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The Interject Injection Therapy Needle Catheter is used for endoscopic injection into gastrointestinal mucosa and submucosa to: • introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system • aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures • control non-variceal hemorrhage

The Interiect™ Injection Therapy Needle Catheter that consists of a handle with a hub for injection, a catheter sheath, and a needle. It is available in a variety of configurations with varying needle lengths, gauges, and catheter lengths.

The provided document is a 510(k) premarket notification for a medical device called the "Interject Injection Therapy Needle Catheter." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics as might be found for novel devices or PMAs.

Therefore, the document does not contain the requested information regarding acceptance criteria, study details (sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance), or training set information.

Instead, the document focuses on demonstrating that the new Interject Injection Therapy Needle Catheter is substantially equivalent to existing predicate devices.

Here's what can be extracted from the document conceptually related to performance and testing, though not in the format requested for acceptance criteria and a study proving those:

1. Acceptance Criteria and Reported Device Performance: This information is not provided in a quantified, tabular format. The document states that the proposed device "meets the requirements of ISO 10993-1, ISO 11135, and ISO 10993-7." These are standards for biological evaluation of medical devices, sterilization, and ethylene oxide sterilization residuals, respectively. Meeting these standards is a form of acceptance criterion, but specific performance metrics (e.g., tensile strength, injection force, flow rate) are not detailed, nor are the actual measured performance values reported.

2. Sample size used for the test set and the data provenance: Not applicable or not provided. The substantial equivalence argument relies on the fact that the proposed device is "identical" to one predicate (K012864) and has only "minor differences" (sheath outer diameter) from others, which are stated not to "alter the suitability of the proposed device for its intended use." This comparison suggests that new, extensive performance testing on a specific "test set" to establish entirely new performance metrics was not deemed necessary by the submitter beyond verifying compliance with the mentioned ISO standards.

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 type of information is relevant for studies involving human interpretation or clinical endpoints, which are not detailed in this 510(k) summary.

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 device is an injection therapy needle catheter, not an AI diagnostic tool.

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. "Ground truth" in the context of clinical or diagnostic performance is not relevant for this type of device submission based on substantial equivalence to a physical instrument.

8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

In summary, the document demonstrates substantial equivalence through:

• Stating "identical technological characteristics" to the predicate Interject Injection Therapy Needle Catheter (K012864).
• Acknowledging "similar technological characteristics" and "minor difference in sheath outer diameter" to Olympus InjectorForce Max (K902736) and Wilson-Cook Variable Length GI Injection Needle (K941305), but asserting this difference "does not alter the suitability of the proposed device for its intended use."
• Stating compliance with key ISO standards (10993-1, 11135, 10993-7) for biological evaluation and sterilization, noting that the "design and materials remain unchanged from that of the predicate Interject Injection Therapy Needle Catheter (K012864)."

The "study" here is implicitly the verification that the device maintains the same performance characteristics as the predicate through design and material equivalence and compliance with relevant industry standards for safety aspects (biocompatibility, sterilization). No specific clinical or comparative performance study with human readers or AI algorithms is described.

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The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.

The Injectra Injection Needle is a device that is used to deliver solutions into tissues of the digestive tract through the accessory channel of a legally marketed endoscope.

Acceptance Criteria and Study Details for Injectra Injection Needle

This submission (K061222) pertains to the Injectra Injection Needle and demonstrates its substantial equivalence to a predicate device. The performance data focuses on verification that the new device meets established requirements and maintains safety, rather than providing complex clinical trial outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state a sample size for a test set in the traditional sense of a clinical or analytical study with a defined dataset. The performance data section refers to "Design verification data" and "Biological testing," which are typically internal engineering and laboratory tests.

• Test Set Sample Size: Not explicitly stated as a defined "sample size" for a dataset. Design verification and biological testing are usually conducted on a set number of manufactured devices or materials.
• Data Provenance: The nature of "Design verification data" and "Biological testing" suggests these are results from internal testing conducted by the manufacturer, Medi-Globe Corporation. The country of origin and whether it is retrospective or prospective are not specified, but such tests are generally prospective (performed on new designs or materials).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission does not involve expert-established ground truth for a test set in the context of diagnostic accuracy. The "ground truth" for this type of device (an injection needle) is largely based on engineering specifications, material properties, and established biological safety standards. There is no mention of external experts being used to establish a ground truth for performance.

4. Adjudication Method for the Test Set

Not applicable. The performance data described are based on objective engineering and laboratory tests, not subjective interpretations requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Injectra Injection Needle is an interventional accessory device.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only) was not conducted. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance relies on:

• Engineering Specifications and Performance Requirements: Measured against pre-defined functional parameters (e.g., fluid delivery capability, structural integrity, compatibility with endoscopes).
• Predetermined Safety Standards: Biological testing confirms the device meets accepted biocompatibility standards.
• Equivalence to Predicate Device: The primary ground truth is established by demonstrating that the new device performs identically or equally well to the legally marketed predicate device (K955558) in terms of its intended function and safety profile.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI system that requires a training set.

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

Not applicable, as there is no training set for this device.

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