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ASCOT® is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to accommodate anatomic requirements. Fixed and variable angle screws are available in numerous length/diameter combinations. In addition, a center graft screw is offered.

The provided text describes the 510(k) summary for the ASCOT® anterior cervical plate system. This is a medical device and not an AI or software-based diagnostic tool. Therefore, the questions related to AI performance, ground truth, sample sizes for training/test sets, expert adjudication, and MRMC studies are not applicable.

The "acceptance criteria" for this type of device are related to its mechanical performance and substantial equivalence to predicate devices, rather than diagnostic accuracy metrics.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This is a hardware medical device; performance was evaluated through mechanical testing, not a diagnostic test set with patient data.

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

• Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant for this mechanical device.

4. Adjudication method for the test set

• Not Applicable.

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. This is not an AI device.

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

• Not Applicable. This is not an AI device.

7. The type of ground truth used

• Not Applicable. The "ground truth" for this device would be the physical properties and mechanical stability under specified loads, measured against established engineering standards (ASTM F1717) and compared to predicate devices. This isn't a diagnostic ground truth.

8. The sample size for the training set

• Not Applicable.

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

• Not Applicable.

Summary of Relevant Information Regarding Device Acceptance:

The acceptance of the ASCOT® device for 510(k) clearance was based on demonstrating substantial equivalence to existing legally marketed predicate devices (TOSCA®, TOSCA® II, VERTEBRON SCP™, Uniplate™). This was primarily achieved by showing:

• Mechanical Testing: According to ASTM F1717, static and dynamic compression bending, and static torsion tests were performed on the "worst case" ASCOT® configuration. The results showed performance "substantially equivalent" to the predicate devices.
• Technological Characteristics: The device possesses the "same technological characteristics" as the predicates, including:
  • Performance (as described by mechanical testing).
  • Basic design (plate and screw system).
  • Material (titanium alloy - Ti-6Al-4V ELI, ASTM F136).
  • Sizes (component dimensions are within the ranges offered by the predicates).
• Intended Use: The intended use for anterior cervical fixation (C2-C7) for specific indications (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities/curvatures, tumor, pseudarthrosis, failed previous fusion) is the same as the predicate devices.

The FDA's decision letter (K132310) confirms the determination of substantial equivalence, allowing the device to be marketed.

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This medical device is indicated for use by patients with known or suspected hypertension or diabetes that a physician wants to monitor blood pressure, pulse, and/or blood glucose at home.

This medical device is a software based device which runs on a Windows based Computer or netbook. This medical device receives readings from supported FDA approved devices in the home and serves as a remote communication link between the home and the physician or qualified medical provider. The physician or qualified medical provider will review the patient information from a web interface and may make medication changes and transmit those changes back to the patient for display on the Home Medical Station(HMS).

This medical device receives blood pressure, heart rate and blood glucose readings from the supported FDA approved medical devices via USB or serial connection to the HMS. The HMS communicates with the server via standard wireless or wired communication protocols such as cellular data, and wired or wireless internet.

HMMS has been tested to work with Homedics BPA-260-CBL, Omron HEM-7901T and OneTouch Ultra Mini, OneTouch Ultra 2 and OneTouch UltraLink.

This medical device is automation of the exiting process of reporting results to the physician over the phone.

This medical device is not intended to provide real time monitoring. It is not intended for emergency calls or for transmission of any time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

This medical device does not provide diagnosis of any disease or medical condition and is not a substitute for professional healthcare judgment.

This medical device uses standard communication protocols and encryption to protect patient privacy.

The Ascot HMMS (Home Medical Monitoring System) is a software based device which receives readings in the home or clinical setting from various FDA approved devices (such as home Blood Pressure monitor with pulse or Glucose testing monitor) and transmits readings to the Ascot Central Server (ACS) for review by the Physician. If the Physician modifies medication dosages, the patient medication dosage instructions ordered by the Physician, are transmitted back to the patient and displayed on the HMS. Receipt of each transmission is confirmed within the system.

The Ascot HMMS (Home Medical Monitoring System) reduces risks to health because it speeds up the communication between the Physician and the patient. It improves accuracy because readings are transmitted directly from the home to server for later review by the Physician.

The Ascot Home Medical Monitoring System (HMMS) is a software-based device intended to automate the process of reporting medical readings (blood pressure, pulse, blood glucose) from a patient's home to a physician and transmitting medication dosage changes back to the patient. It acts as a communication link between FDA-approved medical devices used at home and a central server for physician review.

Here's an analysis of the acceptance criteria and study information provided:

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

The provided 510(k) summary does not explicitly state specific acceptance criteria with numerical thresholds for the device's performance. Instead, it focuses on the device's functional equivalence to predicate devices and its ability to accurately and securely transmit data and facilitate communication. The "acceptance criteria" are implied by the claims made and the comparison to predicate devices, which suggest the device must perform these functions reliably and securely.

Below is a table summarizing the claimed features and implied performance:

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

The document does not specify a separate "test set" sample size or data provenance in the context of an evaluative study that would typically be described for a diagnostic or AI/ML device. The submission focuses on functional equivalence to predicates and validation of data transmission capabilities. The "devices which have been tested to operate with the Ascot Home Medical Monitoring System" (OneTouch Ultra Mini, OneTouch Ultra 2, OneTouch UltraLink, Omron HEM-790IT, HoMedics BPA-260-CB) implicitly form the "test set" for demonstrating compatibility and successful data exchange, but no specific number of test cases or patients is provided for this. These are tests of system integration and function, not clinical performance.

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

This information is not applicable and therefore not provided in the document. The device is a data management and communication system, not a diagnostic tool that requires expert-established ground truth for its output. The "ground truth" for this device would be whether the data is transmitted accurately and securely, and if medication instructions are accurately displayed, functionality that is typically verified through system testing and validation rather than expert consensus on medical conditions.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in studies where a diagnosis or interpretation of medical images/data is being assessed for accuracy against a consensus ground truth. The Ascot HMMS does not provide diagnoses or interpretations.

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 comparative effectiveness study was not conducted and is not mentioned. This type of study is relevant for devices that assist human readers in tasks like image interpretation or diagnosis. The Ascot HMMS is a data management and communication system, not an AI-assisted diagnostic tool.

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

This information is not applicable in the traditional sense. The device is a software system for data transmission and management, which inherently involves human interaction (patient providing readings, physician reviewing and giving instructions). Its performance is evaluated on its ability to accurately and securely transmit data, rather than on an "algorithm only" performance in a diagnostic context. The core function is providing the data to the human-in-the-loop (the physician) for their decision-making.

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

The document does not describe "ground truth" in terms of medical outcomes or diagnoses. For this device, the "ground truth" related to its performance would be the accurate and secure transmission of physiological readings from the patient device to the server, and the accurate display of physician-ordered medication changes to the patient. This would be established through technical validation and system testing, ensuring data integrity, security, and correct communication protocols, rather than medical consensus or pathology.

8. The sample size for the training set

The concept of a "training set" in the context of machine learning algorithms is not applicable to this device as described. The Ascot HMMS is a software system for data management and transmission, not an AI/ML-based diagnostic or predictive algorithm that requires a training set.

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

As there is no described training set for an AI/ML algorithm, this information is not applicable.

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