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SWFIPS is a combination product intended to be used by patients, pharmacists or physicians for the reconstitution and administration of approved prescription drug products.

SWFIPS is not labeled or intended for stand alone use. The indications for use of the reconstituted drug or biologic are contained in the package insert for each product.

SWFIPS is a glass piston syringe filled with USP Sterile Water for Injection.

SWFIPS is composed of an assembled glass piston syringe filled with a diluent, Sterile Water for Iniection. USP.

SWFIPS is used for the reconstitution of non-liquid injectable drugs, in containers, and subsequent injection, according to their labeling.

The provided text is a 510(k) summary for a medical device called SWFIPS (Sterile Water for Injection Prefilled Syringe). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical or performance study in the way a new, non-equivalent device might.

Therefore, the sections of your request regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth for training are not directly applicable or available in the typical 510(k) summary. The document focuses on comparing the new device to a predicate device to establish substantial equivalence.

Here's an analysis based on the information available in the provided text, addressing your points where possible and explaining why others are not present:

1. Table of Acceptance Criteria and the Reported Device Performance

This 510(k) summary does not present a table of specific acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity) and corresponding reported device performance for the SWFIPS device in the way a diagnostic or therapeutic device might.

Instead, the "performance" described relates to its characteristics, intended use, and conformance to existing standards for its components and contents, primarily to establish substantial equivalence to a predicate device.

The document states:

• "The Sterile Water for Injection contained in the syringe conforms to USP monograph specifications at release and throughout the shelf life."
• "The glass and the elastomeric closures meet USP requirements."
• "The SWFIPS has been tested according to a stability protocol designed to support the shelf life claim."

These statements imply that the performance (e.g., sterility, chemical composition of water, integrity of materials) meets relevant USP (United States Pharmacopeia) standards and internal stability protocols. However, no quantitative performance metrics or specific acceptance criteria are provided in a table format.

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

This information is not provided in the 510(k) summary. The document describes a comparison to a predicate device and mentions stability testing, but it does not detail any specific "test set" in terms of patient data or clinical samples. The "tested according to a stability protocol" likely refers to in-house laboratory testing of the product itself, not a study involving human subjects or patient data.

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)

This information is not applicable and not provided. SWFIPS is a prefilled syringe with sterile water, not a device that generates data requiring expert interpretation or "ground truth" establishment in a diagnostic sense.

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

This information is not applicable and not provided. Similar to point 3, the device type does not involve an adjudication process for a test set.

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 information is not applicable and not provided. MRMC studies are typically for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. This device is a prefilled syringe for drug reconstitution and administration, with no AI component or human interpretation task.

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

This information is not applicable and not provided. The device is a physical medical product (a syringe with sterile water), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

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

This information is not applicable in the traditional sense for this device. The "ground truth" for components like the Sterile Water for Injection is its conformance to USP monograph specifications, which are established chemical and physical standards. For the physical components (glass, closures), it's conformance to USP requirements. This is a form of "ground truth" based on established scientific and regulatory standards for chemical purity and material properties, rather than clinical outcomes or diagnostic certainty.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable and not provided. As above, there is no "training set" for this device.

Summary of Device Comparison for Substantial Equivalence:

The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, the BD® GLASPAK® syringe. The substantial equivalence argument is based on:

• Intended Use: Both used for reconstitution of non-liquid drugs and injection of drug solutions.
• Material Compatibility: Both container materials are biocompatible and chemically compatible with Sterile Water for Injection.
• Syringe Tip Compatibility: Both syringe tips are compatible with a female Luer fitting.
• Technological Characteristics: Both employ the same technological characteristics, with the key difference being that SWFIPS is pre-filled.

Differences noted, without adverse effect to safety or efficacy:

• SWFIPS is filled with 1 mL Sterile Water for Injection (predicate is empty).
• SWFIPS is terminally sterilized by steam (predicate by ethylene oxide).

The 510(k) states that these differences do not adversely affect safety or efficacy, therefore supporting the claim of substantial equivalence. The "performance" described relates to the components meeting USP standards and stability protocols, which implicitly demonstrate that the device is safe and effective for its stated intended use and is equivalent to an already marketed device.

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