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CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordoric interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treated with the CancelleX device.

CancelleX Porous Titanium Lumbar Interbody devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure Titanium (ASTM F67). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.

This document is a 510(k) Premarket Notification from Xenco Medical, LLC. for their CancelleX Porous Titanium Lumbar Interbody Device. It outlines the regulatory submission process and the data provided to demonstrate substantial equivalence to legally marketed predicate devices.

The document does not describe a study involving an AI/Machine Learning device or a study comparing device performance to human readers with or without AI assistance. It focuses on a medical implant (an intervertebral body fusion device) and demonstrates its substantial equivalence through biocompatibility testing and bench testing, as typically required for physical medical devices of this type.

Therefore, I cannot provide the information requested in your prompt because it is designed for studies of AI/ML-driven diagnostic or assistive devices, and this document pertains to a physical medical implant.

The document specifically states:

• "Animal performance data was not required to determine substantial equivalence."
• "Clinical performance data was not required to determine substantial equivalence."

It concludes that "Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent."

Since the information you requested (acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth types, and training set details for AI/ML) is not present in this document, I cannot generate a response that fulfills those specific points based on the provided text.

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The Stryker Orthopaedic Acetabular Shells for use with the Total Hip Instruments are intended for use in total hip arthroplasty and are intended for either primary or revision total hip arthroplasty. The Stryker Orthopaedic Hip Implant Stems for use with the Total Hip Instruments are intended for use in total or hemi-arthroplasty of the hip and are intended for either primary or revision procedures. The Direct Superior Approach does not change the intended use of the subject devices.

Indications for Use (Trident PSL Shell, Tritanium Shell, Trident Hemispherical Shells):

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
  The Trident shells are intended for cementless fixation within the prepared acetabulum.

Indications for Use (Tritanium Acetabular Shell System):

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
  The Tritanium Acetabular Shell System is intended for cementless use only.

Indications for Use (Accolade II Femoral Stem):
The indications for use for total hip arthroplasty with stems include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Accolade II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:
• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Secur-Fit Advanced Hip Stem):
The indications for use for total hip arthroplasty with stems include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Secur-Fit Advanced Hip Stems with compatible Howmedica Osteonics Constrained Liners:
• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Anato Hip Stem):
The indications for use for total hip arthroplasty with stems include:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Anato Hip Stem with compatible Howmedica Osteonics Constrained Liners:
• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  The Anato Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.

The devices covered by this submission include Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments. The Instruments consist of Retractors, Cup Impactors, U-Joint Bolt Driver, Alignment Guide, Angled Reamer Handle, Instrument Trays and a Case. All instruments are hand-held surgical instruments used during orthopaedic surgery and are nonsterile, reusable devices. All Class II devices in this submission have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The acetabular shells and femoral stems are manufactured from the following materials: titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium plasma spray, commercially pure titanium and PureFix® hydroxylapatite (HA).

This document is a 510(k) premarket notification from Stryker Orthopaedics to the FDA for their Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach.

It is important to note that this submission is for a labeling modification to introduce a new surgical approach (Direct Superior Approach) for existing devices, not for a new device requiring extensive performance studies. Therefore, the details requested for acceptance criteria and studies proving device performance (like sample sizes, expert qualifications, etc., which are typically associated with evaluating a new device's diagnostic or predictive performance) are largely not applicable in the context of this specific regulatory submission.

Here's an attempt to address your request based on the provided document, highlighting what is (and isn't) present:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report on device performance based on a study, because the submission is for a labeling modification of already cleared and marketed devices. The core of the submission is to demonstrate that the new surgical approach (Direct Superior Approach) does not fundamentally change the intended use, safety, or effectiveness of the previously cleared devices.

Instead of performance metrics, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the new labeling (for the Direct Superior Approach) does not raise new questions of safety or effectiveness and that the devices, when used with this new approach, are as safe and effective as existing legally marketed predicate devices.

The "performance" in this context is the general safety and efficacy of the existing devices, which was established in their original 510(k) clearances.

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

Not applicable. No specific test set to evaluate device performance for a new device was used. The submission focuses on the surgical approach for existing devices.

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

Not applicable. No new test set requiring expert ground truth establishment for a diagnostic or predictive device was involved. The safety and effectiveness of the devices themselves were established in prior 510(k)s.

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

Not applicable. There was no test set requiring ground truth 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 not an AI/diagnostic device submission.

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

Not applicable. This is not an AI/diagnostic device submission.

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

Not applicable in the sense of a new performance evaluation for a new device. The "ground truth" for this submission is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

Not applicable. No new device or algorithm requiring a training set was involved.

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

Not applicable. No new device or algorithm requiring a training set was involved.

Summary of the Study (as per the document):

The document explicitly states:

• Non-Clinical Testing: "Performance testing was not required in support of this submission because this submission covers a labeling modification to introduce an additional surgical protocol, Direct Superior Approach."
• Clinical Testing: "Clinical testing was not required as a basis for substantial equivalence."

Conclusion of the Study:

The "study" in this case is the review of the modified labeling and comparison to predicate devices, rather than experimental testing of the device itself.

The conclusion is that the Stryker Orthopaedics Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach are substantially equivalent to the predicate devices identified in the premarket notification. This substantial equivalence is based on:

• The intended use and indications for the implants with the Direct Superior Approach being identical to those of the cleared predicate devices.
• The materials, design features, and functionality for the components being substantially equivalent to previously cleared predicate devices.
• The fundamental scientific technology of the modified device (i.e., the surgical instruments for the new approach) not having changed relative to the predicate devices.
• The material and design of the Total Hip Surgery Instruments for use with the Direct Superior approach being identical to those of the predicate devices cleared for use with other approaches (Posterolateral Approach and Direct Anterior Approach), and their operational principles being similar.

In essence, the "study" for this submission was a comparative analysis of design, materials, intended use, indications for use, and operational principles between the proposed devices (with the new approach) and their already cleared predicates, confirming that no new safety or effectiveness concerns were raised by adding the Direct Superior Approach to the labeling.

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The Trident® Tritanium® PST® Acetabular Shell System is in skeletally mature individuals undergoing surgery for total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;

· Acute traumatic fracture of the femoral head or neck;

· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The subject Trident® Tritanium® PST® Acetabular Shell is the predicate PST® Acetabular Shell, which has been modified to incorporate the acetabular bearing mating features of the predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells, to allow compatibility with existing Stryker Orthopaedics acetabular bearings including the Trident polyethylene and Modular Dual Mobility (MDM) bearing families.

The subject Trident® Tritanium® PST® Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface. The subject shells feature a dome hole, and are available either in a solid shell (no screw holes) configuration, or in a cluster screw hole configuration for optional supplemental bone screw fixation. The subject Tritanium® PST® Acetabular Shells are compatible with the optional predicate PST Acetabular Shell system bone screws (titanium alloy), with the optional predicate Stryker Orthopaedics Torx head acetabular dome hole occluder (CP titanium), and with an optional new hex head acetabular dome hole occluder (titanium alloy).

The provided text is a 510(k) Summary for the Trident® Tritanium® PST® Acetabular Shells. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/software device would.

This document describes a medical device (an acetabular shell for hip replacement), not a software or AI product. The "Performance Testing" section refers to comparisons of materials, manufacturing methods, design features, and disassembly testing per ASTM F1820 (including push-out, and torsional testing) to demonstrate substantial equivalence to predicate devices.

Therefore, most of the requested information (related to AI performance, sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of regulatory submission for a physical medical device.

I can only extract the following relevant information:

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

Based on the document, specific acceptance criteria and reported device performance in terms of quantifiable metrics like sensitivity, specificity, accuracy, etc., are not applicable as this is a physical medical device, not an AI/software device with such performance metrics.

The performance testing mentioned is mechanical in nature, focused on demonstrating substantial equivalence to predicate devices.

• Comparison of manufacturing methods: Same manufacturing methods as predicate PST® Acetabular Shells.
• Comparison of design features: Same outer profile and porous structured surface as predicate PST® Acetabular Shells.
• Disassembly Testing: Per ASTM F1820, including push-out and torsional testing (for worst-case style and size of compatible Stryker Orthopaedics acetabular bearings). |
  | Compatibility | - Incorporates acetabular bearing mating features of predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells.
• Compatible with existing Stryker Orthopaedics acetabular bearings, including Trident polyethylene and Modular Dual Mobility (MDM) bearing families. |
  | Sterilization | Same sterilization methods as predicate PST® Acetabular Shells. |
  | Packaging | Similar packaging to predicate PST® Acetabular Shells. |

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

This information is not applicable to this device. The testing described is mechanical performance (e.g., disassembly testing per ASTM F1820) of physical components, not data analysis or clinical studies in the typical sense of AI/software device evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the context of expert review for AI/software, is not relevant for the mechanical testing of a physical implant.

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

This information is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations for ground truth establishment, which is not relevant here.

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

This information is not applicable. MRMC studies are for evaluating human performance with and without AI assistance for tasks like image interpretation, which is not relevant for an orthopedic implant.

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

This information is not applicable. This describes a physical medical device, not an algorithm.

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

This information is not applicable. The "ground truth" for a physical device is its adherence to specified material properties, mechanical strength characteristics, and design specifications as evaluated through engineering tests, not clinical or pathological outcomes in the context of expert consensus as described for AI/software.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/software device.

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

This information is not applicable. There is no "training set."

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The ReUnion RSA Shoulder System 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 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.

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, Glenoid Baseplate, Center Screw, Peripheral Screws and Glenosphere. 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. The ReUnion RSA Shoulder System components are indicated for primary reverse shoulder or revision reverse shoulder replacement procedures having gross rotator cuff deficiency.

The provided document is a 510(k) premarket notification for the ReUnion RSA Shoulder System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria in terms of clinical performance or algorithm accuracy.

Therefore, the requested information, which is typically associated with studies demonstrating the performance of diagnostic algorithms or standalone software, cannot be found in this document.

Specifically, the document states:

• "Clinical Testing: Clinical testing was not required for this submission." (Page 5)

This means there is no study presented in this 510(k) that evaluates the device's clinical performance against specific acceptance criteria in the manner requested. The document primarily focuses on non-clinical testing (e.g., fatigue strength, micromotion) to demonstrate substantial equivalence in design and materials to predicate devices.

As such, I cannot populate the table or answer the specific questions about acceptance criteria, reported performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. This information is simply not part of a 510(k) for a physical implantable device like a shoulder system, especially when clinical testing is explicitly stated as not required.

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