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The Omnia Medical PsiF DNA™ System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. The PsiF DNA™ may be implanted via a transverse or inline approach. When PsiF DNA™ is implanted inline, it must be used with a PsiF DNA™ screw implanted transversely across the same sacroiliac joint.

The Omnia Medical PsiF DNA™ System consists of screws and washers manufactured from Ti-6Al-4V ELI per ASTM F3001 and ASTM F136, respectively. The screws are available in one diameter and a variety of lengths to accommodate varying patient anatomy. The system includes instrumentation for implantation that is manufactured from surgical grade stainless steel or aluminum. During the procedure, the implant is inserted through the ilium to pierce its medial cortex, across the sacroiliac joint and into the sacrum to pierce its lateral cortex, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery. The implants and instruments are provided in two surgical kit options. In one kit, the implants and instruments are provided non-sterile and sterilized by the end user. In the other kit, the implants and instruments are single-use and provided sterile.

Based on the provided FDA 510(k) clearance letter for the Omnia Medical PsiF DNA™ System, there is no information about specific acceptance criteria or a study that proves the device meets those criteria in the context of AI/Software performance.

The clearance letter focuses on the device being a physical medical device (a bone fixation fastener) and its substantial equivalence to predicate devices based on mechanical and cadaveric testing.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria for a device, a test set, expert ground truth, MRMC studies, or training sets, as these concepts are typically applied to the evaluation of software as a medical device (SaMD) or AI-enabled medical devices, not to a physical implant like the Omnia Medical PsiF DNA™ System.

The document explicitly states:

• "Clinical testing was not required to support a substantial equivalence determination for the PsiF DNA™ device." This confirms that there was no clinical study, let alone one focused on human-in-the-loop performance or AI assistance.
• The non-clinical testing listed consists entirely of mechanical and cadaveric tests, which are standard for orthopedic implants to assess their structural integrity, strength, and biomechanical compatibility.

In summary, none of the requested information (table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth types) is present in this 510(k) document because the cleared device is a physical implant, not an AI/software product requiring such performance evaluation.

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The TransLoc 3D Screw is intended for sacroiliac joint fusion for conditions including:

· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.

TransLoc 3D implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as a Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone and may be used in the same procedure with CornerLoc bone graft. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint. All implants are provided sterile packaged for single use. Non-sterile instruments are available to assist with the surgical procedure and must be sterilized prior to use.

I am sorry, but the provided text focuses on the regulatory clearance (510(k) submission) of the TransLoc 3D device. It outlines the device's indications for use, its description, and its substantial equivalence to a predicate device based on non-clinical testing and technological characteristics comparison.

The document does not contain any information regarding acceptance criteria, reported device performance metrics, particulars of a study (like sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or details about training sets.

Therefore, I cannot provide the requested table and study information based on the given text.

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The Sacrix® Sacroillac Joint Fusion Device System is intended for fusion of the sacroillac joint for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

The InSpan® ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.

The Invue® MAX™ + Invue Inset Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma; (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudloarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and reoperation for failed fusion or instability following surgery for above indications.

The FacetFuse® Screw Fixation System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1) Trauma, including spinal fractures and/ or dislocations: 2) Spondylolisthesis: 3) Spondylolysis: 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.

The Sacrix® Sacroiliac Joint Fusion Device System implants consist of Solid and Fenestrated Screws. Solid and Fenestrated Screws are available in varying diameters and lengths. Solid and Fenestrated Screws are fabricated from medical grade titanium alloy, Ti-6AI-4V ELI per ASTM F136. Solid and Fenestrated Screws have a cannulated core to allow packing of allograft or autograft material. Solid Screws have a solid outer wall, while Fenestrated Screws have fenestrations on the outer wall.

The Inspan® ScrewLES Fusion System consists of a variety of sizes of plates, set screws, and associated instruments. The plates are offered in five hub diameters (8 mm in 2 mm increments) and five wing length configurations (35 mm to 47 mm increments). The device height (measured from the base of the central hub to the top of the wing) is fixed across all configurations at 18.85 mm for InSpan® and 13.89 mm for InSpan® Slim. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating post-operatively. The components of the Inpan® ScrewLES Fusion System are fabricated from medical grade titanium alloy Ti-6AI-4V ELI per ASTM F136.

The Invue® MAX™ + Invue Inset Anterior Cervical Plate System consists of a variety of shapes and sizes of plates, screws, and the associated instruments. The plates are available in four levels to accommodate one to four levels of fixation. The one level plates have lengths ranging from 17 mm in 2 mm increments, two level plates range from 33 mm in 2 mm increments, three level plates range from 48 mm to 78 mm in 3 mm increments, and the four-level plates range from 61 mm in 4 mm increments. A lock is integrated in the plate and screw to secure the screw from backout. Ø4.2 mm self-drilling screws and Ø4.5 mm self-tapping screws are offered. All screws are offered in lengths of 12 mm, 16 mm, 18 mm, and 20 mm. The Invue® MAX™ + Invue Inset Anterior Cervical Plate System components are single use and are fabricated from titanium alloy Ti-6AI-4V ELI per ASTM F136.

The FacetFuse® Screw Fixation System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. The FacetFuse® Screw Fixation System offers partially threaded screws. The partially threaded screws are available in Ø4.5 mm diameter screw (in 0.5 mm increments) offered in lengths of 25 mm to 50 mm (in 5 mm increments). The fully threaded screws are available in diameters Ø4.5 mm and Ø5.0 mm in lengths from 20 mm in 5 mm increments. The device is fabricated from titanium alloy Ti-6Al-4V ELI per ASTM F136. The devices are offered with a built in washer or without a washer. The washers are intended to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories.

The purpose of this submission is to offer sterile packaged options of each implant.

The provided text is a 510(k) summary for several medical devices (Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System). It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily due to changes in sterilization and packaging.

The document does not contain information about an AI/ML-based device or a study involving human readers and AI assistance. Therefore, I cannot provide details regarding acceptance criteria, performance data, ground truth establishment, or multi-reader multi-case studies for an AI/ML device from this text.

The "Performance Data" section explicitly states that "The results of these non-clinical tests showed that each system is substantially equivalent to legally marketed predicate devices. The changes in sterilization and packaging do not affect mechanical performance and require no additional bench testing for this submission." This indicates that the performance evaluation was based on previously conducted mechanical and physical testing of the devices, not on data from clinical studies or AI/ML evaluations.

In summary, the provided document does not contain the information required to answer your questions regarding acceptance criteria and study proving device performance for an AI/ML component.

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The 2.4mm Secure Locking Variable Angle Distal Radius Plate and Ø2.4 mm Secure Locking Screws, Self-Tapping are intended for fixation of complex intra- and extra-articular fractures arid osteotomies of the distal radius.

The 2.7mm/3.5mm Secure Locking Distal Humerus Medial Plate, 2.7mm/3.5mm Secure Locking Distal Humerus, Dorsolateral Plate, and 2.7mm/3.5mm Secure Locking Distal Humerus Plate, Dorsolateral With Lateral Support are indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, and nonunions of the distal humerus.

The 3.5mm Secure Locking Small Plate, 3.5mm Secure Locking T-Plate, Small with 3 Head Holes, and Ø3.5 mm Secure Locking Screws, Self-Tapping, are indicated for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula.

The 3.5 mm Secure Locking Superior-Anterior Clavicle Plate and 3.5 mm Secure Locking Superior-Anterior Clavice Plate With Lateral Extension is indicated for fixation of fractures, malunions, and ostectornies of the clavice in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The 3.5mm Secure Locking Olecranon Plate is indicated for fractures, osteotomies, malunions and non-unions of the olecranon.

The 3.5 mm Secure Locking Philos Proximal Humeral Internal Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The 4.5/5.0mm Secure Locking Narrow LC Dynamic Compression Plate is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, and fixation of nonunions or malunions in adult patients.

The 4.5mm/5.0mm Secure Locking Distal Femoral Plate is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures, nonunions and malunions, and osteotomies of the femur.

The 4.5mm/5.0mm Secure Locking Medial Proximal Tibia Plate is intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of nonunions of the medial proximal tibia and tibia shaft.

The 4.5mm/5.0mm Secure Locking L Buttress Plate and 4.5mm/5.0mm Secure Locking T Buttress Plate are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial tibia. Also, for use in fixation of non-unions and malunions.

The 3.5mm/4.5mm/5.0mm Secure Locking Distal Tibia Plates are intended treatment of non-unions, and fractures of the distal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The Ø3.5mm CORTICAL SCREW and Ø4.5mm CORTICAL SCREW are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Ø2.7 mm Secure Locking Screws, Self Tapping, and Ø 2.7mm Cortical Screws are intended for fractures and osteotomies of small bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Ø5.0mm Secure Locking Screws, Self-Tapping are intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions.

The 6.5mm Cancellous Screw, 16mm Thread, 32 Thread, Ø4.0mm CANCELLOUS SCREW, Partial Thread, Full Thread, and Ø4.0mm SMALL CANCELLOUS CANNULATED SCREW, Partial Thread, Full Thread are indicated for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.

The 6.5mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, Full Thread, and 7.0mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, are indicated for fracture fixation of large bone fragments, such as tibial plateau fractures, ankle arthrodeses, intercondylar femur fractures; and subtalar arthrodeses.

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shapes and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws. The subject device system also consists of a variety of general use instruments (Class I), which include drill bits, forceps, plate benders, and drill guides.

The plates and screws are manufactured from Stainless Steel and Titanium alloy.

The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available, such as:, Reconstruction Plates, T-Plates, Anatomical Plates, Clavicle Plates.

These all are mainly divided into:

• . Large Fragment Plates
• Small Fragment Plates ●
• Mini Fragment Plates .

The locking screw implants are offered in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying from a minimum length of 6 mm to maximum length of 90mm.

The non-locking screw implants are offered in 2.7mm, 3.5mm and 4.5mm diameters, with lengths ranqing from 10mm to 80mm.

The cancellous screw implants are 4.0mm and 6.5mm in diameter, with lengths ranging from 10 to 120 mm. The cancellous cannulated screw implants are offered in 4.0mm. 6.5mm and 7.0mm diameters and lengths ranging from 16mm to 130 mm.

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided non-sterile, the products must be sterilized prior to use. All implants are for single use only.

This document describes the 510(k) summary for the HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The information provided pertains to the substantial equivalence of a medical implant (bone plates and screws) to predicate devices, focusing on material, design, and mechanical performance rather than AI/ML algorithm performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device from the given text.

The document discusses the following:

• Device Name: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
• Intended Use: Fixation of various bone fractures and osteotomies.
• Predicate Devices: A list of Synthes Locking Compression Plate Systems and Screws.
• Non-Clinical Testing:
  • Material Standards: ASTM F136, ASTM F138, ASTM F139 (for Stainless Steel and Titanium alloy).
  • Performance Standards: ASTM F382 (Metallic Bone Plates), ASTM F384 (Metallic Angled Orthopedic Fracture Fixation Devices), ASTM F543 (Metallic Medical Bone Screws), and FDA guidance documents for orthopedic screws and fracture fixation plates.
  • Performance Results: Conforms to Static Four Point Bend Test, Dynamic Four Point Bend Test (for plates), Torsional Properties, Driving Torque, and Pull-out Test (for screws).
• Clinical Evaluation: Not necessary to demonstrate substantial equivalence, as the device is similar in design, pattern, and intended use to predicate devices.

In summary, the provided text does not describe an AI/ML device or its performance evaluation. It details the regulatory clearance process for a traditional medical implant based on substantial equivalence.

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The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.

The Cannulated Compression Device System is used to aid in the alignment and stabilization of bone fractures. The system consists of the following parts:

• A cannulated compression device body with distal threads for bone engagement and distal portals that allow passage of deployable integral anchors to achieve stabilization distally within the bone. The anchors may be retracted for removal of the device if and when it is necessary. The device will be provided in a pre-assembled condition with the deployable anchors and a distal end cap already installed. The device will be available in a variety of lengths.
• A compression nut will be provided separately in various configurations, including both threaded and non-threaded versions. The compression nut has a proximal head and internal threads. The proximal head engages the bone fragment. The internal threads allow engagement to the cannulated compression device body. As the compression nut is tightened onto the device body compression is achieved across the bone fragments. The rate of compression varies based on the proximal head configuration selected.
  ODi-NA will manufacture the implants from implant grade titanium allov (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.

The provided text is a 510(k) summary for the Cannulated Compression Device System. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, it does not contain the information required to fill in the table and answer all the questions about acceptance criteria and a study proving a device meets them, particularly in the context of an AI/ML algorithm.

This document describes a physical medical device (cannulated compression device for bone fracture fixation), not an AI/ML algorithm or software. Therefore, many of the requested fields are not applicable to the content provided (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance).

Here's what can be extracted and what cannot:

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

Note: The document states that the device was "evaluated" and "tested" against these standards and criteria, and that it "meets the specified endotoxin limit." Specific numerical results of these evaluations and tests are not provided in this summary. The "acceptance criteria" here refers to the standards used for mechanical and biological testing of the physical hardware, not the performance of an AI/ML system.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The study described is for a physical medical device, involving mechanical and biological testing according to ASTM standards. There is no "test set" in the context of software/AI data, nor "data provenance." The tests would involve physical samples of the device and biological samples for pyrogen testing.

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)

• Not applicable / Not provided. This information is relevant for AI/ML studies where human experts establish ground truth for image interpretation or diagnosis. For a physical device, ground truth is established by measured physical properties or biochemical assays against established standards.

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

• Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among human experts when establishing ground truth. This is not relevant for the mechanical and biological testing of a physical device.

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 / Not provided. MRMC studies are specific to evaluating AI/ML systems, particularly in medical imaging, to compare human performance with and without AI assistance. This document describes a physical bone fixation device.

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

• Not applicable / Not provided. This pertains to the performance of an AI/ML algorithm without human intervention. The device in question is a physical surgical implant.

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

• For the mechanical tests (torsional strength, driving torque, pullout strength, bend strength), the "ground truth" would be the measured physical properties of the device, compared against the specifications defined by the ASTM standards (F543-17 and F1264-16).
• For the pyrogen testing, the "ground truth" is the measured endotoxin level compared against the specified limit of 20.0 USP Endotoxin Units per device, as per ANSI/AAMI ST72 using the Limulus amebocyte lysate (LAL) test.

8. The sample size for the training set

• Not applicable / Not provided. This is relevant for AI/ML algorithms.

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

• Not applicable / Not provided. This is relevant for AI/ML algorithms.

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ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• fractures in osteopenic bone
• nonunions
• malunions
  Smaller-sized ARMAR™ / ARTISTM plates are used for small bones and small fragments of the hands and feet.
  ARMARTM / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous.

ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSSTM/FIXIONT™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone.
Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically,

• Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
• Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Proximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia.

ARMAR™ / ARTISTM 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomnies of the distal radius and other small bones in adults.

ARMARTM / ARTISTM Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

ARMARTM / ARTISTM Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.

ARMARTM / ARTISTM Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

The Meril Healthcare Trauma System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The Trauma System utilizes medical grade stainless steel and titanium. Trauma System implant are provided clean and non-sterile with instructions for steam sterilization. The instruments are provided non-sterile and are reusable. The implants are provided nonsterile and are single use only.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically bone plates and screws. It does not contain information about an AI/ML device, AI acceptance criteria, or a study proving an AI device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding AI device performance, acceptance criteria, sample sizes, expert ground truth, MRMC studies, or training/test set details from this document. The document describes the substantial equivalence of bone fixation appliances to existing predicate devices based on technological characteristics and mechanical performance data (e.g., static four-point bending, dynamic four-point bending, static torsion, static axial pullout).

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CAPTIVATE™ Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

CAPTIVATE™ VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.

CAPTIVATE™ VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, carpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.

CAPTIVATE™ Compression Screws consist of bone screws designed to compact juxtaposed bone for reconstruction and enhanced arthrodesis. The implants are available in various diameters and lengths to accommodate patient anatomy, with headless, partially or fully threaded, solid or cannulated, and variable length (VL) options. CAPTIVATE™ implants are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537 and F138.

This document is a 510(k) premarket notification summary for CAPTIVATE™ Compression Screws. It describes the device and its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in human clinical performance metrics.

The "Performance Data" section discusses mechanical testing of the device (bending strength, torsional strength, driving torque, pullout testing, cyclic bending, and bacterial endotoxin testing). This type of testing is typically done to ensure the physical integrity and safety of the device itself, rather than to evaluate its performance in a clinical setting against specific clinical acceptance criteria for human outcomes.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially concerning clinical performance, AI performance, MRMC studies, or standalone algorithm performance) cannot be extracted from the provided text. The document focuses on regulatory clearance based on substantial equivalence to existing devices through similar technological characteristics and laboratory-based mechanical performance data.

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The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The iFuse Implant System consists of cannulated triangular, titanium (Ti 6A1 4V ELI, ASTM F136/F3001) implants with a porous surface and an instrument system. The principle of operation is that the triangular implant shape and porous surface are designed to prevent and minimize motion/micromotion of the sacroiliac (SI) joint, and thereby stabilize the SI joint. The mechanism of action is that the interference fit allows fixation, stabilization and fusion. The delivery system uses guide pins for accurate permanent surgical placement. The implants are available in varying lengths and diameters, and are provided sterile (gamma sterilization). Fenestrations allow packing of autograft and/or allograft material.

The provided text is a 510(k) summary for the iFuse Implant System® - iFuse-3D implant. It describes a medical device, its intended use, and its comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, the document does not contain information related to a study proving a device meets acceptance criteria via a performance study involving AI or human readers, nor does it describe specific acceptance criteria and reported device performance in the context of an AI-assisted diagnostic or assistive device. It primarily discusses mechanical, biocompatibility, and sterilization testing for an implantable device to demonstrate substantial equivalence to existing devices.

Therefore, without the requested information in the provided input, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria for an AI or diagnostic device.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions "performance testing" but it refers to mechanical (static and fatigue bending, pull-out), MR safety, LAL (endotoxin), and biocompatibility testing for an implantable bone fastener. It does not provide specific performance metrics or acceptance criteria for a diagnostic/AI device.
2. Sample sized used for the test set and the data provenance: Not applicable or provided for an AI system. The "test set" here refers to physical implants undergoing mechanical and other lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant is typically established through material science standards, engineering specifications, and biological safety assessments, not expert image interpretation.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This study focuses on an implantable device, not a diagnostic or AI-assisted interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this medical device (an implant), ground truth relates to material properties, structural integrity, biocompatibility, and sterility, verified through laboratory testing.
8. The sample size for the training set: Not applicable. This document is not about an AI model with a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes regulatory approval for a physical medical implant (iFuse Implant System® - iFuse-3D implant) and uses laboratory and mechanical testing to demonstrate substantial equivalence. It does not contain any information about an AI-powered diagnostic device, its performance studies, or related acceptance criteria.

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Indications for the SIGN Hip Construct (SHC) include all peritrochanteric, reverse oblique, subtrochanteric fractures and osteotomies in the proximal femur, with proper soft tissue management.

The SHC is an internal fixation device consisting of multiple components; Standard Hip Nail, Fin Hip Nail (Intramedullary Nails), Bone Plates, Interlocking Screws, Compression Screws, Bone Screws, and a set of Surgical Instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138 or F139. All implants are single use and provided nonsterile.

This document is an FDA 510(k) Premarket Notification for the SIGN Hip Construct (SHC). It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets clinical acceptance criteria. Therefore, much of the requested information regarding clinical studies, sample sizes, expert involvement, and ground truth generation is not available in this document.

Here's a breakdown of the available and unavailable information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance that would be found in a clinical study. Instead, it relies on bench testing to demonstrate equivalent mechanical performance to a previously cleared predicate device.

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

• Sample size for test set: Not applicable and not mentioned. This document describes non-clinical bench testing, not a clinical trial with a "test set" of patient data.
• Data provenance: Not applicable. The "data" refers to results from mechanical bench testing, not patient data.

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

Not applicable. Ground truth for clinical cases is not established as this document describes non-clinical bench testing.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication.

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 (intramedullary fixation rod), not an AI diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used

Not applicable. The "ground truth" here is the physical properties and mechanical performance of the device as measured in controlled laboratory settings (bench testing), compared against established standards and predicate device performance.

8. The sample size for the training set

Not applicable. This document does not describe the development of a machine learning model or an algorithm that requires a training set.

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

Not applicable. As above, there is no training set for an algorithm.

Summary of what the document does provide regarding device performance:

The document focuses on demonstrating substantial equivalence for the SIGN Hip Construct (SHC) to its predicate devices, primarily K083582 (SIGN Hip Construct (SHC)), K022632 (SIGN IM Nail), and K021932 (Synthes 6.5mm Cannulated Screw).

The study that proves the device meets the acceptance criteria (of substantial equivalence) is non-clinical performance data (bench testing).

• Type of Study: Cyclic fatigue testing simulating walking gait. These tests were explicitly stated to be duplicates of tests performed for the primary predicate device.
• Purpose: To validate that the device can withstand patient use until fracture consolidation occurs and to ensure safety and effectiveness given the expanded indications (reverse oblique fractures and osteotomies) and additional lengths compared to the predicate SHC.
• Results: "The results did not raise any issues on the safety or effectiveness of the device." The conclusion states that the testing data indicates the proposed device is "safe and effective, and performs as well or better than the predicates," supporting the substantial equivalence claim.
• Grounds for Acceptance: Substantial equivalence is established based on the similar design, performance, functions, intended use, and materials to the predicate devices, substantiated by the non-clinical bench testing results.

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The SIJFuse™ Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroilitis.

The SIJFuse™ Sacroiliac Joint Fusion Device System implants consist of Solid and Fenestrated Screws. Solid and Fenestrated Screws are available in varying diameters and lengths. Solid and Fenestrated Screws are fabricated from medical grade titanium alloy (Ti-6A1-4V Eli). Solid Screws have a solid outer wall, while Fenestrated Screws have fenestrations on the outer wall. Solid and Fenestrated screws have a cannulated core. Fenestrated screws allow packing of allograft or autograft material.

This document is a 510(k) premarket notification for the "SpineFrontier® SIJFuse™ Sacroiliac Joint Fusion Device System". It describes the device, its intended use, and presents data to demonstrate substantial equivalence to predicate devices. However, this is NOT a study describing acceptance criteria and device performance as typically understood for AI/software devices.

The information provided describes a medical device (implants), specifically screws for sacroiliac joint fusion, and is not an AI/Software as a Medical Device (SaMD). Therefore, the requested information categories (AI-specific acceptance criteria, sample sizes for AI training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, AI ground truth, etc.) are not applicable to this document.

Instead, this document focuses on mechanical performance data to demonstrate the physical characteristics and safety of a hardware implant.

Here's the relevant information provided by the document regarding the device's performance and acceptance:

1. Table of Acceptance Criteria (or rather, performance data compared to predicates):

The document states: "The results of this non-clinical testing show that the strength of the SIJFuse™ Sacroiliac Joint Fusion Device System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The following tests were performed:

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

• Sample Size: Not explicitly stated as a numerical count of devices or tests, but "multiple tests" are implied by the nature of the standards. ASTM F2193 and F543 are standards that specify test methodologies, which would include guidelines on the number of samples required for statistically valid results. This document only states that the tests were performed.
• Data Provenance: The tests were non-clinical, meaning they were performed in a laboratory setting. No country of origin for data is specified beyond the company being US-based (Beverly, MA). It is not retrospective or prospective in the clinical sense, as it refers to engineering tests.

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

• Not Applicable. This is a hardware device. The "ground truth" for mechanical testing is established by adherence to ASTM standards and engineering principles, not by expert medical interpretation.

4. Adjudication method for the test set:

• Not Applicable. Mechanical tests are adjudicated by meeting specified physical criteria outlined in the ASTM standards.

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 hardware implant, not an AI or imaging device involving human readers.

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

• Not Applicable. This is a hardware implant, not an algorithm.

7. The type of ground truth used:

• Mechanical Engineering Standards: The "ground truth" for this device's performance is compliance with established ASTM (American Society for Testing and Materials) standards for orthopedic implants (F2193 and F543) and demonstrable equivalence in mechanical properties to legally marketed predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a hardware implant, not an AI model requiring a training set.

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

• Not Applicable.

In summary, the provided document relates to a physical medical implant and its mechanical performance testing for FDA 510(k) clearance, not an AI or software device. The acceptance is based on demonstrating substantial equivalence in mechanical properties to already cleared devices, as proven by adherence to specific ASTM testing standards.

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