Search Results

The SOLOPASS 2.0 System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intraventricular catheter.

The SOLOPASS® 2.0 System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy without the use of preoperative imaging. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location.

The SOLOPASS® 2.0 System consists of three main sub-systems:

1. The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.
2. The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
3. The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.

Ask a specific question about this device

The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons and urologists.

The intended use of the DEXTER ENDOSCOPE ARM is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The DEXTER ENDOSCOPE ARM is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, DEXTER ENDOSCOPE ARM is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the DEXTER ENDOSCOPE ARM are general surgeons, gynecologists, cardiac surgeons and urologists.

The intended use of the ARTip solo is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The ARTip solo is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, ARTip solo is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic, decompression fixation, wedge resection, lunq biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the ARTip solo are general surgeons, gynecologists, cardiac surgeons and urologists.

DEXTER ENDOSCOPE ARM and ARTip solo + ARTip solo voice are based on the same concept as the already cleared SOLOASSIST II + Voice Control (K200473) and differ only in minor details. All 3 robotic arm systems emulate an arm operating in multiple degrees of freedom. The intended use of the three robotic arm systems is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The surgeon can control the arm with either a joystick, voice control, or by pressing a button on the distal end of the arm. Movement is controlled by 3 motorized axes. The endoscopic camera is registered in the TROCAR POINT, which serves as the pivot point. Starting from this zero point, the device independently calculates the required individual movements of the axes to achieve the desired overall movement. The system offers a wide range of motion, allowing a 360° panoramic view with the endoscope tilted up to 90° from the vertical. Despite their wide range of motion, all arms are lightweight and compact and are attached directly to the operating table with a quick-release clamp. Only a STERILE COVER is required for safe use.

The ARTip solo is functionally identical to the already cleared SOLOASSIST II (K200473), but differs only in the color and inscription of the covers and the visual design of the control panel on the arm.

The ARTip solo can also be controlled with the ARTip solo voice. This is also identical to the already cleared VOICE CONTROL (K200473) except for the color and inscription. The ARTip solo is not compatible with the VOICE CONTROL (K200473).

In addition, the ARTip solo can also be controlled with a joystick. It can only be controlled with the JOYSTICK-IH-IA or JOYSTICK-RH-IIA, which are specially made for the ARTip solo and are only compatible with it.

DEXTER ENDOSCOPE ARM is the trade name of the SOLOASSIST IID, which was developed within the SOLOASSIST II. The special feature of the DEXTER ENDSCOPE ARM is that it provides an interface to a customer-specific device and can be controlled by it.

The arm can also be controlled by the JOYSTICK LH and JOYSTICK RH.

The SOLOASSIST IID has its own CANTILEVER, JOINT, PROBE PIN and ENDOSCOPE CLAMP, which in combination with a tension sleeve hold the endoscope.

I am sorry, but the provided text does not contain the detailed information necessary to complete some sections of your request. Specifically, it lacks data on:

• Specific acceptance criteria for individual performance metrics.
• Sample sizes for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone algorithm performance.
• Type of ground truth for the test set.
• Sample size for the training set.
• How ground truth for the training set was established.

The provided text focuses on demonstrating substantial equivalence to a predicate device based on technological similarity and non-clinical testing. It states that new devices "can be classified as equally safe and effective as the predicate device" based on these tests, but does not provide specific performance metrics or detailed study designs for acceptance criteria.

Therefore, I cannot populate all the requested fields. However, I can provide the information that is present in the document which describes the testing and conclusions regarding the devices' safety and effectiveness.

Here's a summary of the available information based on your request:

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

The document does not explicitly list specific numerical acceptance criteria or quantitative performance metrics for the device. Instead, it refers to non-clinical tests carried out with predicate devices and additional tests for the new devices to "prove the safety and effectiveness with regard to the differences to the predicate device." The conclusion is that the new devices are "as safe and effective as the predicate device."

• Acceptance Criteria: Not explicitly stated with numerical values. The implicit acceptance criterion is likely to demonstrate equivalence in safety and effectiveness to the predicate device through successful completion of the listed non-clinical tests and software verification.
• Reported Device Performance: The document concludes that "The non-clinical tests have shown that the SOLOASSIST IID, ARTip solo voice and SOLOASSIST II + VOICE CONTROL are as safe and effective as the predicate device." No specific quantitative performance data (e.g., accuracy, precision, error rates) are provided.

Table of Acceptance Criteria and Reported Device Performance (Based on provided text, specific metrics are not detailed)

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

The document does not specify sample sizes for test sets, nor does it provide information on data provenance (country of origin, retrospective/prospective) as the tests described are non-clinical, likely bench testing.

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 applicable. The tests mentioned are non-clinical (e.g., temperature, lifetime, functional tests) and do not involve expert-established ground truth in the context of diagnostic interpretation.

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

Not applicable, as expert adjudication for ground truth is not mentioned for the non-clinical tests.

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. The device (SOLOASSIST IID / DEXTER ENDOSCOPE ARM, ARTip solo, ARTip solo voice, SOLOASSIST II, VOICE CONTROL) is described as a robotic computer-driven system to hold and position endoscopes, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is outside the scope of this device's intended use and the provided documentation.

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

This refers to a standalone performance of the entire device system (robotic arm with its software and controls), not a standalone algorithm in the context of AI diagnostic performance. The non-clinical tests described (e.g., temperature, lifetime, functional tests for various components and control methods) represent tests of the device in its standalone (intended operational) capacity, without human intervention for evaluation of diagnostic output. The device itself is designed to be operated by a human surgeon.

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

For the non-clinical tests conducted, the "ground truth" would be established by engineering specifications, physical measurements, and functional requirements of the device and its components (e.g., a power supply providing the correct voltage, a quick-release connector functioning as designed, voice commands being correctly interpreted). It is not expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. The sample size for the training set

Not applicable, as the document describes a robotic surgical assistant system and associated controls, not an AI algorithm that requires a "training set" in the machine learning sense for diagnostic purposes. The software changes mentioned are related to bug fixes, parameter additions, and compatibility checks, not statistical model training.

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

Not applicable, for the same reason as point 8.

Ask a specific question about this device

SOLO-L is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.

SOLO-L is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

SOLO-L 2-screw cages may be used as a standalone device only when two vertebral body bone screws are used. SOLO-L 4-screw cages may be used as a standalone device only when at least two vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use SOLO-L anterior cages with fewer than two screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.

SOLO-L is an anterior lumbar interbody fusion device (ALIF) intended to improve stability of the spine while supporting fusion. The SOLO-L constructs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1. The cages include a central graft window which may be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft prior to implantation. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. SOLO-L is made from titanium alloy (Ti-6Al-4V ELI). An optional interbody component composed of polyetheretherketone (PEEK) with tantalum markers is available for modular cages.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is an FDA 510(k) clearance letter for a medical device called SOLO-L, an intervertebral body fusion device.

The document states:

• "No additional non-clinical testing was provided to demonstrate substantial equivalence."
• "No clinical data were provided in order to demonstrate substantial equivalence."

This indicates that no new studies were conducted by Aurora Spine Inc. to demonstrate the performance of the SOLO-L device against specific acceptance criteria. The clearance was based on the device having identical technological characteristics (design, dimensions, materials, and manufacturing processes) to a previously cleared predicate device (A-Link Z, K201671).

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.

The SOLOPASS® System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location.

The SOLOPASS® System consists of three main sub-systems:

1. The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.
2. The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
3. The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.

The SOLOPASS® System provides 2mm Imaging Accuracy at 4-7cm depth and 3mm Targeting Accuracy at 6cm depth.

The provided text describes the SOLOPASS® System, a neuronavigational system that collects intraoperative ultrasound imaging and positional data to aid in the frontal placement of an intra-ventricular catheter. The document details the device's comparison to a predicate device and summarizes non-clinical testing performed to support its substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

The document primarily focuses on two key performance metrics related to accuracy: "System Targeting Accuracy" and "System Imaging Accuracy."

Additionally, other acceptance criteria are implicitly met by passing various tests:

• Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, non-pyrogenic, negative for acute systemic toxicity, bacterial endotoxins

Ask a specific question about this device

The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.

The SOLOASSIST II allows the user to hold and control the movements of a rigid endoscope by using a joystick or manually by pushing the release button on the Control Panel that is located on the SOLOASSIST II.

The joystick is linked to related connection of the SOLOASSIST II by a wire. The joystick is mounted on the surgical instrument of the surgeon. The movement will be controlled by three motorized axes inside the SOLOASSIST II. The SOLOASSIST II simulates an arm working in several degrees of freedom. The Control Panel of the SOLOASSIST II has 2 buttons and 5 indications. One button is used to set the TROCAR POINT and the other button is used to move the SOLOASSIST manually by pushing the button while moving the arm.

The Tension Sleeve and the Endoscope clamp are loosely screwed together. The combination of Tension Sleeve and Endoscope clamp are slide over the endoscope and the tension sleeve is tightened so the endoscope can't move out but still can turn. It is important to use the right tension sleeve for the right diameter of the endoscope. On the rigid endoscope normally there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the SOLOASSIST II.

The starting point of the movement for an operation will be saved as the TROCAR POINT. The Universal Joint has to be mounted on the SOLOASSIST II. A mounted Universal Joint can be removed by using the release slider. To define the Trocar point the Universal Joint has a small tracer pin. The tracer pin is placed near the body opening for the endoscope. The TROCAR POINT has to be saved by pushing the button on the control panel of SOLOASSIST

The Endoscope Clamp (together with Tension Sleeve and Endoscope) is mounted on the Universal Joint, so the SOLOASSIST II is ready for operation.

Based on the trocar point and the desired view of the software of the device calculates the required individual movements of the axes in order to achieve the desired total movement. For example by pushing the left button on the joystick the image on the monitor moves left, while the SOLOASSIST II is moving to produce the desired view. By pushing the buttons on the joystick it is possible to move the image on the monitor to the left, right, up, down, zoom in and zoom out.

Additionally it is possible to move the arm of the SOLOASSIST II without the use of the iovstick. Therefore the user has to hold the control panel on the SOLOASSIST II and push the unlocking button (release button) while moving the arm system.

To allow the surgeon to convert to an open surgery in case of an emergency, the SOLOASSIST II can be completely mounted or removed by a quick fastener.

The provided text describes the 510(k) summary for the SOLOASSIST II device. However, it does not contain information about acceptance criteria for particular performance metrics, nor does it detail a study proving the device meets specific performance thresholds in a clinical or human-in-the-loop setting.

The document focuses on non-clinical testing for substantial equivalence, primarily covering:

• Biocompatibility
• Electrical safety and electromagnetic compatibility (EMC)
• Software verification and validation
• Mechanical, acoustic, and bench testing (though these are more about general device robustness and function, not specific performance metrics like speed, accuracy, or image quality that would typically have acceptance criteria for an AI/robotic system controlling an endoscope for image acquisition)
• Cybersecurity risk assessment
• Sterilization
• Human Factors testing (focused on safety and usability, not quantitative performance against acceptance criteria)
• Packaging

Crucially, Section 8.2 states: "No clinical evaluation was conducted for this device." This means there would be no data from a study involving human users or patients to establish performance against acceptance criteria in a real-world or simulated clinical scenario, which is usually where such detailed acceptance criteria for AI-driven assistance systems are measured.

Therefore, I cannot fulfill the request as the necessary information regarding acceptance criteria and a study proving quantitative performance against those criteria (especially for AI assistance) is not present in the provided text. The device, SOLOASSIST II, is described as a "robotic computer driven system" that holds and positions an endoscope, but the performance data presented is entirely non-clinical and focused on safety, usability, and basic functional integrity, not AI-driven performance metrics.

If this were an AI-driven system requiring a clinical or human-in-the-loop study with specific performance acceptance criteria, the provided document would be insufficient.

In summary, based only on the provided text, there is no information to construct the requested table or answer the specific questions about acceptance criteria and performance study details related to an AI-driven component (beyond the general "software verification and validation"). The document explicitly states "No clinical evaluation was conducted for this device."

Ask a specific question about this device

The SoloPath® Re-Collapsible Access System is intended to be inserted percutaneously into the femoral artery, over a guidewire and once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery.

The SoloPath® Re-Collapsible Access System is a cardiovascular device designed to be used as a guide for catheters and/or devices introduced into the femoral artery. The device is provided sterile for single use. Onset Medical Corporation's SoloPath® Re-Collapsible Access System is a sterile, single use device. It consists of a flexible, reinforced polymer sheath with an external collapsible outer jacket and specially folded, radially-collapsed distal end (the Sheath) pre-mounted over a central balloon dilatation catheter (the Expander), and equipped with a proximal hub assembly incorporating a hemostasis valve. The folded distal region of the Sheath is small in diameter, thus facilitating passage through the vessel. The SoloPath Assembly is inserted percutaneously into the femoral artery, over a guidewire, with the deflated Expander in place. Once positioned into the artery, the Expander balloon, when inflated with liquid, exerts controlled radial force, enlarging the folded distal region of the Sheath and surrounding anatomy. The Expander balloon is deflated and the Expander is removed leaving a large central lumen extending from the proximal end to the distal end of the Sheath, which maintains its expanded size by means of malleable distal reinforcement. The Sheath is designed as a guide for catheters and/or devices introduced into the femoral artery. Prior to removal, the outer jacket is activated with liquid unde pressure, collapsing the outer sheath diameter for ease of removal. The sheath is capable of expanding and actively collapsing.

The SoloPath® Re-Collapsible Access System is a cardiovascular device designed to be used as a guide for catheters and/or devices introduced into the femoral artery. The device is provided sterile for single use.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document mentions that "both the 19Fx35 cm and 24Fx35cm the SoloPath® Re-Collapsible Access System" were tested. This implies testing was conducted on at least two distinct configurations of the device. However, the exact number of units tested for each specific test (e.g., how many sheaths for a burst test) is not provided.
• Data Provenance: The study was conducted as in vitro bench studies. There is no mention of human or animal studies, or clinical data. Therefore, there is no country of origin for patient data, and it is entirely retrospective in the sense of being laboratory-based testing, not involving ongoing patient recruitment.

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

• This information is not applicable as the studies conducted were in vitro bench studies and biocompatibility testing. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The ground truth was based on pre-defined engineering and biological standards and criteria.

4. Adjudication Method for the Test Set:

• This information is not applicable for the same reasons as above. No adjudication method was necessary as these were objective measurements against pre-defined engineering and biological acceptance criteria.

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, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. The SoloPath® Re-Collapsible Access System is a physical medical device, and its performance is evaluated through bench testing and biocompatibility.

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

• No, this is not applicable. The SoloPath® Re-Collapsible Access System is a physical medical device, not an algorithm or software-only device. Its performance is inherent to its physical properties and design, not an algorithm.

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

• The ground truth for the bench studies and biocompatibility testing was based on pre-defined engineering specifications, performance standards, and established international biocompatibility standards (ISO 10993-1). It was not derived from expert consensus, pathology, or patient outcomes data.

8. The sample size for the training set:

• Not applicable. There was no "training set" for this device. This concept is relevant for machine learning or AI algorithms, which are not involved in the SoloPath® Re-Collapsible Access System's evaluation as described.

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

• Not applicable. As there was no training set, there was no ground truth for a training set to be established.

Ask a specific question about this device

SoloCem is indicated for

• permanent cementation of root posts of all types
• permanent cementation of crowns, bridges, inlays, onlays
• permanent cementation of implant abutments

Not Found

I am sorry, but the provided text is a 510(k) premarket notification approval letter from the FDA for a dental cement called SoloCem. This document focuses on the regulatory approval process and does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets particular criteria.

Therefore, I cannot extract the requested information such as a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Ask a specific question about this device

The SoloHealth Station is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate and his/her own weight. Additionally, the SoloHealth Station is intended to screen adults for clarity of central vision. SoloHealth Station does not provide a general screening of visual function and does not provide a diagnosis of eye health or other disease. The SoloHealth Station only screens clarity of central vision. Users should consult their personal physicians if they have concerns regarding their eyesight.

The SoloHealth Station is an automated system for measuring blood pressure and pulse rate designed to be used by the general public in indoor high-traffic commercial areas. It is completely automatic, and measures blood pressure by the oscillometric method. The user is guided by a series for interactive screen and voice instructions. Additionally, the SoloHealth Station measures weight, screens clarity of central vision, and does a risk factor analysis. Users are advised to consult a physician. Upon completion, data may be stored by the user and accessed via a website or sent via electronic mail to the user.

The SoloHealth Station is an automated system intended for the general public to measure blood pressure and pulse rate, weight, and screen for clarity of central vision.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Blood Pressure:

  • The blood pressure module (component within the SoloHealth Station) underwent clinical testing according to AAMI SP10 by its supplier. The number of subjects for this initial testing is not specified in this document.
  • Subsequently, "confirmatory testing was completed with the SoloHealth Station on a limited number of subjects" in Duluth, GA. The exact number of subjects for this confirmatory study is not provided.
  • Data Provenance: The confirmatory testing was done in Duluth, GA, presumably in the USA. It appears to be prospective data collection for the confirmatory study. The provenance of the supplier's clinical data is not specified.

• Vision Screening: The document states that "confirmatory testing was completed with the SoloHealth Station on a limited number of subjects." The exact sample size is not provided.

  • Data Provenance: Testing was done in Duluth, GA, presumably in the USA. This appears to be prospective data collection.

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

• Blood Pressure: For the AAMI SP10 clinical testing, the standard requires specific expertise for ground truth measurements. While not explicitly stated in this document, AAMI SP10 typically necessitates trained observers for auscultatory reference measurements.
• Vision Screening: The ground truth for vision screening was established by comparison to the "screenings of a licensed Optometrist." The number of optometrists is not specified.

4. Adjudication method for the test set

• The document does not specify a formal adjudication method (e.g., 2+1, 3+1) for either the blood pressure or vision screening test sets.

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 involving human readers with and without AI assistance is mentioned in the provided text. The device is a standalone kiosk for self-measurement and screening.

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

• Yes, the performance testing for the SoloHealth Station (which includes the blood pressure and vision screening functions) appears to be focused on its standalone performance in comparison to established standards and human expert assessment. The device is an "automated system" for self-measurement by the general public.

7. The type of ground truth used

• Blood Pressure: The ground truth for blood pressure measurements is based on compliance with the AAMI SP10 standard, which involves comparison to reference methods (typically auscultatory measurements by trained observers).
• Vision Screening: The ground truth for vision screening is "similarity to a licensed Optometrist." This implies a comparison of the device's screening results to those obtained by a human optometrist.

8. The sample size for the training set

• The document does not provide information on a specific training set or its sample size. The focus is on the performance testing against established standards and human expert equivalents.

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

• Given that no specific training set is outlined, information on how its ground truth was established is not provided. The development process would likely have involved data for algorithm development, but this document focuses on regulatory performance testing.

Ask a specific question about this device

The SoloV2TM Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

This system contains a speaking function that provides audible test results for users with low vision.

The SoloV2TM Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets said criteria. The document is a 510(k) summary for a blood glucose monitoring system, primarily focused on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the information that is and is not present, based on your request:

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

• Not present. The document states that Biotest Medical Corp. "has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements." However, it does not detail what those acceptance criteria were (e.g., accuracy standards like ISO 15197) or present specific performance data.

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

• Not present. The document mentions "Performance Studies" in a very general way, but does not provide any specifics about sample sizes, study design (retrospective/prospective), or data provenance.

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 applicable/Not present. This type of information is typically relevant for studies involving subjective assessment (e.g., image interpretation), where expert consensus establishes ground truth. For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by expert consensus interpreting images. The document does not describe how ground truth was established for any performance studies.

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

• Not applicable/Not present. Similar to point 3, adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant for a blood glucose meter's performance assessment.

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 present. MRMC studies are used to evaluate the impact of AI on human reader performance, particularly in diagnostic imaging. This device is a blood glucose monitoring system and does not involve AI assistance for human readers in the way an imaging AI would.

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

• Not applicable/Not present. While the device itself is a "standalone" system for measuring glucose, the concept of "standalone (algorithm only without human-in-the-loop performance)" is usually applied to AI algorithms that process data independently. This device is a physical diagnostic tool; its performance is inherently a standalone measurement. The document does not describe any specific "algorithm-only" performance study in the context of AI.

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

• Not explicitly stated, but inferred to be a laboratory reference method. For blood glucose meters, the ground truth is typically a highly accurate laboratory reference method (e.g., hexokinase method). The document does not explicitly state this, but it's the standard for such devices.

8. The sample size for the training set:

• Not applicable/Not present. This device is not described as involving machine learning or AI models that require a "training set" in the conventional sense. Its performance is based on its electrochemical measurement technology.

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

• Not applicable/Not present. As there's no mention of a training set for an AI/ML model, this information is not provided.

In summary:

The provided 510(k) summary for the SoloV2™ Blood Glucose Monitoring System focuses on demonstrating substantial equivalence to a predicate device (SuperCheck 1 Blood Glucose Monitoring System) by listing modifications and asserting that "necessary verification and validation activities" were performed. It does not include detailed performance data, specific acceptance criteria, or study methodologies that would address most of your requested points, which are more typically found in documents for AI/ML-based medical devices or more comprehensive clinical study reports.

Ask a specific question about this device

The Solo™ MicroPump Insulin Delivery System is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Solo™ Insulin Patch Pump is for prescription use only.

The Solo™ MicroPump Insulin Delivery System (Solo™) is a miniature, portable programmable insulin pump, which adheres to the patient's skin. The MicroPump is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The MicroPump is controlled via a remote control unit.
The Solo™ is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician, and includes the features available in the predicate devices.

The document provided is a 510(k) summary for the Solo™ MicroPump Insulin Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. It also mentions performance testing in the context of usability studies. However, the document does not contain detailed acceptance criteria, specific reported device performance metrics against those criteria, or the methodology of a study that directly proves the device meets such criteria in terms of clinical efficacy or diagnostic accuracy.

The provided text focuses on demonstrating substantial equivalence, primarily by addressing a change in the age contraindication.

Therefore, much of the requested information cannot be extracted from this specific document.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

Acceptance Criteria and Reported Device Performance

This document does not define specific acceptance criteria (e.g., accuracy of insulin delivery, specific safety thresholds) nor does it present a table of reported device performance against such criteria. The "Performance Testing" section refers to usability studies rather than objective performance metrics.

Study Information

The document describes two simulated clinical use studies to support the 510(k) submission, specifically for non-adult users and sharps injury prevention features.

• Sample size used for the test set and the data provenance: Not specified in terms of numbers. The studies were "simulated clinical use studies" for "non-adults and their caregivers." The provenance is Medingo Ltd., Israel. These studies appear to be prospective usability studies.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were usability studies, not diagnostic accuracy studies using ground truth established by experts.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned.
• 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. This is not an AI/diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for insulin delivery.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for usability studies. The "ground truth" for usability would be successful completion of tasks and user feedback, not clinical outcomes or expert consensus on diagnosis.
• The sample size for the training set: Not applicable. This describes usability studies, not machine learning model training.
• How the ground truth for the training set was established: Not applicable.

Summary of Available Information

Conclusion based on the provided text: The document provides excellent detail regarding the regulatory submission (510(k)), device description, and predicate devices. However, it does not include the detailed performance study information with acceptance criteria that would typically be associated with clinical efficacy or technical performance specifications for the device's primary function (insulin delivery). The "performance testing" described is specifically related to usability and safety for an expanded user population (non-adults), rather than comprehensive performance metrics.

Ask a specific question about this device