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The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.

The SIMS Portex Anesthesia Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks.

The catheter is available as 21g (O.D. .033"/I.D. .019"). The catheters have a nominal length of 38 inches. The catheters may include a stylete.

The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics, analgesics, and/or narcotics. The catheter may be used in conjunction with an infusion pump. The catheter may be used, outside of the epidural space, for up to 30 days. An insertion device may be provided to aid the placement of the catheter into the introducer needle. They are provided sterile in individual packages or as a component of a regional anesthesia procedure tray (K965017).

The provided document, K994275, describes a 510(k) premarket notification for the SIMS Portex Anesthesia Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically found in a study demonstrating acceptance criteria for a novel device, such as detailed performance metrics from a specific test set, expert adjudication, or MRMC studies, is not present in this document.

Instead, the document emphasizes equivalence through non-clinical data demonstrating that the new catheter performs equivalently to predicate devices for specific characteristics.

Here’s an analysis based on the provided text, addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Inner Diameter (ID)
• Outer Diameter (OD)
• Length | Demonstrated equivalency to predicate devices. |
  | Functional Characteristics | - Flow Rate
• Leakage
• Eye Patency
• Tensile Strength
• Percentage Elongation
• Luer Taper
• Security of Connection of the catheter to the catheter connector
• Hub/Catheter Detachment | Demonstrated equivalency to predicate devices. |
  | Material Safety | - ETO residuals (Ethylene Oxide sterilization residuals)
• Biological Safety per ISO 10993 | Data submitted covers ETO residuals and biological safety per ISO 10993. |

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

The document does not specify a distinct "test set" in the way one would for a clinical study with patients or a specific set of images for an AI algorithm. The performance evaluation was based on non-clinical data comparing the new device's characteristics against predicate devices. The exact sample sizes for each physical or material test (e.g., number of catheters tested for flow rate, tensile strength, etc.) are not provided in this summary.

Data provenance (country of origin, retrospective/prospective) is not applicable in the context of these non-clinical, bench-top type tests. The tests would likely have been conducted in a lab setting by the manufacturer (SIMS Portex Inc., likely in Keene, NH, USA).

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

This information is not applicable as the evaluation was based on objective, quantifiable physical and material tests against manufacturer specifications and predicate device characteristics, not subjective interpretations by experts to establish a "ground truth" in a clinical diagnostic sense.

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

This is not applicable for the non-clinical, bench-top tests conducted.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an anesthesia catheter, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is an anesthesia catheter, not an algorithm.

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

The "ground truth" in this context refers to the established specifications and performance characteristics of the predicate devices and recognized industry standards (e.g., ISO 10993 for biological safety). The new device's performance in dimensional, functional, and material safety tests was compared directly to these objective benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. The device is an anesthesia catheter and does not involve a training set as would be used for machine learning.

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

This question is not applicable for the reasons stated above.

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The Alpha Infusion Pump is intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered percutaneously through a catheter. The Alpha Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

The proposed device, the Alpha Infusion Pump, is an elastomeric chamber infusion pump intended to deliver medications or fluids to a patient by an intravenous, intra-arterial, subcutaneous, or epidural route. These pumps are ambulatory, external, disposable infusion pumps which deliver medication or fluids percutaneously to the patient via a catheter. They control flow rate using a flow restrictor.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) summary and approval letter for an infusion pump, focusing on its substantial equivalence to predicate devices and regulatory compliance rather than performance study results.

Therefore, I cannot provide the requested table or answer the specific questions about the device's acceptance criteria and study that proves it meets them.

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The Nerve Block Infusion Kit is intended to provide continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative general and orthopedic surgery. Additional routes of infusion include percutaneous, subcutaneous, epidural and into the intraoperative (soft tissue / body cavity) site and synovial cavity.

The Nerve Block Infusion Kit is nearly identical to the I-Flow PainBuster Infusion Kit with the exception of a new intended use, the addition of three new pump models and the addition of three new kit components (insulated Tuohy needle, hemostasis valve assembly and hookup wire). The kit is comprised of an elastomeric infusion pump (K944692) and various components such as catheter, needle, syringe, dressing, tape, gauze, hemostasis valve assembly, hookup wire and accessories such as carry case, power ring and clothing attachment clip (E-Clip). The Nerve Block pump is a disposable device intended for single patient use. The Nerve Block pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

Here's an analysis of the provided text regarding the Nerve Block Infusion Kit, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "nominal fill volumes for each model" but does not provide specific numbers of pumps or tests conducted.
• Data Provenance: Not explicitly stated, but it is implied to be internal testing conducted by I-Flow Corporation ("Testing occurred at standard operating conditions. Testing occurred at nominal fill volumes for each model."). There is no mention of external validation or data from specific countries. It is prospective in nature, as the testing was performed to support the premarket notification.

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

Not applicable. The study is a performance test of a medical device (infusion pump flow rate) and does not involve human expert interpretation or a "ground truth" in the clinical sense. The ground truth here is the physical measurement of the flow rate against a specified engineering tolerance.

4. Adjudication Method for the Test Set

Not applicable. This was a technical performance test, not a subjective assessment requiring adjudication.

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

Not applicable. This device is an elastomeric infusion pump, not an AI-powered diagnostic or assistive technology involving human readers.

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

Yes, a standalone performance test was done. The device (Nerve Block pump) was tested to measure its flow rate performance against pre-defined accuracy claims. This refers to the intrinsic performance of the pump itself, independent of human interaction during operation beyond initial setup.

7. The Type of Ground Truth Used

The ground truth used was engineering specification/measurement against a defined tolerance. The "ground truth" for flow rate accuracy is the desired flow rate, and the measured flow rate must fall within ±15% of that desired rate at a 95% confidence interval.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."

9. 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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