the predicate devices.

This 510(k) summary does not contain information regarding
acceptance criteria, device performance,
sample sizes, ground truth establishment, or any studies conducted (such as MRMC or standalone studies).

The document is a premarket notification for the American TeleCare's Aviva Systems, seeking substantial equivalence to previously marketed predicate devices. It focuses on describing the device's intended use, principles of operation, and technological characteristics, highlighting that it is a "Telemedicine Communications Module" used for remote monitoring and not for diagnostic purposes. The key difference mentioned is the use of a standards-based video phone in the Aviva Systems compared to older/proprietary models in the predicates.

Therefore, I cannot populate the requested table or answer the specific questions about studies, acceptance criteria, sample sizes, or ground truth from the provided text.

Ask a specific question about this device

The Digital Personal Telemedicine Module is intended to be used solely as a monitoring device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds.

The Digital Telemedicine Module ("Digital PTM") and the predicate devices listed above have the same intended use and principles of operation and very similar technological characteristics. Specifically, both the Digital PTM and the Personal Telemedicine Module ("PTM") consist primarily of a blood pressure meter, a telephonic stethoscope, and a speaker/microphone circuit; these three components are placed in a common housing but are not interconnected by hardware or software.

The provided text describes the 510(k) submission for American TeleCare's Digital Personal Telemedicine Module (K973873). The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel claim.

Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in the provided document. The submission is primarily a comparison to existing, already cleared devices.

Here's what can be extracted and inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The "acceptance criteria" here are implied by the substantial equivalence framework. The text doesn't explicitly state quantitative performance acceptance criteria for a new claim.)

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

The document mentions "clinical studies" for the telephonic stethoscope component but does not provide details on sample size, data provenance (country of origin), or whether these studies were retrospective or prospective. It is likely these were comparison studies to ensure the signal quality wasn't degraded, rather than studies designed to establish stand-alone clinical accuracy against a ground truth.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not provided in the document. The general nature of the device (a remote monitoring module for a healthcare professional) suggests that a traditional MRMC study for diagnostic performance improvement with AI assistance would not be applicable, as it's not an AI-powered diagnostic device. The device facilitates data transmission for human review.

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

This information is not provided in the document. The device is described as a "monitoring device" where a "health care professional can... communicate with the patient" and "listen to the patient's heart and lung sounds." This inherently implies human-in-the-loop operation, as the device's function is to transmit data to a professional.

7. The Type of Ground Truth Used

The document mentions "bench testing and clinical studies" demonstrating that modifications "do not adversely affect the quality of the transmitted signal" for the telephonic stethoscope. This implies the ground truth for these studies would likely be the signal quality of the predicate device (CareTone II) or an objective measure of acoustic fidelity, rather than clinical outcomes or pathology for a diagnostic claim (since it's explicitly stated "Neither device is intended to be used for diagnostic purposes").

8. The Sample Size for the Training Set

This information is not provided in the document. As the device is primarily a hardware module for transmitting data, and not a machine learning algorithm, the concept of a "training set" as it relates to AI/ML devices is not applicable here.

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

This information is not provided in the document. See point 8.

Ask a specific question about this device

The intended use of American Telecare, Inc.'s CareTone II is to conduct a stethoscope examination of a patient by a nurse or physician at another location using a communications line.

To use the CareTone, a patient plugs the sending unit's telephone cable into a telephone wall outlet and the examiner plugs the receiving unit's telephone cable into a telephone wall outlet. The examiner dials the patient's telephone number to connect the receiving unit and sending unit over the telephone line. When the connection is made, the patient places the stethoscope chest piece on his/her chest. The sounds captured by the chest piece are transmitted to the patient end unit of the sending unit by a microphone located within the chest piece. The signal is processed within the circuitry of the patient end unit and transmitted over the telephone line to the receiving unit and through headphones to the examiner.

The provided 510(k) summary for the American Telecare, Inc.'s CareTone II Telephonic Stethoscope is a submission seeking substantial equivalence to a predicate device, the CareTone Telephonic Stethoscope. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical study data for novel acceptance criteria.

Based on the provided text, the "acceptance criteria" discussed are primarily related to the equivalence in performance and safety to the predicate device rather than rigorously quantified clinical performance targets. The "study" proving this largely relies on engineering tests and a qualitative physician assessment.

Here's an attempt to answer your request based only on the provided text:

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

The text emphasizes: "It also has very similar principles of operation and technological characteristics as they both transmit an auscultatory signal to a receiver. The minor technological differences between the CareTone II and the CareTone, primarily, use of companding circuitry and the use of data communication cables, do not raise new questions of safety or effectiveness." This implies the "acceptance" is that these changes do not degrade effectiveness. |
| Intended Use: Device maintains the same intended use as the predicate. | Same Intended Use: "The CareTone II has the same intended use as the CareTone: to conduct a stethoscope examination of a patient by a nurse or physician at another location using a communications line." |
| Principles of Operation & Technological Characteristics: Similar to predicate. | Similarities stated: "It also has very similar principles of operation and technological characteristics as they both transmit an auscultatory signal to a receiver." |

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

The document does not specify a quantitative sample size for any clinical test set. The "physician assessment" is mentioned, but details on the number of patients, recordings, or the nature of the assessment (e.g., specific clinical scenarios) are absent. Data provenance is not specified (e.g., country of origin) and the assessment appears to be prospective in nature as it evaluates the new device specifically.

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

The document mentions "a physician assessment." It does not specify the number of physicians involved, nor does it detail their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1). The assessment is simply referred to as "a physician assessment."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No MRMC comparative effectiveness study is described. The assessment is qualitative and focuses on the signal quality of the CareTone II itself, rather than a comparative study of human readers with and without AI assistance. (Note: This device is a telephonic stethoscope, not an AI diagnostic tool, so an MRMC study in the context of AI assistance would not be expected.)

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

The CareTone II is a medical device for transmitting sounds, not an algorithm. Therefore, "standalone algorithm-only performance" is not applicable in the way it would be for an AI diagnostic tool. Its performance is intrinsically tied to human interpretation of the transmitted sounds. The "physician assessment" mentioned is effectively the human-in-the-loop performance.

7. The type of ground truth used

The concept of a formal "ground truth" (e.g., pathology, outcomes data) in the context of a diagnostic aid like a telephonic stethoscope is less straightforward than for a disease detection AI. For this device, the "ground truth" for its effectiveness is implicitly assumed to be the clinical interpretability and utility of the sounds transmitted by the device, as judged by a physician. The document states "a physician assessment of the quality of the signal received," which serves as the surrogate for "ground truth" in this context.

8. The sample size for the training set

This document describes a 510(k) submission for a physical medical device (telephonic stethoscope), not an AI algorithm. Therefore, there is no "training set" in the machine learning sense. The device is built based on established engineering principles and, in this case, by modifying an existing predicate device.

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

As there is no "training set" in the AI sense, this question is not applicable. The functional performance of the device (signal transmission) is verified through engineering tests and the qualitative physician assessment.

Ask a specific question about this device

The Personal Telemedicine is intended to be used solely as a monitorium device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, and to listen to the patient's heart and lung sounds.

The PTM 1 consists of a blood pressure meter, a telephonic stethoscope and a speaker/microphone circuit. Both the blood pressure meter and telephonic stethoscope have been cleared by FDA. Neither device has been altered for use with the PTM 1. Instead, they have been placed in a common enclosure for the convenience of the patient. The principal differences between the PTM 1 and the PTS are: (1) the removal of the videophone; (2) the addition of the speaker/microphone circuitry, and (3) the modification of the enclosure.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for American Telecare, Inc.'s Personal Telemedicine Module, focusing on its substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily discusses the device's intended use, its components (blood pressure meter, telephonic stethoscope, and speaker/microphone circuit), and justifies its substantial equivalence by highlighting that its core components were previously cleared by the FDA and the modifications do not raise new safety or effectiveness concerns. It mentions that the company "has conducted testing which demonstrates the compatibility of this device in the new enclosure," but provides no details about this testing, its criteria, or results.

Ask a specific question about this device

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.

Ask a specific question about this device