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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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The Reprocessed HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic procedures, and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

The reprocessed HARMONIC 700 with Advanced Hemostasis are designed for soft tissue incisions requiring bleeding control and minimal thermal injury. The instruments serve as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in various procedures, including general, pediatric, gynecologic, urologic, and thoracic surgeries, as well as in the sealing and transection of lymphatic vessels. They enable the coagulation of vessels up to 7 mm in diameter using the Advanced Hemostasis hand control button.

The instruments are available in three (3) shaft lengths: 23cm, 36cm, and 45cm lengths (HAR723, HAR736, and HAR745 respectively). Each shaft length has a diameter of 5 mm. The following features are essential to the control and performance of the device:

• An actuating trigger that closes and releases the clamp arm, securing tissue against the scalpel rod.
• MIN/MAX control buttons that adjust energy levels between minimum and maximum modes on the generator, enabling vessel sealing up to 5 mm.
• An Advanced Hemostasis button that allows the clinician to activate an additional energy mode, enabling vessel sealing up to 7 mm.
• A rotation knob to rotate the shaft 360° unless energy is being delivered.
• A torque wrench, a sterile, single-use component, used to apply the correct amount of torque when attaching the Hand Piece to the device.

The instruments connect to a generator and hand piece, which are essential for the device's functionality but are outside the scope of this submission.
The hand piece is a reusable component that attaches to the device and plugs into the generator, allowing the device to interface with the generator. This component contains the transducer, which converts electrical power to ultrasonic mechanical energy.

The generator is a reusable component that generates the electrical signal. Colored light indicators on the front panel of the generator visually communicate device status information to the user.

This document is a 510(k) premarket notification for reprocessed medical devices, not an AI medical device. Therefore, the questions related to AI device performance, such as MRMC studies, training and test sets, ground truth establishment, and expert adjudication, are not applicable to the content provided.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria from the provided text, focusing on the reprocessed medical device context.

Here's the information based on the provided FDA 510(k) letter for the Reprocessed HARMONIC 700 Shears:

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

The document describes functional performance tests conducted to demonstrate safety and effectiveness. While explicit numerical acceptance criteria values are not provided, the general categories of testing imply the criteria for performance equivalence to the predicate device. The reported performance is that the device meets these criteria and is at least as safe and effective as the predicate.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices or tests) for each bench and laboratory test.
• Data Provenance: The studies were conducted as part of the manufacturer's premarket notification submission to the FDA. They are internal validation studies performed by Stryker Sustainability Solutions. The document does not specify country of origin for the data or whether it was retrospective or prospective, but these studies for 510(k) submissions are typically prospective and specifically designed for the submission.
  • For the preclinical laboratory evaluations, an "animal model" was used.

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 to traditional reprocessing medical device submissions. Ground truth in this context is established through engineering specifications, material science, and performance testing against established standards and predicate device performance, not expert consensus on medical images or patient outcomes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert review processes for AI model output or image interpretation, which is not relevant for this type of device submission. Device performance is determined through standardized engineering and biological tests.

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 device is a reprocessed surgical instrument, not an AI-assisted diagnostic or therapeutic device. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic imaging.

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

Not applicable. This is not an AI algorithm. Its performance is inherent to its physical properties and functionality.

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

The "ground truth" for this device's performance is established by:

• Engineering specifications and design requirements: The device must meet predefined physical, mechanical, and electrical parameters.
• Performance of the original (new) predicate device: The reprocessed device must demonstrate substantial equivalence in performance to the original, legally marketed predicate device.
• Established industry standards: Compliance with standards like ISO 10993-1 (Biocompatibility) and ISO 11135 (EO Sterilization) serves as a ground truth for safety aspects.
• Preclinical (animal) studies: In vivo performance (e.g., thermal spread, hemostasis) in animal models serves as a proxy for clinical performance.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a reprocessed medical device. The device itself is manufactured and reprocessed, not "trained" like a machine learning model.

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

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

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The indications for use of these internal fixation devices include:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Supracondylar fractures, including those with intraarticular extension
• Fractures involving osteopenic and osteoporotic bone
• Fractures distal to a total hip prosthesis
• Periprosthetic fractures
• Nonunions and malunions

The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.

T2 Alpha Femur Retrograde Nailing System, previously cleared in K203819, consists of sterile implants (intramedullary nails in various diameter and sizes, compression screw and end caps), as well as nonsterile instruments (targeting devices).

The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of anatomically pre-contoured struts and interlinking dowels designed to be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.

All struts are manufactured from Ti6Al4V ELI (Type II anodization) and are available in different sizes and left/right versions; these will be provided both non-sterile and sterile packaged. Interlinking dowels to the femoral nail are manufactured from CoCr and will be provided sterile packaged.

This appears to be a 510(k) clearance letter for an orthopedic implant, not an AI/Software as a Medical Device (SaMD). The document describes the "T2 Alpha Femur Retrograde Nailing System," which is a physical device used for internal fixation of femoral fractures.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert ground truth, MRMC studies, standalone performance, and training/test set provenance does not apply to this clearance document. These criteria are typically evaluated for AI/SaMD products, where algorithmic performance and human-AI interaction are critical.

The provided document details:

• Device Type: Intramedullary fixation rod (physical implant).
• Performance Data: Non-clinical bench testing (fatigue strength, cut-out performance, stiffness, shear-off, pull-out, insertion, static bending, fretting corrosion, targeting accuracy, MR assessment, packaging) and references to clinical evidence from peer-reviewed scientific literature.
• Comparison to Predicate Devices: Focuses on material, manufacturing, intended use, and mechanical performance equivalence.

No mention of AI, algorithms, or software performance evaluation is present.

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