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The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites. Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

The Autofuser system consists of a family of disposable infusion pumps and associated procedure kits. The pump is comprised of a balloon-style medication reservoir and an integrated flowrate-controlling administration set. When the Autofuser pump is packaged in a procedure kit, the kit includes legally marketed components such as filling syringe, catheter, catheter introducer, and pump carrying pouch.

Here's an analysis of the provided text regarding the Ace Medical Autofuser Elastomeric Infusion Pump System (K090300) and its performance criteria and study details:

Summary of Acceptance Criteria and Device Performance (Based on available information):

Detailed Study Information:

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

   • See the table above. The document broadly states that the modified device "met its predetermined performance specifications" and is "as safe and effective" as the predicate device. Specific numerical acceptance criteria or detailed individual performance metrics are not provided in this summary.

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

   • The document does not specify the sample size used for the test set.
   • The document does not specify the data provenance (e.g., country of origin) or whether it was retrospective or prospective. It only mentions "Performance testing was performed to verify/validate the modifications to the system."

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):

   • This question is not applicable as the device is an infusion pump, not an AI/diagnostic device that typically relies on expert-established ground truth for a test set. The performance testing would likely involve engineering and functional tests rather than expert opinion on output.

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

   • This is not applicable for this type of device and study. Adjudication methods are typically used in studies involving human interpretation (e.g., medical image reading) where multiple experts or readers are involved.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices involving human readers. This device is an elastomeric infusion pump.

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

   • This is not applicable in the AI sense. This device is a physical medical device (an infusion pump), not a software algorithm being tested for standalone performance. The "performance data" refers to the physical pump's functional integrity.

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

   • For a device like an elastomeric infusion pump, the "ground truth" would be established by engineering standards, predetermined specifications, and validated measurement techniques (e.g., flow rate accuracy, pressure limits, material compatibility, duration of infusion). The document broadly states that the device "met its predetermined performance specifications," implying these engineering benchmarks were used.

8. The sample size for the training set:

   • This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

   • This is not applicable for the same reason as point 8.

Conclusion:

The 510(k) summary for the Ace Medical Autofuser Elastomeric Infusion Pump System (K090300) indicates that the device met its predetermined performance specifications and was found to be as safe and effective as its predicate device (K060258) after modifications. However, the summary provides very high-level information about the "Performance Data." It does not include specific numerical acceptance criteria, detailed test methodologies, sample sizes for testing, or the specific types of "predetermined performance specifications" that were met. The document uses general statements to affirm substantial equivalence, rather than detailed quantitative results commonly found in AI/diagnostic device studies. Due to the nature of the device (an infusion pump), many of the questions related to AI studies (experts, ground truth for training/test sets, MRMC studies) are not relevant.

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The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites.

Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button.

General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

The modification to the existing device is the addition of new flow rates, new reservoir size and procedure kit components.

Here's an analysis of the provided text regarding the Ace Medical Autofuser System (K060258), broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific numerical acceptance criteria for the device's performance (e.g., "flow rate must be within X% of target"). Instead, it states that:

From the text, "The design verification and validation activities have been performed and the results demonstrate that the predetermined acceptance criteria were met," implies that internal criteria were established and achieved, but the specific metrics are not detailed in this summary.

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

The provided document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The submission focuses on modifications to an existing device and demonstrating substantial equivalence through design verification and validation, rather than a clinical study with a patient-based test set.

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

The document does not mention the use of experts to establish ground truth for a test set. The evaluation appears to be based on engineering verification and validation of the device's performance against internal specifications and comparison to predicate devices, not on expert consensus regarding clinical outcomes.

4. Adjudication Method for the Test Set

As no test set involving human assessment or expert review is described, there is no adjudication method mentioned.

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

The document does not describe an MRMC comparative effectiveness study. This submission is for modifications to an elastomeric infusion pump, which typically does not involve this type of study design. The focus is on the device's mechanical and functional performance, not on human interpretive tasks that would benefit from MRMC studies.

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

The device is an elastomeric infusion pump. There is no "algorithm only" or "standalone" performance described in the context of AI or software. The performance assessed would be the physical pumping mechanism and its ability to deliver fluids at specific rates.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is implicit in its design specifications and functional requirements. For example, a target flow rate, reservoir size, and bolus delivery mechanism. The document states that "design verification and validation activities have been performed and the results demonstrate that the predetermined acceptance criteria were met." This implies the ground truth was based on engineering specifications and established performance benchmarks for infusion pumps, not on pathology, outcomes data, or expert consensus in a clinical sense.

8. Sample Size for the Training Set

As this is a submission for a medical device (an elastomeric infusion pump) and not an AI/ML algorithm that requires a training set, the concept of a "training set" does not apply to this document.

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

Since there is no training set for an AI/ML algorithm for this device, information on how its "ground truth" was established is not applicable.

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