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The intended function of the tilt/recline seating system is for repositioning and/or weight shift for pressure relief for individuals who cannot do this independently due to injury or disability. The elevate function is intended primarily to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility. The Invacare 3G Tarsys is rated for a combined user and accessory weight of 300 pounds. The tilt only and recline only versions are rated for a combined user and accessory weight of up to 400 pounds. The seating system is intended to be used with power wheelchair bases for which it is found to be compatible.

The Invacare 3G Tarsys is a battery powered, motorized seating system designed for use with power wheelchairs. The seating system is rated for 300 pounds. Tilt only and recline only versions are rated for 400 pounds. An electrically operated linear actuator drives the tilt and recline functions with weight balance maintained through the stability of the base. The recline function incorporates a mechanical sliding back mechanism to reduce back shear as well as optional power elevating leg rests. The elevate function is driven by an electrically operated linear ball screw actuator mounted in a vertical fashion and allows the seat to be elevated to a maximum of 7" ± .25". The tilting, reclining and elevating systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline/elevate system, a combination of tilt/recline, tilt/elevate or as separate tilt only, elevate only systems depending on the user's needs. The joystick in conjunction with the Tilt Recline Elevate Control Mechanism (TRECM) and the Invacare MK V EX controller activates the power positioning modules.

This response is based on the provided text, which is a 510(k) summary for the Invacare 3G Tarsys seating system. The document focuses on regulatory approval based on substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria. As such, much of the requested information, particularly regarding specific performance metrics, sample sizes, expert ground truth, and comparative effectiveness studies, is not present in the provided text.

Here's an analysis of what can be extracted and what is missing:

Invacare 3G Tarsys Seating System: Acceptance Criteria and Study Details

The provided 510(k) summary describes the Invacare 3G Tarsys seating system, a battery-powered, motorized seating system for power wheelchairs, and seeks to establish its substantial equivalence to legally marketed predicate devices. The document does not contain a detailed study proving the device meets specific quantitative acceptance criteria in the format typically seen for algorithm performance. Instead, it relies on demonstrating that the device's design, intended use, and performance characteristics are similar to existing approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of quantitative acceptance criteria with corresponding performance data in the typical sense of a clinical study or algorithm validation. The "performance" discussed is primarily related to safety, operational features, and design equivalence to predicate devices.

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

The document does not describe a "test set" in the context of an algorithm or device performance study involving human subjects or collected data specific to the 3G Tarsys. The testing mentioned appears to be internal engineering verification and validation.

• Sample Size for Test Set: Not applicable/Not mentioned for performance claims. The "testing" referred to appears to be internal engineering verification on the device itself.
• Data Provenance: Not applicable. No external data or clinical data is cited for performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not present. The 510(k) summary does not describe a study that used expert consensus to establish ground truth for performance metrics.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is described as there is no mention of a clinical or performance "test set" requiring expert review for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or is mentioned. The submission focuses on device design and functional equivalence to predicate devices, not on comparing reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical power wheelchair seating system, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the claims appears to be derived from:

• Engineering specifications and measurements: E.g., 7" ± .25" elevation.
• Internal safety testing: E.g., drive lock-out functionality, stability testing.
• Compliance with recognized standards: E.g., CAL 117 flammability, ANSI/RESNA Section 7.
• Substantial equivalence to predicate devices: The primary basis for regulatory clearance, implying that if predicate devices are safe and effective, a substantially equivalent new device will also be.

8. Sample Size for the Training Set

Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in this context.

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

Not applicable. No training set exists for this type of device submission.

In summary: The provided text is a regulatory submission (510(k) summary) focused on demonstrating "substantial equivalence" of a physical medical device (a power wheelchair seating system) to pre-existing, legally marketed predicate devices. It outlines the device's features, intended use, and general safety considerations, along with basic performance specifications (like weight capacity and elevation range) determined through internal testing and adherence to relevant industry standards. It does not contain information about clinical studies with specific acceptance criteria, sample sizes, expert ground truth, or AI-related performance metrics, as these are typically not required for this type of 510(k) submission for a mechanical device.

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The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.

Sinus applications would embody:

• ethmoidectomy/sphenoethmoidectomy .
• polypectomy .
• septoplasty and .
• procedures such as .
  • antrostomy .
  • endoscopic DCR .
  • frontal sinus drill-out .
  • frontal sinus trephination and irrigation .
  • septal spurs removal .
  • trans-spehnoidal procedures .

Nasopharyngeal/laryngeal procedures would comprise:

• adenoidectomy ●
• laryngeal lesion de-bulking ●
• laryngeal polypectomy .
• tracheal procedures ●
• . tonsillectomy

Head & Neck procedures would encompass:

• . soft tissue shaving
• rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
• removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
• acoustic neuroma removal .

Otology procedures would include:

• mastoidectomy .
• mastoidotomy .

The Diego Powered Dissector and Drill System Handpiece, cleared under 510(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter that will allow the Dissector blades and burs to be tracked in real time in the surgical field.

The provided text is a 510(k) summary for the Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece. This document is related to a medical device's regulatory review and does not contain information about acceptance criteria or a study proving device performance in the context of typical AI/software device evaluation.

The 510(k) is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the way an AI/software device would. The modifications described are about allowing the existing "Diego Powered Dissector and Drill System Handpiece" to integrate with BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri) through an adapter. This likely involves mechanical integration and compatibility, rather than a clinical performance study with statistical endpoints.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/software device is not present in this document.

Here's an attempt to answer based on the spirit of the request, highlighting what's missing in the context of your questions, and what can be inferred.

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria for device performance in terms of clinical accuracy or outcome metrics as would be seen for an AI/software device. Instead, the "acceptance criteria" for a 510(k) submission are largely based on demonstrating substantial equivalence to a predicate device, which implies that the modified device will perform as safely and effectively as the predicate.

The document implicitly "reports device performance" by stating its intended use and showing equivalence to predicate devices for navigation. The performance here is in terms of compatibility and retaining the function of the original dissector and drill system while integrating with image guidance.

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

• Sample Size: Not applicable/Not provided. This 510(k) submission does not describe a clinical performance study that would use a "test set" in the context of an AI/software device evaluation. The assessment is likely based on engineering verification and validation of the mechanical and functional integration with the IGS systems, rather than a statistical sample of patient data.
• Data Provenance: Not applicable/Not provided for a clinical "test set."

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

Not applicable. There is no mention of a "test set" with expert ground truth in this submission, as it's not an AI/software device undergoing such a performance evaluation. The review for 510(k) is about substantial equivalence based on engineering, bench, and potentially pre-clinical (e.g., cadaveric) testing, and comparison to existing predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. As no clinical "test set" requiring expert ground truth or adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI-assisted diagnostic or therapeutic guidance system that would typically undergo an MRMC study to show human reader improvement. The device itself is a surgical tool, and the modification enhances its guidance capabilities, but the submission doesn't include an MRMC study comparing surgeon performance with/without the image-guided assistance provided by this specific adapter.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a manual surgical tool that is guided by an image-guided surgery system. Its function inherently involves a human operator (the surgeon) and the image navigation system. There is no "algorithm only" component that would perform a task independently. The performance is the combined system's ability to track the instrument accurately.

7. Type of Ground Truth Used:

Not applicable in the context of an AI/software device's performance study. For a mechanical device, "ground truth" would relate to engineering specifications, e.g., the true position of the instrument as measured by highly accurate systems, or the physical dimensions and tolerances of the adapter. However, the submission does not detail these engineering verification methods beyond stating the intent to integrate with image-guided systems.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical surgical instrument; it does not utilize a "training set" for machine learning.

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

Not applicable. As there is no training set for this type of device.

Summary of what the document DOES provide:

• Device Description: A modified handpiece for the Diego™ Powered Dissector and Drill System, designed to accept adapters for BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri).
• Intended Use: Cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures, with specific examples listed.
• Predicate Devices: BrainLAB Kolibri IGS System (K014256) and BrainLAB Vectorvision2 IGS System (K003589). The modification makes the Gyrus ENT device "compatible" with these predicate image-guided systems.
• Regulatory Classification: Class II, Stereotaxic instrument (HAW).
• 510(k) Clearance: The document is the FDA's clearance letter, stating substantial equivalence to predicate devices, thus permitting marketing.

This 510(k) focuses on the mechanical and functional compatibility of a modified surgical instrument with existing image-guided navigation systems, rather than a new AI/software diagnostic or therapeutic device whose performance would be assessed with detailed statistical studies against clinical ground truth.

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The BrainLAB VectorVision Frameless Biopsy System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies.

Spinal Procedures: Spinal implant procedures such as pedicle screw placement.

ENT Procedures: Transphenoidal procedures. Intranasal procedures. Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections and Frontal sinusotomies

The VectorVision Frameless Biopsy System contains features to improve the support and guidance of surgical instruments. A multiarticulated arm facilitates the use of miscellaneous instruments for serial approaches along a determined trajectory to a specific target as well as the guidance of a single instrument to multiple targets along the same trajectory. Combined with the IGS features of VectorVision's software, the determination and repeated locating of trajectories is considerably simplified. By mechanical support, the degrees of freedom of the instrument can be limited either to zero or to one, thus giving the surgeon's hand mechanical support for increased stability, alleviating the surgeon's task of holding or inserting instruments and enhancing the efficiency of the surgery.

This 510(k) summary describes a modification to the VectorVision Frameless Biopsy System, a medical device designed for image-guided surgery. However, the provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or comparative effectiveness studies.

The document details the device's intended use and substantial equivalence to previously cleared devices. It states:

• Product: VectorVision Frameless Biopsy System
• Manufacturer: BrainLAB AG
• Indications for Use: Intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data (CT, X-ray, or MR). It is indicated for medical conditions where stereotactic surgery is appropriate and a reference to a rigid anatomical structure (skull, long bone, vertebra) can be identified. Examples include cranial (biopsies, tumor resections), spinal (pedicle screw placement), and ENT procedures.
• Modification: The new features are aimed at improving support and guidance of surgical instruments. A multiarticulated arm facilitates the use of various instruments for serial approaches or guiding a single instrument to multiple targets along the same trajectory. This, combined with existing IGS features, simplifies trajectory determination and locating. Mechanical support can limit instrument degrees of freedom, providing stability and alleviating the surgeon's task.
• Substantial Equivalence: The device was found substantially equivalent to BrainLAB's VectorVision2 System (K983831, K003589).

Therefore, based solely on the provided text, I cannot complete the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement. The 510(k) summary focuses on the device's intended use and its substantial equivalence determination, rather than detailed performance study results against predefined acceptance criteria.

To provide the requested information, a separate performance study report or a more detailed section within the 510(k) describing validation testing would be necessary.

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