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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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The Stimwave Technologies Incorporated Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral pain. The FRT4-A001 device is solely used for trial stimulation (no longer than 30 days) of the permanent FRE4-A001 device.

The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column neural stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral or bilateral pain. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on nerves near the dorsal column of the spine. The System is comprised of an implantable stimulator (Freedom-4 Stimulator) and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Trial Freedom-4 Stimulator.

The document describes the Stimwave Technologies Incorporated Freedom Spinal Cord Stimulator (SCS) System and provides information to support its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies, formatted as requested:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding reported device performance values in a side-by-side format. Instead, it describes compliance with various national and international standards and design requirements through a series of non-clinical tests. The "reported device performance" is generally stated as having "passed," "met the criteria," or being "lower/higher than the allowable limit."

However, a comparison table (Table 5A) is provided that compares the technological characteristics of the Stimwave Freedom SCS System with three predicate devices. This table implicitly defines "acceptance" as being similar to or within the range of these predicate devices for many parameters.

Implicit Acceptance Criteria and Reported Performance (derived from Table 5A and non-clinical testing sections):

Study Details

The document refers to a "submission" rather than a single specific study. The evidence for meeting acceptance criteria is predominantly based on non-clinical performance testing and a comparison to predicate devices.

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

   • Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of device performance, but rather individual components were tested according to various standards. For example, "all tested samples" for leakage current and "all tested stylets in all tested stimulator samples" for insertion/withdrawal. The exact number of units/components tested for each non-clinical test is not specified.
   • Data Provenance: The testing was conducted by Stimwave Technologies Incorporated to verify compliance with national and international standards (AAMI ANSI ISO, ASTM, IEC). The data is prospective in the sense that the testing was performed on the Stimwave Freedom SCS System components specifically for this submission. The "data provenance" regarding the location of testing is not specified, but it's presumed to be within the manufacturer's testing facilities or accredited laboratories.

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

   • This question is not applicable in the typical sense for this submission. The "ground truth" for the non-clinical tests is established by the specific requirements and acceptance criteria of the referenced national and international standards (e.g., ISO, ASTM, IEC). These standards are developed and recognized by expert bodies in their respective fields. No adjudication by specific medical experts for interpreting test results is described; rather, results are objectively compared against predefined numerical or qualitative criteria from the standards.

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

   • "None" in the context of human expert adjudication as this was non-clinical engineering and materials testing against established standards. The review process for the submission at the FDA would involve regulatory experts assessing the manufacturer's presented data against requirements.

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 MRMC study was done. This document pertains to a Spinal Cord Stimulator, a medical device that delivers electrical impulses for pain relief, not an imaging or diagnostic AI device that would involve "human readers" or AI assistance in interpretation. The nature of this device does not fit the MRMC study paradigm.

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

   • This question is not applicable. The device is a physical medical implant system, not a standalone algorithm. Its performance is inherent to its design and function, not an AI algorithm.

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

   • The "ground truth" for demonstrating substantial equivalence against legally marketed predicate devices primarily relies on:
     • Standardized Test Methods and Acceptance Criteria: As set by numerous international and national standards (e.g., ISO 10993, AAMI ANSI ISO 14708-3, ASTM F2182-11a, IEC 60601-1) for biocompatibility, safety, and performance.
     • Direct Comparison to Predicate Devices: Explicitly measuring and comparing physical and electrical parameters against established values of legally marketed devices (Table 5A).
     • Design Requirements: Manufacturer-defined design specifications and requirements that the device must meet, often derived from industry best practices and safety considerations.
   • There is no mention of pathology or outcomes data as "ground truth" for this specific 510(k) submission, as it focuses on non-clinical substantial equivalence.

7. The sample size for the training set:

   • This is not applicable. This is not an AI/ML device requiring a training set. The term "training set" is usually associated with machine learning models.

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

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

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The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exist.

The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The entire implant is made from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the Delivery Device provided in the Freedom Inquinal Hernia Repair Kit. The Delivery Device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. Currently, the implants come in two different sizes; 25mm and 40mm with corresponding Delivery Devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.

The provided text describes a 510(k) summary for the Freedom Inguinal Hernia Implant, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and the study that proves a device meets those criteria in the context of AI/ML performance metrics.

The document is a regulatory submission for a surgical mesh, which is a physical medical device, not a software-driven diagnostic or AI/ML product. The "Performance Data" section discusses:

• Biocompatibility testing: Previously conducted and applicable.
• Bench testing and in vivo simulated use experiments: Conducted in hernia simulators and fresh bovine meat.

These tests are designed to demonstrate the physical and material performance of the surgical mesh, ensuring it meets product specifications and intended use. They are not related to AI/ML performance metrics such as sensitivity, specificity, or AUC.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) because the document does not present an AI/ML device or its associated performance evaluation.

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The Freedom® PCK Components are designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System, and is indicated for the following:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods
• Revision surgery where sufficient bone stock and soft tissue integrity are present
  The Freedom® PCK Components are intended for cemented use only. The optional Freedom Stemmed Tibial Augments are intended for screw attachment to the Stemmed Tibial Base Plate. This device is for single use only.

The Freedom® PCK Components is a progressive constraint cemented prosthesis system. The PCK Components consists of CoCrMo composed Stemmed Femoral Component, UHMWPE composed Tibial Liner and Ti-6A1-4V composed Posterior and Distal Femoral Augments. The components are a modification of the previously cleared Freedom® Stemmed Tibial Components (tibial augment) and Freedom® Total Knee System (PS femoral component and PS tibial liner). Also, the Freedom® PCK Components are intended for use with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System for total knee replacement (TKR) surgery. The Components will be prescription products consisting of single use only, implantable devices for implanting into patients in an operating theatre by a qualified surgeon.

The devices are to be packaged and terminally sterilized by gamma radiation or ethylene oxide. The packaging is to keep devices sterilized for 5 years. The packaging will be able to be opened easily in an operating theatre without instruments and in a manner that allows the implant to remain sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Freedom® PCK Components:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for each test. Instead, it describes the objective of each non-clinical test. The document implies that the device "meets" its objectives through these tests, but no pass/fail thresholds are given.

Explanation of "Assumed to meet performance for substantial equivalence": In 510(k) submissions, for devices deemed substantially equivalent, direct numerical results and their comparison to specific acceptance criteria are often presented in detailed test reports not typically included in the public 510(k) summary. The FDA's clearance (K131481) implies that the provided data (including these performance tests) was sufficient to demonstrate that the device performs as safely and effectively as the predicate devices.

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

• Sample Size: Not explicitly stated. The tests are non-clinical, likely involving a number of physical specimens of the device components. The document doesn't provide a count of how many components were tested for each study.
• Data Provenance: The studies are non-clinical (laboratory/mechanical testing) performed on the device components themselves. There is no mention of human data, country of origin related to human data, or whether it's retrospective or prospective, as clinical testing was not required.

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

This information is not applicable as the studies are non-clinical engineering/mechanical tests, not human studies requiring expert interpretation of results for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical engineering/mechanical tests. Adjudication methods are typically used in clinical studies for interpreting human data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor was it required. This is a medical device (knee implant) and not an AI/imaging diagnostic device that would involve human readers interpreting output. Clinical testing in general was not required for this submission.

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

No, this is not an algorithm-based device. It is a physical implantable medical device. Therefore, standalone algorithm performance is not relevant.

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

For the non-clinical tests, the "ground truth" would be established by engineering and biomechanical principles and standards for knee prostheses. For example:

• Standard ASTM or ISO test methods for fatigue, strength, stability, and range of motion for orthopedic implants.
• The performance of the predicate devices.
• The documented design specifications of the Freedom® PCK Components.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" for physical mechanical testing.

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

This information is not applicable as there is no "training set" for physical mechanical testing.

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Intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic, laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications.

For intended use in Dermatology for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte, and treatment of benign cutaneous lesions, such as warts, scars and striae. Also intended for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

For intended use on all skin types (Fitzpatrick I-VI), including tanned skin.

For intended use in Podiatry for the ablation, vaporization, incision, excision, and coagulation of soft tissue, including Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.

For intended use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).

The FREEDOM Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the FREEDOM Laser System and contains the Nd: YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the LCD display.

The provided document, a 510(k) summary for the Lutronic Corporation FREEDOM Laser System, explicitly states "Performance Data None presented." Therefore, based solely on the provided text, there is no study described that proves the device meets acceptance criteria, nor are there any acceptance criteria defined within this document.

Consequently, I cannot fill out the requested table or answer the specific questions related to a study's methodology, sample sizes, expert involvement, or comparative effectiveness.

Without any performance data or acceptance criteria detailed in the submission, the table would be empty for the "Acceptance Criteria" and "Reported Device Performance" columns. All other points requesting information about a study would also be unanswerable from the provided text.

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The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exists.

The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The implant is wholly manufactured from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the delivery device provided in the Freedom Inguinal Hernia Repair kit. The delivery device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. There are two different sizes of implants and corresponding delivery devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.

The provided text describes a 510(k) premarket notification for the "Freedom Inguinal Hernia Implant." This document primarily focuses on establishing "substantial equivalence" to predicate devices rather than deeply detailing acceptance criteria of a standalone study for an AI/algorithm-based device.

However, I can extract information related to the device performance and acceptance criteria implied by the studies conducted to demonstrate its safety and effectiveness for substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a structured table of "acceptance criteria" and "reported device performance" in the way one would for an AI algorithm's metrics (e.g., sensitivity, specificity, AUC). Instead, it describes general desired outcomes for a hernia implant. Based on the objectives of the clinical studies, here's an attempt to structure the information:

• "Safe and effective for the treatment of inguinal hernias" (Group 1, n=61)
• No reports of unresolved post-operative complications (Group 1, n=61) |
  | Freedom from hernia recurrence (1, 6, 12, 24, 36 months) | - No recurrences after 3 years (Group 1, n=61)
• No long term complications or recurrences (Amato Study, n=30, mean 25.23 months follow-up)
• No recurrences (Petrella/Venditti Study, n=24, mean 4.5 months follow-up) |
  | Secondary Complications Objectives | |
  | No perioperative/postoperative complications (1, 6, 12, 24, 36 months) | - No reports of unresolved perioperative complications (Group 2, n=30)
• No reports of tissue injury or spermatic cord complications (Group 2, n=30)
• No long term complications (Amato Study, n=30) |
  | No bleeding, swelling, hematoma from dilation/delivery | - No reports of tissue tearing injury or spermatic cord injury (n=78 total with dilation technique) |
  | No seroma, infection/abscess, testicular/spermatic cord injury, wound complications, symptomatic pain, or chronic pain syndrome | - No reports of spermatic cord injury or compression complications due to device rotation/sizing (Group 2, n=27, 1 year+ follow-up)
• No chronic discomfort (Amato Study, n=30) |
  | Biocompatibility | Complies with requirements for device classification (Pre-Clinical Tests) |
  | In vitro Performance | Meets pre-determined acceptance criteria or specifications (Pre-Clinical Tests) |
  | In vivo Performance | Validated implantation procedure, demonstrated tissue incorporation (Pre-Clinical Tests) |
  | Delivery Device Performance | Successfully deployed implant in proper location (Cadaver studies), validated implantation technique (Cadaver studies) |

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

The document describes several clinical experiences and studies, rather than a single "test set" for an algorithm. It uses data from patient groups as clinical evidence for substantial equivalence.

• Group 1 (Retrospective Data):
  • Sample Size: n=61 patients
  • Data Provenance: Single center, single surgeon clinical experience. Likely unknown specific country, but general clinical practice data. Retrospective (patients followed for a minimum of 3 years after implantation with custom implants).
• Group 2 (Prospective/Retrospective Mixed):
  • Sample Size: n=30 patients (received Insightra manufactured implant). 27 followed for a year or more.
  • Data Provenance: Unspecified country, but clinical experience with Insightra's device. Follow-up ranged from perioperative to one year post-implantation, with a mean of 25 months for those followed longer. This suggests a prospective collection for at least part of the follow-up, but the initial collection might have been retrospective to some degree.
• Amato Study (Prospective):
  • Sample Size: n=30 patients (total implants n=34 due to bilateral hernias)
  • Data Provenance: Single center, single investigator. Country not specified. Prospective study enrollment June 2009 to August 2011.
• Petrella/Venditti Study (Prospective):
  • Sample Size: n=24 enrolled patients (target enrollment = 80)
  • Data Provenance: Single center, two investigators. Country not specified. Prospective study enrollment Dec 2011 to present (at time of filing).

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

For these clinical studies involving surgical implants, the "ground truth" is typically established by the implanting surgeon(s) and following clinicians who assess patient outcomes (recurrence, complications, comfort).

• Group 1: Single implanting surgeon (qualifications not specified beyond "surgeon").
• Group 2: Unspecified number of clinicians involved, likely the surgeons performing the implantations and follow-ups.
• Amato Study: 1 investigator (likely implanting surgeon). Qualifications not specified.
• Petrella/Venditti Study: 2 investigators (likely implanting surgeons). Qualifications not specified.

There is no mention of "experts" in the context of independent review or adjudication of study endpoints, as might be done for imaging-based diagnostic devices.

4. Adjudication Method for the Test Set

There is no explicit mention of an adjudication method (like 2+1, 3+1) for the clinical outcomes in any of the studies. The outcomes were likely recorded by the treating physicians/investigators. For surgical outcomes like hernia recurrence or complications, direct clinical examination and patient reporting, sometimes supplemented by imaging, serve as the basis for recorded outcomes.

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 performed. This document describes a medical device (hernia implant), not an AI algorithm for diagnosis or interpretation that would involve "human readers."

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

No, this document describes an implanted medical device, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the effectiveness and safety of the hernia implant primarily relies on:

• Clinical Outcomes Data: Direct observation of procedural success, absence of recurrence or complications, patient-reported symptoms (pain, discomfort), and clinician assessment of tissue injury, seroma, infection, etc.
• Pathology/Histology (Implied): The in vivo survival study demonstrated "tissue incorporation," which would typically involve histological examination of explanted tissue.
• Imaging Data (Limited): Ultrasound findings were mentioned for a subset of patients in the Amato study ("Full and stable obliteration of twelve patients examined at 3, 6 and 12 months.") but not for the Petrella/Venditti study.

8. The Sample Size for the Training Set

This document does not describe an AI/ML algorithm, so there is no "training set." The "development" of the device involved:

• In vitro and In vivo (animal) tests: For material properties, mechanical performance, and biocompatibility.
• Cadaver studies: To validate implantation procedure and technique.
• Early clinical experience: The Group 1 patients (n=61) received "custom implants fabricated by the implanting surgeon," which can be seen as preceding the Insightra manufactured implant, providing early clinical insights that might conceptually relate to "training" in an operational sense, but not algorithmic.

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

As there is no "training set" in the context of an AI algorithm, this question is not applicable. For the pre-clinical and early clinical development of the device, "ground truth" was established through standard laboratory testing, animal studies (pathology, tissue incorporation), and clinical follow-up by surgeons/investigators.

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The Freedomaire III Surgical Helmet System is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

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This document is a 510(k) premarket notification decision letter from the FDA regarding the "Freedomaire III Surgical Helmet System." It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and does not contain detailed information about specific acceptance criteria or an overarching study proving the device meets said criteria.

Therefore, I cannot provide the requested information from this document. The document focuses on regulatory approval based on equivalence rather than performance study results against specific criteria.

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The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component consists of a cobalt-chromium molybdenum (CoCrMo) femoral component designed to be used with the Freedom® Total Knee System, and the Freedom® Total Knee Metal Backed Tibial Components. The Freedom Total Knee System is indicated for the following:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities,
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods
  The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component is intended for cemented use only. This device is for single use only.

The Maxx Orthopedics' Freedom® CR Femoral Component is compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019 and the Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.
The proposed Freedom® CR Femoral Component consist of a cobalt-chromium molybdenum (CoCrMo) component that is designed to be used with the Freedom® Total Knee System described in K082019 and the Freedom Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component (posterior stabilizing), an all-poly tibial component, and a patellar component. The Freedom Metal Backed Tibial Component subject of K090411 consists of a metal backed tibial component and polyethylene insert. The proposed CR Femoral Component will provide the surgeon with an alternative femoral component in the event that the surgeon prefers to use a CR component rather than the PS component with the Freedom® Total Knee System. In addition, a second metal backed tibial component was cleared for use with the Freedom Total Knee System under K090411. The proposed CR Femoral Component and a (UHMWPE) insert will be used in place of the PS Femoral component with the Freedom® Total Knee System.
The CR Femoral Component of the Freedom® Total Knee System CR is designed to replace the articulating surface of the distal femur. The cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (Freedom® Total Knee Cruciate Retaining (CR) Femoral Component) and focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, along with some general information about performance testing.

Specifically, the document states:

• "Mechanical and functional testing described in K082019, K090411 and in Section 8 demonstrates that the Freedom® CR Femoral Component are mechanically and functionally similar to the parent Freedom UHMWPE Tibial Component and other legally marketed knee systems."
• "Evaluations were performed to determine the material and mechanical characteristics of the Maxx Orthopedics' Freedom® CR Femoral Component and the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Fernorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
• "The verification and validation testing have been performed which demonstrate that the CR Femoral Component functions as intended and is safe and effective for its intended use."

However, it does not provide:

1. A table of specific acceptance criteria.
2. Reported device performance against those criteria.
3. Details about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for software/AI components. This is likely because the device is a physical knee implant, not a software or AI-driven diagnostic/treatment tool.

Therefore, I cannot provide the requested table and information.

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The intended use of the Freedom Sciences Version 1.5 Motion Control Module is to allow for remote motion control of a powered wheelchair that uses the Invacare MK6 Electronics while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.

The MCM Version 1.5 is compatible with powered wheelchairs that use Invacare MK6 Electronics.

The Freedom Sciences Version 1.5 Motion Control Module for powered wheelchairs is a wireless, remote control product designed for use with powered wheelchairs which use the Invacare MK6 Electronics . Its intended function and use is to allow for remote motion control of the powered wheelchair only while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.

The MCM v1.5 allows for remote motion control using high level motion control commands. It interfaces to the power wheelchair using the host wheelchair attendant control interface on the motor controller. This method of interfacing with the powered wheelchair retains all configured safety interlocks inherent to the host motor controller itself and is the standard means for integrating auxiliary input devices.

The provided text describes a Special 510(k) Premarket Notification for the "Freedom Sciences LLC Version 1.5 Motion Control Module (MCM)". This device is intended for remote motion control of unoccupied powered wheelchairs that use Invacare MK6 Electronics.

However, the document is a premarket notification for a medical device and not a study report. It does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and performance studies in the requested format for an AI/device performance study.

Here's an attempt to answer the questions based on the limited information provided in the document:

1. Table of acceptance criteria and the reported device performance

• Ability to provide remote motion control of a powered wheelchair.
• Compatibility with Invacare MK6 Electronics.
• Retention of host motor controller's safety interlocks.
• Operation only when the wheelchair is unoccupied. | The MCM v1.5 allows for remote motion control using high-level motion control commands.
  It interfaces to the power wheelchair using the host wheelchair attendant control interface on the motor controller.
  This method of interfacing with the powered wheelchair retains all configured safety interlocks inherent to the host motor controller itself and is the standard means for integrating auxiliary input devices.
  "The Freedom Sciences MCM v1.5 met the applicable required performance criteria and functioned as intended."
  "It is not intended for use when a person is seated in the wheelchair." |
  | Safety:
• Adherence to safety standards.
• Prevention of use when a person is seated. | The device's interface method retains all configured safety interlocks inherent to the host motor controller.
  Its intended use explicitly states, "It is not intended for use when a person is seated in the wheelchair."
  The study mentioned was "as required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles"". This guidance would implicitly cover safety aspects. |
  | Substantial Equivalence:
• Equivalence to a predicate device (Freedom Sciences Motion Control Module for Powered Wheelchairs, K073330). | The Freedom Sciences MCM v1.5 Motion Control Module is "substantially equivalent to the Freedom Sciences Motion Control Module (MCM) for powered wheelchairs (K073330)." |

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 a "test set" sample size or data provenance in the context of an AI/algorithm performance study. The testing refers to the "MCM v1.5 was tested as required by FDA's July 26, 1995, draft publication entitled 'Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles'". This guidance would relate to engineering and functional testing of the physical device, not an AI model requiring a test dataset.

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 information is not applicable and not provided. The device is a motion control module for a wheelchair, not an AI diagnostic or analytical tool that requires expert-established ground truth for a test set.

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

Not applicable and not provided.

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 and not provided. This device is not an AI assistance tool for human readers.

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

This device itself is a "standalone" system in the sense that it operates independently to control the wheelchair remotely. However, it's not an "algorithm only" in the context of typical AI performance studies. Its performance is about the module's ability to transmit commands and the wheelchair's response, which is a functional test. The document states it allows for "remote motion control using high level motion control commands," implying the module's algorithms are responsible for interpreting and executing these commands. The testing "met the applicable required performance criteria and functioned as intended." This confirms its standalone functional performance was evaluated.

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

The "ground truth" for this device's performance would be objective measurements of its functional capabilities (e.g., successful remote control of movement, adherence to safety interlocks, reliability of communication) against engineering specifications and regulatory guidance for powered wheelchairs. It is not based on expert consensus on diagnoses, pathology, or outcomes data.

8. The sample size for the training set

Not applicable and not provided. This is not an AI model that undergoes "training" with a dataset in the conventional sense. The "training" would be more akin to software development and hardware testing.

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

Not applicable and not provided.

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