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Connected OR Hub with Device and Voice Control:
The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

SDC4K Information Management System with Device and Voice Control:
The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consist of the following components:

1. Base Console which includes:
   a. Medical Device Data System (MDDS) functionalities
   b. Optional Device Control feature
   c. Optional Voice Control feature
   d. Optional Video Image Processing (VIP) feature

2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)

3. Voice Control Package (software activation USB dongle and a wireless headset and base station)

4. Video Image Processing package (software activation USB dongle)

5. Connected OR Spoke (MDDS)

The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e., non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control and/or Voice Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.

In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Medical Device Data System. Once the Connected OR Hub or SDC4K Information Management System Console is connected to the Spoke, Device Control and Voice Control can be extended to compatible devices which are directly connected to the Spoke. Ethernet-compatible devices are connected to the Secondary Spoke via an ethernet cable/switch.

When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm and removal of surgical smoke through a compatible insufflator.

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The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can be implanted for greater than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI Systems (MOLLI System and MOLLI 2 System)), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI Systems (MOLLI System and MOLLI 2 System) are intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

The MOLLI Systems (MOLLI System and MOLLI 2 System) are precision surgical marking and guidance systems for locating non-palpable lesions during surgery. The system consists of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand/MOLLI 2 Wands), and a visualization tablet (MOLLI Tablet/MOLLI Tablet 2). The MOLLI Wand/MOLLI 2 Wand Family and MOLLI Tablet/MOLLI 2 Tablet constitute the system. The MOLLI System is intended for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

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The Stryker Hoffmann LRF System is indicated in pediatric (2 through 21 years of age) and adult patients for the treatment and fixation of:

• Open and Closed Fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures of the distal radius
• Bone transport

The Hoffmann LRF System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Lisfranc dislocations

The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient. The system components are manufactured from aluminum, carbon fiber, stainless steel, and various polymers. The system also encompasses a web application and mobile application.

Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System. Use of these components does not confer MRI compatibility to the Hoffmann LRF System.

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Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Target Detachable Coils are indicated for endovascular embolization of:

• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature

Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano, Target 360 Ultra, Target 360 Soft, Target 360 Standard, Target Helical Nano, Target Helical Ultra, Target 3D, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra.

Target Detachable Coils are stretch resistant, electrolytically detachable coils consisting of a platinum-tungsten alloy coil attached to a stainless steel delivery wire.

Target Detachable Coils are specifically designed for use with Stryker Neurovascular's InZone® Detachment System (sold separately).

Target Detachable Coils are compatible with Stryker Neurovascular 2-tip marker microcatheters; refer to Instructions for Use (IFU) for the compatible microcatheter sizes.

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The InZone IST Detachment System is intended for use with all versions of Stryker Neurovascular embolization devices in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Stryker Neurovascular's InZone IST Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular embolization devices. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.

Stryker Neurovascular's IZDS Connecting Cable is a 180 cm cable intended for use with the InZone IST Detachment System in the detachment of monopolar embolization devices. The cable completes the connection between the InZone IST unit and a patient return electrode (a 20 or 22 gauge uncoated stainless-steel hypodermic needle) inserted subcutaneously at the patient's groin.

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The Stryker Robotic Precision System (RPS) Primary TKA Software application, when used with the Stryker Guidance Systems, is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to rigid anatomical structures during orthopedic procedures.

The RPS Primary TKA Software application is indicated for use in total knee arthroplasty (TKA) procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified.

RPS is a total joint bone preparation system to support total knee arthroplasty (TKA) consisting of functionality for intraoperative planning, kinematic analysis, boundary control, and guided resection. The Complete Workflow allows for the placement of Stryker Triathlon CR/PS Total Knee Implants (cemented or cementless), and plans/resects all 6 primary femoral/tibial resections. The Quick-Cut Workflow allows for placement of implants with implant-specific cut guides requiring primary distal femoral and proximal tibial cuts.

A handheld robotic saw is guided via camera visualization in relation to patient anatomy and the surgical plan established intraoperatively. The robotic saw movement is partially controlled by the RPS Console which determines, based on surgical plan and localization data, how the saw actuators need to move within three degrees of freedom (elevation, pitch, roll) to maintain the planned cut plane. The surgeon controls the remaining degrees of freedom.

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The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, breast (including mastectomy and lumpectomy) and electrophysiology implant (for implantation, upgrade and revision of Cardiac Implantable Electronic Devices (CIED) and leads) procedures.

The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, breast (including mastectomy and lumpectomy) and electrophysiology implant (for implantation, upgrade and revision of Cardiac Implantable Electronic Devices (CIED) and leads) procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The PhotonBlade 3 (Model No: 0730-101-000) and PhotonBlade 3 Smoke Evacuation (Model No: 0730-102-000) devices are sterile, single use, electrosurgical devices. The devices have a monopolar electrode at the distal end, which delivers radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode is located at the distal end of a rotatable and extendable shaft. The devices have integrated LED-based illumination. In addition, the PhotonBlade 3 Smoke Evacuation features integrated smoke evacuation tubing for removal of smoke generated by electrosurgery when connected to a smoke evacuation unit. A cable with a universal connector attaches the device to an IEC 60601 compliant electrosurgical generator.

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The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The T2 Alpha Humerus Nailing System is an intramedullary humerus fracture nailing system consisting of sterile implants (Nails, End Caps, Compression Screw, and Washer) and non-sterile indication-specific instrumentation. The Nails, End Caps, Compression Screw, and Washer are made of titanium alloy as per ASTM F136. The T2 Alpha Humerus Nailing System will be used with the existing Locking Screws and Advanced Locking Screws of the IMN Screws System.

The IMN Screws System includes bone screws (Locking Screws and Advanced Locking Screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are sterile and made of titanium alloy (Ti6Al4V ELI) per ASTM F136.

The T2 Humeral Nail System is an intramedullary nailing system that allows antegrade and retrograde humeral nailing. The nails, end caps, compression screw, and washer are provided sterile and made of titanium alloy as per ASTM F136.

The provided FDA 510(k) clearance letter (K251400) does not concern an AI/software device. Instead, it pertains to a physical medical device: the Stryker T2 Alpha Humerus Nailing System, IMN Screws System, and T2 Nailing System, which are intramedullary fixation rods and bone screws used for treating humerus fractures.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/software performance metrics (e.g., accuracy, sensitivity, specificity, F1-score, expert consensus, MRMC studies) are not applicable to this submission.

The document discusses non-clinical performance testing for the physical device, focusing on mechanical properties, sterilization, packaging, and biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.

Key points from the document regarding "performance":

• Non-Clinical Performance: This section details various engineering and material tests performed on the physical implants, such as dynamic and static bending, torsional stiffness, targeting accuracy, insertion torque, pull-out force, MRI assessment (magnetically induced displacement/torque, RF-induced heating, image artifacts), packaging tests, and biocompatibility evaluation. All these tests are standard for orthopedic implants.
• Clinical Performance: The document explicitly states: "Clinical data were not needed for the subject devices to demonstrate substantial equivalence to the predicate devices." This is a common situation for 510(k) submissions of physical devices where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

Since the request asks for information relevant to AI/software device performance, and this document is for a physical orthopedic device, I cannot extract the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) because it is not present and not relevant to this specific biological device 510(k) submission.

In summary, there is no AI/software component in this device clearance that would require the types of performance statistics and study methodologies described in the prompt.

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