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• The FROG device is a hypodermic needle and filter combination intended for use with syringes for general purpose fluid injection/aspiration and filtering.
• The FROG removable filter allows the device to first withdraw medications from glass ampules and filter out glass fragments prior to subsequent administration after the removal of the filter cover.
• The FROG device is intended to be used by health care practitioners supporting medical care of any patient where delivery of drug housed in a glass primary container (where there is potential for glass particulate to get into drug upon opening of said primary container) is required.

The FROG device is a prescription device intended for use by healthcare professionals in a healthcare or outpatient setting. The FROG device incorporates a removable filter, which surrounds the hypodermic needle and allows the filtered aspiration of glass-contaminated drug into the syringe. After aspiration, the filter is removed from the device, permitting injection with the hypodermic needle which is already attached to the syringe. Each package will include an assembled FROG device. The device is intended for single use and provided sterile.

The provided FDA 510(k) clearance letter and documentation for the FROG (Filter Removal of Glass) device focuses on demonstrating substantial equivalence to a predicate device, the BD Precision Glide Needle (K021475). The documentation outlines detailed testing performed to support this claim, especially concerning the unique filter feature of the FROG device.

Here's an analysis of the acceptance criteria and study data based on the provided text, structured as requested:

Acceptance Criteria and Reported Device Performance

The documentation does not explicitly provide a table of quantitative acceptance criteria and corresponding reported device performance values in the typical sense of a clinical study assessing diagnostic accuracy (e.g., sensitivity, specificity). Instead, the performance evaluations are designed to demonstrate the device meets established engineering, biocompatibility, and sterilization standards, and that its unique filtering functionality is effective and comparable to a reference device.

The "Assessment of Equivalence" column in Table 5-1 implicitly serves as a form of "reported device performance" against the predicate and reference devices, indicating whether the FROG device met the functional and safety expectations.

Study Details

The provided document primarily details design verification and validation testing, not a traditional clinical study with patient data.

1. Sample size used for the test set and the data provenance:

   • The document does not specify sample sizes for individual performance tests (e.g., filtration efficiency, residual volume, needle penetration, biocompatibility). It generally states "Performance Data" and lists categories of tests performed.
   • Data Provenance: The nature of the tests (e.g., ISO standard testing, biocompatibility) implies lab-based testing rather than patient data. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This concept is not applicable as the studies described are engineering and bench testing rather than clinical or diagnostic studies requiring expert review for ground truth establishment. The ground truth for these tests is defined by international standards (e.g., ISO 7864, ISO 10993-1) and objective measurements.

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

   • Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of patient data. This is not relevant to the engineering and bench testing described in this 510(k) summary.

4. 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:

   • No MRMC study or any study involving human readers/AI assistance was conducted or described. The device is a physical medical device (hypodermic needle with a filter), not an AI-powered diagnostic tool.

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

   • Not applicable. This is not an algorithm-based device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the engineering and performance tests, the "ground truth" is based on:
     • Defined specifications and standards: Adherence to ISO standards (e.g., ISO 7864 for needle requirements, ISO 10993-1 for biocompatibility).
     • Physical measurements: For parameters like filtration efficiency (e.g., 5-micron particle filtration) and residual volume, these are direct, objective measurements against defined targets.
     • Comparison to a reference device: The BBraun Filter Straw serves as a performance benchmark for the filtering capability and residual volume.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

8. How the ground truth for the training set was established:

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

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The forceps valve is intended to facilitate passage of an endotherapy device, to prevent leak or back flow of air and/or fluids, and to enable the suction function of a FUJIFILM or Olympus gastrointestinal endoscope.

The FROG forceps valve forms a tight seal with the biopsy port to prevent leakage of biomaterial, provide easy passage of endotherapy devices, and support the suction function.

The provided document is a 510(k) premarket notification letter and a 510(k) summary for the FROG Forceps Valve (VAL1-F1-100). This device is an endoscope accessory and its clearance is based on substantial equivalence to a predicate device (JAZZ Forceps Valve (part of JAZZ Disposable Valve Kit) K210625).

The document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on bench testing, biocompatibility testing, and a comparison of technological characteristics to a predicate device.

Therefore, the requested information regarding acceptance criteria, performance data, sample sizes, expert involvement, ground truth establishment, and MRMC studies related to an AI device cannot be extracted from this document, as it pertains to a different type of medical device clearance (forceps valve, not AI/ML).

The information that can be extracted regarding the FROG Forceps Valve is as follows:

FROG Forceps Valve (VAL1-F1-100) Analysis:

This device is a physical accessory for endoscopes, not an AI/ML diagnostic or assistive tool. The performance evaluation is based on bench testing and biocompatibility, not on AI model performance metrics or human reader studies.

1. Table of acceptance criteria and the reported device performance:

The document states: "Additional performance specifications were evaluated against pre-defined acceptance criteria to demonstrate the effectiveness of the device over its stated 2-year shelf life." However, the specific acceptance criteria and the detailed reported performance values are NOT provided in this summary.

2. Sample sizes used for the test set and the data provenance:

• Bench Testing: The document states "Bench testing was conducted to confirm the compatibility of the subject device with Olympus scopes." and "Additional performance specifications were evaluated...". The specific sample sizes for these bench tests are not mentioned.
• Biocompatibility Testing: The document refers to consensus standards (ISO 10993-1, -5, -7, -10) and FDA guidance for biocompatibility. Specific sample sizes for these tests are not provided.
• Data Provenance: The tests are likely laboratory-based bench tests and biocompatibility assessments, not clinical data from patients. The manufacturer is FUJIFILM medwork GmbH, located in Höchstadt, Germany, implying the testing would likely be performed in a controlled laboratory environment. Retrospective or prospective classification is not applicable here as it's not a clinical data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications:

• This is not applicable as the device is a physical medical device (forceps valve), not an AI/ML diagnostic. Ground truth (e.g., for diagnostic accuracy) is not established by human experts in the context of this device's performance evaluation for FDA clearance. Performance is assessed via engineering and biocompatibility testing.

4. Adjudication method for the test set:

• Not applicable for this type of device and performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was NOT done. This type of study is relevant for diagnostic AI tools where human readers' performance with and without AI assistance is evaluated. This document concerns a physical endoscope accessory.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• For biocompatibility: Adherence to ISO standards and FDA guidance for biological evaluation.
• For performance: Engineering specifications and functional requirements (e.g., tight seal, easy passage of devices, support suction function). The "ground truth" is based on the device's ability to meet these pre-defined engineering performance criteria.

8. The sample size for the training set:

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

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

• Not applicable.

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A non-sterile gravity medicine delivery device for use with a nasogastric or percutaneous endoscopic gastrostomy ( PEG) tube to administer crushed and diluted medications and liquids.

The FROG is functionally similar to the syringe used for delivery of "bolus feedings and medications through a nasogastric feeding tube or a "Peg" feeding tube. By adapting the tip of the syringe barrel to accommodate the secondary medication tubing, adding a cap and hanger and enlarging the barrel of the syringe to accommodate the 240cc capacity, the FROG is capable of delivering a can (240cc) of feeding or medications, hands free and accurately without spillage or waste. The FROG is made of polypropolene, latex free and dishwasher safe for home use. The drip chamber on the delivery tubing allows for back priming in the event crushed medication particles clump and cause a blockage in the flow.

The provided text describes a medical device called "The FROG" (Fluids- Rx medications- On the Go), which is a dosage vessel for indwelling feeding tubes. The 510(k) summary focuses on demonstrating substantial equivalence to existing devices rather than meeting specific performance acceptance criteria through detailed studies. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a typical AI/software device is not present in this document.

Here's an analysis of the provided text in relation to your request:

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

The document does not specify formal, quantitative acceptance criteria in the typical sense for a medical device with measurable performance metrics (e.g., sensitivity, specificity, accuracy). The "performance" described is functional similarity to existing devices and addressing identified user pain points.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size:
  • "In a single clinical test": The sample size is not explicitly stated but implies a very small number, possibly one client ("a client who was capable of giving self feedings and medications").
  • "A clinical test of the 'FROG' with cap and hanger was performed via the 'BUTTON' access, popular for use in children": Again, the sample size is not explicitly stated but suggests potentially a few "children" or "clients." Given the qualitative nature of the findings ("ease and accuracy of use was reported and the level of anxiety related to fear of inaccurate dosing was relieved"), it is unlikely to be a large, statistically powered study.
• Data Provenance: Not specified, but the submission is from Branchville, NJ, USA, so it's reasonable to infer the testing took place in the USA.
• Retrospective or Prospective: The descriptions "In a single clinical test" and "A clinical test [...] was performed" suggest prospective testing, even if small in scale and scope.

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 device is a mechanical delivery system, and its "ground truth" is its functional performance and user experience, not diagnostic accuracy requiring expert consensus. The "ease and accuracy of use" and "relief of anxiety" were reported by the users or caregivers in the clinical tests, acting as the subjective "truth-tellers." No external experts for ground truth establishment are mentioned.

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

Not applicable. As noted above, this summary describes functional testing and user feedback, not a study requiring an adjudication method for ground truth or performance assessment.

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 or diagnostic device that involves "human readers."

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

Not applicable. This is not an AI or algorithm-based device.

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

The "ground truth" is primarily based on:

• Functional observation: Does it deliver 240cc? Does it flow hands-free? Does it prevent spillage?
• User feedback/reported experience: "Ease and accuracy of use was reported" and "the level of anxiety related to fear of inaccurate dosing was relieved."
• Direct observation of physical phenomena: "The airway on the tubing, the cap and hanger have proven to resolve these issues (reflux) as well."

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable for the same reason as above.

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