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The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM) or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers who routinely administer injections. The Biojector® 2000 may also be used by patients authorized by their healthcare practitioner to self inject, or have other individuals administer injections of prescribed medication.

The addition of the intradermal indication is facilitated by using the new Intradermal Spacer with a No. 2 Syringe. Intradermal injections of vaccines and other pharmaceuticals are performed on the same patient populations that are now being treated with the Biojector® 2000 for the previously cleared indications.

The Bioject® 2000 Needle-Free Injection Management System is designed to deliver vaccines and other pharmaceutical injectables by producing a high pressure injectate stream that penetrates the dermis. The system is composed of three major components: (1) the injector -Biojector® 2000; (2) sterile single use disposables - syringes in multiple orifice sizes, safety cap, filling adapter and intradermal spacer (packaged for use with a No. 2 syringe only); and (3) power source - carbon dioxide (CO2) cartridge or tank.

The depth of injectate penetration is dependant upon the svringe orifice diameter. In general. the larger the diameter of the syringe orifice, the deeper into the tissue the fluid will be deposited. Disposable syringes with a variable volume from 0.1 ml to 1 ml are numbered 2, 3, 4, 5 and 7, and have increasing syringe orifice diameters, 0.04", 0.08", 0.10" and 0.14" respectively. Intradermal injections (ID) are only performed using a No. 2 syringe (the smallest diameter) and an ID Spacer. As the distance from the syringe orifice to the skin is increased, the energy density of the fluid stream is decreased. The ID Spacer utilizes this principle to provide the optimum distance from the syringe to the skin to provide enough energy for the injectate to penetrate the epidermis, but not enough energy to transverse the underlying dermal tissue Subcutaneous (SC) injections are performed using a No. 2 syringe that is in direct contact with the skin, no spacer is utilized. Intramuscular (IM) injections are performed using syringes in contact with the skin and with larger orifice diameters.

The disposable syringe assemblies are provided sterile in a Tyvek blister peel pouch. The ID Spacer is manufactured from a high density polyethylene that meets the same environmental, biocompatibility and sterility requirements as the disposable syringes. The ID Spacer is packaged as a component with Biojector® No. 2 syringe assemblies.

This looks like a 510(k) premarket notification for a medical device, not an AI/ML medical device. The information requested (such as expert consensus, MRMC studies, or training set data) is typically relevant for evaluating AI/ML device performance and isn't provided in traditional medical device submissions like this.

However, I can extract the closest equivalent information from the given text based on how a traditional medical device's performance is demonstrated to meet its acceptance criteria.

Here's the analysis of the provided text in the context of your questions:

The submission K121270 is for the Biojector® 2000 Needle-Free Injection Management System to add a new Indication for Use for administering intradermal injections using an ID Spacer. The primary method of demonstrating acceptance is through non-clinical performance testing and a comparative animal study against predicates.

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

The acceptance criteria are primarily derived from the international standard ISO 21649:2006 for Needle-free injectors and biocompatibility/sterilization standards. For the intradermal indication, the performance is also evaluated against a needle and syringe and a predicate needle-free injector concerning specific injection characteristics.

2. Sample size used for the test set and the data provenance

• Non-Clinical Performance Testing (ISO 21649:2006, Biocompatibility, Sterilization): The document does not specify the exact sample sizes for these tests (e.g., how many devices were tested for dose accuracy, how many samples for biocompatibility). These are typically standard tests with defined sample sizes per the respective ISO standards. The data provenance is from non-clinical laboratory testing presumably conducted by or for Bioject, Inc. (manufacturer).
• Animal Studies: The text states, "Testing in an accepted porcine model was conducted." The exact number of animals or injections performed is not specified. The provenance is prospective animal (porcine) study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in this type of submission. Ground truth for device performance in this context is established through objective measurements (e.g., instrument readings for dose accuracy, histological analysis in animal studies) rather than expert human interpretation.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretation or clinical outcomes, which is not relevant to the non-clinical and animal studies described here.

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

This is not applicable. This is a submission for a mechanical medical device, not an AI device, so MRMC studies involving human readers with/without AI assistance are not relevant.

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

This is not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

• For Non-Clinical Performance (e.g., Dose Accuracy, ISO 21649:2006): The ground truth is based on objective measurement standards and engineering specifications.
• For Biocompatibility and Sterilization: The ground truth is based on defined biological responses or chemical analyses as per the ISO standards.
• For Intradermal Injection Equivalence (Animal Study): The ground truth was established by direct observation and measurement within the porcine model for "wheal size, depth of penetration, and dye dermal contact area." This would likely involve histological analysis or other direct measurement techniques after injection.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device, and therefore does not have a "training set" in that context. The device's design and engineering would have involved iterative development and testing, but not in the sense of an AI training set.

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

This is not applicable for the same reason as above.

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