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510(k) Data Aggregation
(25 days)
Biocorp Production
The MallyaG Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors.
The Novo Nordisk PDS290 Injection pens compatible for growth disorder treatment are:
- Sogroya (somapacitan-beco)
- Norditropin FlexPro
The MallyaG Injection Pen Adapter is a smart sensor composed of a button to be assembled onto a pen injector by covering the injection pen button. It is designed to be mounted on specific Novo Nordisk® PDS290 platform injection pens. A USB cable, necessary to charge the MallyaG device, is also provided in the package. The information is captured through the rotation of the dosing button of the pen into a value indicating the dose increment injected.
The MallyaG Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors. The manufacturer, Biocorp Production, claims that the device is 99% accurate in matching recorded doses with dialed doses, with a margin of error of +/- 1 increment. This claim is supported by performance data from bench testing guided by ISO 11608-1.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claim | Reported Device Performance |
|---|---|
| Device accuracy: 99% of the recorded doses match the dialed doses with a margin of error of +/- 1 increment. | Performance data from bench testing (ISO 11608-1 as a guide) was generated to verify the design. (No specific numerical reporting of the test result against the 99% claim is provided in the summary, but the general statement suggests it met the criteria). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing (bench testing). It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The performance testing appears to be bench-based, guided by a standard (ISO 11608-1), which typically relies on calibrated equipment and defined procedures rather than expert human assessment for ground truth.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. Given the nature of bench testing for dose accuracy against a standard, an adjudication method for human interpretation would likely not be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The MallyaG Injection Pen Adapter is a device for capturing and transmitting dose information, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was done in the form of "Bench testing on performance, using ISO 11608-1 as a guide." This type of testing evaluates the device's ability to accurately capture and transmit dose information independently of human interaction beyond the initial setup and use.
7. The Type of Ground Truth Used
The ground truth for the performance testing (dose accuracy) was implicitly established by the dailing of specific increments on the injection pens and then comparing the device's recorded dose against that known dialed dose. This is a form of measurement against a known input/standard as guided by ISO 11608-1.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of device performance. This device is an adapter for capturing data, not a machine learning or AI model that typically requires a training set. The performance testing focuses on verifying the device's accuracy in capturing physical actions.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for this device.
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(30 days)
BioCorp Production
The MallyaD Injection Pen Adapter is indicated for the capture and wireless transmission of compatible reusable and disposable pen injectors.
The Novo Nordisk PDS290 Injection pens compatible for diabetes treatment are:
-
insulin degludec molecule (Tresiba U-100 FlexTouch and Tresiba U-200 FlexTouch)
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insulin aspart molecule (Fiasp FlexTouch)
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insulin degludec and liraglutide molecules (Xultophy)
The concerned Mallya Injection Pen Adapter, also called Mallyaº, is a smart sensor composed of a button to be assembled onto a pen injector by covering the injection pen button. It is designed to be mounted on specific Novo Nordisk® PDS290 platform injection pens. A USB cable, necessary to charge the Mallya® device is also provided in the package.
The given text is a 510(k) Premarket Notification from the FDA for a medical device called the "MallyaD injection pen adapter (MallyaD)". It details the device's indications for use, technological characteristics, and a comparison to a predicate device. While it mentions various tests and guidelines, it does not contain the specific information required to fully answer your request regarding the acceptance criteria and the study that proves the device meets them in the context of an AI/ML medical device.
The "MallyaD" device, as described, appears to be an adapter that records and transmits dosing information from an injection pen. It's a hardware device with associated software, but there is no explicit mention of it being an AI-powered medical device or using machine learning. The "Software controlled" attribute in the table refers to its internal operation rather than AI/ML algorithms.
Therefore, many of your requested points, which are highly relevant for AI/ML device studies, are not present in this document. For example, there's no mention of:
- A table of acceptance criteria for AI model performance (e.g., sensitivity, specificity, AUC).
- Sample sizes for a test set in the context of an AI model's performance on medical images or other data types.
- Data provenance for an AI test set.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI model.
- Multi-Reader Multi-Case (MRMC) studies for AI assistance.
- Standalone performance for an AI algorithm.
- Type of ground truth for AI model training or testing (e.g., pathology, outcomes data).
- Sample size or ground truth establishment for an AI training set.
The document primarily focuses on the substantial equivalence to a predicate device based on its intended use, technological characteristics (e.g., BLE communication), and physical attributes, along with general performance tests like dose accuracy, biocompatibility, electrical safety, and cybersecurity. The "Dose accuracy: 99% of the recorded doses match the dialed doses with a margin of error of +/- 1 increment" is a performance claim, but it's for the device's basic function, not an AI/ML model's diagnostic or predictive performance.
In summary, based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria as if it were an AI/ML medical device because the document describes a hardware device with embedded software for data capture and transmission, not an AI/ML algorithm or model for diagnostic or predictive purposes.
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(205 days)
Biocorp Production
The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.
The device is made of a cap to be assembled onto a pen injector by covering the injection pen button. The overall device size is 21.4mm diameter & 23.3mm height. A USB cable, necessary to charge the SoloSmart® device is also provided in the package.
The provided FDA 510(k) summary for the SoloSmart Injection Pen Adapter does not contain information related to a study proving the device meets acceptance criteria for an AI/ML-based medical device. This document describes a traditional medical device (an adapter for injection pens) and its substantial equivalence to a predicate device, focusing on its physical and functional characteristics, rather than AI performance.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.
The document discusses performance data related to the physical device and its ability to accurately record and transmit dosing information, but not the performance of an AI algorithm.
Here's a breakdown of what is in the provided text, and why it doesn't align with the request for AI/ML device performance:
- Device Type: SoloSmart Injection Pen Adapter, a physical device that attaches to insulin pens to capture and transmit dosing data. It is not described as an AI/ML device.
- Performance Data (Section 13): This section outlines "Bench testing on performance" for the physical adapter, including:
- Dose accuracy of pen not affected by SoloSmart®.
- Recording and transmission Accuracy.
- Dose Prime Differentiation.
- Complete Dose Notification.
- Incomplete Injection Identification.
- Physical Interaction with pen.
- Other Testing: Biocompatibility, Lifetime, Electrical safety, EMC and Radiocommunication, Cybersecurity Testing and Software Verification and Validation. These are standard tests for medical devices, not specific to AI/ML performance.
- Human Factor Validation (Section 14): Confirms usability of the device form factor and instructions for use.
- Substantial Equivalence (Section 8 & 12): The core of the 510(k) submission is to demonstrate that the SoloSmart® is substantially equivalent to a legally marketed predicate device (Mallya Injection Pen Adapter). This comparison focuses on indications for use, intended use, fundamental scientific technology, and technological characteristics (e.g., Bluetooth Low Energy communication, mechanism for recording dose).
In summary, the provided text does not describe an AI/ML-based medical device or any studies related to its AI performance. Thus, it is impossible to extract the requested information regarding AI acceptance criteria and proof of meeting those criteria.
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(90 days)
Biocorp Production
The Mallya Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.
The device is made of two parts to be assembled onto a pen injector. The Mallya base part (about 6 x 3 x 2 cm) which clips around the body of the injection pen and the Mallya button (about 2.5 x Ø2 cm) that slips over the injection pen button. A USB cable, necessary to charge the MALLYA device, and a reset key are also provided in the package.
This is a description of the Mallya Injection Pen Adapter, K222689. The document is for a 510(k) premarket notification, indicating it's a medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility and Electrical Safety | IEC 60601-1 and appropriate collateral requirements (IEC 60601-2 and IEC 60601-1-11) | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion. |
| Performance (Bench Testing) | ISO 11608-1 (as a guide) | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion, and specific sub-criteria are listed below. |
| Performance (Dose Accuracy) | Dose accuracy of pen is not affected by Mallya | Implied successful completion as "Dose accuracy of Mallya dose recording has been assessed and verified during Design Verification." and listed as part of performance data. |
| Performance (Recording and Transmission Accuracy) | Recording and transmission Accuracy | Implied successful completion as "Dose accuracy of Mallya dose recording has been assessed and verified during Design Verification." and listed as part of performance data. |
| Performance (Dose Prime Differentiation) | Dose Prime Differentiation | Listed as part of performance data, implying successful evaluation. |
| Performance (Complete Dose Notification) | Complete Dose Notification | Listed as part of performance data, implying successful evaluation. |
| Performance (Incomplete Injection Identification) | Incomplete Injection Identification | Listed as part of performance data, implying successful evaluation. |
| Performance (Physical Interaction with pen) | Force to mount, maintain, and remove Mallya | Listed as part of performance data, implying successful evaluation. |
| Biocompatibility | ISO 10993-1 and FDA guidance; permanent contact with intact skin | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion. |
| Lifetime | Operational/Function for 2 years (Use Lifetime) following storage for up to two years (Shelf Life) | The product met test criteria to verify it will operate/function for 2 years (Use Lifetime) following storage for up to two years (Shelf Life). |
| Cybersecurity | Cybersecurity Testing and Software Verification and Validation per FDA Guidelines | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion. |
| Human Factors | HF Validation per FDA guidance | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for the test set (e.g., number of injections, number of devices tested). It mentions "Bench testing on performance, using ISO 11608-1 as a guide" and "Design Verification." It does not provide information on the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document does not provide details on the number of experts or their qualifications for establishing ground truth for the test set. The tests appear to be primarily engineering and performance-based (bench testing, dose accuracy assessments) rather than involving subjective expert interpretation of medical images or conditions.
4. Adjudication method for the test set
The document does not discuss any adjudication method (e.g., 2+1, 3+1). The nature of the tests (bench testing, electrical safety, lifetime, etc.) suggests objective measurements rather than subjective assessments requiring adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Mallya Injection Pen Adapter is a device that captures and transmits dosing information; it is not an AI-powered diagnostic or assistive tool for human readers interpreting medical cases. Therefore, the concept of improving human readers with AI assistance does not apply to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone mechanism for capturing and transmitting data from an injection pen. Its performance (e.g., dose recording accuracy, transmission accuracy) would inherently be "standalone" in the sense that the device performs these functions automatically without direct human intervention in the data capture and transmission process itself. However, it requires a human to operate the injection pen. The specific "standalone" performance details (like sensitivity, specificity, accuracy metrics typically associated with algorithms) are not presented in this summary beyond general statements of accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth for most of the performance tests would be objective physical measurements or established engineering standards. For example:
- Dose accuracy: The ground truth would be the actual dose dialed and delivered by the injection pen, measured precisely using calibrated equipment.
- Recording and transmission accuracy: The ground truth would be the known, actual dose input/occurrence, compared to what the Mallya device records and transmits.
- Electrical safety/EMC: Ground truth is defined by compliance with the referenced IEC standards.
- Lifetime: Ground truth is reaching or exceeding the specified operational and shelf life under test conditions.
8. The sample size for the training set
The document does not mention any "training set." This type of device does not typically involve machine learning or AI models that require training data in the conventional sense. Its functionality is based on sensing physical rotation and transmitting data, rather than learning patterns from a dataset.
9. How the ground truth for the training set was established
As there is no mention of a training set or machine learning components, this question is not applicable.
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