(682 days)
The Accu-Chek Solo micropump system with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Accu-Chek Solo micropump system is able to communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Accu-Chek Solo micropump system is intended for single patient, home use and requires a prescription. The Accu-Chek Solo micropump system is indicated for use in individuals 2 years of age and greater.
The Accu-Chek Solo micropump is a portable programmable insulin pump, which adheres to the patient's skin. The patch 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 patch is controlled via a connected Device. The Accu-Chek Solo micropump is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as per your detailed request.
The document is a 510(k) premarket notification summary for the Accu-Chek Solo micropump system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Omnipod DASH Insulin Management System). While it lists various non-clinical tests performed (e.g., human factors, biocompatibility, sterility, electrical safety, software, cybersecurity, interoperability, and system reliability/safety testing), it does not provide specific acceptance criteria or detailed results that quantify device performance against those criteria.
Specifically, it lacks the following information crucial for your request:
- A table of acceptance criteria and reported device performance: The document mentions "The Performance testing of the Accu-Chek Solo micropump System demonstrated that the device met all device specifications," but it does not specify what those specifications are beyond broad categories like "Accuracy of Insulin Delivery" with some general percentages (e.g., "±18% or better at 0.1 U/h" for basal rates). It doesn't present a clear table linking acceptance criteria to actual measured performance for various functionalities.
- Sample sizes used for the test set and data provenance: Details on the number of samples/devices tested for the various non-clinical tests are not provided. There is no mention of a "test set" in the context of an AI/ML device or data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish ground truth & qualifications: This information is completely absent, as the document doesn't describe a study involving expert assessment or ground truth labeling in the context of AI/ML performance.
- Adjudication method for the test set: Not applicable based on the document's content.
- MRMC comparative effectiveness study: The document does not describe any multi-reader multi-case study, nor does it discuss human reader improvement with or without AI assistance. This device is an insulin pump, not an AI-assisted diagnostic tool.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device (insulin pump) with software, not a standalone AI algorithm being evaluated for diagnostic or predictive performance.
- Type of ground truth used: Given the device type, ground truth would relate to physiological parameters (e.g., actual insulin delivered, occlusion detection). While some performance metrics are mentioned (e.g., accuracy of insulin delivery, occlusion detection time), the specific "ground truth" methodology for establishing these values in testing is not detailed in the way one would describe for an AI/ML model (e.g., pathology, outcomes data).
- Sample size for the training set: Not applicable. The document discusses software verification and validation testing, but it does not refer to a "training set" in the context of machine learning model development.
- How ground truth for the training set was established: Not applicable.
The document primarily focuses on:
- Substantial equivalence comparison to a predicate device.
- Confirmation of various engineering and regulatory compliance tests (e.g., electrical safety, EMC, software V&V, cybersecurity, human factors, biocompatibility, sterility, insulin compatibility) without providing specific quantitative results for most acceptance criteria.
- A brief mention of a "clinical study" for the insertion process of the cannula, stating its aim was to prove safety, robustness, and pain-freeness, but it does not provide study details (e.g., sample size, specific outcomes, or quantitative results against acceptance criteria).
Therefore, I cannot fulfill your request based on the provided text, as it describes a clearance for an insulin pump, not an AI/ML device requiring the typical performance evaluation metrics you've outlined.
§ 880.5730 Alternate controller enabled infusion pump.
(a)
Identification. An alternate controller enabled infusion pump (ACE pump) is a device intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (
e.g., head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.
(ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (
e.g., occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability (
e.g., temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment.
(vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing.
(2) Design verification and validation activities must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented.
(ii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers (
e.g., battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption (
e.g., reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the system must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (
e.g., establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters.
(iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is 250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.