Search Results

Indications for the MRS Stems and Intercalary Stems (presented in K952970):

· This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.

· The Intercalary System is intended for use in situations arising from in femoral mid-shaft tumor resection. or for prosthetic knee fusion.

Indications for the Global Modular Replacement System (presented in K023087):

· Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581)

· Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.

Indications for the Modular Replacement System Cemented Stems (cleared in K040749):

· Femoral and/or proximal tibial replacement due to:
- Trauma
- Failed previous prosthesis
- Tumor resection

The Global Modular Replacement System is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System or the Modular Rotating Hinge Knee System. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis. The subject Global Modular Replacement System components are unchanged since the last premarket notification for the devices in K222056.

This document is entirely focused on a 510(k) premarket notification for a medical device called the "Global Modular Replacement System." It is a request for approval to market the device, and the content details its intended use, a comparison to legally marketed predicate devices, and a summary of its technological characteristics.

Crucially, this document does not contain any information about acceptance criteria, device performance testing results, ground truth establishment, sample sizes for training or test sets, expert qualifications, or MRMC studies for an AI/software device. The request is specifically for a physical medical device (hip and knee prostheses) and its purpose is to update labeling, including adding a contraindication and updating MRI safety information.

The sections you've requested (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, MRMC studies) are typically relevant for AI/Software as a Medical Device (SaMD) submissions where software algorithms are being evaluated for diagnostic or prognostic purposes.

Therefore, I cannot fulfill your request as the provided text does not contain the information you are asking for. It explicitly states:

"No additional testing was conducted for this submission, as the only changes being made are to modify the labeling to add a contraindication and an update to the MRI safety information to align with an FDA guidance document. Testing performed in the previously cleared premarket notifications is applicable to this submission." (Page 10)

This confirms that no new performance studies, as would be required for an AI/Software component, were performed or are detailed in this 510(k) submission.

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· 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.

The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E) are unchanged since the last premarket notification for the devices in K180612. The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are unchanged since the last premarket notification for the devices in K172326.

The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E), Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are collectively referred to throughout this submission as the subject devices.

The purpose of this "Change Being Effected" premarket notification is to add a contraindication for the Triathlon® PKR X3® Tibial Inserts, Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate. Additionally, minor clarifications are being made to the labeling.

The provided text is a 510(k) summary for the Triathlon PKR System, which describes a partial knee joint replacement device. This document is a regulatory submission to the FDA and primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Crucially, the document explicitly states: "No additional testing was conducted for this submission, as the only changes being made are the addition of a contraindication and minor labeling clarifications. Testing performed in the previously cleared premarket notifications is applicable to this submission."

Therefore, this specific 510(k) submission (K203099) does not contain independent studies or data proving the device meets new acceptance criteria. Instead, it relies on the acceptance criteria and studies from its predicate devices (referenced as K180612, K172326, K082567, and K071881). Without access to those specific predicate 510(k) summaries, a detailed answer to your request cannot be fully provided based solely on the text you've supplied.

However, I can extract information regarding the device's indications for use and the general statement about relying on prior testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this submission did not involve new testing, there are no new acceptance criteria or reported performance data specific to this submission. The device is considered to meet the same performance criteria as its predicates due to "identical in intended use, indications, design, technological characteristics and operational principles."

Missing Information (Cannot be answered from the provided text as this submission relies on predicate data):

• Sample sizes used for the test set
• Data provenance for the test set
• Number of experts used to establish ground truth for the test set
• Qualifications of those experts
• Adjudication method
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done
• Effect size of human reader improvement with AI vs. without AI assistance
• Whether a standalone (algorithm only) performance study was done
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

Key Takeaway from this Document:

This 510(k) submission (K203099) for the Triathlon PKR System is primarily an administrative update to add a contraindication and clarify labeling. It does not present new performance data or studies. Instead, it asserts substantial equivalence by retaining the intended use, indications, design, technological characteristics, and operational principles of its previously cleared predicate devices, thereby leveraging the testing and acceptance criteria established in those earlier submissions (K180612, K172326, K082567, and K071881). To answer the more detailed questions about acceptance criteria and study designs, one would need to review the 510(k) summaries for the predicate devices.

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The Restoration® Modular Hip System is indicated for use in:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis; o
• 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 indications specific to the Restoration Modular Hip System:

The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

The Restoration® Modular Hip System is a bowed shaped femoral distal stem which is plasmasprayed with commercially pure titanium and coated with PureFix™ hydroxylapatite (HA). The device (6276-5-6XX) is available in stem diameters 11-26 mm and length 317 mm. The design of the device is identical to the bowed plasma distal stem cleared under the predicate device 510(k)s.

A Thermoplastic Polyurethane (TPU) sleeve will be added to the previously cleared packaging configuration and the thickness of the outer carton (cardboard box) will be increased. No changes will be made to the previously cleared sterile barrier materials.

This document is a 510(k) Premarket Notification for the Restoration® Modular Hip System by Stryker Orthopaedics. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a new AI/software-based medical device.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be found in this document for the Restoration® Modular Hip System.

The document explicitly states:

• "Non-clinical testing was not required as a basis for substantial equivalence."
• "Clinical testing was not required as a basis for substantial equivalence."

The "testing" mentioned in the document is related to packaging modifications and pyrogenicity for the physical device, not performance relative to clinical efficacy or diagnostic accuracy.

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Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic 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.
When used with MDM® Liners
Treatment of nonumion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner
The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Acetabular Shells are indicated for cementless use only.

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and dome hole plugs are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident® Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments. The purpose of this Special 510(k) is to add an additional dome hole plug option for use with the Trident® II Acetabular System.

This document is a 510(k) summary for the Stryker Orthopaedics Trident® II Acetabular System. It primarily focuses on demonstrating substantial equivalence to a predicate device for the addition of an acetabular dome hole plug option.

Based on the provided text, the device is a medical implant, not an AI/ML powered device, and therefore the request to describe acceptance criteria and associated studies for an AI/ML device is not applicable.

Here's the breakdown of why the requested information cannot be provided from this document:

• No AI/ML Component: The device described, the Trident® II Acetabular System, is a hip joint prosthesis. The document discusses its components (shells, screws, liners, dome hole plugs), intended use, indications for use, and a comparison to predicate devices, all of which are characteristic of traditional medical devices. There is no mention of artificial intelligence, machine learning, software algorithms for image analysis, or any computational diagnostic or prognostic functionality.
• Focus on Substantial Equivalence for a Physical Component: The primary purpose of this 510(k) filing is to add an "additional dome hole plug option." The entire "Non-Clinical Testing" section explicitly states "No new non-clinical testing was performed." Instead, it references analyses for "equivalence in dimensions and MR evaluation" and prior bacterial endotoxin testing. This is typical for a minor modification to an already cleared physical device, not for a new AI/ML product.

Therefore, the following information points from your request are not present because they relate to the evaluation of an AI-powered medical device:

1. A table of acceptance criteria and the reported device performance: Not applicable.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Stand-alone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this document describes a physical medical device (hip implant components) and its regulatory clearance process, which does not involve the type of AI/ML performance evaluation criteria and studies you are inquiring about.

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General Total Knee Arthroplasty (TKR) Indications:

• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
• Post-traumatic loss of knee joint configuration and function.
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• Revision of previous unsuccessful knee replacement or other procedure.
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture -management techniques.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.

The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

• Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• Absent or non-functioning posterior cruciate ligament.
• Severe anteroposterior instability of the knee joint.

Additional Indications for Total Stabilizer (TS) Components:

• Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Indications for Bone Augments:

• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
• Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.

Additional Indications for Cone Augments:

• Severe degeneration or trauma requiring extensive resection and replacement
• Femoral and Tibial bone voids
• Metaphyseal reconstruction

The Triathlon® Tritanium® Cone Augments are intended for cemented or cementless use.

Triathlon® Tritanium® Central Femoral Cone Augment:
The subject Triathlon® Tritanium® Central Femoral Cone Augment is an extension of the Triathlon® Total Knee System product line and is intended to be used as an optional accessory component in primary or revision Total Knee Arthroplasty. It is a sterile, single-use device that is composed of commercially pure titanium (raw material per ASTM F1580, processed material per ASTM F67).

The subject Triathlon® Tritanium® Central Femoral Cone Augment is designed to be used with the Triathlon® Total Stabilizer (TS) femoral components and is compatible with other Triathlon® Total Knee System components. The Triathlon® Tritanium® Central Femoral Cone Augments are intended to be cemented to the respective Triathlon® femoral components and are intended for fixation within the distal femur with or without bone cement. Triathlon® Tritanium® Central Femoral Cone Augments are intended to be used where there is a femoral metaphyseal defect secondary to trauma, failed previous prosthesis, or severe degeneration.

Triathlon® Femoral Distal Augment:
The subject Triathlon® Femoral Distal Augment is a modified version of the Triathlon® Femoral Distal Augment that is a component of the Triathlon® Total Knee System product line. It is intended to be used as an optional accessory component in primary or revision Total Knee Arthroplasty. It is a sterile, single-use device that is composed of either Cobalt-Chrome-Molybdenum (Co-Cr-Mo per ASTM F75) or Cobalt-Chrome (per ASTM F1537). These are the same materials as the predicate devices identified in this 510(k) premarket notification.

The subject Triathlon® Femoral Distal Augment is designed to be used with the Triathlon® TS or Triathlon® Posterior Stabilizer (PS) femoral components and is compatible with other Triathlon® Total Knee System components. The subject device is intended for attachment to the respective Triathlon® TS or PS femoral components with a locking screw; the augment-femoral component construct is intended to be cemented into the prepared distal femur. The Triathlon® Femoral Distal Augments are intended to be used in cases with severely inadequate medial or lateral femoral bone stock requiring additional fixation of the femoral components.

This is a medical device 510(k) premarket notification for knee joint replacement components, not an AI/ML device. Therefore, the requested information (acceptance criteria for an AI device, associated study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training, etc.) is not applicable to this document.

The document describes non-clinical testing performed for the orthopedic implants, such as:

• Characterization of chemistry, physical, and mechanical properties.
• Impaction test & morphology analysis.
• Micromotion analysis.
• Cantilever fatigue test.
• Torque test analysis.
• MRI analysis (to determine if the device created a new worst-case for image artifact, magnetically induced torque, displacement, or RF induced heating).
• Tolerance analysis.
• Fatigue strength analysis.

The document states that "Clinical testing was not required as a basis for substantial equivalence." This further indicates the absence of a study that would address the acceptance criteria relevant to an AI/ML device's performance.

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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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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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General Total Knee Arthroplasty (TKR) Indications:

• . Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), theumatoid arthritis or post-traumatic arthritis.
• Post-traumatic loss of knee joint configuration and function.
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
• Revision of previous unsuccessful knee replacement or other procedure. ●
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard ● fracture -management techniques.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.

The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

• Ligamentous instability requiring implant bearing surface geometries with increased ● constraint.
• Absent or non-functioning posterior cruciate ligament. ●
• Severe anteroposterior instability of the knee joint. ●

Additional Indications for Total Stabilizer (TS) Components:

• Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Indications for Bone Augments:

• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
• Salvage of previous unsuccessful total knee replacement or other surgical procedure, ● accompanied by bone loss.

Additional Indications for Cone Augments:

• Severe degeneration or trauma requiring extensive resection and replacement ●
• Femoral and Tibial bone voids
• Metaphyseal reconstruction

The Triathlon TS Cone Augments are intended for cemented or cementless use.

The subject Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components are a modified version of the predicate Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components. The device designs are identical to the predicate devices which are available in the posterior stabilized (PS), cruciate retaining (CR), condylar stabilizing (CS) and total stabilizing (TS) designs for the tibial inserts, and the symmetric and asymmetric designs for the patellar components. The subject inserts and patellar components 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. Like the predicate devices, the subject Triathlon® X3® CR, CS, PS and TS+ tibial inserts will contain a Cobalt Chromium locking wire as per ASTM F90, and the Triathlon TS+ tibial insert will also additionally contain a Cobalt Chromium tibial support pin as per ASTM F1537.

The provided text does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, the document is a 510(k) premarket notification for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components, which are orthopedic implants (knee joint replacement components).

The document details the substantial equivalence of this device to previously cleared predicate devices based on material, design, intended use, and non-clinical performance testing. It explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence."

Therefore, I cannot provide the requested information, including:

1. Table of acceptance criteria and reported device performance: This document does not specify performance metrics or acceptance criteria for an AI/ML driven device.
2. Sample size, data provenance: Not applicable as no clinical study for an AI/ML device is discussed.
3. Number of experts, qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study, effect size: Not applicable.
6. Standalone performance: Not applicable.
7. Type of ground truth: Not applicable.
8. Training set sample size: Not applicable.
9. Ground truth for training set: Not applicable.

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The Trident® II Acetabular System is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.

Indications for Use:
• 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.

When used with MDM Liners:
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

• Dislocation risks

When used with Constrained Liners:
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

The Trident II Acetabular Shells are indicated for cementless use only.

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and Hex Dome Hole Plug are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular System is an extension of the Trident System product line and features the same locking mechanism as the current Trident® and Trident® II Tritanium® product lines. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments.

The Trident® II Tritanium® implant consists of a unique configuration of both solid and porous sections that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology. Tritanium® is a novel highly porous titanium material designed for biological fixation. The Trident® II PSL® Clusterhole HA and Trident® II Clusterhole HA Acetabular Shells feature hydroxylapatite coating over a Commercially Pure Titanium plasma sprayed surface for cementless fixation.

This document describes a 510(k) premarket notification for the "Trident® II Acetabular System," a medical device for total hip arthroplasty. The submission asserts substantial equivalence to previously marketed predicate devices, and therefore, clinical testing was not required. The information provided focuses on non-clinical testing.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly present acceptance criteria in a table format with corresponding reported performance for each criterion. Instead, it lists a series of non-clinical tests performed, implying that the device "meets the requirements" or was "characterized according to methods" outlined in various ASTM standards and FDA guidance documents.

Here's a partial reconstruction of what could be inferred as acceptance criteria and "device performance" based on the text:

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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.
When used with MDM Liners:
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner:
The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Tritanium Acetabular Shells are indicated for cementless use only.

The Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screws are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Tritanium® Acetabular Shell is an extension of the Trident System product line and features the same locking mechanism as the current Trident® Tritanium® product line. The Trident® II Tritanium® Acetabular Shell is intended to be used with existing Trident® polyethylene inserts, MDM® liners and existing surgical instruments.
The subject device is manufactured from Ti-6Al-4V ELI alloy. The implant consists of a unique configuration of both solid and porous structures that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology.
There are three designs of Trident® II Tritanium® Acetabular Shells:
Solidback (sizes 42A-66H)
Clusterhole (sizes 42A-66H)
Multihole (sizes 42A-72J)
The new compatible 6.5mm Low Profile Hex Screws feature a hex geometry and are manufactured from wrought Ti-6Al-4V ELI. The new screws range in lengths from 15-80mm.

The provided document is a 510(k) premarket notification for a medical device called "Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document as it pertains to AI/ML device validation, which is not the subject of this 510(k) submission.

However, I can extract the following relevant information based on the typical requirements for a 510(k) submission for a non-AI/ML device:

1. Acceptance Criteria and Reported Device Performance:
   The document states that "performance testing show that the Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screw are substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles." This implies that the acceptance criteria are met if the device's performance is comparable to the predicate devices. The performance is assessed through various non-clinical laboratory tests.

   Acceptance Criteria (Implied: Substantially Equivalent to Predicate)	Reported Device Performance (Summary)
   Mechanical strength and fixation (e.g., push-out, lever-out, torque-out, fatigue, plastic deformation)	Device demonstrated acceptable performance in all listed non-clinical tests (e.g., Push out (ASTM F1820), Lever out (ASTM F1820), Torque out (ASTM F1820), Fatigue, Plastic Deformation) ensuring substantial equivalence to predicate.
   Bone screw performance	Demonstrated acceptable performance based on Bone Screw Testing (ASTM F543).
   Porous surface characteristics	Porous surface meets requirements outlined in FDA guidance documents ("Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement").
   Biocompatibility / Pyrogenicity	Achieved acceptable endotoxin limit as specified in ANSI/AAMI ST72:2011 via Bacterial endotoxin testing (BET).
   Range of Motion	Acceptable Range of Motion Analysis was performed.
   Fretting Evaluation (for MDM liner)	Acceptable Fretting Evaluation of the MDM liner was performed.
   Material Chemistry	Acceptable Material Chemistry evaluations were performed.

2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission. The tests are laboratory-based, often using a small number of physical samples (e.g., implants, screws) for mechanical testing to destruction or specific load cycles.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance is typically established through adherence to standardized test methods (e.g., ASTM standards) and material science principles, interpreted by engineers and material scientists.

4. Adjudication method for the test set: Not applicable. Performance data from laboratory tests do not involve human adjudication in the way clinical or image-based studies do.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is a physical medical implant, not an AI/ML diagnostic or assistive device.

6. If a standalone performance study was done: The non-clinical laboratory testing represents the standalone performance evaluation of the device's physical and mechanical properties.

7. The type of ground truth used: The "ground truth" for this device's performance is defined by established engineering and materials science principles, standard test methodologies (e.g., ASTM standards), and regulatory guidance documents for orthopedic implants. For example, for mechanical strength tests, the ground truth is often a failure point or a resistance level under specific applied loads. For biocompatibility/pyrogenicity, it's the defined acceptable endotoxin limit.

8. The sample size for the training set: Not applicable. This device is not an AI/ML product developed using a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) document is for a traditional medical device (hip implant) and therefore lacks the detailed information typically requested for AI/ML device validation studies. The "study" mentioned here refers to the battery of non-clinical laboratory tests performed to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

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