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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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· 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 Restoration Anatomic Shell are identical to the primary predicate device cleared in K142462. The purpose of this submission is to add compatibility of Trident Polyethylene Liners and clarify the indications for use for specific compatible liners.

This document is a 510(k) premarket notification for a medical device and therefore describes a device that is substantially equivalent to a predicate device. Information regarding acceptance criteria and detailed study results as requested in the prompt are generally not included in 510(k) summaries to the same extent as they would be for a PMA application or a clinical trial publication.

Based on the provided text, the device is the Restoration Anatomic Shell, which is a hip joint prosthesis component. The submission is for adding compatibility with Trident Polyethylene Liners and clarifying indications for use.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of numerical thresholds or performance targets for a device that uses AI/algorithm. Instead, it refers to non-clinical testing performed to establish substantial equivalence to predicate devices. This type of regulatory submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The non-clinical tests performed are:

Important Note: This document does not describe the acceptance criteria or performance of an AI/algorithm-based device. It pertains to a physical medical device (a hip prosthesis component).

Regarding AI/Algorithm-specific questions (which are not applicable to this document):

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device, not an AI algorithm.
• 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): Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Additional Information from the Document:

• Study Type: Non-clinical laboratory testing.
• Clinical Testing: The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.
• Basis for Equivalence: The submission claims substantial equivalence to predicate devices (Restoration Anatomic Shell K142462 and Trident Porous Titanium Acetabular Shell K010170) in terms of intended use, indications, design, materials, performance characteristics, and operational principles.
• Device Description: The device is a sterile, single-use, cementless acetabular shell made from Ti-6Al-4V ELI alloy with a porous CP-Ti coating. Its design features and screw hole locations are identical to its primary predicate. The submission focuses on adding compatibility with different liners.

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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.

The Restoration® Anatomic Shell is indicated for cementless use only.

The Restoration Anatomic Shell is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The basic design of the Restoration Anatomic Shell is similar to two other commercially available total hip systems, which are Stryker Orthopaedics' Trident Porous Titanium Acetabular Shell, and DePuy's S-ROM Oblong Cup. The Restoration Anatomic Shell will be available in 14 sizes, 54mm - 80mm diameter in 2mm increments. There will be a left and right shell configuration for each size. The subject device is designed to accept the existing Modular Dual Mobility (MDM) liners. The locking mechanism is identical to the locking mechanism of the predicate Trident Porous Titanium Acetabular Shell. The implant will be made of Ti-6Al-4V ELI alloy (ASTM F136) and will have a porous Commercially Pure (CP)-Ti (ASTM F1580) coating allowing for biological fixation. The inner locking mechanism is positioned eccentrically relative to the outer surface of the shell, thus creating a build-up of solid material intended to be positioned in the superior region of the acetabulum. The area outside the locking mechanism will have a recessed or beveled surface to reduce the amount of implant that is exposed outside of the native acetabulum. The shell will have multiple screw hole options located in the superior and inferior regions of the shell as well as peripheral screw holes located outside the locking mechanism. The Restoration Anatomic Shell is compatible with the optional currently marketed Stryker Orthopaedics Acetabular Dome Hole Plug made from CP Titanium (ASTM F-67).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Restoration Anatomic Shell" hip replacement device:

It is important to note that this document is a 510(k) Premarket Notification for a medical device. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to independently prove the device's efficacy and safety through extensive clinical trials. Therefore, the information provided will reflect this type of regulatory submission, which often relies heavily on non-clinical (bench) testing and comparison to established predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format, as one might expect for a software or diagnostic device. Instead, the "acceptance criteria" are implied by the performance characteristics demonstrated through the non-clinical tests, and by the claim of substantial equivalence to predicate devices. The "reported device performance" is largely framed within the context of these non-clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

Since the study relies on non-clinical (bench) testing, the concept of a "test set" in the sense of patient data is not applicable. For non-clinical tests, the "sample size" would refer to the number of physical device units or components tested for each specific test (e.g., how many shells were subjected to push-out, or how many fatigue samples were run). This specific number is not provided in the summary.

Data Provenance: The data is generated from laboratory testing performed by the manufacturer, Stryker Orthopaedics. It is inherently prospective in the sense that the tests were conducted specifically for this submission, using newly manufactured devices or components. The concept of "country of origin of the data" typically relates to clinical studies; for bench testing, it refers to the location of the testing facility, which would likely be in the US given the submitting company's location (Mahwah, NJ) and the FDA submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to this 510(k) submission, as no clinical test set relying on expert ground truth was performed. The evaluation is based on engineering and materials science principles and direct comparison to predicate devices, not on human interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a mechanical implant device like a hip shell. The submission explicitly states: "Clinical testing was not required as a basis for substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

This question is not applicable. The "Restoration Anatomic Shell" is a physical medical device, not a software algorithm or AI. Therefore, there is no "standalone algorithm" performance to evaluate.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the non-clinical tests is established by:

• Engineering specifications and standards: Adherence to ASTM (American Society for Testing and Materials) standards for materials (e.g., F136, F1580, F-67).
• Established mechanical testing protocols: Performance measurements against defined biomechanical limits or within expected ranges identified through established engineering principles and prior device testing.
• Comparison to predicate devices: The "ground truth" for substantial equivalence is primarily the performance and characteristics of the legally marketed predicate devices (Trident Porous Titanium Acetabular Shell and S-ROM Oblong Cup). The subject device must perform similarly or better in relevant non-clinical tests to be considered substantially equivalent.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this device, as it is a physical implant and not a machine learning model.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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