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Nexpowder™ is used for hemostasis of nonvariceal gastrointestinal bleeding.

The Nexpowder is used for hemostasis of non-variceal gastrointestinal bleeding. It is a prescription only, single-use device provided with a powder pre-packaged in a vial, and a delivery system, which consists of a spray body, a connector and a delivery catheter is inserted through an endoscope's working channel to deliver the powder to the intended hemostasis target site. Nexpowder is almost identical to the currently marketed device (K202929) and has the same technological characteristics and mechanism of action, but differs in the indications for use, where the subject device is also indicated for lower GI bleeding.

Here's a breakdown of the acceptance criteria and study information for the Nexpowder™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device, which implies that the Nexpowder™ should perform comparably to the predicate for the expanded indications. The reported performance is primarily about showing comparability.

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

• Sample Size: A total of 260 lower GI cases.
• Data Provenance: Clinical data was collected:
  • Outside the United States (OUS)
  • Prospective study conducted in Korea.
  • Retrospective studies conducted in Korea.
  • Aggregated data collected in the European Union (EU).

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

The document does not specify the number of experts used to establish ground truth for the clinical studies, nor does it detail their qualifications (e.g., "radiologist with 10 years of experience"). It generally refers to "clinical data" without providing these specifics.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the test set.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with AI vs. without AI assistance. This device is a physical hemostatic device, not an AI/software device, so an MRMC study would generally not be applicable in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as Nexpowder™ is a physical medical device (hemostatic powder and delivery system), not an algorithm or software. There is no "algorithm only" performance to be assessed.

7. Type of Ground Truth Used

The "ground truth" for the clinical studies would be clinical outcomes related to hemostasis of non-variceal gastrointestinal bleeding. This would involve medical assessment of whether bleeding was successfully stopped using the device.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a physical medical device, not an AI/software product, so the concept of a training set as often discussed in AI studies is not applicable here. The "training" for the device would be its prior development and testing, including the clinical data supporting its previous clearance (K202929).

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

As above, the concept of a "training set" in the AI sense is not applicable. For the development and prior clearance (K202929) of Nexpowder, the "ground truth" would have been established through a combination of:

• Pre-clinical testing: Laboratory and animal studies to demonstrate the hemostatic properties and safety of the powder and delivery system.
• Clinical studies (for K202929): Data from human trials (likely for upper GI bleeding) to establish safety and effectiveness, similar to the type of clinical outcome data described above for the lower GI indication expansion.

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Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding.

The Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding. The Nexpowder™ is a prescription only, single-use device provided with a pre-packaged powder, a vial, and a Delivery System, which consists of a Spray body, a Connector and a Delivery Catheter. The powder vials are provided in a sterile condition with gamma radiation sterilization and the non-sterile external Spray Body delivery system with its sterile Connector and sterile Delivery Catheter. The hemostatic powder agents of the Nexpowder™ are primarily composed of succinic anhydride ({-poly-L-lysine) and oxidized dextran and are endoscopically applied through a catheter channel of the delivery system to control qastrointestinal bleeding in the upper qastrointestinal tract. Utilizing the installed battery power, air pressures are generated from the air pump placed in the spray body of Nexpowder™ delivery system to provide effective physical force to move the hemostatic powder agent into the delivery catheter. The hemostatic agents of the Nexpowder™ ultimately get sprayed onto the hemostasis target site in the gastrointestinal tract. Nexpowder is excreted from the patient's gastrointestinal or digestive system primarily by peristalsis of the human digestive system within the three days.

The device described is Nexpowder™, a hemostatic device for intraluminal gastrointestinal use. The information provided outlines the device's characteristics and the studies performed to demonstrate its safety and effectiveness for FDA 510(k) clearance.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device (Hemospray® Endoscopic Hemostat) and the various testing performed to demonstrate substantial equivalence, particularly in terms of hemostatic efficacy and safety. The performance metrics focus on initial hemostasis rates, re-bleeding rates, and the absence of adverse events.

2. Sample Size for the Test Set and Data Provenance

The "test set" for performance evaluation consists of both animal studies and human clinical data.

• Animal Studies (Porcine Studies I & II):

  • Sample Size:
    • Study I: 6 Nexpowder™ treated, 6 Hemospray® treated (predicate), 3 sham controls (total 15 pigs).
    • Study II: 6 Nexpowder™ treated, 3 Hemospray® treated (predicate) (total 9 pigs).
  • Data Provenance: Prospective animal studies conducted in a controlled environment (porcine model for upper gastrointestinal bleeding).

• Human Clinical Data (Real-world evidence from OUS market):

  • Sample Size:
    • Clinical Study A: 76 patients (37 Nexpowder™ in test group)
    • Clinical Study B: 56 patients
    • Clinical Study C: 17 patients
    • Clinical Study D: 41 patients
    • Clinical Study E: 50 patients (Retrospective Aggregated Data Collection survey)
    • Total: 240 patients (excluding the 39 from study A that likely received a comparator or were not Nexpowder treated based on the provided numbers, and noting that the document states "315 patients with an additional 50 patients from a Retrospective Aggregated Data Collection survey" which doesn't perfectly match the sum of individual study patient numbers provided. Assuming the sum of reported patients in the table are the test set.)
  • Data Provenance: Real-world evidence (RWE) from the OUS (outside U.S.) market. Clinical Studies A, B, C, D are likely retrospective or prospective observational studies from OUS. Clinical Study E is explicitly stated as a "Retrospective Aggregated Data Collection survey." The specific countries of origin are not detailed in this summary.

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

This information is not explicitly provided in the given text.

• For the animal studies, histopathological evaluation was performed, implying expert pathologists. However, the number and qualifications are not mentioned.
• For the human clinical data, clinical outcomes (hemostasis, re-bleeding, adverse events) are reported, which by definition would be assessed by medical professionals. However, the specific number of experts, their role in establishing "ground truth," or their qualifications (e.g., "radiologist with 10 years of experience") are not detailed. It's common in clinical trials for treating physicians to establish these outcomes.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the given text.

• For the prospective clinical study (Study A), it is described as "Prospective, Multicenter, Single-blind (subject) Controlled Clinical Trial." This suggests formal data collection, but it does not specify if an independent adjudication committee was used for outcomes like hemostasis or adverse events, or if a 2+1/3+1 consensus method was employed for ground truth establishment.
• For the other clinical studies and the retrospective survey, the adjudication method for reported outcomes is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is typically performed for diagnostic imaging devices where human readers interpret images with and without AI assistance. This device, Nexpowder™, is a hemostatic device, not an imaging or diagnostic device. Therefore, an MRMC comparative effectiveness study as described (human readers with/without AI assistance) would not be applicable and was not performed.

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

This question is also not applicable in the context of Nexpowder™ as it is a physical medical device (hemostatic powder and delivery system), not an AI algorithm. The device's performance is inherently "standalone" in how it acts on the tissue, but it still requires a human operator (endoscopist) for delivery. There is no AI component to the device itself that would be evaluated in an "algorithm only" manner.

7. The Type of Ground Truth Used

• Animal Studies:
  • Direct observation: Initial hemostasis, re-bleeding episodes.
  • Histopathology: Microscopic examination of tissue at the device application site, likely confirmed by expert pathologists.
• Human Clinical Data:
  • Clinical Outcomes: Initial hemostasis, re-bleeding events, and adverse events as observed and documented by treating clinicians. This represents clinical consensus based on standard medical practice and diagnostic criteria.

8. The Sample Size for the Training Set

This information is not applicable as Nexpowder™ is a physical medical device, not an AI, algorithm-driven, or machine learning device that requires a "training set." The development of the device involves engineering, chemical formulation, and preclinical testing, rather than data-driven model training.

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

This information is not applicable for the same reasons as point 8.

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