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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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The Lobster device is intended for use with a ImL glass syringe, containing a fixed needle of 27G to 29G gauge, and drug product solutions with a viscosity between 1 and 4 mPa*s. The Lobster auto-injector is a reusable injection device for the subcutaneous injection of FDA approved drugs.
For single patient or individual use only.

The Lobster Auto-injector is a reusable, spring-loaded injection device that is for use with 1.0 ml pre-filled glass syringes with staked needle. Lobster Auto-injector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.

The provided text describes the 510(k) summary for the Lobster Auto-injector, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with an AI component.

Therefore, the information required to answer the prompt (acceptance criteria, details of a study proving the device meets them, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth, and training set details) is not present in the provided text.

The text does mention performance data in Section 5.8:

"Lobster Auto-injector was assessed using the applicable sections and methods specified in the ISO standard, ISO 11608:2012, "Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems". Activation force, needle extension, injection time, completeness of injection, functionality, and robustness were assessed; Lobster auto-injector met all requirements and specifications."

However, this is a general statement about meeting ISO standard requirements for mechanical performance, not a detailed description of an AI-driven system's study. The ISO standard itself would contain the "acceptance criteria," but those are not explicitly stated here.

In summary, the provided document does not contain the information requested to describe the acceptance criteria and the study that proves an AI-driven device meets them. The Lobster Auto-injector is a mechanical auto-injector, not an AI or imaging device.

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Push-On Needle is intended for hypodermic injection of fluids into the body when attached to a compatible auto injector.

The Push-On Needle is a sterile, non-pyrogenic, single-use, pen needle designed for use with a compatible auto-injector. The Push-On Needle consists of a 30GX 8 mm stainless steel cannula, plastic hub, plastic shield and a protective sealing paper. The assembled Push-On Needle has a circular hub design that clicks and attaches to a cartridge retainer ridge of an auto-injector. Push-On Needle is used by peeling the sealing paper, thus exposing the non-patient end of the needle and pushing this end up against the auto-injector nozzle, and then attaching the needle hub to the auto injector nozzle. The needle shield can be pulled off making the Push-On Needle ready to use.

The provided text describes the Push-On Needle, a sterile, single-use hypodermic needle intended for use with a compatible auto-injector for fluid injections.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample sizes used for the individual performance, biocompatibility, sterilization, or shelf-life tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, although regulatory submissions for new devices typically involve prospective testing.

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

This information is not provided in the document. The device's substantial equivalence is primarily based on meeting established international and internal performance standards, not on expert-adjudicated ground truth in a clinical context.

4. Adjudication Method for the Test Set:

This information is not provided. The testing described is largely objective measurement against specified standards, rather than subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not relevant for this type of device. This device is a hypodermic needle, and its effectiveness is determined by its physical and material properties meeting safety and performance standards, not by human reader interpretation of images or data. Therefore, an effect size of human readers improving with or without AI assistance is not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

A standalone performance study was not explicitly mentioned in the context of an algorithm. However, the performance and safety data presented (e.g., ISO 7864, ISO 9626, ASTM F2824, ISO 10993-1, AAMI TIR 33:2005, ISO 11607-1:2006) describe the "algorithm only" or device-only performance without human interaction during the actual functioning of the device for its intended purpose.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is based on established international and industry standards. For example:

• Performance: ISO 7864 (Sterile hypodermic needles for single use), ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods), ASTM F2824 (Standard Test Method for Determining Peel Resistance of Medical and Surgical Adhesive Tapes and Dressings to Skin), and an internal standard for shield pull-off force.
• Biocompatibility: ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
• Sterilization: AAMI TIR 33:2005 (Sterilization of health care products — Radiation — Guidance on the method for validating a sterility assurance level of 10⁻⁶).
• Shelf-life: ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems).

These standards define the objective and measurable criteria that the device must meet.

8. Sample Size for the Training Set:

This information is not applicable as the Push-On Needle is a physical medical device (hypodermic needle), not an AI algorithm or software that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8; there is no training set for a physical hypodermic needle.

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