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The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patient authorized by their physicians to self inject at home.

The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body.

This submission (K051985) is for a "label-only" modification to an already marketed device, the BioValve Mini-Ject Needlefree Injection System. As such, the submission explicitly states that no performance data was required or provided to demonstrate the device meets acceptance criteria because the technological characteristics and the device itself remained unchanged.

Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable to this specific 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

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

• Not applicable. This submission focuses on updating the Instructions for Use (labeling) for an already marketed device. The text explicitly states: "No change was made to the Mini-Ject device and therefore no physical testing was required to confirm the injectors meet their specifications." This indicates that previous acceptance criteria were met by the device itself, but those criteria and performance data are not part of this submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No new performance testing was conducted for this label-only modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No new performance testing was conducted for this label-only modification, so no ground truth establishment for a test set was required.

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

• Not applicable. No new performance testing was conducted for this label-only modification.

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 device is a needle-free injection system, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers or MRMC studies.

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

• Not applicable. This device is a mechanical injection system, not an algorithm.

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

• Not applicable. No new performance testing was conducted for this label-only modification.

8. The sample size for the training set

• Not applicable. This device is a mechanical injection system, not a machine learning model that requires a training set.

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

• Not applicable. This device is a mechanical injection system, not a machine learning model.

Summary of the 510(k) Submission (K051985):

This 510(k) submission sought to update the Instructions for Use (IFU) for the BioValve Mini-Ject Needlefree Injection System. The device itself (including its technological characteristics) remained unchanged from the previously cleared version (K021969). Therefore, the manufacturer stated, and the FDA determined, that no new performance data or testing was required to demonstrate substantial equivalence for this specific submission, as it was solely a labeling modification. The substantial equivalence was based on the device being identical to the legally marketed predicate device, with only the instructions for use being updated to clarify and simplify warnings, precautions, and contraindications.

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The BioValve Insulin Delivery System (BIDS) is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

BioValve Technologies proposes to market a disposable pump for the basal and bolus delivery of insulin.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BioValve Insulin Delivery Systems (BIDS):

Overall Assessment:

The provided document set is a 510(k) summary and the FDA's clearance letter for the BioValve Insulin Delivery Systems (BIDS). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or determining specific performance metrics against pre-defined acceptance criteria in the same way a clinical trial for a new drug or an AI-powered diagnostic might.

Therefore, many of the requested elements for a detailed study report (like sample sizes, ground truth establishment, MRMC studies, standalone performance metrics, etc.) are not present in this type of regulatory submission. The "performance data" mentioned in the 510(k) summary refers to demonstrating that the device functions equivalently to its predicate, often through bench testing and engineering comparisons, not necessarily through a clinical study with detailed statistical outcomes.

Acceptance Criteria and Device Performance Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The acceptance criteria are not explicitly listed in numerical targets (e.g., "accuracy > 95%"). Instead, the primary acceptance criterion is substantial equivalence to existing legally marketed devices, particularly the Insulet iXL Diabetes Management System (K031373). The reported device performance is that it meets this substantial equivalence. The "performance data" mentioned is to demonstrate this equivalence, likely through engineering tests, comparison of materials, and functional testing to show it operates similarly for continuous insulin delivery.

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

• Sample Size for Test Set: Not specified in the provided documents. In a 510(k) for a mechanical device like this, the "test set" would typically refer to bench testing or engineering verification rather than a clinical dataset of patients.
• Data Provenance: Not specified. Again, for this type of device, the "provenance" would relate to where the engineering tests were conducted, not patient data from a specific country or whether it was retrospective/prospective.

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

• Number of Experts: Not applicable/specified. This type of regulatory submission for a simple mechanical device typically relies on engineering and functional testing, not expert consensus on ground truth labels for a dataset.
• Qualifications of Experts: Not applicable/specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/specified. Adjudication methods like "2+1" or "3+1" are used for resolving disagreements in expert labeling of data, which is not relevant for this type of device submission.

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

• MRMC Study: No. This is a non-AI, mechanical insulin pump. MRMC studies are specific to evaluating diagnostic algorithms, often AI-powered, and their impact on human reader performance.

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

• Standalone Study: No. This device is a mechanical pump and does not involve an "algorithm" in the sense of a software-based diagnostic or decision support tool. Its performance is inherent in its mechanical function.

7. The Type of Ground Truth Used

• Type of Ground Truth: For a device like this, the "ground truth" for its performance would be based on engineering specifications and validated functional tests. This would include parameters like:
  • Accuracy of insulin delivery (flow rate, dose per actuation).
  • Reliability (consistent performance over time, resistance to occlusion).
  • Safety (leakage, biocompatibility of materials).
  • These are validated against established industry standards and the performance of predicate devices. It is not "expert consensus," "pathology," or "outcomes data" in the context of clinical diagnostics.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. As this is not an AI/ML device, there is no "training set" in the computational learning sense. The device is designed, built, and tested based on engineering principles.

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

• Ground Truth for Training Set Establishment: Not applicable. There is no training set for this mechanical device.

Summary of what the documents do tell us:

The 510(k) summary and FDA letter confirm that the BioValve Insulin Delivery Systems (BIDS) achieved substantial equivalence to predicate devices. This means the FDA determined that the device is as safe and effective as other legally marketed insulin infusion pumps. This determination was based on "Performance Data" which, in this context, refers to engineering and functional testing demonstrating that the BIDS operates similarly to existing devices for its intended use (continuous insulin delivery at set and variable rates), despite having different technological characteristics (no electronic power or software).

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The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This non electrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patients authorized by their physicians to self inject at home.

The Mini-Ject is a sterile, single use medical device. The Mini-Ject delivers 0.5ml subcutaneously. The device consists of an injector and a luer adapter to provide a means of filling the device using a standard slip lock syringe. The device is powered by a proprietary charge system wholly contained in the distal portion of the device.

The provide submission does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a typical diagnostic or AI/ML device submission would. This 510(k) submission is for a physical medical device—a needle-free injection system—and its approval is based on demonstrating substantial equivalence to a predicate device rather than performance against a set of predefined acceptance metrics for accuracy, sensitivity, or specificity.

Instead, the submission focuses on:

• Device Description: Detailing the components and function of the "Mini-Ject Needlefree Injection System."
• Substantial Equivalence: Comparing the proposed device to a legally marketed predicate device (Biojector 2000) based on intended use, system configuration, materials, packaging, sterility, shelf life, and fill adapter. The goal is to show that the new device is as safe and effective as the predicate.
• Intended Use Statement: Clearly defining the purpose and user population for the device.

Based on the information provided, here's how to address your questions in the context of this device type:

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

No explicit acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) are provided for this needle-free injection system in the document. The regulatory pathway here is demonstrating "substantial equivalence," not meeting quantitative performance targets in the same sense as an AI/ML or diagnostic device.

The "performance" is implicitly demonstrated through the comparison table, showing that:

The main "study" proving the device meets the (implicit) acceptance criteria is the comparison to the predicate device, asserting that its fundamental technology, materials, and intended function are comparable, and any differences (like being fully disposable and fixed volume/route) do not raise new questions of safety or effectiveness.

Regarding your other questions, they are largely not applicable to this type of 510(k) submission for a physical, non-AI medical device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" in the context of diagnostic performance or AI model evaluation is mentioned. Device testing would have been conducted for aspects like sterility, material compatibility, dose delivery accuracy, and shelf life, but details on sample sizes for such engineering/bench tests are not provided in this summary document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 a physical injection device, not an AI or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would relate to successful fluid delivery, sterility, and material safety, which are confirmed through engineering tests and material specifications, not clinical outcomes or expert consensus on a diagnostic interpretation.

8. The sample size for the training set
Not applicable. This device does not have a "training set" as it's not an AI/ML product.

9. How the ground truth for the training set was established
Not applicable.

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