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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.

Ask a specific question about this device

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:

Ask a specific question about this device