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The Whisper JECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a BD 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.

The WhisperJECT™ autoinjector is a reusable, spring-loaded injection device that is for general use with 1.0 ml pre-filled glass syringes. WhisperJECTTM autoinjector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.

The provided text is a 510(k) summary for the WhisperJECT Autoinjector. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not include detailed information regarding specific acceptance criteria, reported device performance against those criteria, or the study specifics that would prove the device meets these criteria. The section "Performance Data 5.8" only states that the device will be assessed using ISO 11608:2012 and that it is intended to meet all requirements and specifications. It explicitly says "WhisperJECT™ auto-injector is intended to meet all requirements and specifications prior to being marketed. As per SHL Pharma's commitment included in section 9.0, WhisperJECT autoinjector device will only be marketed after required testing has been completed and all acceptance criteria met." This means the results of the studies were not included in this 510(k) summary.

Therefore, I cannot provide accurate answers to most of your questions based only on the provided text.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that performance data will be assessed and that the device is intended to meet all requirements, but it does not provide the actual acceptance criteria or the reported performance data.

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

Not available in the provided document. The document mentions that applicable sections and methods specified in ISO 11608:2012 will be used for assessment, but it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable/Not available in the provided document. As this is a medical device (autoinjector) and not an AI/diagnostic software, the concept of "ground truth established by experts" in the way it's typically applied to diagnostic AI models (e.g., radiologists interpreting images) is not directly relevant here. The performance is assessed against engineering and physical standards (ISO 11608:2012).

4. Adjudication Method for the Test Set

Not applicable/Not available in the provided document. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a medical device (autoinjector), not a diagnostic AI system with human-in-the-loop performance measurement. Therefore, an MRMC study with human readers assisting AI or without AI assistance is not applicable.

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

Not applicable. As this is a physical medical device (autoinjector), the concept of an "algorithm only" standalone performance is not relevant in the context of AI. The performance assessment mentioned (activation force, needle extension, injection time, completeness of injection, functionality, and robustness) refers to the physical device's characteristics.

7. The Type of Ground Truth Used

Not applicable. As this is a physical medical device, the "ground truth" refers to engineering specifications and performance standards as outlined in ISO 11608:2012 (e.g., calibrated measurements of force, time, distance, successful drug delivery) rather than expert consensus, pathology, or outcomes data in a diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. See point 8.

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