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The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.
To Aid in Percutaneous Access to the Stomach During Gastrostomy Tube Placement.

The PUMA-G Pediatric System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G Pediatric System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G Pediatric System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using either the Sachs-Vine PUSH technique or the Ponsky PULL technique.

The provided FDA 510(k) clearance letter and summary for the PUMA-G Pediatric System describe a medical device designed to aid in the initial placement of gastrostomy feeding tubes. The summary outlines some performance testing, including a small safety clinical study. However, the document does not contain the detailed acceptance criteria or the specific study design elements (beyond a "small safety clinical study" and "single-center study") that would typically be reported for an AI/software device that needs to meet performance criteria for metrics like sensitivity, specificity, or accuracy based on a test set.

The PUMA-G Pediatric System appears to be a mechanical device with an ultrasound visualization component, not an AI/software-driven diagnostic or assistive device that would rely on a test set with ground truth established by experts and MRMC studies. The "performance data" mentioned focuses on mechanical, biocompatibility, and sterilization aspects, along with a safety study.

Therefore, many of the requested information points (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as they pertain to the rigorous evaluation of AI/software algorithm performance against established ground truth, which is not the primary focus of this device's clearance.

Based on the provided information, here's an attempt to answer the questions, highlighting where information is absent or non-applicable:

Device Description

The PUMA-G Pediatric System is a medical device designed to aid in the initial percutaneous placement of a gastrostomy feeding tube. It utilizes a balloon catheter with an internal magnet and an external magnet to coapt the stomach to the anterior abdominal wall. Users then employ their existing ultrasound for visualization and guided needle placement. The system also includes a guidewire.

Acceptance Criteria and Performance Study Analysis (Based on Provided Document)

Given the nature of the device as a mechanical aid with ultrasound visualization (rather than an AI/software algorithm for diagnosis or image analysis), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on safety, functional performance, and effectiveness in facilitating the procedure, rather than typical AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics in the way one would see for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the performance is described qualitatively and through the outcomes of a safety study.

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

• Sample Size for Test Set: Described as a "small safety clinical study." The exact number of patients is not specified in the provided document.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: The study is described as a "single-center study utilized the PUMA-G Pediatric System on pediatric patients indicated for gastrostomy tube." This strongly suggests a prospective design for the PUMA-G Pediatric System arm. Comparison was made to a "historical control," which implies retrospective data for that control arm.

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

• Not Applicable / Not Specified: For a device focused on procedural aid and safety rather than diagnostic interpretation, "ground truth" as established by multiple experts in an AI context is not described. The "ground truth" here is the outcome of the procedure (success, safety, adverse events), which would be assessed by the performing clinicians and documented in patient records. No mention of expert radiologists or similar interpretative experts is made.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified: Since the ground truth primarily relates to the safety and success of the procedure, a formal "adjudication method" among experts (like 2+1 or 3+1 consensus) is not mentioned or typically applied in this context for mechanical device clearance. Procedural outcomes are generally recorded by the treating team.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No: The document describes a "small safety clinical study" and a comparison to a "historical control" which "showed a reduction in radiation exposure compared to fluoroscopy-based gastrostomy (historical control)." This is a clinical outcome study, not an MRMC comparative effectiveness study involving human readers' performance with and without AI assistance. The device is a procedural aid, not an AI diagnostic tool.

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

• Not Applicable: The device is a physical, mechanical system used in a procedure with human interaction and guidance (ultrasound visualization). It is not an AI algorithm that operates standalone.

7. The Type of Ground Truth Used

• Outcomes Data and Clinical Assessment: The ground truth for the clinical study was the successful completion of the gastrostomy procedure, the absence of serious adverse events or device-related adverse events, and a reduction in radiation exposure compared to a historical control. This is based on clinical outcomes and safety data, not expert consensus on image interpretation or pathology.

8. The Sample Size for the Training Set

• Not Applicable / Not Specified: As this is a mechanical device, there is no "training set" in the context of machine learning or AI algorithm development. The "training" for such a device would involve engineering design, bench testing, and potentially animal/cadaver studies, but not a data-driven training set for an algorithm.

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

• Not Applicable: There is no "training set" for ground truth in the AI context. The "ground truth" for the engineering and functional development would be derived from physical properties, established medical principles, and preclinical testing results (e.g., "Performance test results demonstrate scientific evidence that the PUMA-G Pediatric System can effectively bring together the stomach and anterior abdominal wall while maintaining healthy tissue.").

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The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).

The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed using the guidewire and Seldinger technique.

The provided text describes the PUMA-G System, a medical device intended to affix the stomach to the anterior abdominal wall to facilitate the initial percutaneous placement of a gastrostomy feeding tube.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a formal table or list. However, the "Performance Data" section describes the types of performance data collected and the conclusions drawn regarding effectiveness and safety.

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

The document mentions "Bench performance data were collected..." and refers to "Functional Testing" and "Magnetic Characterization." It also mentions "Post-Market Analysis" for the subject device and "GLP Animal Safety" for the predicate in Table 1. However, specific sample sizes for any test set are not provided in the document. The data provenance seems to be internal company testing, as it's presented as "Bench performance data." The document does not specify country of origin or whether the studies were retrospective or prospective, though bench testing is inherently prospective for the device being tested.

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

The document does not describe any studies involving human experts establishing ground truth for a test set. The performance data discussed appears to be primarily technical/mechanical bench testing.

4. Adjudication Method for the Test Set:

Not applicable, as no expert-based test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided text. The evaluation method appears to be focused on the device's technical performance and comparison to a predicate device based on technological characteristics and bench testing.

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

The PUMA-G System is a physical medical device (catheter, guidewire, external magnet), not an algorithm or AI-driven system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device facilitates a procedure for human users.

7. The Type of Ground Truth Used:

For the bench performance tests mentioned, the "ground truth" would be established by:

• Physical measurements and engineering standards: For magnetic force characterization, coupling strength, and mechanical performance.
• Biocompatibility standards: ISO 10993 for materials.
• Sterilization validation standards: ISO 11135 for ethylene oxide sterilization.
• Animal safety data: Referenced for the predicate device ("GLP Animal Safety"), likely pathological or physiological outcomes.

8. The Sample Size for the Training Set:

The concept of a "training set" typically applies to machine learning or AI algorithms. Since the PUMA-G System is a mechanical device, there is no training set in the traditional sense of AI algorithm development. Device development likely involves iterative design, prototyping, and testing, but not a "training set" for an algorithm.

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

As there is no training set for an AI algorithm, this question is not applicable.

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