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LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server and two types of client interfaces, one that is provided by Windows client and one that is provided by a web client interface. LifeStream 5, like the predicate LifeStream 4.0, is configured to accept patient data that is acquired periodically and displayed retrospectively from Honeywell HomMed Patient Monitors (e.g. Genesis Touch). LifeStream 5 can also interface with 3nd party compatible medical device data systems (e.g. Govsphere TV). LifeStream 5 has the same intended use as the predicate, LifeStream 4.0. LifeStream 5, like LifeStream 4.0 is not intended for emergency use or real-time monitoring. Both are designed to retrospectively receive, display and store scheduled vital sign parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, ECG, peak flow, prothrombin time and retrospective PERS messages.

The Honeywell HomMed LifeStream™ 5 is a software program designed to retrospectively receive, display, and store monitored vital signs parameters and related data for review and interpretation by healthcare professionals. It is not intended for emergency use or real-time monitoring.

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific quantitative acceptance criteria for performance. The "acceptance criteria" here are implied by the claim of substantial equivalence in intended use, users, use environment, technological characteristics, and safety to the predicate device, LifeStream™ 4.0.

The performance reported is qualitative, stating that LifeStream 5 is substantially equivalent to LifeStream 4.0 and that differences "do not affect the relative safety and/or effectiveness."

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

The document does not specify a "test set" in the context of clinical performance evaluation using patient data. This 510(k) submission primarily relies on demonstrating substantial equivalence through non-clinical performance testing (bench testing) and comparison of technological characteristics with a predicate device.

Therefore, there is:

• No specific sample size for a test set of patient data mentioned.
• No data provenance (country of origin, retrospective/prospective) related to a clinical test set.

The "validation testing of complete systems" and "black box testing" likely used simulated data or internal test cases, but no details on their size or origin are provided.

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

Since there is no mention of a clinical test set requiring expert ground truth, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As there is no clinical test set with expert ground truth mentioned, no adjudication method is described.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical and functional comparison to a predicate device and non-clinical testing, not on comparative effectiveness with human readers.

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

The device itself is a "standalone, prescription-based software program" for retrospective display and storage of vital signs, intended for use by healthcare professionals for review and interpretation. The "Performance / Bench Testing" section describes functional, validation, automated regression, black box, localization, and deployment testing, along with "External evaluation by Honeywell clinical team." This evaluation represents the standalone performance of the software in its intended function of receiving, displaying, and storing data correctly, as it is a device intended to assist human professionals, not to make diagnoses autonomously. However, these are engineering/software tests, not clinical performance studies measuring diagnostic accuracy of an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance/bench testing, the "ground truth" would be established by the expected behavior and output defined in the software's functional specifications and requirements. For example:

• Functional Testing: The "ground truth" is that the software correctly performs its intended function (e.g., displaying specific vital sign data accurately, registering alerts based on defined thresholds).
• Validation Testing: The "ground truth" is that the complete system meets all specified requirements.
• Automated Regression Testing: The "ground truth" is that previously corrected defects remain fixed and new changes haven't introduced new errors.

There is no mention of pathology, outcomes data, or expert consensus serving as ground truth for a clinical dataset in this submission.

8. The Sample Size for the Training Set

Not applicable. This submission describes a medical device, LifeStream™ 5, which is a software system for managing vital signs data. It is not an AI/Machine Learning algorithm that typically requires a "training set" of data to learn patterns or make predictions. The software's functionality is pre-programmed based on defined rules and specifications.

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

Not applicable, as there is no training set for an AI/Machine Learning algorithm. The software's "ground truth" for its development would be its functional and system requirements.

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The Podimetrics Remote Temperature Monitoring System™ (RTM System™) is intended to be used by a patient in conjunction with a healthcare professional or caretaker for periodic evaluation of the temperature over the soles of the feet for signs of inflammation. It will provide information indicating when the patient and healthcare provider should communicate for further evaluation and treatment regarding any persistent localized inflammation observed on the feet via the electronic sensing system and remote visualization of its data. The Podimetrics RTM System™ is intended to be used under the direction of a healthcare professional as an adjunct to, and not in replacement of, self-examination and periodic foot care and examination conducted by a healthcare professional and does not diagnose any specific disease state.

The Podimetrics RTM System™ is designed to help a patient and healthcare professional periodically evaluate the temperature over the soles of the feet for signs of inflammation. This evaluation may be helpful for determining when the patient and healthcare provider should communicate for physical examinations or care in addition to normally scheduled visits.

The system is comprised of the Podimetrics Mat and the Thermogram Explorer™ internet application. The Podimetrics Mat is about the same size and shape as a floor mat and placed on the floor of the patient's home. The patient stands on the mat once per day for about 20 seconds to collect a thermal scan of the soles of the feet. The thermal scan is recorded electronically via 2-dimensional array of temperature-sensitive resistors covering the top surface of the mat and the data is transmitted by an internal cellular modem to a remote server via cellular network.

The thermal scan data is processed and stored on the remote server and is displayed in Thermogram Explorer™, an internet application. The patient and healthcare professional can use Thermogram Explorer™ to access the thermograms and evaluate them for signs of inflammation. If any signs are observed, the patient can see the healthcare professional for a physical examination.

The Podimetrics Remote Temperature Monitoring System™ underwent a series of bench tests to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Human Factors Study (Mat Use): A "14-day in-home human factors study" was conducted. The document does not specify the exact number of participants, but it implies a sample of patients. No specific country of origin is mentioned, but "in-home" suggests users in typical environments. The study was prospective in nature.
• Other tests (Accuracy, Scan Time, Battery Life, Service Life, Electrical Safety, Wireless Data Transmission, Biocompatibility, Floor Safety, Shipping): These appear to be bench testing or laboratory-based tests. The document does not specify sample sizes for these tests, which is typical for engineering and material performance assessments rather than clinical trials. The data provenance is laboratory testing.

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

• The document does not mention the use of experts to establish ground truth for the performance characteristics. Most of the tests are objective engineering or physical performance measurements (e.g., temperature accuracy, battery life, electrical safety standards).
• For the human factors studies, users themselves were the evaluators of their experience, not experts establishing a medical ground truth.

4. Adjudication method for the test set:

• No adjudication method is described, as the tests primarily involve objective measurements or user feedback rather than subjective interpretations requiring expert consensus.

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 MRMC comparative effectiveness study was done. The device is a monitoring system and not primarily an AI algorithm for diagnosis or interpretation that would typically require such a study to demonstrate improvement in human reader performance.

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

• The document describes the device as a "Remote Temperature Monitoring System™" and an "adjunct to, and not in replacement of, self-examination and periodic foot care and examination conducted by a healthcare professional." While the system processes and visualizes data, it is not presented as a standalone diagnostic AI algorithm. The performance characteristics focus on the accuracy and reliability of the physical device and its data transmission, not the diagnostic accuracy of an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth for most of the performance characteristics (e.g., accuracy, battery life, electrical safety) is based on established engineering and physical measurement standards.
• For the human factors studies, the "ground truth" was user experience and their ability to use the device as intended, reported directly by the users. There is no mention of medical ground truth (like pathology or clinical outcomes) being established for these specific performance tests, as the device's main function is data acquisition and presentation, not medical diagnosis.

8. The sample size for the training set:

• The document does not describe an AI algorithm or machine learning component that would require a distinct "training set" in the context of typical AI device development. The device's function is explained as an electronic sensing system that records and displays thermal scan data.

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

• As no training set for an AI algorithm is described, this question is not applicable based on the provided text.

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The Constant Care LILAH Home Health Monitoring System is a non-emergency, delayed, remote patient monitoring device available by prescription. The Constant Care LILAH Home Health Monitoring System is designed to be used in the home of a patient or healthcare setting to provide remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and realtime video conferencing technology.

The Constant Care LILAH Home Health Monitoring System connects to commercially available wireless and wired medical devices such as glucose meters, weight scales, blood pressure monitors, electronic thermometers, peak-flow meters and pulse oximeters. The Constant Care LILAH Home Health Monitoring System stores and displays the information on a computer screen and transmits the information to the Caretaker Portal secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless, Internet, or Ethernet.

Healthcare professionals and remote caregivers can review the transmitted information unilizing the Caretaker Portal and set thresholds to trigger non-emergency alerts based on specific thresholds being exceeded.

The Constant Care LILAH Home Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when timecritical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use, Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered.

The Constant Care LILAH Home Health Monitoring System - Multi-User Version is a software device consisting of two components: patient-side software to be installed on hardware compatible with an Asus EeeTop PC ET1611PUT 15.6 inch TouchScreen Atom D425 All-in-One PC, or an Acer ICONIA Tab W500-C52G03iss 10.1' LED Tablet PC for use in performing patient monitoring, and sending data to the Caretaker Portal secure host server; and caregiver-side software for receiving patient-side data and transmitting that data to healthcare professionals and remote caregivers through the Caretaker Portal secure host server.

The patient-side software component is offered in two different versions. The single-user version, designated as "LILAH Version 1.1," is designed to be used by one individual, and is streamlined for simplicity of use. The multi-user version, designated as "LILAH Multi-User," allows for multiple individuals to be monitored through a single application. Changes covered by this clearance are applicable to both the LILAH Multi-User and LILAH Version 1.1 versions of the patient-side software component.

The Constant Care LILAH Home Health Monitoring System - Multi-User Version is a remote patient monitoring device available with or without prescription designed to be used in the home or healthcare setting of patients undergoing remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System - Multi-User Version can be used to monitor and track a single patient or multiple patients. The Constant Care LILAH Home Health Monitoring System - Multi-User Version provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and real-time video conferencing technology.

Here's an analysis of the provided text regarding the Constant Care LILAH Home Health Monitoring System:

This 510(k) summary does not contain the information requested about acceptance criteria and a study proving the device meets them.

The document is a 510(k) submission, which is a premarket notification for medical devices. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed performance study results against specific acceptance criteria.

The key statement regarding performance is: "Results of software validation and verification activities establish the device as safe and effective for its intended use, which is comparable to other predicate devices." This is a general statement and does not provide specifics about the studies or acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document. Here's a breakdown of what can be inferred or is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in this document. The document states that "software validation and verification activities establish the device as safe and effective," but it does not specify acceptance criteria or report specific performance metrics from those activities.

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

Not available in this document. No details about a specific test set, its size, or data provenance (e.g., country of origin, retrospective/prospective) are provided.

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

Not available in this document. Since no specific test set or ground truth establishment is described, this information is not present.

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

Not available in this document. No information on adjudication methods for a test set is provided.

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

Not applicable/Not available in this document. The Constant Care LILAH system is a remote patient monitoring system that provides data, reminders, and communication tools. It is not an AI-driven diagnostic or interpretative tool that would typically involve human "readers" improving performance with AI assistance in the way a MRMC study would measure for imaging or pathology. The document does not describe any such study.

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

Not available in this document. The device is described as a system integrating patient data, providing guidance, and connecting to healthcare professionals. Its function isn't primarily a standalone algorithmic interpretation in the way, for example, an AI-powered diagnostic algorithm would be evaluated. The "software validation and verification activities" likely focused on the software's functionality, data integrity, and compliance with its intended use, rather than a standalone performance metric against a ground truth.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not available in this document. No specific ground truth type is mentioned as no detailed performance study is described. The "validation and verification activities" would typically involve testing the system's functions (e.g., data transmission, alarm triggering, user interface functionality) against design specifications and user requirements.

8. The sample size for the training set

Not applicable/Not available in this document. This device is a software system for monitoring, not a machine learning or AI model that requires a "training set" in the conventional sense of supervised learning. Its "training" would be its software development and testing phases.

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

Not applicable/Not available in this document. As with point 8, the concept of a "training set ground truth" is not relevant for this type of device based on the information provided.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and broadly states that "software validation and verification activities establish the device as safe and effective." It does not delve into the detailed performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert evaluations that would be expected for a device with an AI/ML component performing diagnostic or interpretative tasks.

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EZ-ASSIST-FILL is intended to assist the user with refilling a portable liquid oxygen tank. The device is for use in homes or clinics. The EZ-ASSIST-FILL is neither a life-sustaining, nor life-supporting device. The device is intended for Over-the-Counter use.

EZ-ASSIST-FILL is designed to support any combination of portable and reservoir units that use downward pressure to effect the transfer connection. EZ-ASSIST-FILL consists of a telescoping spring arm assembly mounted on a fiberglass base plate using pivot which allows the spring arm to rotate through 90 degrees to swing over the portable unit when in refill position. The entire unit is held in place by the weight of the reservoir, which rests entirely on the base plate. There is no need to remove the reservoir from EZ-ASSIST-FILL between uses.

Here's a breakdown of the acceptance criteria and the study details for the EZ-ASSIST-FILL, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document states that "EZ-ASSIST-FILL devices were tested," implying multiple units, but a specific number is not provided.
• Data Provenance: The study was a bench test conducted by the submitter (Assist Fill, LLC), not clinical data from patients. The country of origin for the data is not explicitly stated but would presumably be the location where Assist Fill, LLC conducted their testing. It is a prospective test in the sense that units were tested according to a pre-defined protocol.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth was based on the direct observation and measurement of the device's functionality during bench testing against predetermined criteria, rather than expert interpretation of data.
• Qualifications of Experts: Not applicable for establishing ground truth in this context.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The results of the bench test were objectively measured against technical specifications, not subject to human expert adjudication.

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

• MRMC Study Done? No. This device is a physical daily activity assist device, not an imaging or diagnostic device that would typically involve human readers. Clinical testing was explicitly stated as not performed.

6. Standalone Algorithm Performance

• Standalone Performance Done? Yes, in the sense that the device's performance was evaluated purely on its own mechanical function during the bench test, without human intervention during the filling process once the device was in position. However, it's not a "standalone algorithm" in the typical sense of AI/software performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was objective functional criteria established for the device's operation. This involved verifying that the device held the tank in place without manual intervention and that the tank was successfully filled.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical assist device, not an AI/machine learning algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable.

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The Constant Care LILAH Home Health Monitoring System is a non-emergency, delayed, remote patient monitoring device available by prescription. The Constant Care LILAH Home Health Monitoring System is designed to be used in the home of a patient or healthcare setting to provide remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System provides guidance in operating medical sensor devices: reminders for medication compliance and connectivity to healthcare professionals through text messaging and realtime video conferencing technology.

The Constant Care LILAH Home Health Monitoring System connectally available wireless and wired glucose meters, weight scales, blood pressure monitors, medication reminders, and pulse oximeters. The Constant Care LILAH Home Health Monitoring System stores and displays the information on a computer screen and transmits the information to the Caretaker Portal secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless, Internet, or Ethernet.

Healthcare professionals and remote caregivers can review the transmitted information utilizing the Caretaker Portal and set thresholds to trigger non-emergency alerts based on specific thresholds being exceeded.

The Constant Care LILAH Home Health: Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real, time data: The data is made available to the patients when timecritical care is not required. The device is contraindicated for patients requiring direct medical or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered.

A list of devices that are compatible with the Constant Care LILAH Home Health Monitoring System will be available in the user's manual and the Constant Care website.

The Constant Care LILAH Home Health Monitoring System consists of two components: patient-side software to be installed on either an Asus EeeTop PC ET1611PUT 15.6 inch TouchScreen Atom D425 All-in-One PC, or an Acer ICONIA Tab W500-C52G03iss 10.1' LED Tablet PC for use in performing remote patient monitoring, and sending data to the Caretaker Portal secure host server; and caregiver-side software for receiving patient-side data and transmitting that data to healthcare professionals and remote caregivers through the Caretaker Portal secure host server.

The provided text is a 510(k) summary for the Constant Care LILAH Home Health Monitoring System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study that details device performance against such criteria.

The text states: "Results of software validation and verification activities establish the device as safe and effective for its intended use, which is comparable to other predicate devices." This is a general statement about meeting regulatory requirements for safety and effectiveness, but it doesn't provide the detailed performance metrics, study design, or ground truth information typically associated with acceptance criteria tables and clinical or performance studies.

Therefore, I cannot answer most of your questions based on the provided text.

Here is a summary of what can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the text.
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: Not provided in the text. This type of study is more common for diagnostic AI tools, whereas this device is for remote monitoring.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "software validation and verification activities," which implies testing of the algorithm/software, but it does not detail a standalone performance study in a way that would allow for specific performance metrics to be extracted.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the text.
8. The sample size for the training set: Not provided in the text.
9. How the ground truth for the training set was established: Not provided in the text.

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The SentiCare PillStation is intended for medical purposes to provide alerts to patients and healthcare providers for pre-determined medication dosing schedules. The device incorporates wireless communication and electronic imaging.

The SentiCare PillStation includes an electronic pillbox for home use (the PillStation), and server software for communicating and programming the PillStation (PillStation Manager Software). The SentiCare PillStation is designed to assist individuals with medication organization, self administration, and adherence. Specifically, the PillStation is designed to aid individuals in medication organization and reconciliation: identify incomplete or inappropriate removal of medications with corrective feedback; teach and coach about medications and daily medical procedures; provide alerts of dose times; and ensure timely relills of all medications self-administration. The SentiCare PillStation is a daily assist device with many features to alert users and caregivers of pre-determined scheduled medication times: easy to use pill tray, pill bins highlighted by light-up indicators, pill alarms, and LCD serven messaging. Through PillStation's built in scanning system, high quality, static digital images are sent from the PillStation to PillStation Manager software. Remote monitors, are other alled "Call Center Advisors", monitor and verify PillStation's medication contents with PillStation users' prescriptions in order to keep track of medication aterts and verify that the user and/or caregiver has loaded their prescribed medications into the PillStation pill tray. This monitoring is accomplished through the PillStation Manager software. The SentiCare PillStation is a novel approach to medication organization and may be of great assistance to those individuals and caregivers who look to improve upon their own medication organization, adherence, and self administration.

The SentiCare PillStation is a daily activity assist device (medication reminder). The 510(k) summary states that "Applicable tests were carried out as part of the software design process, where the key functions of the SentiCare PillStation (including both the PillStation and the PillStation Manager software) were verified and/or validated. The results of the testing met specifications, and established the device as safe and effective for its intended use, which is comparable to other predicate devices."

However, specific acceptance criteria and detailed study results beyond this general statement are not provided in the 510(k) document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, particularly highlighting the unique feature of imaging the pill tray contents.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not available in the provided text.

Here is what can be extracted and what information is missing:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The document indicates that "Remote monitors, are other alled 'Call Center Advisors', monitor and verify PillStation's medication contents with PillStation users' prescriptions." These 'Call Center Advisors' might be considered the "experts" in the context of the device's function, but their number and specific qualifications are not detailed.

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

• Not specified. The text mentions "Remote monitors... monitor and verify PillStation's medication contents," which implies a form of verification, but no specific adjudication method (like 2+1) is described.

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 MRMC comparative effectiveness study is mentioned. The device's primary function is to assist users and caregivers, with "Call Center Advisors" monitoring. The document does not describe a study comparing human performance with and without AI assistance for tasks like image recognition, as the device itself does not perform image recognition.

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

• The device's core functionality involves imaging and uploading data, which is then monitored by human "Call Center Advisors." The 510(k) explicitly states: "the SentiCare PillStation does not perform image recognition or prohibit access to medications stored in the device." Therefore, a standalone algorithm-only performance study for image recognition would not be applicable, as that is not a function the device performs autonomously. The "standalone" testing described is of the system's "key functions" meeting specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for verifying medication contents appears to be the user's prescriptions, as verified by "Call Center Advisors." The document states they "monitor and verify PillStation's medication contents with PillStation users' prescriptions."

8. The sample size for the training set

• Not applicable/Not specified. This is not a machine learning device that requires a distinct "training set" in the conventional sense. The testing described is performance validation of software and hardware functions.

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

• Not applicable/Not specified, as there is no mention of a training set for a machine learning model.

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The Insulin Protector is designed to protect bottles of insulin while keeping them cool. It is not designed to carry or store human organs, fluids, or tissue in any form. This device's target population is people who require insulin.

The Medicool Insulin Protector™ is a capsule-like portable container designed to transport insulin in a temperature controlled environment and protect it from environmental shock and other trauma. The Insulin Protector™ essentially consists of three main parts: the cooling tray, the foam insulation, and the outer casing. The cooling tray is a hollow-walled plastic container which has a cavity formed therein. The cooling tray is filled with water, which can be refrigerated in an ordinary household refrigerator. The cavity in the cooling tray receives up to two bottles of liquid insulin. The bottom and sides of the cavity include a plurality of ribbed members to prevent direct contact between the insulin bottles and the side walls of the cooling tray. The cooling tray fits inside the foam insulation snuggly to minimize heat transfer and loss, thus effectively stabilizing the inside temperature. This sleeve insulating foam is manufactured by Marko Foam and referenced as BI-99. The foam is flexible and helps provide protection from shock and trauma to the insulin bottles being stored in the cooling tray. The foam has cavities in both the top and bottom sections to receive the removable cooling tray. When the cooling tray is inserted into the cavity, a portion of the cooling tray extends above the surface of the foam. However, when the top section is closed, the cooling tray extends into the cavity of the top foam. The foam insulation containing the cooling tray fits snuggly inside the outer casing. The outer casing is stitched together using Cordura material, which is quality fabric known for its durability and resistance to abrasion. A zipper is used to open and close the main compartment that holds the foam insulation and the cooling tray. On the outside of the bag are two smaller pockets that close the cooling these pockets are designed to hold accessories, such as syringes, alcohol wipes, swabs, etc.

This document describes the Insulin Protector™, a device for transporting insulin in a temperature-controlled, protected environment. The information provided is primarily focused on the device's physical and functional characteristics and the testing conducted to support its 510(k) submission.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Durability Test): "several trials using different methods of generating shock" - specific number not provided.
• Sample Size (Cooling Test): "Insulin vials in the only 2 variations that we have seen in our 22 years in business, a 10mL US vial and a 10mL EU vial." - This indicates the use of two types of insulin vials.
• Data Provenance: The tests were conducted internally by Medicool, Inc. ("Our test was conducted..."). The document does not specify a country of origin for the data beyond the company's location in Torrance, CA, USA. The studies appear to be prospective tests performed on the device itself.

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

• Not Applicable. The described tests are performance verification studies for a physical device, not diagnostic or clinical studies requiring expert ground truth for interpretation. The "ground truth" here is the physical state of the insulin bottles (intact vs. damaged) and the temperature of the insulin over time.

4. Adjudication Method for the Test Set

• Not Applicable. As these are physical performance tests, there is no mention of an adjudication process for subjective interpretation. The results are objective measurements (e.g., presence/absence of damage, temperature readings).

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

• No. This device is a physical container, not an AI or diagnostic tool that would typically involve human readers or MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

• Not Applicable. This is a physical product, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Physical Observation/Measurement:
  • For the durability experiment: The "ground truth" was the physical condition of the insulin bottles after various shock tests (e.g., whether they were damaged or preserved).
  • For the cooling experiment: The "ground truth" was the measured temperature of the insulin vials over a 12-hour period, compared against the manufacturer's safe temperature limit.

8. The Sample Size for the Training Set

• Not Applicable. As a physical device, there is no "training set" in the context of an algorithm or AI system. The device was likely designed and developed through iterative prototyping and engineering, not machine learning.

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

• Not Applicable. See point 8.

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TempStat" is a daily activity assist device that is intended to assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. TempStat" will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. TempStat™ is intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state.

The Visual Footcare Technologies TempStat® device is a daily activity assist designed to make the examination of the plantar surface of the foot simple and easy to accomplish. It consists of a plastic pancl that has a 2X convex mirror in the center third scction, with two polycarbonate plastic pads on either side of the mirror. The plastic pads are contructed primarily of liquid crystallinc cholesteric esters that react to skin surface temperature and change to a specific color relative to that level of temperature. With this device, the patient can visually examine his foot and also see a graphical representation of the heat pattern on the plantar solc of his foot. The device is designed to sit on the floor in front of the patient, who is seated in a chair. The patient leans over and raises his foot to see the bottom of his foot in the mirror, and then places them on the polycarbonate pads. After 60 seconds, the patient can remove his feet and can visualize the pattern of skin tempcrature from the plantar surface of his foot.

The Visual Footcare Technologies, LLC TempStat™ device, as described in the 510(k) summary, includes performance testing centered on the accuracy of its liquid crystal pads and its ability to assist patients in visualizing their foot's plantar surface. Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

Detailed Study Information

The provided 510(k) summary offers limited detail on the specific study methodologies for each criterion. Based on the available information:

1. Sample size used for the test set and the data provenance:

   • Temperature Accuracy Study: Not explicitly stated. The study references ASTM E 1061-01 Standard, which might specify sample sizes for such tests, but this detail is not present in the 510(k).
   • Patient Preference Study: Not explicitly stated. The text says "All study subjects felt...", which implies a sample was used, but the number is not provided.
   • Data Provenance: Not explicitly stated, but given it's for a US regulatory submission, it's highly likely to be US data, and given the nature of the device, likely prospective studies (i.e., experiments designed to test the device).

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

   • Temperature Accuracy Study: No experts were mentioned for establishing ground truth for the temperature accuracy. The ground truth would likely be established by a calibrated reference thermometer or laboratory equipment against which the device's color changes are compared, as per ASTM E 1061-01.
   • Patient Preference Study: No experts were described as establishing ground truth. This type of study relies on direct feedback from the "study subjects" themselves regarding their perception of the device's utility in visualization, rather than an expert's assessment of their visualization ability.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified for either study.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The studies focused on functional accuracy and user preference rather than reader performance.

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

   • Temperature Accuracy Study: This would be considered a standalone performance test of the device's physical components (liquid crystal pads) to accurately reflect temperature. It assesses the intrinsic accuracy of the temperature display mechanism.
   • Patient Preference Study: This involved human interaction ("study subjects" viewing their feet), so it was not standalone in the sense of "algorithm only."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Temperature Accuracy Study: The ground truth was likely established by reference to a calibrated temperature standard (e.g., a precise thermometer) as implied by the ASTM E 1061-01 standard.
   • Patient Preference Study: The "ground truth" was the self-reported perception of the study subjects regarding the device's assistance in visualization.

7. The sample size for the training set: Not applicable, as this device does not use machine learning algorithms that would require a training set. Its functionality is based on physical properties of liquid crystals and mirror optics.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

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The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.

The proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit thereby eliminating the need for a separate holder. The operating principle remains the same. The modified syringe holder accessory can still be used with both empty and prefilled (not the subject of this 510(k) application) Carpuject® Syringe Cartridges. The proposed name for this modification is the iSecure Syringe Cartridge Holder.

The provided text is a 510(k) summary for the iSecure Syringe Cartridge Holder. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. As such, most of the information requested in your prompt is not available in this document.

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

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

The document does not specify any quantitative acceptance criteria or numerical performance metrics for the iSecure Syringe Cartridge Holder. The "performance" described is largely qualitative, asserting that it functions the same as the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available in the provided document. The 510(k) relies on a comparison to a predicate device and does not detail specific new performance testing data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available. No such expert-verified test set is described.

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

This information is not available. No test set requiring adjudication is described.

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

An MRMC study was not done, as this device is a syringe cartridge holder, not an AI-powered diagnostic tool. The concept of "human readers improving with AI" is not applicable here.

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

A standalone performance study was not done in the context of an algorithm. This device is a mechanical holder, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to performance studies (especially for AI or diagnostic devices) is not applicable here. The substantial equivalence is based on the device's design and intended use being the same as the predicate.

8. The sample size for the training set

This information is not available. There is no "training set" as this is not an AI/machine learning device.

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

This information is not available. As above, no training set or ground truth in that context exists for this device.

Summary of available information regarding substantial equivalence (not a performance study):

The 510(k) summary for the iSecure Syringe Cartridge Holder focuses on demonstrating substantial equivalence to a predicate device, the Empty Sterile Carpuject® Cartridge Syringe holder Accessory.

• Basis for Equivalence: The claim for substantial equivalence is based on the following technological characteristics:
  • Both devices are intended to be used with either empty or prefilled Carpuject cartridges.
  • The technology and operating principles are the same for both devices.
  • The plunger rod for both devices is attached to the end of the syringe cartridge to actuate an injection.
• Proposed Change: The only proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit, eliminating the need for a separate holder. The operating principle, however, remains the same.

Therefore, while the document confirms the device meets the regulatory requirement for substantial equivalence, it does not provide the details of a quantitative performance study with specific acceptance criteria that you have requested.

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The PILL PHONE is a medication reminder and information system utilizing software that operates on a user's cell phone or other wireless device. The PILL PHONE will also have the ability to receive multiple question surveys from the PILL PHONE server.

The PILL PHONE software device will be sold to users of cell phones (or other communication devices) through their cell phone service. The software will have a feature to send out reminders to a cell phone owner of the dosing schedule that has been programmed into the phone, whether the dosing schedule is for the user, a child, or an elderly parent. The software will also enable the delivery of information about medications, such as indications for use, dosing, side effects, and even photographs of different pills. The PILL PHONE software is a Minor Level of Concern.

The provided text primarily focuses on the 510(k) summary and FDA clearance for the PILL PHONE medication reminder software device. It details the device's classification, predicate devices, and a brief description of its features. However, it does not include any information about formal acceptance criteria or a study proving the device meets specific performance criteria.

The document is a regulatory submission for market clearance based on substantial equivalence to existing devices, not a scientific study reporting performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details, sample sizes, expert qualifications, or ground truth establishment.

The relevant sections are:

• 1. A table of acceptance criteria and the reported device performance: Not found in the document.
• 2. Sample sized used for the test set and the data provenance: Not found in the document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found in the document.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not found in the document.
• 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: Not found in the document. The device is a standalone software, not an AI assistance tool for human readers in a diagnostic context.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as "software that operates on a user's cell phone or other wireless device" and is a "medication reminder and information system." This strongly implies a standalone algorithm providing reminders and information. However, no specific performance study is mentioned.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance study is described.
• 8. The sample size for the training set: Not found in the document.
• 9. How the ground truth for the training set was established: Not applicable, as no training set or ground truth for it is described.

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