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1. Painful hip arthritis refractory to medical management resulting from post-traumatic arthritis, osteoarthritis, or rheumatoid arthritis.

2. Painful femoral head. cup arthroplasty, or bi-polar or universal type femoral head replacement.

3. Cases where more conventional arthroplasty techniques or arthrodesis are contraindicated because of a difficult clinical management problem, age, sex, occupation, or height of the patient

The Biocore9 Acetabular Cup System components are intended for use in total hip arthroplasty in primary or revision surgery of skeletally mature patients. The Biocore9 Acetabular Cup System shells and liners are single use implants intended for cemented or cementless arthroplasty.

The subject Biocore9 Acetabular Cup System includes acetabular shells, liners, and acetabular bone screws. Components are intended to replace the articular surface of the acetabular socket in the patient's hip joint. It is intended for the reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis or rheumatoid arthritis for patients who would be candidates for total hip procedure, whose acetabular socket has not been excessively damaged by disease or trauma and where damage is primarily associated with the articular surface damage. Acetabular components are available in nine sizes with available outside diameters from 50 mm to 66 mm in 2 mm increments. Bearing components are available in fourteen sizes from 39 mm to 52 mm ID in 1 mm increments. Screw components are available in 6.5 mm diameter in five sizes from 15 mm to 50 mm lengths.

Biocore9 Cancellous Bone screws are manufactured from Ti6A14V alloy (ASTM F136) with low profile screw heads designed to fit the Acetabular shells with nominal diameter of 6.5 mm.

The acetabular shell components are manufactured from Ti-6A1-4V alloy (ASTM F136) with a single radius spherical outer geometry coated with three layers of Commercially Pure (CP)-Ti (ASTM F67) spherical bead porous coating allowing for cemented or cementless fixation and an anatomical shaped rim to limit impingement with the femoral side of the joint or the psoas muscle. A crescent peripheral groove provides for assembly interlock and three rim tabs provide anti rotational interlock with the bearing liner. The acetabular shells are available in two configurations: one with no screw holes and a second with five screw holes for supplemental bone screw fixation. All surfaces are coated with Titanium Nitride (TiN) thin film ceramic coating. Porous structured acetabular shells are intended for cemented fixation.

The acetabular cup bearing liner components are manufactured from UHMWPe (ASTM F648), GUR 1020 Highly cross linked UHMWPe (75KGy MRad /post irradiation annealed) which locks into the acetabular cup shell with ten flexible lip tabs and has three rotation resisting tabs. The liners have inner diameters (ID) intended for use with modular, unipolar, self-centering (bipolar), metallic or ceramic femoral heads within the 39-52 mm OD range and articulate with a femoral head of an appropriate corresponding diameter.

The components of the subject device are compatible with the BioPro PSL Hip System femoral head and stems.

The 510k numbers for the compatible BioPro devices are listed below:

• BioPro PC Femoral Hip Component (K882146), O
• O BioPro Hemi-Endo Modular Head (K895886),
• BioPro Ziralloy Modular Femoral Head (K912641 & K925682), O
• BioPro PSL Total Hip Replacement System (K922500), O
• BioPro Hemi-Endo Modular Ceramic Head (K954768), O
• BioPro BiPolar Head (K100761) O

This document is a 510(k) premarket notification for a medical device called the "Biocore9 Acetabular Cup System." As such, it does not contain the type of detailed study data and acceptance criteria information (such as AI model performance, expert ground truth establishment, or mMRMC studies) that would be found in a submission for an AI-powered device or diagnostic tool.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing of the physical components (e.g., material strength, wear simulation, screw testing). It does not describe an AI/ML component or a study to prove AI model performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device, as those details are not present in the provided text.

The information provided is relevant to the safety and effectiveness of the physical hip implant components, not to the performance of an algorithm or AI model.

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· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid 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.
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 Restoration Anatomic Shell is indicated for cementless use only.

The Restoration Anatomic Shell is a sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The subject device substrate is manufactured from Ti-6Al-4V ELI alloy and has a porous CP-Ti coating. The materials, design features and screw hole locations of the subject Restoration Anatomic Shell are identical to the predicate device cleared via premarket notifications K153345, K151264, and K142462.

The provided text is a 510(k) summary for the Restoration Anatomic Shell, a hip joint prosthesis. It does not describe any acceptance criteria or a study that proves the device meets those criteria from a performance or clinical standpoint.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, with the only changes being to the packaging configuration.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided text.

Here's a breakdown of what the document does say regarding testing, which relates to the packaging change:

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

• Acceptance Criteria: The document mentions that packaging configuration changes necessitated specific testing. The criteria for these tests would be defined within the referenced standards.
• Reported Device Performance: The document states that a "ship test study was completed on the subject device to qualify the proposed packaging configuration." It also mentions "Product bioburden and cytotoxicity testing were executed as the proposed packaging configuration constitutes a change in packaging materials that contact the product after final cleaning."
  • Packaging Performance: "Testing was completed per ISO 11607-1, ASTM F1886, ASTM D4169, ASTM F2825, ASTM F88/F88M, and ASTM F2096, and ASTM F2097." The outcome is implicitly positive, as the device received 510(k) clearance, suggesting the packaging met the requirements of these standards.
  • Bioburden Performance: "Bioburden testing was completed per ISO 11737-1."
  • Cytotoxicity Performance: "Cytotoxicity testing was completed per ISO 10993-5."
  • Results: The conclusion that "The proposed modifications do not affect safety or effectiveness" implies these tests were passed, but specific performance metrics are not detailed in the provided text.

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 provided in the document as it did not involve clinical or performance studies for the device itself, only packaging validation.

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 as there was no test set requiring expert ground truth establishment for clinical performance.

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

• This information is not applicable as there was no test set requiring adjudication for clinical performance.

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 as this is a hip joint prosthesis, not an AI-assisted diagnostic device, and no MRMC study was conducted or required.

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

• This information is not applicable as this is a hip joint prosthesis, not an algorithmic diagnostic device, and no standalone performance study was conducted or required.

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

• This information is not applicable as there was no clinical performance study for the device described. The "ground truth" for the packaging validation would be the physical and biological integrity after testing, as per the specified ISO and ASTM standards.

8. The sample size for the training set

• This information is not applicable as no training set was involved (no AI or analytical model development for device performance was described).

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

• This information is not applicable for the reasons mentioned above.

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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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