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Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• There is destruction of the joint surfaces, with or without significant bone deformity.
• The cruciate and/or collateral ligaments do not stabilize the knee joint.
• The ligaments are inadequate and/or the musculature is weak. And/or
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:

• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with compatible GMRS components:

• Where segmental resection and/or replacement of femur and/or proximal tibia is required

The subject THK components are a line extension of the previously cleared Triathlon® Hinge Knee System (K223528, K230416). The THK System (K223528, K230416) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of previously cleared MRH or THK Bushings and an MRH or THK Axle (K994207, K002552, K223528, K230416). A bumper locks this assembly. This assembly provides motion through the MRH or THK Axle/Bushings combination in the flexion/extension plane. The articulation between the bearing surfaces on the underside of a tibial bearing component and a tibial insert provides motion in the rotating plane. A hinge tibial insert is assembled to a Triathlon® Hinge Revision Tibial Baseplate that incorporates a longitudinal bore to accept a previously cleared MRH Tibial Sleeve (K994207, K002552) or Triathlon Tibial Sleeve (K223528, K230416). Optional distal femoral and tibial augments are available to fill bone defects.

The subject Triathlon® Hinge Small Proximal Tibial Bearing Component and Triathlon® End Cap are sterile, single use devices intended for cemented use only and are being added to the previously cleared THK system (K223528, K230416) as an extension. They can be used with previously cleared MRH Knee components (K994207, K002552), GMRS (K023087, K222056), and Triathlon® Knee System components (K172634, K172326, K190991, K143393, K141056, K132624, K070095, K061521, K053514, K052917, K051948, K051146, K040267).

This FDA 510(k) clearance letter is for a mechanical medical device (a knee implant system), not an AI/software as a medical device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" using metrics relevant to AI/software (like sensitivity, specificity, MRMC studies, ground truth for training/test sets, etc.) is not applicable here.

The document provided details about the substantial equivalence of the "Triathlon® Hinge Knee System" to previously cleared predicate devices. The "study" proving the device meets acceptance criteria for a mechanical implant typically involves non-clinical (benchtop) testing and engineering analyses to demonstrate performance, material compatibility, and safety, rather than clinical trials or AI performance evaluations with ground truth.

Here's how the provided information relates to the typical evaluation of such a device, addressing the closest analogues to your requested points:

Acceptance Criteria and Device Performance for a Mechanical Implant:

For mechanical implants like the Triathlon® Hinge Knee System, "acceptance criteria" are generally tied to the successful completion of various non-clinical (benchtop) tests and analyses. These tests simulate the physical stresses and conditions the implant will experience in the human body. The "study" proving the device meets these criteria is the execution and successful outcome of these non-clinical tests.

No direct table of "acceptance criteria" vs. "reported device performance" in the AI sense is provided in this 510(k) summary. Instead, the summary lists the types of non-clinical tests performed to demonstrate performance and substantial equivalence to predicate devices. The implied acceptance is that the device passed these tests, meaning its performance in these simulated scenarios was deemed acceptable and comparable to existing, legally marketed devices.

Table of Non-Clinical Tests (Analogous to Performance Metrics):

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Exeter X3 RimFit Cup: The indications for use for total hip arthroplasty include: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic 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 techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or madequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. The Exeter X3 RimFit Cup is intended for cemented use only.

Exeter V40 Femoral Stem: The indications for use for total and hemi hip arthroplasty 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, treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The subject Exeter X3 RimFit Cup sterilized by ethylene oxide (EtO) is referred to throughout this submission as the Exeter X3-EtO RimFit Cup. The subject Exeter X3-EtO RimFit Cup is a modified version of the predicate Exeter X3 RimFit Cup and features an alternate terminal sterilization method with EtO, an additional polyethylene resin consolidation method (conventional method which meets the specifications of ASTM F648), an alternate cement spacer material in Acrylic Resin Colacryl® TS2270 PMMA, minor dimensional changes related to flange diameter and blow hole locations, and newly introduced Magnetic Resonance (MR) Conditional labeling. The geometry and design of the subject Exeter X3-EtO RimFit Cup is similar to the predicate Exeter X3 RimFit Cup. There are minor modifications to the flange diameter and blow hole locations between the subject Exeter X3-EtO RimFit Cup and predicate Exeter X3 RimFit Cup. The alternate terminal sterilization method and polyethylene resin consolidation method were previously cleared for Stryker Orthopaedics knee devices in K173849 and Stryker Orthopaedics hip devices in K182468. The alternate cement spacer material was previously cleared in K191414. The MR Conditional labeling was previously cleared in K171768.

The subject Exeter X3 RimFit Cup sterilized via gas plasma (GP) is referred to throughout this submission as the Exeter X3-GP RimFit Cup and has device designs identical to the predicate Exeter X3 RimFit Cup in terms of design and geometry. In comparison to the predicate Exeter X3 RimFit Cup, the only change to the subject Exeter X3-GP RimFit Cup is that the labeling is updated to add MR Conditional information. The MR Conditional language was previously cleared in K171768.

The subject Exeter V40 Femoral Stem is a modified version of the predicate Exeter V40 Femoral Stem in that the stem component is packaged with two polymethyl methacrylate (PMMA) centralizers that are manufactured from an alternate PMMA material (Acrylic Resin Colacryl® TS2270 PMMA). The alternate PMMA material was previously cleared in K191414. The subject device is identical to the predicate device in terms of design and geometry. The labeling for the subject device maintain the MR Conditional designation that was previously cleared in K171768 and K174399 (certain sizes of Exeter V40 Femoral Stem only).

This document, K193429, is a 510(k) premarket notification for hip replacement devices (Exeter V40 Femoral Stem, Exeter X3 RimFit Cup). It does not describe an AI/ML powered device or a study involving human readers or expert ground truth establishment for a diagnostic output. Instead, it focuses on demonstrating substantial equivalence of modified conventional medical devices to legally marketed predicate devices through non-clinical bench testing, material testing, biocompatibility evaluation, sterilization validation, and MRI compatibility analysis.

Therefore, many of the requested criteria related to AI/ML device performance, reader studies, and ground truth establishment are not applicable.

Here's an attempt to address the applicable parts of your request based on the provided document:

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

The document outlines non-clinical testing to demonstrate substantial equivalence, rather than a clinical performance study with acceptance criteria for a diagnostic output. The "acceptance criteria" here are implicitly tied to the successful completion and positive results of the listed non-clinical tests, demonstrating the modified devices meet established standards and are safe and effective.

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

• Test Set Sample Sizes: The document does not specify exact sample sizes for each non-clinical test (e.g., how many material samples were tested, how many centralizers). This level of detail is typically found in the full test reports referenced by these summaries.
• Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Stryker Orthopaedics/Howmedica Osteonics Corp). The document doesn't specify the country of origin for the data, but the company is based in Mahwah, New Jersey, USA. All data would be prospective in the sense that these tests were conducted specifically for this submission.

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

• Not Applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic output. The "truth" in this context is determined by the physical, chemical, and mechanical properties of the device as measured by standardized engineering and material science tests.

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

• Not Applicable. This is not a study involving human readers or subjective interpretations 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 document is for a conventional hip implant and does not involve AI/ML or comparative effectiveness studies with human readers.

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

• Not Applicable. This document is for a conventional hip implant and does not involve an algorithm.

7. The type of ground truth used:

• The "ground truth" for the non-clinical tests is established by objective, quantitative measurements against recognized industry standards (e.g., ASTM, ISO) and FDA guidance documents. Examples include:
  • Material properties (e.g., tensile strength, wear rates)
  • Biocompatibility assessments (e.g., cytotoxicity, sensitization)
  • Sterilization effectiveness (e.g., sterility assurance level)
  • Mechanical performance (e.g., centralizer retention force)
  • MRI compatibility (e.g., induced heating, image artifact).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML product; therefore, there is no training set mentioned or implied.

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

• Not Applicable. As there is no training set for an AI/ML product, this question is not relevant.

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Trident Acetabular Component System:
Painful, disabling joint disease of the hip 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 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.

Restoration ADM Acetabular Cup and MDM Liner Systems:
The indications for use for total hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6. Dislocation risks
   RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only.

Accolade II Hip System:
The indications for use of the total hip replacement prostheses include:

1. noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. 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 ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:
6. 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 intraoperative instability.
   ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

The subject X3 UHMWPE Acetabular Inserts for the Trident, Restoration ADM and MDM Liner systems are a modified version of their respective predicate devices. The subject device designs are identical to their respective predicates, but the subject devices will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648.

The subject Accolade II Hip System is identical to the predicate Accolade II Hip System, with the exception that it has additional compatibility with new instrumentation which utilizes an addendum to the current surgical protocol.

The provided text is a 510(k) summary for joint replacement devices (Trident® X3® UHMWPE Acetabular Inserts, Restoration ADM® and MDM® X3® UHMWPE Acetabular Inserts, Accolade® II Hip System). It describes the devices, their intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study that proves the device meets the acceptance criteria:

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

The document explicitly states: "The subject device designs are identical to their respective predicates... The subject Accolade II Hip System is identical to the predicate Accolade II Hip System..." and "The subject X3 UHMWPE Acetabular Inserts are identical in intended use, indications, design, and operational principles to the predicate devices."

The performance is implicitly compared to the performance of the legally marketed predicate devices. The acceptance criteria for the new devices are that their performance, after modifications (sterilization method and instrumentation compatibility), remains equivalent to the predicate devices. The non-clinical tests serve to confirm this equivalence.

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

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" for a diagnostic algorithm. The document refers to "non-clinical laboratory testing." For these tests (e.g., material testing, mechanical testing), typical sample sizes would be based on statistical power analyses for the specific test, but these details are not provided.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of this submission. The tests are laboratory-based and non-clinical.

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

This information is not applicable. The submission is for orthopedic implants and relies on engineering and biological testing, not expert interpretation of diagnostic images or clinical data to establish a ground truth.

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

This information is not applicable, as there is no diagnostic test set or human interpretation involved to warrant 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:

This is not applicable. The device is a medical implant (hip replacement components), not an AI diagnostic tool or software-as-a-medical device, therefore no MRMC study was performed.

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

This is not applicable as the device is a medical implant, not an algorithm.

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

The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F648, ISO/DIS 14242-1, ISO 11135:2014) and regulatory guidance (e.g., FDA Guidance for UHMWPE, ISO 10993 for biocompatibility). The performance of the modified device is compared against these established standards and the known performance characteristics of the legally marketed predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set:

This is not applicable as the submission is for a medical implant and not an AI/ML algorithm that requires a training set.

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

This is not applicable.

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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 cuff 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.

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 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 to a hemiarthroplasty, 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.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market new devices within the ReUnion TSA System and ReUnion RSA System, including modifications to:

• ReUnion TSA System to add shorter length ReUnion S humeral stems
• · ReUnion TSA System to add EtO sterilized X3 glenoid components
• ReUnion RSA System to add EtO sterilized X3 humeral inserts

A line extension to the existing standard ReUnion TSA humeral stems is being introduced to the existing system. The line extension, also referred to as ReUnion S, will consist of reduced length humeral stems. While the ReUnion S stem is shorter in length compared to the standard stems, both stems share similar instrumentation and surgical workflow.

In addition to the line extension, this submission will introduce Reunion X3 Glenoids and Inserts that are identical in their design to the predicate components, Glenoids and Inserts (K181742). The subject inserts will use a different method of terminal sterilization of ethylene oxide per ISO 11135 and will be formed by consolidating resin via conventional methods which meet the specifications of ASTM F648. The same change was previously cleared in K172634 and K180612.

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.

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 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.

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.

Note: ReUnion TSA Humeral Stems include both standard length ReUnion TSA stems and shorter length ReUnion S stems.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, specifically concerning AI/human reader performance in a medical context.

The document is an FDA 510(k) Premarket Notification for orthopedic devices (shoulder arthroplasty systems) and primarily focuses on demonstrating substantial equivalence to a predicate device. It details:

• Device Name: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
• Regulation Number and Name: 21 CFR 888.3660 (Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis)
• Indications for Use: Detailed descriptions for each system (RSA, TSA, RFX) specifying conditions like degenerative arthritis, rheumatoid arthritis, fractures, and revisions.
• Device Description: Explanations of the components (humeral stems, glenoid components, humeral heads, etc.) and their intended mechanisms.
• Non-Clinical Testing: Lists various material tests (ASTM F648, F2565), biocompatibility testing (ISO 10993-1), sterilization validation (ISO 11135), dynamic and static evaluations, LAL testing, and MRI compatibility testing.
• Clinical Testing: Explicitly states, "Clinical testing was not required for this submission."

Therefore, I cannot extract the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth information relevant to the AI-assisted medical device performance that you are asking for, as this information is not present in the provided FDA submission.

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Triathlon® PKR X3® Tibial Inserts are components of the Triathlon® PKR System that is indicated for:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
• Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
• Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
  These components are intended for implantation with bone cement.

Mako X3® Uni Onlay Tibial Inserts are components of the RESTORIS™ Multicompartmental Knee (MCK) System that is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

• Medial unicondylar
• Lateral unicondylar
• Patellofemoral
• Medial bi-compartmental (medial unicondylar and patellofemoral)
  RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

The subject Triathlon PKR X3® Tibial Inserts and Mako X3® Uni Onlay Tibial Inserts are identical in design to their currently marketed predicates. The subject inserts will use a different method of terminal sterilization of ethylene oxide per ISO 11135 and will be formed by consolidating GUR1020 resin via conventional methods which meet the specifications of ASTM F648. The device sterilization method is identical to that used for the reference Triathlon X3 Tibial Inserts and Patellar Components.

This FDA 510(k) summary (K180612) describes a premarket notification for new versions of tibial inserts for knee replacement systems. Crucially, the document explicitly states that "Clinical Testing was not required as a basis for substantial equivalence." This means that the device's acceptance criteria and proof of meeting them are not based on clinical performance data (e.g., patient outcomes, diagnostic accuracy of an AI). Instead, the substantial equivalence determination relies on comparisons to legally marketed predicate devices through non-clinical testing.

Therefore, many of the questions you asked, which are relevant to clinical studies (especially those involving AI or human readers), cannot be answered from this document.

Here's an analysis based on the provided text, addressing what can be inferred and explaining why other information is not present:

Device Acceptance Criteria and Performance (Based on Non-Clinical Testing)

Since clinical testing was not required, the acceptance criteria are based on mechanical and material properties, sterilization efficacy, and biocompatibility, demonstrating that the new devices are equivalent to established predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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