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The SafeStep® MAX™ Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports.

The SafeStep® MAX™ Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with ports that are indicated for power injection of contrast media into the central venous system, the SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.

The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature.

The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring intravascular administration set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling.

The SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles. and 2 ml/s for 22 gauge needles.

The device functions in a similar manner to all the predicate devices. The insertion site is prepared and the device is primed using a 10 ml syringe containing normal saline and inserted into the port septum. Patency is confirmed and the device is dressed per institutional protocol. Removal of the device is accomplished by flushing per institutional protocol, stabilizing the base of the device by securely holding the base down and firmly pulling the textured handle up until you feel a firm stop and the needle is locked into the safety position. Dispose the set into a sharps container.

The provided text describes the SafeStep® MAX™ Power-Injectable Infusion Set and its substantial equivalence to predicate devices, focusing on its safety and effectiveness. However, it does not contain a specific table of acceptance criteria with reported device performance alongside the criteria. The document only generally states that "The SafeStep® MAX™ Power-Injectable Infusion Set met all established acceptance criteria for performance testing and design verification testing."

Therefore, I cannot generate the table as requested.

Regarding other points, here's what can be extracted:

• Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards" and "Performance data gathered in design verification testing." However, specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are not detailed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to a medical device's physical and functional performance, not diagnostic imaging or clinical judgment where expert consensus on "ground truth" would be established. The "ground truth" here is the performance against established engineering and safety standards.
• Adjudication method for the test set: Not applicable for this type of device submission.
• 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 medical device, not an AI or diagnostic imaging system involving human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
• The type of ground truth used: For this device, the "ground truth" is based on established engineering standards, guidance documents (e.g., FDA's guidance for Intravascular Administration Sets and Medical Devices with Sharps Injury Prevention Features), and ISO standards (ISO 11135, ISO 11137, ISO-10993). Performance against these standards serves as the benchmark for safety and effectiveness.
• The sample size for the training set: Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
• How the ground truth for the training set was established: Not applicable.

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The LumiLoc™ Safety Introducer Needle is intended to be used for percutaneous procedures utilizing a sheathed introducer trocat/needle for guidewire introduction during percutaneous gastrointestinal procedures.

The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath.

The LumiLoc™ Safety Introducer Needle helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip.

The LumiLoc™ Safety Introducer Needle consist of a stainless steel trocar/needle with a colored translucent hub and a colored translucent safety guard, a sheath attached to a translucent hub having a standard female Luer lock hub connector. The trocar/needle hub has a bevel-up orientation indicator. The sheath hub utilizes a phosphorescent material. The LumiLoc™ Safety Introducer Needle's sheath hub has an integral Seldinger shield. The stainless steel trocars/needles have a specialty coating to enhance percutaneous entry.

The LumiLoc™ Safety Introducer Needle incorporates an intuitive easy to use safety guard which is an integral part of the device. The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath and helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip. A visual. tactile, or audible confirmation of the locking component over the trocar/needle confirms lockout of the safety guard over the trocar/needle.

LumiLoc™ Safety Introducer Needles will be marketed to the clinical end-user as sterile single use devices. Additionally, the device will be placed in Percutaneous Endoscopic Gastrostomy (PEG) procedural trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the procedural tray or kit manufacturer. The LumiLoc™ Safety Introducer Needies will be incorporated into a procedurai tray or kit, packaged and sterilized.

The provided text describes the LumiLocTM Safety Introducer Needle and its regulatory submission. It does not contain information about an AI/ML device or its performance characteristics. This device is a physical medical instrument, not a software algorithm. Therefore, many of the requested categories related to AI/ML device evaluations (e.g., sample size for training set, MRMC studies, ground truth establishment, number of experts for ground truth) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and the study that "proves" it meets them, based on the context of a 510(k) submission for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 500 LumiLoc™ Safety Introducer Needles.
• Data Provenance: The study was a "simulated use study." This implies a controlled laboratory or clinical simulation environment rather than actual patient data. The country of origin is not specified, but the submission is to the US FDA, so the testing was likely conducted in the US or under US regulatory standards. It's prospective in the sense that the testing was performed specifically for this submission.

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

• Number of Experts: Not explicitly stated, but the study involved "clinicians" performing the simulated insertions and activations. The exact number of clinicians is not provided.
• Qualifications of Experts: Described as "clinicians." Specific qualifications (e.g., years of experience, specialty) are not detailed in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not described. This was a direct performance test where the device's physical function (activation, no injuries, no failures) was observed. There isn't a "ground truth" to adjudicate in the typical sense of subjective interpretations. The outcomes (e.g., "no sharps injuries," "no failures") are direct observational results.

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 not an AI/ML device. This type of study is not applicable.

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

• Standalone Performance: Not applicable, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the objective observation of the device's physical performance during the simulated use study.
  • Successful insertion: Observed directly.
  • Safety guard activation: Observed directly.
  • Lack of sharps injuries: Observed directly.
  • Lack of failures: Observed directly.
  • The "material testing" mentioned also contributed to proving substantial equivalence, suggesting engineering specifications and quality control data likely formed part of the ground truth for material properties.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML model that requires a training set. The development process would involve iterative design and testing, but not a "training set" in the computational sense.

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

• How Ground Truth for Training Set Was Established: Not applicable.

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