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The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.

The FREEDOM Integrated Syringe Infusion System with the FREEDOM60® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, meropenem, oxacillin, and tobramycin.

The Freedom Integrated Syringe Infusion System consists of the following components:

• FREEDOM60® Syringe Driver
• Precision Flow Rate Tubing™M
• HIgH-Flo Subcutaneous Safety Needle SetsTM
• HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®).

The FREEDOM60® Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653).

The FREEDOM® Integrated Syringe Infusion System is a single-channel, volumetric infusion pump. The FREEDOM60® Integrated Syringe Infusion System consists of four primary components:

• 1. FREEDOM60® Syringe Driver,
• 2. Precision Flow Rate Tubing™ and
• 3. HIgH-Flo Subcutaneous Safety Needle Set™, or
• 4. HIgH-Flo Super26TM Subcutaneous Safety Needle Set

1. FREEDOM60® Syringe Driver:
   The FREEDOM60® Syringe Driver in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Subcutaneous Safety Needle Sets (sterile) makes up the Freedom Integrated Syringe Infusion system. The FREEDOM60® Syringe Driver is a non- sterile, reusable non-electric driver that infuses immunoglobulins subcutaneously and antibiotic solutions intravenously to patients.

The FREEDOM60® Syringe Driver is an ambulatory device designed to accommodate a BD Luer- Lok™ 50mL Syringe (Catalog No.: 8881-560125, BD 309653), and fluid volumes ranging from 10cc to 60cc may be used. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe.

The Freedom Integrated Syringe System is assembled by loading the syringe with tubing into the Freemdom60® driver.

2. Precision Flow Rate Tubing™:
   The Freedom Integrated Syringe System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each F-number provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed.

3. HIgH-Flo Needles Sets:
   The HIgH-Flo Subcutaneous Safety Needle SetsTM
   The HIgH-Flo Subcutaneous Safety Needle Sets™ (provided sterile) are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Subcutaneous needles come in different lengths to administer immunoglobulins and antibiotics.

Subcutaneous Safety Needle Sets comes in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm, 6mm, 9mm, 12mm, and 14mm lengths combined with 24 or 26 Gauge. Using the Y-Connector, the patient can have up to 8 sites for drug delivery.

The HIgH- Flo Subcutaneous Safety Needle Sets™ also allow each needle to be enclosed between the wings after use.

The HIgH-Flo Super26TM Subcutaneous Needle Sets
The HIgH-Flo Super26TM Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Subcutaneous Administration Sets, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90degree, 26-gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medical grade tubing. Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately as needed. HIgH-Flo Super 26TM Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3needle, 4-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.

Here's a breakdown of the acceptance criteria and the study information presented in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and provides performance data for flow rates with different configurations. It doesn't explicitly state "acceptance criteria" in a singular table, but rather details the performance characteristics that were measured and compared. The key performance aspect is the flow rate accuracy.

Subject Device (K200176): Flow rates will fall between the minimum and maximum predicted values as specified in the Instructions for Use (IFU). The document then provides extensive tables of min-max predicated flow rates per site for various drugs (Cutaquig®, Xembify®, Cuvitru®, Gammagard Liquid®, Hizentra® PI, Hizentra® CIDP) across different needle sets (HIgH-Flo 26G, HIgH-Flo Super26, HIgH-Flo 24G) and tubing types (F120-F2400). |
| Biocompatibility | Materials comply with ISO 10993-1 and FDA Blue Book Memorandum #G95-1. Testing included Cytotoxicity, Sensitization, and Irritation. |
| Human Factors | Human factors studies were conducted per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016). Results demonstrate validation of the device per its intended use. |
| Reprocessing/Cleaning | Compliance with AAMI TIR12:2010, AAMI TIR30:2011(R)2016, "Reprocessing Medical Devices in Health Care Settings," and ISO 17664:2017. Worst-case design for cleaning and low-level disinfection efficacy studies were reviewed and compared. |
| Packaging | Compliance with ISO 11607-1:2019 (Packaging for terminally sterilized medical devices). The nylon film pouch maintains sterile barrier. |
| Sterility | Compliance with ISO 11137-2:2013 (Sterilization of health care products - Radiation). |
| MR Safety | Compliance with ASTM F2503-13 ("Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment"). |
| Safety Assurance | A safety assurance case was provided, addressing: device requirements, risk identification/mitigation, and device reliability. |

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

The document does not explicitly state a sample size for a "test set" in the context of an accuracy study with patient data. The performance data presented (flow rate combinations) appears to be derived from bench testing and theoretical calculations, rather than a clinical trial or a test set of patient data.

• Provenance: This is bench testing data, not human or animal data. The origin would be the testing laboratories where the physical measurements were taken. No country of origin is specified for the testing. It is not retrospective or prospective clinical data.

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

Not applicable. The "ground truth" for the flow rate performance is established through direct measurement on the physical device during bench testing, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. There is no human adjudication process described, as the evaluation is based on physical device performance measurements.

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 a medical device for infusion, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance for human readers are not relevant.

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

Not applicable. This is a mechanical infusion system, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the flow rate performance is based on direct physical measurements (bench testing) of the device under various configurations and theoretical calculations. This is supplemented by compliance with recognized international standards and FDA guidance documents for biocompatibility, sterility, packaging, human factors, and reprocessing.

8. The Sample Size for the Training Set:

Not applicable. This is a mechanical infusion system, not an AI model that requires a training set.

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

Not applicable, as there is no training set for an AI model.

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RMS High-FLO Super26™ Subcutaneous Needle Sets are indicated for subcutaneous infusion of medications in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling for the capacity for infusion of high flow rates including human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling for: Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); and Cuvitru™ Immune Globulin Infusion (Human) 20% (manufactured by Shire).

The RMS HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Class II Subcutaneous Administration Set, per 21 CFR 880.5440, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90-degree, 26gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medic al grade tubing (Figure I). Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately; as needed. RMS HigH-Flo Super 26TM Subcutaneous Needle Sets are available as a single-needle set, as well as 2-needle, 4- needle, 5-needle, 6-needle sets; through use of a Y-connector, 7-needle and 8-needle sets may also be assembled. The device is for single use only.

The provided document is a 510(k) premarket notification for a medical device (HIgH-Flo Super26™ Subcutaneous Needle Sets) and focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving acceptance criteria for a new AI/software-based device.

Therefore, many of the requested details regarding acceptance criteria for a study proving device performance (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) are not applicable to this document as it's primarily a regulatory submission for a physical medical device based on bench testing for an incremental design modification, not a study of an AI algorithm or a diagnostic tool requiring extensive human reader involvement or ground truth establishment in a clinical context.

However, I can extract information related to the acceptance criteria for this specific device, which are mainly focused on bench performance to demonstrate equivalence.

Here's an attempt to answer the questions based on the provided text, noting where specific questions are not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance Study (Based on 510(k) Submission)

The study described here is a bench performance study designed to demonstrate that the redesigned device (HIgH-Flo Super26™ Subcutaneous Needle Sets) is substantially equivalent to its predicate device (Integrated Catch-up Freedom Syringe Driver Infusion System) despite differences in tubing diameter and needle set configurations. The primary performance metric assessed is flow rate.

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

Given that this is a 510(k) summary for a physical device where the "acceptance criteria" are implicitly meeting functional specifications and demonstrating performance comparable to a predicate, the "acceptance criteria" are not explicitly stated with numerical thresholds in the same way they would be for an AI algorithm's performance metrics (e.g., sensitivity > X%, specificity > Y%). Instead, the "conclusion" is that the device "performs as intended and is substantially equivalent to the predicate device" based on bench testing.

The reported device performance presented is the achievable flow rates under various conditions (different fluid types, number of needles, and pump settings). The tables themselves represent the performance data that presumably met the implicit acceptance criteria of demonstrating comparable or improved flow for the intended use.

Implicit Acceptance Criteria (derived from context):

• Biocompatibility: Device materials must meet ISO 10993 standards and be non-hemolytic.
• Flow Rate: The device must achieve flow rates suitable for the intended subcutaneous infusion of specified medications (Hizentra, Cuvitru) across various needle configurations and pump settings, and ideally meet or exceed drug manufacturer's recommended flow rates. The stated purpose of the design modification was to allow for "high flow rates."
• Sterility, non-pyrogenicity, single-use, safety features: These are standard performance and design criteria for such devices.

Reported Device Performance:

The document provides tables of "Achievable Flow Rates with Super26™ and Specific Medications/Indications." These tables are the reported performance data. For brevity, only a summary of insights from these tables is provided here, rather than reproducing them entirely:

• 1 needle: 19.5 ml/hr/site
• 4 needles: 5.8 ml/hr/site
• 8 needles: 3.0 ml/hr/site
  Some combinations "Exceeds drug manufacturer's maximum indicated flow rate." |
  | Hizentra® CIDP - Max Flow Rate Per Site (ml/hr/site) (Example rows) | Varied by needle count and pump setting. Examples (F275 pump setting):
• 1 needle: 19.5 ml/hr/site
• 4 needles: 5.8 ml/hr/site
• 8 needles: 3.0 ml/hr/site
  Some combinations "Exceeds drug manufacturer's maximum indicated flow rate." |
  | Cuvitru™ PI - Max Flow Rate Per Site (ml/hr/site) (Example rows) | Varied by needle count and pump setting. Examples (F275 pump setting):
• 1 needle: 19.1 ml/hr/site
• 4 needles: 5.7 ml/hr/site
  Some combinations "Exceeds drug manufacturer's maximum indicated flow rate."
  *Some combinations were "Flow rate per site is lower than what is recommended on the biologic label" (e.g., 1-4 needles at lower F-settings). |

Note on "Acceptance Criteria" for this submission: The document states, "Bench testing has been conducted to verify that the product performance of the subject device and predicate device are substantially equivalent." The tables of flow rates are the data used to demonstrate this equivalence, implicitly meeting the "acceptance criteria" that the new design performs effectively for its intended use.

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

• Sample Size: Not specified in terms of number of devices tested for flow rates. The text only mentions "Bench Performance Studies" and "Flow Rate Testing." Typical bench testing involves a statistically significant number of samples, but the exact count isn't in this summary.
• Data Provenance: The data is generated from bench testing conducted by the manufacturer, Repro-Med Systems, Inc. dba RMS Medical Products. It is not clinical data from patients.
• Retrospective or Prospective: N/A. This is bench testing, not a clinical study.

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

• N/A. This is a physical device (subcutaneous needle set) and the "ground truth" for flow rate performance is established through repeatable physical measurements using laboratory equipment (e.g., pumps, timers, volume measurements), not by expert human interpretation of images or other clinical data.

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

• N/A. See point 3.

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

• N/A. This is not an AI/diagnostic device.

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

• N/A. This is not an AI/diagnostic device.

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

• The "ground truth" for the performance (flow rate) is established via direct physical measurement during bench testing. For biocompatibility, it's based on laboratory test results (ISO 10993 series standards, Modified ASTM Hemolysis).

8. The sample size for the training set

• N/A. This is not an AI/machine learning device that requires a training set. The device is a physical product for which performance is verified through engineering bench tests.

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

• N/A. See point 8.

In summary: The provided document is a 510(k) premarket notification for a physical medical device, not an AI or software-based medical device. Therefore, many of the questions related to AI study design, expert ground truth, and human reader studies are not applicable. The "study" proving the device meets acceptance criteria is primarily bench testing to demonstrate functional equivalency, particularly concerning flow rates and biocompatibility, compared to a legally marketed predicate device.

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The Integrated Catch-Up Freedom Syringe Driver Infusion System (ICFSDIS), which includes the FREEDOM60® and FreedomEdge® syringe pumps, is indicated for the intravenous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The ICFSDIS is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Hizentra, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Shire); and Cuvitry Immune Globulin Infusion (Human) 20% (manufactured by Shire). The ICFSDIS is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: meropenem, ertapenem, oxacillin, and tobramycin.

The FreedomEdge® Syringe Infusion System is indicated for use with the BD 20 ml (model no. 302830/301031) or BD 30 ml (model no. 30103) syringe. The Freedom60 Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no. 309653).

• 1. Freedom60® Syringe Driver: The Freedom60 Syringe Infusion driver in combination with RMS Freedom60 Precision Flow Rate Tubing™ (sterile) and RMS HIgH-Flo Subcutaneous Safety Needle Sets (sterile) makes up the Freedom60 infusion system. The Freedom60® driver is a non-sterile, reusable non-electric driver that infuses immunoglobulins subcutaneously and antibiotic solutions intravenously to patients.
     The Freedom60® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 60mL Syringe (Catalog No.: 8881-560125, BD 309653), and fluid volumes ranging from 10cc to 60cc may be used. The pump uses a constant force spring mechanism to apply pressure to the plunger-end svringe.

The Freedom60 system is assembled by loading the prefilled syringe with tubing into the Freemdom60 driver.

• 2. FreedomEdge® Syringe Driver: The FreedomEdge® Syringe Infusion driver is used with a syringe in an infusion system for administering therapeutic fluids. The infusion system or related kits can include, in addition to the pump assembly, a luer connector or disc luer connector for connecting the syringe to components of the infusion system, an RMS Precision Flow Rate Tubing™ (sterile) and RMS HIgH-Flo Subcutaneous Safety Needle Sets (sterile) for administering the therapeutic fluid subcutaneously into a patient's body.
     The FreedomEdge® driver is a portable device designed to accommodate BD Luer-Lok™ 20mL syringe, Catalog No.: 302830 and 301031 or BD Luer-Lok™ 30mL, Catalog No.: 301033. The pump uses a constant force spring mechanism to apply pressure to the plunger- end syringe.

The FreedomEdge® is comprised of housing that has a distal end and a proximal end. The housing comprises an expandable base with a first base section and a second base section. wherein the first base section is in sliding engagement with the second base section such that the first base section and the second base section move relative to each other between a closed position and an expanded position. The base in the expanded position is adapted to seat a syringe with the plunger.

There is also an expandable cover consisting of a first cover section and a second cover section, wherein the first cover section is in sliding engagement with the second cover section. The cover is pivotally connected to the base at a position allowing the cover to open and close in a sliding motion of the second base section, which is relative to the first base section moving together.

When the cover is in the closed position, a pusher is in sliding engagement with the base. The pusher is in position to contact the head of the plunger and a puller is in position with the sliding engagement of the base. There is a spring at the first end portion and a second end portion. The first end portion is connected to the puller, while the second end portion is connected to the pusher and a set of linkages pivotally coupled to the cover and the puller.

The pivots of the linkages are located to move the puller towards the distal end when the cover is lowered and move the puller towards the proximal end when the cover is raised. Moving the puller towards the distal end by lowering the cover when the syringe is seated in the base causes the pusher to contact and exert force on the head of the plunger, thereby causing ejection of any fluid contents in the syringe barrel.

• 3. Precision Flow Rate Tubing Set:
     The Freedom60 Infusion system includes a range of Freedom Precision Flow Rate Tubing™. The tubing ranges from F0.5 to F2400. Each F-number provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed.
• 4. High-Flo Needles set: The HIgH-FloTM Subcutaneous Safety Needle Sets are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Typical uses are to administer immunoglobulins and antibiotics and for such applications subcutaneous needles come in different lengths.
     Subcutaneous Safety Needle Sets comes in multiple configurations (single, double, tri, and quad). Needles are available in 4mm, 6mm, 9mm, 12mm lengths combined with 24 or 26 Gauge. Using the Y-Connector, the patient can have up to 8 sites for drug delivery.

The HIgH- Flo™ Subcutaneous Safety Needle Sets also allow each needle to be trapped between the wings after use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Integrated Catch-up Freedom Syringe Driver Infusion System.

It's important to note that the provided text is a 510(k) Summary, which is designed to demonstrate substantial equivalence to a legally marketed predicate device, rather than a detailed clinical study report proving the device alone meets specific effectiveness criteria through a groundbreaking study. The focus here is on bench testing and compatibility, not human performance or effect size with AI. Therefore, many of your requested points related to human readers, experts, and training sets for an AI/machine learning device are not applicable to this particular document.

Acceptance Criteria and Device Performance for Integrated Catch-up Freedom Syringe Driver Infusion System

Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through performance testing, specifically flow rate testing, and drug-device compatibility testing. The summary doesn't explicitly state quantitative acceptance limits for all parameters, but rather "results showed acceptable" or provides tables of achieved flow rates as evidence of performance.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note on "Acceptance Criteria": This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device. For areas like drug-device compatibility, the statement "results showed acceptable" implies that the performance met internal benchmarks or recognized standards for maintaining the integrity and efficacy of the drugs. For flow rates, the tables themselves represent the demonstrated performance characteristics under specific conditions, which are then used to inform safe and effective use.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of how many individual devices, tests, or samples of drugs were used. It refers to "detailed flow rate testing" and "drug-device compatibility testing" without providing the number of units tested or repetitions.
• Data Provenance: The studies appear to be retrospective in the sense that they are laboratory/bench tests conducted by the manufacturer, rather than prospective clinical trials with human subjects. The country of origin of the data is not explicitly stated but is implicitly from the manufacturer, Repro-med Systems, Inc., DBA RMS Medical Products, located in Chester, New York, USA.

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

• Not Applicable. This document describes the performance of a mechanical infusion pump system through bench testing and compatibility studies. There is no mention of human experts or ground truth establishment in the context of diagnostic interpretation, as would be relevant for an AI/machine learning device. The "ground truth" for flow rates and drug compatibility comes from physical measurements and chemical analyses, not expert consensus.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human experts involved in establishing a "ground truth" for interpretation, no adjudication method is relevant or mentioned. The data is quantitative from laboratory measurements.

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 a mechanical infusion pump, not an AI/machine learning diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

• Not Applicable. This device is a mechanical pump, not an algorithm. Its performance is inherently "standalone" in mechanical function, but "human-in-the-loop" applies to its operation by a user, not its analytical process.

7. The Type of Ground Truth Used

• The "ground truth" for the performance testing is based on:
  • Direct Physical Measurements: For flow rates (mL/hr) and time taken (hours:minutes), measured during the detailed flow rate testing.
  • Chemical and Biological Assays: For drug-device compatibility (e.g., measuring protein concentration, particulate count, Fc-function of immunoglobulins).
  • Engineering Analysis: For the safety assurance case (FMEA documents).

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles, material science, and physical testing, not data training.

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

• Not Applicable. See point 8.

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RMS HigH-Flo™ Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are a Class II Intravascular Administration Set per 21 CFR 880.5440 and intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile packaged kit including the infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set has a 90-degree stainless steel grade needle mounted to a butterfly assembly on one end, and a luer lock on the other end, connected by medical grade tubing. The needles are available in 24 and 26 gauges and in lengths of 4mm, 6mm, 12mm and 14mm. The 4mm and 14mm lengths are added for children and obese adult patients, respectively. The optional convenience 24" Extension Set is used to add length to a needle set when desired.

There is a snap closure to safely capture the needle after use. This minimizes the potential for a needlestick injury. Each leg in a set is equipped with a slide clamp to stop flow immediately, if needed. The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are available for up to 8 infusion sites using our basic sets of one, two, three or four legs ganged together using a low residual "Y-Connector" (for example to achieve a 7 site infusion, a RMS 4 set will be ganged with a RMS 3 set using a Y-Connector). All needle sets, regardless of combination, are for single use only.

The provided text describes the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets and the studies performed to demonstrate its substantial equivalence to predicate devices, particularly focusing on performance, biocompatibility, and safety.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for individual tests within the "Clinical Simulated Use Study" or the flow rate studies. It mentions "medical professionals participated" in the clinical study and "comparative tests" and "flow tested" for the performance studies without giving specific numbers of devices or test runs.

• Provenance: This is a 510(k) summary submitted to the FDA (United States). The studies appear to be internal RMS Medical Products studies ("RMS internal procedure (SOP 8001)") or performed in accordance with international (ISO) and national (USP) standards, indicating the data is likely from studies conducted by or for the manufacturer. The document doesn't specify countries of origin for the test data beyond the manufacturer's location in New York, USA.
• Retrospective/Prospective:
  • Biocompatibility and Sterilization/Shelf Life: These are typically prospective laboratory/animal studies.
  • Clinical Simulated Use Study: This was a prospective study ("medical professionals participated in an RMS Clinical Simulated Use Study, per FDA guidance documents with FDA review of the proposed protocol").
  • Performance Testing (flow rate, residual volume, material/device characteristics): These were prospective laboratory tests.

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

The document mentions "medical professionals participated" in the RMS Clinical Simulated Use Study. However, it does not specify the number or qualifications of these medical professionals, nor does it explicitly define their role in establishing a "ground truth" in the way one might for diagnostic accuracy studies. Their role was to evaluate the device during simulated use, and their subjective and statistical data contributed to the safety determination.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth from multiple experts. For the "Clinical Simulated Use Study," it states, "An analysis of all subjective and statistical data concludes that the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets met the criteria set." This implies an analysis of the collected data rather than a consensus or adjudication process among multiple reviewers to determine a 'truth' independently.

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 MRMC Comparative Effectiveness Study: This device is a medical device (subcutaneous needle set), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed. The studies focus on the physical performance, biocompatibility, and safety of the needle set itself.

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

• Not applicable: As this is a physical medical device and not an AI algorithm, a standalone performance study in the context of AI is not relevant. The device's performance is standalone in the sense that its physical properties (flow rate, material, etc.) are tested without human intervention impacting the measurement of those properties, but it is ultimately used by a human.

7. The Type of Ground Truth Used

The concept of "ground truth" in the context of this device's evaluation is primarily based on:

• Established Scientific Standards: For biocompatibility (ISO standards), pyrogenicity (USP limits), and sterilization (ISO 11137).
• Pre-defined Acceptance Criteria: For the Clinical Simulated Use Study, criteria were "set" and the device "met the criteria."
• Direct Measurement and Comparison: For flow rates, residual volumes, material characteristics, device dimensions, and mechanical properties, the "ground truth" is the measured physical data, which is then compared against predicate devices and internal performance expectations.

8. The Sample Size for the Training Set

• Not applicable: This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

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

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RMS Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

The RMS Subcutaneous Needle Set is a Class II Intravascular Administration Set per 21 CFR 880.5440 and intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile packaged kit including the infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set has a 90-degree stainless steel needle mounted to a butterfly on one end, and a luer lock on the other end, connected by medical grade tubing. Each set is equipped with a slide clamp used to stop flow immediately, as well as a snap together capture arrangement used to close the set upon completion. RMS Subcutaneous Needle Sets are available as single sets, as well as 2-needle, 3-needle, 4-needle, 5-needle and 6-needle assemblies, with the use of a low residual volume Y or multi-connector. The device is for single use only.

The provided text describes a 510(k) summary for the RMS Subcutaneous Needle Set, which aims to demonstrate substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria in the sense of a novel AI or diagnostic device. Therefore, several of the requested sections about AI-specific criteria (e.g., sample size for AI test and training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable to this type of submission.

However, I can extract information related to performance testing that served to support the claim of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are implicitly defined by demonstrating that the device performs similarly to or better than the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The reported performance is compared directly to the predicate devices.

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

• Fluid Flow Rate Testing: The table shows results for 4 individual measurements for each needle set configuration (Needle 1, 2, 3, 4). The "Total" represents the sum of these four measurements for each device type. Therefore, a sample size of 4 measurements per device type/configuration was used.
• Priming/Residual Volume Measurements: Not explicitly stated, but measurements are provided for 1-needle to 6-needle configurations for each device.
• Needle Tip Measurements: One measurement is provided for each characteristic (Top Angle, Side Angle, Length) for each company.
• Wing Flexibility: For each of the three manufacturers (RMS, Marcal, Evans Medical), 4 individual "Butterfly" measurements are provided for flexibility, along with a calculated mean.
• Biocompatibility/Sterility: These are standard compliance tests, typically performed on a statistically significant sample based on the specific ISO standards, but the exact sample sizes for each test are not detailed in this summary.
• Data Provenance: Not explicitly stated. The tests were performed according to RMS's "Needle Set Fluid Flow Rate Test Procedure" (SOP 5071) and ISO standards. The data is likely from laboratory testing conducted as part of the submission process, not from patient studies or specific geographical regions. It is retrospective in the sense that it was generated for the submission.

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

This information is not applicable. The device is a medical accessory (subcutaneous needle set), and the testing performed involves objective physical and material performance measurements (e.g., flow rate, volumes, dimensions, flexibility, biocompatibility), not diagnostic image analysis or clinical assessment requiring expert consensus ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective laboratory measurements, not subjective 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. This is a 510(k) submission for a physical medical device, not an AI/diagnostic software.

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

This is not applicable. This is a 510(k) submission for a physical medical device.

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

The "ground truth" for the performance comparisons in this 510(k) submission consists of objective physical measurements, material properties, and compliance with specified standards (e.g., ISO for sterility and biocompatibility). The predicate devices' performance serves as the benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable as there is no "training set" for physical device performance testing in this context.

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

This is not applicable as there is no "training set" for physical device performance testing in this context.

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The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction ring. Intended use statements for these are as follows.

Vacuum Pump (intended use) - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid.

Constriction Ring (intended use) - used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.

The RESTORE Vacuum Erection Device consists of a vacuum pump, ABS plastic vacuum cylinder, connecting PVC tubing, cylinder end cap, cushion seal, constriction rings, a tube of personal water-based lubricant and a convenient travel case.

The provided text is a 510(k) Premarket Notification summary for the RESTORE Vacuum Erection Device from 1998. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, this document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document states that the RESTORE Vacuum Erection Device is "substantially equivalent" to predicate devices based on:

• Technological Characteristics: The vacuum pump is stated to be substantially equivalent to the Erecaid System Classic (K841257) and Erecaid System / Stay Erec System (K974173). The constriction rings are identical to the Pro-Long rings (K904485).
• Manufacturing: Repro-Med Systems, Inc. manufactured the predicate Osbon products.
• Materials: All component materials are identical to the named predicate devices.

The FDA's letter (K981506) confirms this finding of substantial equivalence, allowing the device to be marketed. This regulatory pathway typically relies on existing data or equivalence to devices already proven safe and effective, rather than new, independent clinical trials with explicit acceptance criteria.

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