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InfuLife is a single-use, sterile, disposable elastomeric infusion pump intended for intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites. InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intra-arterial, subcutaneous, and epidural. Additionally, InfuLife is indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or proximity to nerves for preoperative, and postoperative regional anesthesia and pain management. InfuLife is intended for use by physicians, clinicians, pharmacists, and other licensed healthcare professionals.

InfuLife is a non-electrically driven, portable fixed flow rate infusion pump. The fluid is pushed forward by the pressure of the elastomeric bladder. The flow rate of the device is predetermined by the manufacturer using Hagen-Poiseuille theory, which calculates the volumetric flow rate of a fluid with certain viscosity passing through a cylindrical pipe with a known diameter, at a given pressure and temperature.

The provided text describes InfuLife, an elastomeric infusion pump, and its 510(k) submission for FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device and outlines performance testing against various standards. However, it does NOT contain the specific information requested regarding AI/algorithm performance studies, ground truth establishment, or multi-reader multi-case (MRMC) studies, as this device appears to be a hardware-based medical device (infusion pump) and not an AI/software-as-a-medical-device (SaMD).

Therefore, I cannot provide the requested information about acceptance criteria for an AI algorithm, its performance, or details of studies involving human readers and AI assistance, as these are not relevant to the InfuLife device described.

The document explicitly states:

• "No animal study or clinical trial data was obtained in support of this submission." (Page 10)
• The performance data refers to testing against engineering and biological safety standards (e.g., flow rate accuracy, biocompatibility, sterilization, shelf-life, packaging integrity) for a physical medical device. (Page 9)

If you have a document describing an AI/SaMD, please provide that.

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The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
· Routes of administration: intravenous and subcutaneous.

The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
· Route of administration: intravenous.

The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
· Routes of administration: intravenous and intra-arterial.

The SMARTeZ™ Elastomeric Infusion Pump (SMARTeZ™ Pump) is a sterile, single-use, mechanical (non-electric, non-electronic) infusion pump that consists of an elastomeric fluid reservoir as an energy source and an administration line. The constriction of the elastomeric fluid reservoir drives the fluid through the administration tubing and eventually through a flow restrictor, into the patient connection.

The SMARTeZ™ Pump is intended to administer infusion therapies only, and not for fluid storage.

This Special 510(k) Submission is to inform FDA of the addition to the thirty-nine (39) existing SMARTeZ™ Pump offerings, four (4) new models of different nominal volumes, flow rates and time: 498111: 100 ml, 0.5 ml/h, 200 h; 498121: 100 ml, 1 ml/h, 100 h: 498131: 50 ml, 0.5 ml/h, 100 h: 498141: 50 ml. 1 ml/h, 50 h. with KVO (Keep Vein Open) infusion pump labeling.

This document describes the FDA clearance for the SMARTeZ™ Elastomeric Infusion Pump (K242152), which identifies it as substantially equivalent to a previously cleared device (K151650). This submission is a "Special 510(k)" for the addition of new models with different nominal volumes, flow rates, and infusion times, along with a change to a detachable administration tube.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized international standards. The document doesn't provide a direct "table" of acceptance criteria values alongside specific performance metrics for each, but rather states that tests were performed in conformance with these standards.

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

The document does not explicitly state the numerical sample size for each specific test in the "test set". It mentions "bench performance verifications and validations performed on the Subject device (pump and administration tubing connected) and referred-to existing devices (K151650)". The provenance of the data is not specified in terms of country of origin. The studies are described as "bench performance verifications and validations," indicating controlled laboratory testing, and would be considered prospective for the specific tests performed on the Subject device to support this 510(k).

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

This information is not provided in the document. The document describes bench testing and compliance with standards for a medical device. Ground truth, in the context of expert review, is not applicable here as these are performance tests and biocompatibility assessments, not diagnostic or interpretive tasks.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes objective performance testing and compliance with standards, not a case-based review where expert adjudication would be needed.

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

This information is not applicable. The device is an elastomeric infusion pump, a hardware device for fluid delivery, not a software device or an AI application that assists human readers.

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

This information is not applicable. The device is a physical medical device, an elastomeric infusion pump, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The ground truth for this device's performance is objective measurements against established engineering and biocompatibility standards (e.g., flow rate accuracy within specifications, confirmation of sterility, absence of cytotoxicity).

8. The Sample Size for the Training Set

This information is not applicable. This document describes the clearance of a physical medical device (an elastomeric infusion pump) based on engineering performance and biocompatibility testing, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device.

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ON-Q* Pump is intended to provide continuous delivery of medication (such as local anesthetics) to or around surgical wound sites and/or close proximity to nerves for preoperative and postoperative regional anesthesia and/or pain management. Routes of administration include: intraoperative site, peripheral nerve block, percutaneous and epidural.

ON-Q* Pump is indicated to significantly decrease pain and narcotic use when used to deliver local anesthetics to or around surgical wound sites, or close proximity to nerves, when compared to narcotic only pain management.

ON-Q* Pump with Bolus device is intended for users 18 years of age and older.

The ON-Q* Pump with Bolus consists of an elastomeric pressure source (i.e. elastomeric pump) with an integrated administration set/line. The ON-Q* Pump with Bolus delivers continuous infusion (basal) and allows incremental fixedvolume boluses to be delivered on demand by the patient. In addition to the optional bolus component, the administration line may contain any of the following optional components:

• Filter
• Select-A-Flow variable flow rate assembly ●
• Y-adaptor ●

The bolus component controls the bolus and/or basal flow rate capability of the administration set that connects to the elastomeric pump. The bolus component is an integrated part of the pump system and cannot be used alone. The patient or healthcare provider presses a button to activate bolus delivery. The refill time determines the patient must wait prior to receiving another full bolus dose.

I am sorry, but the provided text does not contain any information about acceptance criteria for a medical device or a study proving that the device meets those criteria. The document appears to be an FDA 510(k) summary for a device called "ON-Q* Pump with Bolus," which discusses substantial equivalence to a predicate device.

The document includes:

• A brief description of the device and its intended use.
• A comparison of the subject device (ON-Q* Pump with Bolus) to a predicate device (K063530) in terms of indications for use, user population, environment of use, and technological characteristics.
• Discussions of differences in technological characteristics and explanations that these differences do not raise new questions of safety or effectiveness.
• A section on "Performance Testing" which lists various types of bench testing, design validation, human factors evaluation, packaging verification, sterilization verification, biocompatibility, drug stability, and MR compatibility that were performed. However, it does not specify concrete acceptance criteria with numerical targets or report the device's performance against such criteria in a tabular format as requested.
• It explicitly states "Clinical Tests: Not Applicable."

Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance, or details about the sample size, data provenance, ground truth establishment, or clinical study methods, as this information is not present in the provided text.

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The SMARTeZ Pump (Long infusion time article) is intended for continuous infusions for general infusion use, including pain management.
• Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusions for general infusion use, including antibiotic delivery.
· Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
· Routes of administration: intravenous and intra-arterial.

The SMARTeZ Pump, is a single-use disposable, non-electric infusion pump that consists of an elastomeric fluid reservoir as energy source with an integrated administration line (see Figure 5-1). The constriction of elastomeric fluid reservoir drives the medication through the tubing and eventually through a flow restrictor out into the patient connection. Drug products should be stored in their approved containers and closures.

The SMARTeZ Pump, an elastomeric infusion pump, underwent a series of bench tests to demonstrate its performance and safety, aligning with ISO 28620:2010 standards. The study aimed to prove that the device consistently delivers medication within specified flow rate tolerances under various conditions, including nominal operation, changes in ambient temperature and solution viscosity, and after exposure to physical stresses like pressure, traction, and drops, as well as refrigeration. It also verified leak-proof integrity and the absence of retrograde flow.

Here is a summary of the acceptance criteria and the reported device performance:

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

• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis confirmed flow accuracy within +/- 15% at 99% confidence (lower- and upper-bounds of -0.400% to +0.151%) when filled with nominal volume and delivering normal saline at 31°C with the pump 40cm below the catheter site. |
  | Flow Rate Test (Change of Ambient Temperature) | Mean flow rates should be no more than 15% slower when compared to those tested at 31°C. | Passed. Mean flow rate was 14.07% slower, confirming the IFU claimed temperature effect. |
  | Flow Rate Test (Change of Solution Viscosity) | Mean flow rates should be no more than 10% slower when compared to those tested with 0.9% NaCl as control solution. | Passed. Mean flow rate was 9.81% slower, confirming the IFU claimed fluid viscosity effect. |
  | Flow Rate Test after Resistance to Pressure Test | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis showed flow rate accuracy was not affected. |
  | Leak-Proof Test after Resistance to Pressure Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Leak-Proof Test after Drop Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Flow Rate Test after Resistance to Traction Test | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis showed flow rate accuracy was not affected. |
  | Leak-Proof Test after Resistance to Traction Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Flow Rate Test after Refrigeration | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both flow rate and leak integrity criteria. Statistical analysis showed flow rate accuracy was not affected. |
  | Leak-Proof Test after Refrigeration | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Retrograde Flow of Infusate Test | Retrograde flow should not be observed when back pressure applied ≤ 0.34bar (5 psi). | Passed. Retrograde flow was observed at 0.8 bar (11.6 psi), which is double the acceptance criteria. |
  | Flow Rate Test under Non-Ambient Pressure (Influence of Routes of Administration) | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal, independent of IV, intra-arterial, and subcutaneous routes. | Passed. Flow accuracy of +/- 15% was maintained, independent of the 3 routes of infusion administered. |
  | Performance/Functionality Testing for Chemotherapy Articles | - Flow accuracies (nominal, after pressure/traction/refrigeration, non-ambient pressure): Mean flow rate ±15% of nominal, 80% nominal volume within ±50% instantaneous.
• Watertight after pressure, traction, drop, and refrigeration.
• No retrograde flow at back pressure ≤ 0.34bar (5 psi). | Passed. All samples met all acceptance criteria. |

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

The document does not explicitly state the specific sample size (number of devices) used for each individual bench test. However, it consistently refers to "All test samples" passing the criteria. It also mentions "The samples were tested."
The data provenance is from bench testing, which implies a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, as these types of studies are typically not applicable to physical bench tests of device functionality.

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 study described is a series of bench tests for device performance against predefined engineering and regulatory standards (ISO 28620:2010), not a study involving expert assessment or clinical ground truth.

4. Adjudication method for the test set:

This is not applicable as the study involves objective physical measurements and functional checks against quantitative acceptance criteria, not subjective human evaluations requiring adjudication.

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:

This is not applicable as the device is a physical infusion pump, not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the device is a physical infusion pump, not an algorithm. The "standalone" performance here refers to the device's inherent mechanical and fluid dynamic performance.

7. The type of ground truth used:

The ground truth for the performance tests was established by objective measurements against quantitative engineering and regulatory standards (ISO 28620:2010), specifically defined numerical tolerances for flow rate, and observable physical properties like leak-proof integrity and retrograde flow.

8. The sample size for the training set:

This is not applicable as the device does not employ machine learning or AI models that require a training set.

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

This is not applicable as the device does not employ machine learning or AI models.

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The I-Flow Elastomeric Pump is intended for infusion of medications including antibiotic delivery, chemotherapy and pain management. Routes of administration include intravenous, subcutaneous and epidural.

The I-Flow Elastomeric Pump is also intended for infusion of medication (such as local anesthetics or narcotics) for local or regional anesthesia and pain management. Routes of administration include: perineural (nerve block), into intraoperative sites (infiltration), percutaneous and epidural.

The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic-only pain management.

The indications for use include hospital, alternate care, ambulatory and home environments.

The I-Flow Silicone/Non-DEHP Elastomeric Pumps consist of an elastomeric pressure source with an integrated administration set. The elastomeric membrane functions as the fluid reservoir and the pressure source. The desired flow rate is regulated by a restrictor orifice or fixed flow tubing that controls flow generated by the pressurized bladder. The pre-attached administration set may incorporate any of the following components:
• Y-tubing for multi-site delivery (single or dual)
• Air and particulate eliminating filter
• Flow Restrictor
• Luer Connector

The pump may be sold as a kit with additional devices or accessories such as the following: catheter, introducer needle, syringe, and E-clip.

This is a 510(k) summary for a medical device called the I-Flow Elastomeric Pump, which is used for infusion of medications. The document describes the device, its intended use, and compares it to predicate devices. It also states that "All the non-clinical data and tests (i.e., flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, chemical characterization, drug compatibility) performed, met the design requirements and acceptance criteria, thereby demonstrating substantial equivalence to the predicate devices."

However, this document does not provide specific acceptance criteria or detailed study results. It only mentions that testing was conducted and met the acceptance criteria. It also mentions a simulated use study for human factors but doesn't provide details on its results in terms of concrete performance metrics.

Therefore,Based on the provided text, I cannot extract the detailed information requested regarding the acceptance criteria and study proving the device meets those criteria. The document states that testing was performed and met acceptance criteria, but it does not specify what those criteria are or present the results of the studies in a quantifiable manner.

Here's a breakdown of what can and cannot be answered from the provided text:

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

• Cannot be provided. The document states: "All the non-clinical data and tests (i.e., flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, chemical characterization, drug compatibility) performed, met the design requirements and acceptance criteria," but it does not specify what those design requirements or acceptance criteria were (e.g., a specific percentage for flow rate accuracy). It also does not report the actual device performance numbers for these tests.

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

• Cannot be provided. The document mentions "non-clinical data and tests" and a "simulated use study of human factors," but it does not disclose the sample sizes for these tests or the data provenance.

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 / Cannot be provided. This device is an elastomeric infusion pump, not an AI/imaging device requiring expert ground truth for interpretation. The document does not mention any expert review or ground truth establishment in this context.

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

• Not applicable / Cannot be provided. Similar to point 3, this is not relevant for a physical medical device's performance testing described here.

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 device.

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

• Not applicable. This is not an AI-assisted device.

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

• Not applicable. For a physical device like an infusion pump, "ground truth" would relate to its physical performance metrics (e.g., actual flow rate against specified flow rate), not diagnostic interpretation. The document doesn't detail how these performance metrics were verified beyond stating they "met the design requirements and acceptance criteria."

8. The sample size for the training set

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

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

• Not applicable. This is not an AI/machine learning device.

In summary: The provided 510(k) summary asserts that the device underwent various non-clinical tests (flow rate accuracy, fill/crack pressure, residual volume, pump integrity, biocompatibility, chemical characterization, drug compatibility) and a human factors study, and that these met the design requirements and acceptance criteria. However, it does not provide the specific numerical acceptance criteria or the actual performance results from these tests. It acts as a summary rather than a detailed report of the testing.

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The MultiBolus II™ is intended to provide intermittent delivery of medication on patient demand, using patient control module allowing bolus doses, at relatively rapid velocity in parallel to a continuous basal flow or without continuous basal flow, to/or around surgical wound site and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous, subcutaneous, intramuscular and epidural.

MFS's MultiBolus II™ is a semiautomatic disposable 100% mechanical device used as a complementary to MFS's pain management system to be controlled by the patient as prescribed and set by an authorized medical team member using either one or two catheters.

The device is to be integrated with the existing cleared MFS's elastomeric pumps and is designed to provide a bolus delivery of pain relief medication with or without parallel continuous basal flow.

The MultiBolus IITM, together with the elastomeric pump creates a PCA (Patient Control Analgesia) infusion pump.

The MultiBolus II™ with Parallel set configuration is used when the delivery of a bolus medication is required to be executed parallel to a continuous basal flow.

The MultiBolus II™ with In-Line set configuration is used when the delivery of a bolus medication is required only.

Both configurations may be used during a dual catheter administration when a flow splitter such as; MFS's FlowSplitter™ (cleared within MFS's 510(k) number: K072053) device is assembled at the set exit port.

The device was developed by MFS to assist patients with pain management following surgical procedures or other pain managements. The device may be used in the hospital, at the clinic and at the home environment for out-patients subject to the physician decision.

The provided document describes the MFS MultiBolus IITM device and outlines its performance data through various tests to support its substantial equivalence to predicate devices and ensure its safety and efficacy.

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

1. Table of Acceptance Criteria and Reported Device Performance

Device: MFS MultiBolus II™ (disposable pain management system)

• Lockout time according to spec (not completely filled after the specified time).
• No parallel flow is allowed when not activated (scale monitor should show: 0.0). | - Device performed as intended.
• Maximum volume tolerance was -0.75ml. No result exceeding +0.0ml was detected.
• When nominal set to 6ml, no complete filling after the specified time occurred.
• Before activation scale monitor showed: 0.0. | Under the Test's conditions all acceptance criteria were met. |
  | 2 | Priming | Verifying priming efficiency and 0.2µ filter effectiveness in trapping air bubbles (Parallel set model) | - No air bubbles after the 0.2µ filter are allowed. | - No air bubbles after the 0.2µ filter were detected. | Under the test condition, all results met acceptance criteria. All air bubbles were trapped by the 0.2µ filter in priming for the parallel set model. |
  | | Priming (In-line set model) | Verifying priming efficiency | - No air bubbles in the tubing between the 0.2µ filter and the exit port after 1st activation are allowed.
• Volume of 2nd & 3rd activations should be as specified. | - No air bubbles after the 0.2µ filter were detected.
• Results were according to spec. | Under the test condition, all results met acceptance criteria. |
  | 3 | Volumes | Verifying that actual volume is within the spec | Actual infused bolus volume range should be according to spec. | Under the test's conditions the actual delivered volume in both semi-automatic and manual activation was according to spec. | Under the test condition, all results met acceptance criteria. |
  | 4 | Velocity | Verifying actual velocity is within the spec | Velocity should be at-least 5 ml/minute. | Under the test's conditions all results were greater than 5ml/minute. | Under the test condition, all results met acceptance criteria. |
  | 5 | Lock-Out Time | Verifying that actual re-filling time at nominal volume of 6ml is within the spec. | Filling time was between 48-72 minutes of nominal volume. | After the specified time reservoirs were not completely filled. After 72 min. all reservoirs were completely filled. Volumes in semi-automatic mode were as specified. | Under the test condition, all results met acceptance criteria. |
  | 6 | Leaks | Verify the device design withstand operation pressure. | No leaks are allowed within at-least 10 seconds under 3 bar. | No leaks (stable pressure level) occurred during test's procedure. | Under the test condition, acceptance criteria was met. |
  | 7 | Tube bonding | Verify the device's tubing connection withstand the forces during use. | - Tube remains connected to the device.
• No leaks after applying 1.5Kg. | During test, no tubing disconnections were detected and no leaks afterwards (according to same method as in test #6). | Under the test conditions, acceptance criteria was met. |
  | 8 | Hydraulic check valve | Verify no flow through the device when not activated. | - Observed leaks;
• Gross weight of the device after 14 days is equal or up to 10 gram less than day 0 (baseline). | During the test's period, no leaks occurred. Maximum gross weight reduction was within defined acceptance criteria. | Under the test conditions, all tested samples met the acceptance criteria. |
  | 9 | External force during use | Verify the device withstand reasonable external forces may be applied during use. | - Cracks in the device cover (shells), or other plastic parts;
• Leaks;
• Device shall be properly activated and function. | Following the test conditions, no cracks, leaks or malfunctioning were detected. | Under the test conditions, all acceptance criteria were met. |
  | 10 | Shelf life equal to 1 year real-time (post accelerated aging) | Verify that the device will function well throughout its shelf life. | Under the test method the product should be operated and functioned according to its spec.
• Volume filled (per test 3),
• Lockout time (per test 5),
• No parallel flow, when not activated (per test 8),
• No visible cracks (per test 9),
• No visual leaks (per test 9). | Under the test method all filled volumes; lockout times; sealing state (no-parallel flow); no-cracks and leaks tests passed successfully. | All tested samples met the acceptance criteria and the product was qualified for 1 year shelf life. |
  | Sterilization | | | | | |
  | 11 | EtO Sterilization validation | Validate that the device may be sterilized for SAL 10-6 through EtO established cycle using overkill approach (also called: Half Cycle Method). | With accordance to the following standards:
• Bio Burden: ISO 11737-1:2006, ISO 11135-1:2007
• ETO/ECH Residues: ISO 10993-7:2008
• LAL Endotoxin: USP 32:2009 Transfusion and Infusion Assemblies and Similar Medical Devices and; FDA's Guidance for Pyrojen & Endotoxins testing (Q&A), June 2012
• Sterility: ISO 11135-1:2007, ISO 11737-2:2010 | All tests' results were determined to be within the standards' acceptance criteria. | Following the sterilization validation, SAL 10-6 was established for MFS's MultiBolus II™ device. |
  | Packaging Integrity | | | | | |
  | 12 | Packaging Integrity | Verify that the shipping packaging the device provides sufficient protection to the device during shipping. | - All packages shall remain whole, unopened and complete.
• No physical damages to the sealed sterile unit are allowed. | None of the below defects have been occurred:
• No significant damage to shipping cases and internal boxes.
• No significant (tears, open) damage to sterile pouches.
• No functional damage to the device. | Following sterile unit's package integrity tests, all acceptance criteria were met and it was concluded that sterility will be maintained along the product's shelf life. |
  | 12.1 | Packaging Integrity | Verify sterile single unit package integrity in order to maintain product's sterility along 3 years shelf life. | Sterile package integrity tests per each test acceptance criteria (as further detailed in section 18 and appendix C of this submission). | All tested items met acceptance criteria for visual test, sterility test, and package integrity tests (peel, dye, burst). | Shelf life of 3 years real-time was established for the sterile unit package. |
  | Usability | | | | | |
  | 13 | Usability (Physicians) | Validate that users of each group (physicians and home users) are capable to properly, safely and effectively set and operate the device and that the device is intuitive for activating. | All 'physicians' participates shall operate the device through the "activation missions" successfully with according to the IFU. | All participants have fulfilled successfully all "activation missions" according to the relevant accompanied IFU. | It was concluded from the usability results that the device is "usable" by its intended users (both physicians and patients) with accordance to IFU. The device met all test's acceptance criteria. |
  | | Usability (Patients) | Validate that users of each group (physicians and home users) are capable to properly, safely and effectively set and operate the device and that the device is intuitive for activating. | All 'patients' participants shall appropriately activate the device, i.e., squeeze the activating lever all the way until it 'clicks'. | (Results for patients not explicitly detailed but implied to meet success based on the overall conclusion.) | It was concluded from the usability results that the device is "usable" by its intended users (both physicians and patients) with accordance to IFU. The device met all test's acceptance criteria. |

2. Sample size and data provenance for the test set

• Sample Size for Test Set:
  • Operating Cycles: 30 activation iterations of each device (number of devices tested is not specified for this specific test, but implies multiple devices were tested).
  • Shelf Life (1 year): Products were tested after accelerated aging. The number of products tested is not explicitly stated but implies multiple samples.
  • Shelf Life (3 years): "All tested items" (number not specified).
  • Other tests: The number of devices/samples tested for other functional, sterilization, and packaging tests is not explicitly stated in the provided text. It is generally implied that multiple samples were used for these bench tests.
• Data Provenance: The tests were conducted internally by MFS - Medical Flow Systems Ltd., an Israeli company. The data is based on prospective bench testing and usability studies. There is no mention of data from country of origin of patients or retrospective data.

3. Number of experts and qualifications for ground truth

• Number of Experts:
  • Usability (Physicians): Not explicitly stated how many physicians participated, but referred to as "All 'physicians' participates."
  • Usability (Patients): Not explicitly stated how many patients participated, but referred to as "All 'patients' participants."
• Qualifications of Experts:
  • Physicians: Described as "educated participant[s]" for the usability study, implying they are medical professionals familiar with such devices.
  • Patients: Not specified beyond "patients," implying they represent the intended end-users.

4. Adjudication method for the test set

• Adjudication method: Not applicable. The studies described are bench tests and usability tests evaluating device performance against pre-defined engineering and usability acceptance criteria. They are not clinical studies requiring expert adjudication of diagnoses or outcomes.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

• Was an MRMC study done? No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a mechanical patient-controlled pain management system, not an AI-powered diagnostic or assistive tool.

6. Standalone (algorithm only without human-in-the-loop performance) study

• Was a standalone study done? The performance data presented is essentially a standalone evaluation of the device as a mechanical system. The "algorithm" here is the device's inherent mechanical function. The tests (Operating Cycles, Priming, Volumes, Velocity, Lock-Out Time, Leaks, Tube Bonding, Hydraulic Check Valve, External Force, Shelf Life) demonstrate the device's performance without the "human-in-the-loop" interaction for diagnosis or interpretation, but rather its mechanical operation. The usability tests then assess the human interaction with this standalone mechanical device.

7. Type of ground truth used

• Main type of ground truth: The ground truth for the performance tests is based on engineering specifications, established standards (e.g., ISO, ASTM, USP), and documented internal protocols that define acceptable ranges for mechanical function, safety, sterility, and packaging integrity.
  • For usability, the ground truth is established by the ability of physicians and patients to successfully perform specified "activation missions" according to the device's Instructions for Use (IFU).

8. Sample size for the training set

• Sample size for training set: Not applicable. The MultiBolus IITM is a mechanical device, not an AI/machine learning algorithm, so there is no "training set" in the context of model development. The development and testing would involve prototypes and iterative design, but not data-driven model training.

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

• How ground truth for training set was established: Not applicable, as there is no training set for this mechanical device.

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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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AccuFlo & AccuFlux devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert.

The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes

The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

The AccuFlo & AccuFlux models are both disposable, non-electric infusion pumps that deliver precise volume of medication at predetermined flow rate for IV therapy.

The provided text describes a 510(k) premarket notification for the AccuFlo & AccuFlux disposable infusion pumps. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance.

The document primarily focuses on:

• Device Description and Intended Use: Disposable, non-electric infusion pumps for precise medication delivery.
• Technological Characteristics: Equivalence to predicate devices and compliance with various international standards (IEC, ISO) related to medical devices, biocompatibility, packaging, sterilization, and risk management.
• Regulatory Information: 510(k) summary, contact information, date prepared, proprietary and common names, classification, predicate devices, and the FDA's clearance letter stating substantial equivalence.

Therefore, I cannot provide the requested information as it is not present in the given text.

The prompt's questions (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth) are typically relevant for AI/ML-based diagnostic devices, which this product (a non-electrically powered disposable infusion pump) is not. Its "performance" would be related to its flow rate accuracy, duration of infusion, material biocompatibility, and manufacturing quality, not diagnostic accuracy based on an algorithm.

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The Alpha Infusion Pump is intended for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. Medication is intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump is intended for use in the hospital or by an ambulatory patient.

The Alpha Infusion Pump consists of two elastomeric chambers, which pressurize the medication. These chambers are protected in a plastic housing. A one-way check valve is provided to fill these chambers. Medication delivered from the elastomeric chambers is filtered through a 5-micron filter and held in an outflow chamber. An internal pressure regulator maintains the pressure of the medication in the outflow chamber at 6 psi in order to provide a constant flow rate through each infusion catheter inserted through the septum into the outflow chamber of the pump.

This document is a 510(k) summary for the Alpha Infusion Pump and describes a change to the device, not a study evaluating acceptance criteria of a device's performance. Therefore, most of the requested information cannot be extracted from the provided text.

The primary purpose of this 510(k) submission is to demonstrate substantial equivalence of a modified Alpha Infusion Pump by changing the elastomeric chamber material. As such, it does not contain a study presenting acceptance criteria and device performance in the manner typically associated with clinical or standalone performance studies for AI/ML-based medical devices.

Here's a breakdown of what can be extracted based on the input text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The document describes a change in material for a component of an infusion pump and asserts substantial equivalence to a predicate device. It does not present specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) or report device performance against such criteria for a new feature or algorithm. The "performance" being assessed here is the functional equivalence of the new material, not a clinical outcome or diagnostic accuracy.

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

• Not Applicable. This document does not describe a test set or data provenance for evaluating an AI/ML device.

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

• Not Applicable. Ground truth establishment by experts is not relevant to this type of device modification submission.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods are not described as there is no test set in the context of an AI/ML performance evaluation.

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/ML device, and no MRMC study is mentioned.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Not Applicable. Ground truth is not relevant to this device modification. The "truth" being established is the functional equivalence of the new material to the old.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

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

• Not Applicable. Not an AI/ML device.

Key Information from the Document:

• Device Name: Alpha Infusion Pump
• Modification: The elastomeric chamber material is being changed from medical grade polyisoprene to medical grade silicone.
• Reason for Change: Silicone is already used elsewhere in the pump (septum, pressure regulator, check valve), and polyisoprene will no longer be used. Silicone elastomer chambers are also used in predicate devices (Accufuser and Accufuser Plus).
• Conclusion of the Manufacturer: The Alpha Infusion Pump with silicone elastomer chambers is "substantially equivalent" to the current Alpha Infusion Pump with polyisoprene chambers.
• FDA Decision: The FDA determined the device is "substantially equivalent" based on the provided information.

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The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a presely for post-operative pain management.

Not Found

The provided text is a Food and Drug Administration (FDA) letter regarding the 510(k) premarket notification for the "GOPump Rapid Recovery System, Disposable Infusion Pump Kit." This document is a regulatory approval letter and does not contain the acceptance criteria or the study details that would demonstrate the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on the regulatory classification and approval process, not on the technical performance studies of the device.

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