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The Freedom60 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 Freedom60 Infusion System with the Freedom60® Infusion Pump 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, oxacillin, and tobramycin.

The Freedom60 Infusion System consists of the following devices:

• Freedom60® Infusion Pump

• Precision Flow Rate Tubing

• High-Flo Subcutaneous Needle Sets

• 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®, lmmune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®)

The Freedom60 Infusion System is indicated for use with the following syringes:

• · BD® 50 ml syringe
• · Medline® 60 ml Syringe
• · Hizentra® 50 ml Prefilled Syringe

The Freedom60 Infusion System is a non-powered infusion system that includes a mechanical infusion pump, subcutaneous needle sets, and tubing sets. The infusion pump exerts a constant force on the medication through the tubing. The tubing set and needle set produce a certain amount of resistance, which moderates the flow rate. The tubing sets and needle sets are provided in a range of sizes and device options (number of needle gauge, tubing diameter, etc). The healthcare provider prescribes the tubing/needle sets based on the intended flow rate and dosage of the drug being administered.

The infusion pump is compatible with specific syringe types. An adapter is included as part of this submission to enable compatibility with certain pre-filled syringes that are compatible for use with the Freedom60 infusion system are the BD 50ml syringe, the Medline 60 ml syringe, and the Hizentra 50 ml pre-filled syringe.

The infusion pump and pre-filled syringe adapter are reusable. The infusion sets are are terminally sterilized via gamma radiation. The Freedom60 Infusion System is manufactured from materials with an established history of biological safety, and is not manufactured with latex or natural rubber.

The provided text is a 510(k) Summary for a medical device (Freedom60 Infusion Pump and associated components). It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not contain information about the specific acceptance criteria, reported device performance in a table, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these typically relate to AI/ML device submissions.

The document refers to mechanical/fluidic performance testing for an infusion pump, not an AI/ML diagnostic system. Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from this document.

For context, I will outline the information that would be present if this were an AI/ML device submission, and then explain why it's not applicable here based on the provided text.

Information NOT available in the provided document (as it's not an AI/ML device):

1. Table of acceptance criteria and reported device performance: This document refers to flow rate verification, reliability/use life verification, dose accuracy, and fitment. It does not provide a table with specific numerical acceptance criteria (e.g., minimum sensitivity, specificity) and corresponding achieved performance metrics (e.g., actual sensitivity, specificity values), which are common for AI/ML diagnostic devices.
2. Sample sizes used for the test set and data provenance: The document mentions "non-clinical testing" and "verification and validation testing" but does not specify sample sizes in terms of patient cohorts or image sets, nor does it mention data provenance (e.g., country of origin, retrospective/prospective), as would be detailed for AI/ML models.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This is irrelevant here because the device is a mechanical infusion pump. Ground truth for an AI/ML diagnostic device usually involves expert annotations (e.g., radiologists, pathologists).
4. Adjudication method for the test set: Not applicable, as there's no diagnostic ground truth being established by experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this is a mechanical device, not an AI-assisted diagnostic tool. MRMC studies evaluate the impact of AI on human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no standalone AI algorithm.
7. The type of ground truth used: For this device, the "ground truth" would be established through engineering measurements of flow rates, dose accuracy, and mechanical reliability against design specifications, not clinical outcomes, pathology, or expert consensus on medical images/data.
8. The sample size for the training set: Not applicable, as this describes a device that undergoes physical manufacturing and testing based on engineering principles, not an AI/ML model that is trained on a dataset.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

What the document does state about testing:

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section (Page 7) states:

• Testing Performed:
  • Flow rate verification
  • Reliability/use life verification
  • Dose accuracy and fitment
  • Human factors validation (per IEC 62366-1 and FDA Guidance)
• Clinical Testing: "Clinical testing is not applicable for this submission." This further confirms it's not an AI/ML diagnostic.
• Conclusion: "All verification and validation testing was successfully completed. The non-clinical testing performed demonstrates that the device is as safe and effective as the legally marketed predicate device meets that the device meets the performance requirements set out as part of the design control process."

In summary, the provided document details the regulatory clearance of a mechanical infusion system, not an AI/ML-driven device. Therefore, the specific acceptance criteria and study details relevant to AI/ML performance (such as sensitivity, specificity, expert ground truth, MRMC studies) are not present and cannot be extracted.

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Precision Flow® HVNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

Precision Flow® HVNI provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. Precision Flow® HVNI is not intended to provide total ventilatory requirements of the patient and not for use during field transport.

The Precision Flow® HVNI system delivers high flow rates of heated and humidified blended breathing gas through high flow nasal cannulas. The Precision Flow® HVNI system can connect to air and oxygen source. The Precision Flow® HVNI may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa). For the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be at minimum 40 psi (276 kPa).The main unit contains an integrated blender that delivers the targeted gas mixture to the disposable patient circuit (DPC). The Disposable Patient Circuit contains:

• Water path: tubing from sterile water supply to vapor transfer cartridge
• . Vapor transfer (humidification) cartridge: 2 types; low flow (1-8 lpm) and high flow (5-40 lpm)
• Delivery Tube: triple lumen tubing
• . Nasal Cannula

The device automatically senses cartridge type. The available set temperature range is 33 °C to 39 °C. The device also contains a backup battery to provide power only for 15 minutes.

Here's a breakdown of the acceptance criteria and the study information for the Precision Flow® HVNI, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Precision Flow® HVNI are primarily non-clinical, focusing on safety, performance standards, software validation, and labeling requirements. The clinical studies establish safety and effectiveness by demonstrating non-inferiority or comparable outcomes to existing treatments.

*   **Data Provenance for all neonate studies:** Published literature, likely international based on author names and journal types, but not explicitly stated for each study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Similar to the adult study, ground truth involved clinical outcomes assessed by treating medical professionals (neonatologists, nurses, etc.) within the context of their respective clinical trials or retrospective data collection. Specific expert qualifications beyond clinical roles are not detailed within the provided text.

3. Adjudication method for the test set:

   • Not explicitly stated as a formal adjudication panel. Outcomes were generally defined by protocol-driven clinical events (e.g., extubation failure, need for intubation, physiological parameters).

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. These are clinical studies comparing therapies, not AI assistance for human readers.

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

   • No.

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

   • Outcomes Data: Primary ground truths included extubation failure rates, rates of intubation/mechanical ventilation, occurrences of pneumothorax, nosocomial infection, ROP surgery, bronchopulmonary dysplasia (BPD), air leaks, IVH, NEC, sepsis, duration of respiratory support, need for surfactant, time to full feeds, length of stay, mortality, and nasal trauma scores.

7. The sample size for the training set:

   • Not applicable.

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

   • Not applicable.

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The Precision Flow® - Heliox is intended to warm and add moisture to breathing gases from an external source for administration to neonate/infant, pediatric and adult patients in the hospital and sub-acute institutions. It adds heat and moisture to a blended medical heliox (79% helium. 21% oxygen)/oxygen mixture and assures the integrity of the precise heliox (79% helium, 21% oxygen)/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

The Precision Flow® - Heliox consists of two parts: The main unit which contains all the electrical and electronic components including the electronic blender and flow controllers. All the sensors are located in the main unit. The main unit has no water pathways and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection. The disposable components comprising the disposable water module, vapor transfer cartridge and heated delivery tube. Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable module.

The Vapotherm Precision Flow® - Heliox is a medical device intended to warm and humidify breathing gases, specifically a heliox/oxygen mixture, for neonate/infant, pediatric, and adult patients in hospital and sub-acute settings.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document lists various standards that the Precision Flow® - Heliox met, with some exceptions. It also includes functional and design verification tests. The "Reported Device Performance" for these tests is generally stated as: "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." Specific quantitative performance data is limited within this summary but is generally implied by compliance with the referenced standards.

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

The 510(k) summary does not provide specific sample sizes for particular performance tests or explicitly mention a "test set" in the context of clinical or image-based studies. The performance data section broadly states: "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." This implies that the design verification tests listed were conducted on the device.

• Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with cited standards and internal design verification plans.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The tests are likely laboratory or bench testing, not clinical studies involving patient data.

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

• This information is not applicable to this type of device and study. The testing for the Precision Flow® - Heliox involves engineering and performance validation against objective technical standards (e.g., flow rates, temperature, alarm function, electrical safety), not subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

• This information is not applicable as the evaluation relies on objective measurements against engineering specifications and regulatory standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a medical gas humidifier/blender, not an AI-powered diagnostic or decision-support tool. It does not involve human readers interpreting cases with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, this is not applicable. The device is hardware with integrated software for control, not a standalone algorithm. Its performance is inherent to its physical operation and control systems.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by objective engineering specifications, technical standards (e.g., ISO, ANSI/AAMI, IEC), and manufacturer-defined design requirements. This includes accuracy of gas blending, flow rates, temperature control, alarm thresholds, electrical safety, and biocompatibility.

8. The Sample Size for the Training Set

• This is not applicable in the context of a traditional "training set" for machine learning or AI models. The device's software is likely developed using standard software engineering practices and verified accordingly, rather than trained on a dataset.

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

• This is not applicable for the reasons stated above. The "ground truth" for the device's operational parameters is derived from engineering design, relevant medical standards, and intended physiological effects of humidified gas delivery.

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Precision Flow™ is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to a blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

The Precision Flow™ consists of two parts: The main unit which contains all the electrical and electronic components including the electronic blender and flow controllers. All the sensors are located in the main unit. The main unit has no water pathways and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection. The disposable components comprising the disposable water module, vapor transfer cartridge and heated delivery tube. Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable module.

This 510(k) summary describes a medical device, the Vapotherm Precision Flow™, which is a respiratory gas humidifier. It is not an AI/ML powered device, therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's an analysis of the provided text based on your request, highlighting the non-applicability of AI/ML specific criteria:

Acceptance Criteria and Device Performance (Non-AI/ML Device)

The Vapotherm Precision Flow™ is cleared based on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data (testing) and a comparison of its technological characteristics to existing devices. The "acceptance criteria" here are implicitly that the device performs its intended functions (humidifying and blending medical gases) safely and effectively, and that these performance characteristics are comparable to legally marketed predicate devices without raising new safety or effectiveness concerns.

Since this is not an AI/ML device, performance metrics like sensitivity, specificity, accuracy, or AUC are not applicable or reported in this 510(k) summary. Instead, the performance is demonstrated through various engineering, safety, and biocompatibility tests.

Non-Applicable (N/A) for AI/ML Specific Questions:

Given that K072845 describes a humidifier, not an AI/ML-powered device, the following categories are not applicable. The submission process for such a device focuses on engineering specifications, safety testing, and performance validation against established standards and predicate devices, rather than statistical performance against a ground truth dataset.

2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML device, no "test set" in the context of an algorithm's classification/prediction performance). Testing involved physical hardware, software, and biological compatibility, not a data-driven test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML device, no ground truth established by experts for algorithmic performance).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A (Not an AI/ML device, no adjudication of algorithm outputs).

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 (Not an AI/ML device. No human-in-the-loop AI assistance involved).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/ML device, no standalone algorithm performance to evaluate).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Not an AI/ML device). The "ground truth" for this device relates to physical measurements meeting specifications (e.g., oxygen percentage, temperature, bacterial counts being zero).

8. The sample size for the training set: N/A (Not an AI/ML device, no "training set"). Software verification and validation are described, but this refers to traditional software engineering processes, not machine learning model training.

9. How the ground truth for the training set was established: N/A (Not an AI/ML device, no "training set" or ground truth in the ML context).

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The Precision Flow OSV II is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

The Orbis Sigma Valve and the Precision Flow OSV IT are both variable resistance valves that manuain a drainage rate close to the rate of CSF secretion (~ 20 ml/h) within the physiological range of intracranial pressure. The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension. The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pln. The diaphragm, held between two polysulfone parts of the casing, reacts to variations in pressure. A synthetic ruby seat is inserted into the center of the diaphragm. The clearance between the seat aperture and the notched synthetic ruby nin varies depending on seat movements along the pin as pressure varies. Precision Flow OSV II and Orbis Sigma Valve are characterized by the same three stages of operation, that are defined below : Stage / - Low Differential Pressure (DP), Stage II - Flow Regulation, Stage III - Pressure Rellef Mode.

This document, K971799, is a 510(k) premarket notification for the Precision Flow OSV II, a Central Nervous System (CNS) Fluid Shunt System. The primary method used to demonstrate safety and effectiveness, and thus meet acceptance criteria, is through substantial equivalence to a predicate device, the Cordis Orbis Sigma Valve.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" are the performance specifications of the predicate device, which the Precision Flow OSV II claims to replicate. The study described focuses on demonstrating that the new device's performance is identical to the predicate device.

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

This submission does not describe a clinical study with a "test set" in the sense of a new patient cohort for the Precision Flow OSV II. Instead, it relies on the established performance of its predicate, the Orbis Sigma Valve.

• Sample Size for Test Set: Not applicable. The "test" is a comparison to the established specifications of the predicate device, not an independent clinical trial on a new set of patients for the Precision Flow OSV II.
• Data Provenance: The hydrodynamic specifications and operating principles are derived from the Orbis Sigma Valve. The document references a clinical study and use over more than seven years validating the concept for the Orbis Sigma Valve (Sainte Rose, Hooven MD, Hirsch JF: A new approach in the treatment of hydrocephalus. J Neurosurg. 86:213-226, 1987). This suggests retrospective data from clinical use of the predicate, likely from various international locations where the device was marketed.

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

• Number of Experts: Not explicitly stated for establishing "ground truth" for the new device.
• Qualifications of Experts: The "concept of the flow regulation linked to the OSV hydrodynamic specifications has been developed by Pr C. Sainte Rose M.D." This indicates that the initial specifications were developed by a medical professional. For the 510(k) submission, FDA reviewers (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices, Office of Device Evaluation) acted as experts in reviewing the claim of substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable, as there was no "test set" requiring adjudication in the context of a new clinical study for the Precision Flow OSV II. The device's performance is asserted as identical to, and therefore meeting the established performance of, its predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a physical medical implant (shunt), not an imaging or diagnostic AI tool that would typically involve a multi-reader study. The evaluation focuses on physical and hydrodynamic equivalence.

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

Not applicable. This device is a physical CNS shunt system and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for the predicate device's performance was established through:
  • Expert Consensus/Development: The concept developed by Pr C. Sainte Rose M.D.
  • Clinical Studies and Use: "Validated by clinical studies and use over more than seven years" (for the predicate Orbis Sigma Valve). This implies outcomes data from a real-world patient population.
• For the Precision Flow OSV II, the ground truth is that its design, materials, manufacturing methods, and performance specifications are identical/equivalent to this established predicate.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI, as this is a physical medical device. The "training" for its design and performance would be the extensive research, development, and clinical validation conducted for its predicate device over several years.

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

Not applicable, as there is no "training set" in the AI sense. The "ground truth" for the predicate device's efficacy and performance, which forms the basis for demonstrating equivalence for the Precision Flow OSV II, was established through a combination of:

• Expert Design and Theoretical Principles: Pr C. Sainte Rose M.D.'s development of the flow regulation concept and hydrodynamic specifications.
• Clinical Validation: "Clinical studies and use over more than seven years" for the predicate Orbis Sigma Valve, which would have involved patient outcomes data to confirm the device's intended therapeutic effect and performance in vivo.

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