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The ReUnion RFX System includes a Reversible Fracture Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended use only.

When used with ReUnion TSA Humeral & Glenoid Components

The ReUnion RFX System, when used with ReUnion TSA Humeral and Glenoid components, is indicated for use as a Hemi or Total Shoulder Replacement:

• · Aseptic necrosis of the humeral head.
• · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, or posttraumatic arthritis.
• · Proximal humeral fractures and/or dislocation.
• · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
• · Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural grovides sufficient bone stock, ReUnion RFX humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion RFX humeral stems can be converted from a total or reverse shoulder arthroplasty as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.

The glenoid components are intended for cemented use only.

When used with ReUnion RSA Humeral & Glenoid Components

The ReUnion RFX System, when used with ReUnion RSA humeral & glenoid components, is intended for primary, fracture, or revision total shoulder replacement. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).

· Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;

• Proximal humeral fractures
• · Revisions of previously failed shoulder joint replacements

In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion RFX humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthropathy failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically suited to receive the implant(s).

Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.

The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s).

• · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis.
• Proximal humeral fracture.
• · Revision of previously failed shoulder joint replacement.

Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.

The Humeral Stem components are intended for both cemented and cementless use.

In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty.

In conjunction with ReUnion RSA humeral and glenoid components, ReUnion TSA humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator ouff with sever arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).

For use as a Hemi or Total Shoulder Replacement

· Aseptic necrosis of the humeral head.

· Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or posttraumatic arthritis.

• Proximal humeral fracture and/or dislocation.

· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

· Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

Glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.

In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural grovides sufficient bone stock, ReUnion TSA humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion TSA humeral stems can be converted from a total or ReUnion RSA reverse shoulder arthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components to the ReUnion RSA, TSA and RFX Systems, previously cleared via K161863.

ReUnion Reversible Fracture System (RFX)

The ReUnion Reversible Fracture System consists of a humeral fracture stem component which may be used in conjunction with TSA or RSA humeral and glenoid components for conventional total shoulder arthroplasty or reverse shoulder arthroplasty. It may also be used in conjunction with TSA humeral components to articulate directly with the anatomic glenoid in a hemi-shoulder application. The device contains various number of suture holes. The stems have a female taper on the proximal end of the shaft to accept TSA and RSA Gleno-humeral components. It is designed to be used in cemented applications only.

ReUnion Reverse Shoulder Arthroplasty System (RSA)

The ReUnion RSA Shoulder System is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The system is comprised of a humeral cup, humeral insert, glenosphere, glenoid baseplate and screws. The Humeral Cup with the Humeral Insert are attached to the humeral side of the joint via the ReUnion TSA Humeral Stem while the Glenosphere is implanted with the Glenoid Baseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws.

ReUnion Total Shoulder Arthroplasty System (TSA)

The Reunion Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a modular humeral neck adapter, single radius humeral heads, and self-pressurizing glenoids (SPG). The humeral stem is offered in both cemented and cementless designs. The cementless humeral stem design features a circumferential Ti-plasma spray and hydroxyapatite (HA) coating at the proximal end and the cemented humeral stems have no coating at the proximal end. These humeral stems were designed to mate with the subject single radius humeral heads or the modular neck adapter, for compatibility with other marketed humeral heads. The self-pressuring glenoids (SPG) mate with the single radius heads. The SPGs are offered in both pegged and keeled configurations.

The provided document describes a 510(k) Premarket Notification for various shoulder arthroplasty systems (ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), and ReUnion Total Shoulder Arthroplasty System (TSA)).

It is crucial to understand that a 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device, not necessarily de novo clinical effectiveness or safety based on new clinical studies with defined acceptance criteria for device performance. In this specific document, the sponsor explicitly states that no clinical testing or non-clinical laboratory testing was required for this submission because they are seeking authorization to market additional components to systems already cleared via K161863, and the subject devices are substantially equivalent to the previously cleared devices in terms of intended use, material, design, and operational principles.

Therefore, the document does not contain the information requested regarding acceptance criteria, study design, sample sizes, expert involvement, ground truth establishment, or clinical performance metrics for proving the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic device.

Here's a breakdown of why the requested information cannot be found in this document:

• This is a 510(k) for orthopedic implants (shoulder arthroplasty systems), not an AI/algorithm-based diagnostic device. The questions posed are standard for evaluating AI/ML medical devices, which typically rely on performance metrics like sensitivity, specificity, AUC, etc., on test datasets with established ground truth.
• The basis of this 510(k) is substantial equivalence to a previously cleared similar device (K161863). The document directly states: "This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components to the ReUnion RSA, TSA and RFX Systems, previously cleared via K161863."
• No new clinical data or non-clinical laboratory data was required for this submission. The document explicitly states:
  • "Non-clinical laboratory testing was not required for this submission." (Page 10, K172210 Page 4/5)
  • "Clinical testing was not required for this submission." (Page 10, K172210 Page 5/5)

In summary, there is no study described in this document that proves the device meets acceptance criteria in the manner an AI device would, because this is an orthopedic implant and the submission relies on substantial equivalence to a predicate, not new performance data.

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The Stryker VariAx 2 Wrist Fusion System is indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include:

• Post-traumatic arthritis of the joints of the wrist .
• Rheumatoid wrist deformities requiring restoration ●
• Complex carpal instability ●
• Post-septic arthritis of the wrist ●
• Severe unremitting wrist pain related to motion
• Brachial plexus nerve palsies
• o Tumor resection
• Spastic deformities

VariAx 2 Wrist Fusion System is a fixation device that consists of plates with different design (standard bend, short bend, and straight) manufactured from Commercially Pure Titanium Grade 2 (ASTM F67). The plates will be available sterile and non-sterile. VariAx 2 Wrist Fusion System will be used with locking and non-locking screws (2.3mm, 2.7 and 3.5mm) previously cleared in K040022 (Stryker® Leibinger Universal Distal Radius System), K073527 (VariAx™ Elbow System), K080667 (VariAx™ Distal Radius Torx Screws), and K140769 (VariAx 2 System). VariAx 2 Wrist Fusion System will be used with new and existing instruments previously cleared in K101056 (VariAx Elbow System), K130009 (VariAx 2 Compression Plating System), and K140769 (VariAx 2 System).

This document describes a 510(k) premarket notification for the Stryker VariAx 2 Wrist Fusion System, a metallic bone fixation appliance. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis based on your requested information:

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied by the performance of the predicate device. The goal is to demonstrate that the new device is as safe and effective as the predicate.

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

The document states: "Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence."

• Sample Size: The exact sample size for the mechanical testing is not specified in this document. It refers to "worst case subject plates," implying a representative selection, but the number is not given.
• Data Provenance: The testing was "non-clinical laboratory testing." The country of origin of the data is not specified, but the sponsor is Stryker Trauma AG, located in Switzerland, and the contact person is in Germany. The testing itself would likely have occurred in a laboratory setting associated with the manufacturer or a contracted testing facility. It is prospective in nature, as it's testing performed specifically for this submission.

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 device is a mechanical implant, not an AI/diagnostic device. As such, "ground truth" in the context of expert consensus for diagnostic interpretation is not applicable. The "ground truth" for the non-clinical testing is established by the ASTM F382-14 standard for metallic bone plates, which defines the acceptable mechanical properties. The "experts" in this context would be the engineers and technicians performing and interpreting the mechanical tests according to the standard. Their qualifications are not specified but would be in mechanical engineering or materials science.

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

Adjudication methods like 2+1 or 3+1 are typically for clinical studies involving human interpretation or subjective endpoints. For non-clinical mechanical testing, there is no adjudication method mentioned or typically required in the same sense. The results are quantitative measurements against an established standard (ASTM F382-14). Discrepancies would be handled through repeat testing or calibration, not expert consensus.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This is a hardware implant device, not an AI or diagnostic software.

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

Not applicable. This section is for AI/software devices. The device is a physical bone fixation system.

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

For the non-clinical mechanical testing, the "ground truth" for evaluating the device's performance is:

• Compliance with the ASTM F382-14 'Standard specification and test method for metallic bone plates'. This standard defines the acceptable mechanical properties, such as fatigue strength.

8. The sample size for the training set

Not applicable. This device is a hardware implant and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable. See point 8.

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The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation.

Indications include:

· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures

• · Non-unions and malunions
• · Normal and osteopenic bone
• · Osteotomies

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plates (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate, Proximal Medial Tibia Plate, Distal Medial Tibia and Distal Anterolateral Tibia Plate (K123964 & K141121). This submission adds the Proximal Lateral Humerus Plate to the 4.0mm System of the AxSOS 3 Ti Locking Plate System. The system includes three (3) types of screws available in various diameter and thread length: locking, cortical, and cancellous (K 123964 & K133440). The plates have been designed with holes that can accommodate either a locking or non-locking screw at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile.

The associated accessories include:

• Aiming Block, Proximal Lateral Humerus, Right ●
• . Aiming Block, Proximal Lateral Humerus, Left
• X-Ray Template, Proximal Lateral Humerus ●
• Tag for Proximal Humerus Plate Insert ●
• . Proximal Lateral Humerus Insert

The provided text is a 510(k) Pre-market Notification for the AxSOS 3 Ti Locking Plate System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than describing a study that proves the device meets specific acceptance criteria based on clinical outcomes or AI performance.

Therefore, many of the requested elements are not applicable to the information contained in this FDA submission.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance or a direct comparison of the subject device's performance against such criteria. Instead, it demonstrates substantial equivalence to a predicate device through non-clinical testing.

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

• Test Set (for non-clinical testing): Not explicitly stated, but the testing would involve a sample of the manufactured plates and screws. The number is typically determined by the testing standard (e.g., ASTM F382-99 requirements).
• Data Provenance: The testing was non-clinical laboratory testing. The submission is from Stryker Trauma AG, Switzerland, but the testing itself would likely be conducted in a controlled lab environment, potentially by the manufacturer or a contracted lab. The document does not specify the country of origin of the raw test data. It is prospective testing designed to support regulatory submission.

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 is not applicable. This submission does not involve expert review or establishment of ground truth in the context of diagnostic performance (e.g., for an AI algorithm). The "ground truth" here is the established performance benchmarks of the predicate device and the requirements of recognized standards like ASTM F382-99 and ISO 10993.

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

Not applicable, as this is not a study involving human reader performance or diagnostic accuracy.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for fracture fixation, not an Artificial Intelligence (AI) diagnostic or assistive tool.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" in this context refers to:

• Mechanical Performance: Established mechanical properties and fatigue limits as defined by the ASTM F382-99 standard and the performance characteristics of the legally marketed predicate device (Synthes (USA) LCP Proximal Humerus Plates, Long, K041860).
• Biocompatibility: Criteria outlined in FDA Blue Book Memorandum #G95-1 and the ISO 10993-1 standard.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm requiring a training set.

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The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults 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 motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones
• Limb lengthening by epiphyseal 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

The Stryker 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

Originally cleared in K113327, the Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolt offset adapters, pin bolts and pin adapters, and washers.

Modifications to the previously cleared telescopic strut and wire bolt components, as part of the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327, were cleared in K130334.

Additional components (carbon foot ring, foot arch, hinge coupling) were cleared in K130907 as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the inclusion of additional components to the previously cleared Hoffmann LRF (Limb Reconstruction Frame) System, in K130907. The additional components of this submission will consist of the following: constrained hinge strut, universal hinge strut, motor struts, spherical washer, hinge bolt, self-locking nut, half hinge, universal joint, adjustment instrument, slotted plate and buckle.

This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II, Hoffman II MRI and Hoffmann 3 External Fixation System, and the Apex Fixation Pins.

The provided FDA 510(k) summary for the Hoffmann LRF (Limb Reconstruction Frame) System describes a medical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the information requested about acceptance criteria for AI models, sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance, and data provenance is not applicable in this context.

This submission is for additional components to an existing external fixation device, and the evaluation relies on non-clinical laboratory testing to demonstrate substantial equivalence to predicate devices, rather than clinical performance data or AI model validation.

Here's the relevant information from the document as it pertains to the device's performance demonstration:

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

Note: The document states "Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System added components are substantially equivalent to the predicate device components." The specific quantitative acceptance values (e.g., maximum deflection, fatigue life cycles) from ASTM F1541-02 and the precise performance metrics achieved are not detailed in this summary. The "acceptance criteria" here are implied by the standard itself and the need to show equivalence.

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

• Sample Size: The document does not specify the number of components or test units used for each non-clinical test (Static Cantilever Bending, Dynamic Cantilever Bending, Dynamic Frame Testing).
• Data Provenance: This relates to non-clinical laboratory testing of mechanical properties, not patient data. It was performed by Stryker Trauma AG, headquartered in Switzerland, though the specific lab location is not stated. These are "prospective" engineering tests designed to evaluate the physical properties of the device components.

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. Ground truth, in the context of AI models, refers to expert-labeled data. For a physical medical device, "ground truth" for non-clinical testing is typically defined by engineering specifications, material properties, and established test standards (e.g., ASTM F1541-02). The "experts" would be the engineers and technicians conducting and analyzing the mechanical tests. Their qualifications are not specified but would be standard for mechanical engineering and materials testing.

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

Not applicable. Adjudication methods are used to resolve discrepancies in expert labeling for AI ground truth. For mechanical testing, if there were issues, they would typically involve repeated tests, calibration checks, or review by senior engineers. The document does not mention an adjudication method.

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 an external fixation system, not an AI-assisted diagnostic or prognostic tool. No human readers, cases, or AI assistance are involved in its performance evaluation as described here.

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

Not applicable. This is not an algorithm or AI model. The "standalone" testing refers to the non-clinical mechanical tests where the device components were tested without human intervention impacting the mechanical properties being measured.

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

The "ground truth" for this device's performance in non-clinical testing is based on:

• Engineering Specifications: The design parameters and material specifications of the device components.
• Standardized Test Methods: Adherence to established industry standards like ASTM F1541-02, which provides defined procedures and expected performance envelopes for external skeletal fixation devices.
• Predicate Device Performance: The mechanical performance of the legally marketed predicate devices, against which the new components are shown to be "substantially equivalent."

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set for an AI/ML device.

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The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including:

· Replantation

• · Joint fusions
• · Corrective osteotomies
• · Osteopenic bone

This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for additional compatibility between the previously cleared VariAx 2 System (K140376) and previously cleared VariAx 2 System screws (K132502 and K140769). The previously cleared screws include the T8 Ø2.4mm, T10/T8 Ø2.7mm, and T10 Ø3.5mm screws. The VariAx 2 System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures and corrective procedures in the foot and ankle.

This document is a 510(k) premarket notification for the Stryker VariAx 2 System, a device for internal fixation, reconstruction, and treatment of foot and ankle fractures. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with detailed acceptance criteria and performance data in the typical sense of a diagnostic or AI-driven device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This document describes a modification to an existing device rather than a new device that requires extensive clinical performance studies as an AI/diagnostic device would.

Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for this type of request:

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

Since this is a submission for a bone fixation system and not a diagnostic or AI device, the "acceptance criteria" are related to mechanical and material performance, and "device performance" refers to its ability to meet established safety and effectiveness standards, often through comparison with a predicate device. The document states that the evaluations demonstrated the device "met the performance requirements" and is "as safe and effective as the predicate device." Specific numerical criteria for mechanical performance (e.g., tensile strength, fatigue life) are not provided in this summary.

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

The document mentions "Non-Clinical Testing" which likely refers to bench testing (mechanical testing, materials characterization).

• Sample Size for Test Set: Not specified. This would typically be a number of physical device units tested, not a patient sample size.
• Data Provenance: Not explicitly stated as retrospective or prospective, but given it's non-clinical testing, it would be laboratory-generated data from newly manufactured devices. The country of origin for the sponsor is Switzerland (Stryker Trauma AG, Selzach, Switzerland).

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

This concept is not applicable here. Ground truth, in the context of device performance, typically refers to expert consensus for diagnostic accuracy or pathology for disease presence. For a mechanical device, performance is established through engineering and biomechanical testing, often against recognized standards. There are no "experts" establishing a "ground truth" in the diagnostic sense for this type of device submission.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, primarily in diagnostic imaging or clinical trials. This is a mechanical device submission.

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 not an AI or diagnostic imaging device.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For this type of device, "ground truth" would be defined by engineering specifications and established test standards (e.g., ISO, ASTM standards for bone fixation implants). The device's performance is measured against these objective criteria in a laboratory setting. Pathology or outcomes data are not used as "ground truth" for demonstrating substantial equivalence of a modified mechanical implant in a 510(k).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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The VariAx Elbow Plating System is intended for fracture fixation of long bones.
The distal humerus plates are indicated for:
• intra-articular or extraarticular fractures of the distal humerus
• osteotomies
• nonunions
The olecranon plates are indicated for:
• intra-articular or extraarticular fractures of the proximal ulna
• osteotomies
• nonunions

This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Elbow Plating System, which was previously cleared in the VariAx Elbow Plating System (K073527 & K101056). The VariAx Elbow Plating System consists of washers, screws, and plates. This submission is intended to introduce 2 & 3-hole plates to the Lateral and Posterior Lateral plate range as well as 3-hole plates to the Posterior Medial, Medial Extended and the Olecranon plate ranges. All of the plates except for the Olecranon plates are Distal Humerus plates. The subject plates are fixed to the distal humerus and Olecranon using 2.7mm or 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056, K132502 and K140769. The subject plates are available sterile and non-sterile. The subject and predicate plates are manufactured from Titanium Alloy per ASTM F136 and Commercial Pure Titanium per ASTM F67.

This submission is for a medical device, the VariAx Elbow Plating System, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's a breakdown of the provided information, focusing on the relevant sections for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as this is a non-clinical, mechanical testing study. The document refers to testing "worst case subject plates," implying a representative sample of each new plate type was tested.
• Data Provenance: The testing was "Non-clinical laboratory testing" performed by Stryker Trauma AG. The country of origin of the data is not specified but is presumably where Stryker Trauma AG conducts its R&D and testing. It is prospective testing designed to evaluate the new plates.

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

This is not applicable to a non-clinical mechanical performance study. Ground truth is established by the ASTM F382-99 standard and the mechanical properties of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. This was mechanical testing against a standard and predicate device performance.

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

Not applicable. This is a medical device for fracture fixation, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. There is no algorithm for this device. The "standalone" performance here refers to the mechanical performance of the device itself. The study confirms that the device's mechanical properties (strength, fatigue, etc.) meet the specified standard and are equivalent to predicate devices.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

• ASTM F382-99 (reapproved 2008) "Standard Specification and Test Method for Metallic Bone Plates": This standard defines the acceptable mechanical properties for bone plates.
• Performance of Legally Marketed Predicate Devices: Specifically, the VariAx Elbow Plating System (K101056) and the Synthes 3.5mm LCP Distal Humerus System (K033995) were used as benchmarks for substantial equivalence comparison.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device and does not involve a "training set" in that context. The "training" in this case refers to the engineering design and manufacturing processes that result in the device.

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

Not applicable. There is no "training set" ground truth in the context of an AI/ML device. The design and manufacturing of the device are based on established engineering principles, biomechanical understanding of bone fixation, and compliance with materials standards (e.g., ASTM F136 and ASTM F67 for titanium alloys).

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The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients. The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. Indications include the following: osteotomies and non-unions, fixation of fractures, normal bone density and osteopenic bone.

The VariAx 2 One-Third Tubular Plating System is an internal fixation device that consists of straight plates used with compatible screws to fit different types of fractures in the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. The subject components will be available sterile. The plates will be available in sizes ranging from 23-191mm in length.

The provided text describes a 510(k) submission for a medical device called the "VariAx 2 One-Third Tubular Plating System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and extensive performance studies.

Therefore, the requested information regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test and training sets, expert involvement, and adjudication methods is not applicable in this case.

Here's why and what information is available:

• Acceptance Criteria and Device Performance: Not applicable. For 510(k) submissions, the device's "performance" is assessed relative to predicate devices through non-clinical testing to demonstrate that it performs at least as safely and effectively. There are no pre-defined numerical performance metrics or acceptance criteria in the typical sense of a clinical study for a novel device.
• Study Proving Acceptance Criteria: Not applicable.
• Sample size for test set and data provenance: Not applicable. No clinical test set.
• Number of experts and qualifications: Not applicable. No ground truth established by experts.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable. No training set as there is no AI algorithm.
• How the ground truth for the training set was established: Not applicable.

What was done (Non-Clinical Testing):

The submission states:

• Non-Clinical Testing was performed on the VariAx 2 One-Third Tubular Plating System components to determine substantial equivalence.
• Testing demonstrated that the VariAx 2 One-Third Tubular Plating System is substantially equivalent to the predicate devices currently cleared for marketing.
• The following testing was performed:
  • 4-Point Bending Out of Plane Testing
  • 4-Point Bending Construct Out of Plane Testing

This non-clinical testing would have involved mechanical tests to compare the strength and performance of the new device to the predicate devices under simulated physiological conditions. The "acceptance criteria" here implicitly would be that the new device's performance in these mechanical tests is equivalent to or better than the predicate devices, thereby supporting the claim of substantial equivalence. However, specific numerical thresholds are not provided in this document.

Summary Table (with N/A where information is not applicable to a 510(k) for a physical device):

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The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:
• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions and malunions
• Normal and osteopenic bone
• Osteotomies
• Periprosthetic fractures of the femur and proximal tibia

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates and screws within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plate (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate (K123964) as well as the subject devices being the Distal Anterolateral Tibia Plate, the Distal Medial Tibia Plate and the Proximal Medial Tibia Plate. The system includes four (4) types of screws available in various diameter and thread length: locking, cortical, cancellous (K123964 & K133440) as well as the subject periprosthetic screws. The plates have been designed with holes that can accommodate either a locking or non-locking screw both at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile.

The provided text describes a medical device, the "AxSOS 3 Ti Locking Plate System," and its clearance process through a 510(k) submission to the FDA. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than demonstrating novel performance against defined acceptance criteria through a clinical or standalone study.

Therefore, many of the requested categories regarding acceptance criteria, study details, and expert involvement are not applicable to the information provided.

Here's a breakdown of the relevant and non-applicable information based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. No test set of patient data (e.g., images for an AI device) was used. The "test set" in this context refers to the worst-case subject plates and screws used for non-clinical, mechanical testing. The provenance of these physical samples is not specified, but they would be manufactured by the sponsor (Stryker Trauma AG).

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

• Not Applicable. As no patient data test set was used, no experts were involved in establishing ground truth for such data. Mechanical testing relies on standardized test methods (ASTM) and engineering evaluations rather than expert consensus on medical conditions.

4. Adjudication method for the test set:

• Not Applicable. No patient data test set requiring adjudication was used.

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 bone plate and screw system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and related metrics are irrelevant.

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

• Not Applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" was derived from established mechanical standards and specifications (ASTM F382-99 and ASTM F543-07) and comparison to the performance of predicate devices. There is no biological "ground truth" in the clinical sense for this type of submission.

8. The sample size for the training set:

• Not Applicable. No training set, in the context of machine learning or AI, was used for this type of medical device submission.

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

• Not Applicable. As no training set was used, no ground truth needed to be established for it.

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The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:

• osteotomies, mal-unions, and non-unions .
• single, segmental, and comminuted fractures .
• normal bone density and osteopenic bone .

The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.

This document describes a 510(k) submission for the VariAx 2 Compression Plating System, a medical device for internal fixation of bone fractures.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "Non-clinical laboratory testing" and "The following testing was performed: - Compression Plates Screw Through Compression Hole 0° and 15° Angulation with VariAx Screws." This implies physical testing of device samples rather than a data-driven test set for an algorithm. The number of physical units tested is not provided.
• Data Provenance: Not applicable in the context of an AI/algorithm-based device. This is a traditional medical device submission based on mechanical testing.

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

• Not applicable. Ground truth as typically understood for AI models (e.g., expert annotations) is not relevant for this type of mechanical device submission.

4. Adjudication method for the test set

• Not applicable. This is a traditional medical device submission based on mechanical testing, not a clinical study involving human readers or adjudicators for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone plate and screw system, not an AI or imaging diagnostic device.

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

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

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

• For this mechanical device, the "ground truth" would be established by engineering specifications and mechanical testing standards. The performance of the modified plates (e.g., strength, stiffness, fatigue resistance) is measured against established benchmarks and compared to the predicate device's performance. The document only broadly states "testing demonstrated that the modified plates are substantially equivalent to the previously cleared K130009," without detailing the specific engineering metrics or benchmarks.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an algorithm that requires a training set.

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

• Not applicable. No training set was used.

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