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For evaluation of colonic transit in adult and pediatic patients (at least 2 years old) with chronic constipation and used to aid in differentiating slow and normal transit constipation.

The device is intended to be used for evaluation of colonic transit time in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation in adults and pediatric patients (at least 2 years old). Ten (10) radiopaque markers per day are swallowed for six consecutive days. On day seven an abdominal radiograph is taken. Based on the number of retained markers and the position in colonic transit time is calculated and compared to reference values. Both total transit and segmental transit dysfunction in the colon can be evaluated with the device. By dividing the particle dose on day six by taking five (5) markers in the morning and five (5) markers in the evening, the whole range of transit times (slow, normal, rapid) transit can be measured from the radiograph.

The device is a convenience package of radiopaque markers (22% Barium Sulphate, 78% Elastosil® R 401/60 Silicone rubber) placed in vegetarian capsules from cellulose (HPMC, Hydroxypropylmethylcellulose), intended for single patient use. The dimension of the markers is 2x4.5mm (ring-formed markers) and 6x2mm (tube-formed markers). The capsules are packed in a blister pack is placed inside a folding box.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Transit-Pellets:

It's important to note that this document is a 510(k) clearance, which determines substantial equivalence to a predicate device, rather than a full pre-market approval (PMA) that requires extensive clinical trials to establish de novo safety and effectiveness. Therefore, the "studies" mentioned often refer to comparisons with predicate devices, existing literature, or post-market follow-up, rather than new, large-scale randomized controlled trials.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative, measurable format with target performance values (e.g., "sensitivity must be >X%", "specificity must be >Y%"). Instead, the performance is demonstrated by showing substantial equivalence to a legally marketed predicate device (Sitzmarks) and by leveraging existing clinical literature and post-market data.

The key performance aspect for Transit-Pellets is its ability to accurately measure colonic transit time (CTT) and thereby aid in differentiating slow and normal transit constipation. The acceptance is implicitly based on the predicate device's established performance and the demonstration that the subject device performs equivalently and safely, especially for the expanded pediatric population.

Table of Performance Comparison (based on equivalence to predicate):

Study Details:

The document primarily refers to a Post-Market Clinical Follow-Up (PMCF) study as the clinical evidence for the expanded pediatric population. This PMCF study appears to be a literature review combined with a user survey.

1. Sample Size Used for the Test Set and Data Provenance:

   • Literature Review: The PMCF study identified 18 clinical investigations involving similar devices. These studies collectively involved 1054 children and young adults.
   • Data Provenance: The document does not specify the country of origin for these 18 studies. The nature of these studies (retrospective/prospective) is also not explicitly stated, but common for such literature reviews, they could include both types.
   • User Survey (part of PMCF): No specific sample size for the user survey is provided, only that it involved "professional users." Data provenance is implied to be from current users of Transit-Pellets or similar devices, likely international given the company's location (Sweden).

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

   • Ground Truth for Literature Review: The "ground truth" in the 18 studies would have been established by the methods and clinicians within those individual studies, which are not detailed here. For colonic transit time, the ground truth is typically the radiological assessment of marker distribution and retention by medical professionals (e.g., radiologists, gastroenterologists).
   • Experts for PMCF Literature Review: The document does not explicitly state how many experts reviewed the identified 18 clinical investigations or their specific qualifications for the PMCF literature review itself. It implies a "literature review carried out during the PMCF study," suggesting a regulatory or scientific team conducted the review.
   • Experts for User Survey: "Professional users" were surveyed, but their number and specific qualifications (e.g., pediatric gastroenterologists, radiologists) are not provided.

3. Adjudication Method:

   • Not explicitly described. For the PMCF literature review, it's unlikely a formal adjudication method (like 2+1 or 3+1 for individual case review) was applied since it was a review of aggregate published data, not individual case interpretations.
   • For the original 18 studies, the adjudication methods would vary per study; this document does not provide such detail.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was not done in the context of this 510(k) submission. This is not typically required for a Class II diagnostic device seeking substantial equivalence, especially when expanding an indication based on existing technology and literature. The focus is on the device's inherent ability to measure CTT, not on reader performance improvement with AI assistance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Yes, in essence, the "device" is standalone. Transit-Pellets are passive markers. The "performance" being evaluated is their physical and chemical properties (biocompatibility, radiopacity, mechanical strength) and their ability to be visualized and used by a clinician to manually calculate colonic transit time from an X-ray image. There is no AI component or algorithm-only performance to assess in the typical sense of software as a medical device. The physician interprets the X-ray/fluoroscopy image and calculates CTT based on the marker count and position.

6. Type of Ground Truth Used:

   • The ground truth for measuring colonic transit time is based on radiological imaging (abdominal radiograph or fluoroscopy) and the subsequent manual counting and positional analysis of the radiopaque markers by a clinician. This is a well-established method in gastroenterology.
   • For the safety and effectiveness in the pediatric population, the PMCF study relied on published clinical investigation results (which would have used radiological ground truth) and user feedback.

7. Sample Size for the Training Set:

   • Not applicable in the typical sense of AI/ML training. There is no "training set" for an algorithm, as this device consists of physical markers interpreted by human readers.
   • If viewed in a broad sense, the "training" for the device's design (marker size, material, dosing regimen) comes from decades of clinical practice and research using radiopaque markers for colonic transit studies, which predates this specific device.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable as there is no specific training set for an algorithm. The principle of "ground truth" in this context refers to the accuracy of colonic transit time measurements derived from the markers. This has been established through clinical consensus and research over time, validating the correlation between marker distribution on X-rays and actual colonic transit physiology.

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For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.

Transit-Pellets is intended to be used for evaluation of colonic transit time in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Ten (10) radiopaque markers per day are swallowed for six consecutive days. On day seven an abdominal radiograph is taken. Based on the number of retained markers and the position in colon a colonic transit time is calculated and compared to reference values. Both total transit and segmental transit dysfunction in the colon can be evaluated with the device. By dividing the particle dose on day six by taking five (5) markers in the morning and five (5) markers in the evening, the whole range of transit times (slow, normal, rapid) transit can be measured from the radiograph.

Transit-Pellets is a convenience package of radiopaque markers (22% Barium Sulphate, 78% Elastosil® R 401/60 Silicone rubber) placed in veqetarian capsules from cellulose (HPMC, Hydroxypropyl-methylcellulose), intended for single patient use. The dimension of the markers is 2x4.5mm (ring-formed markers) and 6x2mm (tube-formed markers). The capsules are packed in a blister pack and the blister pack is placed inside a folding box.

The provided text describes a 510(k) premarket notification for the "Transit-Pellets" device, which is a gastrointestinal motility monitoring system. This document is a clearance letter from the FDA, asserting substantial equivalence to a predicate device, rather than a detailed study report for a novel AI device requiring extensive performance metrics against acceptance criteria.

Therefore, much of the requested information (acceptance criteria for AI, sample size for test sets/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, etc.) is not applicable to this specific device and submission type, as it is a physical medical device (radiopaque markers) and not an AI/ML software. The crucial point is that no AI component is described or evaluated in this document.

However, I can extract and present the information relevant to a traditional medical device's performance and equivalence.

Device Name: Transit-Pellets
Regulation Name: Gastrointestinal Motility Monitoring System
Regulatory Class: Class II
Product Code: FFX
Indications for Use: For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable table as one would for an AI model's performance (e.g., AUC > X, sensitivity > Y%). Instead, the device's performance is demonstrated through comparisons to a predicate device and safety/material testing, confirming it performs "as intended" and is "safe and effective."

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

As this is a physical device and not an AI/ML algorithm, there are no "test sets" in the sense of image datasets used to evaluate an algorithm's performance. The performance evaluation relies on:

• Bench testing: Simulated capsule digestion, dimensional analysis, mass analysis, radiopacity testing.
• Biocompatibility testing: In vitro and in vivo studies on materials.
• Clinical literature: Referenced to support design choices (e.g., marker size and shape influence on transit).
• Comparison to predicate device: Demonstrating equivalence in function and safety.

No specific sample sizes for clinical performance studies are provided, as the substantial equivalence largely relies on the predicate's established performance and material/design testing. The document states "Clinical data was not required to establish the substantial equivalence of the subject and predicate devices." This indicates that extensive de novo clinical trials were not performed or submitted for this 510(k) clearance due to the device's similarity to an already cleared predicate.

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. Ground truth for an AI device (e.g., image annotations by experts) is not relevant for this physical device. The "ground truth" for the device's function is the established physiological process of colonic transit and the ability to visualize markers to determine it.

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

Not applicable. No expert review/adjudication of a test set is described.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

Not applicable in the context of an AI device. For this device, the "ground truth" is the physical behavior of radiopaque markers in the human gastrointestinal tract, as understood and measured by established medical principles and imaging techniques. The performance is validated indirectly by:

• Physical and chemical properties: Ensuring markers are radiopaque, stable, and release from capsules as intended.
• Biocompatibility: Demonstrating safety of materials in physiological conditions.
• Physiological principles: Relying on existing medical understanding of how different marker sizes/shapes traverse the GI tract and how the number/position of markers relates to colonic transit time.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable.

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