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The SteadiSet Infusion Set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.

The subject device, Capillary Biomedical, Inc. SteadiSet Infusion Set, is a sterile, non-pyrogenic, intravascular administration set device used to administer insulin from a reservoir cartridge to a patient subcutaneously through a cannula. The infusion set administers insulin by means of a compatible external pump.

The infusion set consists of an inserter, tube set, and disconnect cover. The inserter consists of a housing, insertion buttons, an infusion set hub (with cannula) and adhesive patch with protective liner. The inserter facilitates insertion of the cannula subcutaneously. The cannula is a soft medical-grade polymer extruded over a stainless-steel coil.

The tube set provides the insulin pathway between the hub's indwelling cannula and an external insulin pump cartridge. The tube set consists of infusion set tubing with a reservoir connector (proximal end) and hub connector (distal end).

The disconnect cover can be connected to the hub to provide cover when the infusion set tubing is disconnected from the hub.

The device is sterilized by Ethylene Oxide (ETO) and is a single-patient, single-use device.

The provided FDA 510(k) Clearance Letter for the SteadiSet Infusion Set does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar design, materials, and intended use, rather than presenting detailed performance study results against specific acceptance criteria.

The "Non-Clinical Performance Data" section lists various tests performed (e.g., Insertion Force and Depth, Strength of Materials, Biocompatibility, Sterility), but it does not provide:

• Specific acceptance criteria values for each test (e.g., "Insertion force must be less than X N").
• Reported device performance values (e.g., "Observed insertion force was Y N").
• Details about the study methodology for these performance characteristics (e.g., sample size, ground truth establishment, expert involvement).

Therefore, I cannot fulfill most of the request based solely on the provided text. The questions asking about sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment (especially for training sets) are all related to robust clinical or non-clinical performance studies that are not described in this clearance letter.

This type of FDA letter confirms clearance based on a submission, but the detailed study reports themselves are typically much more extensive and are not usually part of the publicly available clearance letter.

Here's a breakdown of what can be inferred or stated based on the provided document, and what is missing:

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

• Cannot be provided definitively from this document. The document lists types of tests performed (e.g., "Insertion Force and Depth", "Strength of Materials, Joints, and Connectors"), but it does not specify the quantitative acceptance criteria for these tests nor the measured performance values of the SteadiSet Infusion Set against those criteria. For example, it lists "Insertion Force and Depth" as a test, but doesn't say "Acceptance Criteria: Insertion Force < 10 N, Observed: 8 N".

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

• Cannot be provided from this document. The document does not specify sample sizes for any of the listed "Non-Clinical Performance Data" tests. It also does not mention data provenance details like country of origin or whether studies were retrospective or prospective, as these are typically detailed in the full submission, not the clearance letter.

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/Cannot be provided from this document. This information is typically relevant for AI/ML device studies involving human interpretation (e.g., radiologists for imaging diagnostics). For an infusion set, "ground truth" would be established by bench testing methodologies, physical measurements, and chemical analyses against established standards and specifications, not by human expert consensus or clinical interpretation in the same way. The document does not mention any expert panels or their qualifications for establishing ground truth for the device's technical performance.

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

• Not applicable/Cannot be provided from this document. Similar to point 3, adjudication methods (like 2+1, 3+1 consensus) are typically used for medical image interpretation or clinical outcomes where human judgment needs to be reconciled. For bench tests of an infusion set, performance is measured objectively, and "adjudication" in this sense is not relevant.

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. MRMC studies are specific to AI/ML devices, particularly in medical imaging (e.g., CAD systems assisting radiologists). This is an infusion set, not an AI diagnostic device. Therefore, no MRMC study would have been performed or reported here.

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

• Not applicable. This is an infusion set, not an AI algorithm. There is no "standalone algorithm performance" to assess.

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

• Inferred based on the device type: For an infusion set, "ground truth" for the listed "Non-Clinical Performance Data" would be based on:
  • Benchtop measurements against engineering specifications: For characteristics like Insertion Force, Tubing Elongation, Priming Volume.
  • Validated chemical/biological assays: For Biocompatibility (Cytotoxicity, Sensitization, Irritation, etc.), Sterility.
  • Standardized functional tests: For Functional Performance, Tandem Pump Compatibility, Corrosion Testing.
  • Simulated-use protocols: For Usability/Human Factors.
  • These are based on established standards (e.g., ISO, ASTM, FDA guidance) for medical device evaluation.

8. The sample size for the training set

• Not applicable/Cannot be provided from this document. The concept of a "training set" is relevant for AI/ML models. This is a physical medical device. Manufacturing processes involve quality control, but not "training sets" in the AI sense.

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

• Not applicable/Cannot be provided from this document. As "training set" doesn't apply to this physical device, neither does the establishment of its ground truth.

In Summary:

The provided FDA 510(k) clearance letter serves as confirmation that the FDA has found the SteadiSet Infusion Set to be "substantially equivalent" to a legally marketed predicate device (K061374, AutoSoft™ 30 Infusion Set). This determination is based on the information provided in the original 510(k) submission, which would have included detailed reports of the non-clinical performance data and how the device met specific performance criteria. However, the clearance letter itself does not contain the granular data requested about acceptance criteria, detailed study parameters, sample sizes, or ground truth establishment methodologies with quantified results.

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