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The Progressive Orthopaedic Total Hip System implant components are in cementless reconstruction of the articulating surface of femoral and acetabular portions of the hip that are severely disabled and/or very painful as a result of:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• · Rheumatoid arthritis or traumatic arthritis
• · Correction of functional deformity
• · Non-union femoral neck fracture
• · Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

The present 510k The Progressive Orthopaedic additional screw sizes and apical hole plug are components to be used with the Progressive Orthopaedic Total Hip System, previously cleared via K143314.

This document is a 510(k) premarket notification for a medical device, specifically "The Progressive Orthopaedic Total Hip System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical outcome studies. Therefore, the information you've requested regarding acceptance criteria, study details, and expert opinions for clinical performance is largely not applicable or not present in this document, as clinical testing was not required for this submission.

Here's a breakdown based on the provided text, addressing your points where possible and noting when information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document states under "Non-Clinical Testing": "Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, torsion, driving torque and pull out. In all testing, the subject device shows equivalent properties when compared to predicate products." It further elaborates: "Testing has determined that the device is substantially equivalent to the predicate device in material, construction, and performance characteristics."

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

• Sample Size: Not specified in the document. Mechanical tests typically use a certain number of samples for each test type (e.g., torsion, pull-out), but these numbers are not detailed here.
• Data Provenance: Not specified, but generally, non-clinical bench testing data would be generated in a lab setting by the device manufacturer or a contract research organization. It would be prospective to the submission.

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

• Not Applicable. This document pertains to mechanical and material equivalence, not diagnostic or clinical performance assessed by medical experts. "Ground truth" in this context refers to the measured physical properties and performance characteristics of the device, which are directly measured and compared against established engineering standards or predicate device performance.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical mechanical testing, there is no "adjudication method" in the sense of expert consensus on clinical outcomes or diagnoses. The results are typically quantitative measurements compared to predefined criteria or predicate device 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

• Not Applicable. This document is for a hip implant system, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.

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

• Not Applicable. This document is for a hip implant system, not a standalone algorithm.

7. The Type of Ground Truth Used

• Instrumental Measurements/Benchmarking against Predicates: For the non-clinical testing, the "ground truth" would be the established mechanical properties and performance characteristics of the predicate devices and/or recognized engineering standards for hip implants. The subject device's performance is measured using calibrated instruments and compared directly to these benchmarks.

8. The Sample Size for the Training Set

• Not Applicable. This device did not involve machine learning or AI, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML algorithm.

Summary of Device and Approval Context:

This 510(k) submission is for "The Progressive Orthopaedic Total Hip System," which consists of additional screw sizes and an apical hole plug for a previously cleared system (K143314). The approval is based on demonstrating substantial equivalence to predicate devices (Progressive Orthopaedic Total Hip System (K143314) and NovoSource NovoHip Total Hip System (K140701)).

The evidence for substantial equivalence primarily relies on non-clinical testing which confirmed that the device has equivalent material, construction, and performance characteristics (mechanical characterization, torsion, driving torque, and pull-out strength) when compared to the predicate devices. No clinical testing was required for this 510(k) submission.

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The Progressive Orthopaedic Total Hip System implant components are in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• · Rheumatoid arthritis or traumatic arthritis
• · Correction of functional deformity
• · Non-union femoral neck fracture
• · Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

The present 510k submission is for a non-cemented primary hip prosthesis that consists of a 4part total hip replacement system including femoral Head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.

The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The uni-polar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.

The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offered with different inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.

The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.

The provided document is a 510(k) summary for a medical device called "The Progressive Orthopaedic Total Hip System". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance as would typically be seen for AI/Software as a Medical Device (SaMD).

Therefore, the information requested for AI/SaMD performance studies is largely not applicable to this submission. This document details non-clinical laboratory testing to prove mechanical and material equivalence.

However, I can extract the relevant information from the document as it pertains to the type of acceptance criteria and the testing done to meet regulatory requirements for this specific device.

Acceptance Criteria and Device Performance (Not applicable in the typical AI/SaMD sense as this is a mechanical prosthesis):

The document states that "All devices met the required performance specifications for testing and are considered equivalent to the predicate devices." The acceptance criteria are implicitly tied to the performance of the predicate device and established standards for hip prostheses, but specific numerical thresholds are not detailed in this summary.

Here's a table based on the non-clinical tests performed:

Additional Information (Specific to AI/SaMD, but N/A for this device):

2. Sample size used for the test set and the data provenance: Not applicable. This device is a mechanical prosthesis, not a software device relying on a test set of data. The "samples" would be the physical devices or components tested in the lab.
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 testing is established by physical measurements and engineering standards, not expert consensus on data.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth is based on established engineering standards (e.g., ISO standards for implant testing), material specifications, and performance data from the legally marketed predicate device (NovoSource NovoHip Total Hip System).
8. The sample size for the training set: Not applicable. This device is not developed using machine learning that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The Progressive Orthopaedic Total Hip System underwent a series of non-clinical, in-vitro laboratory tests, including fatigue, strength, stability, and disassembly tests for its various components (stem, femoral head, acetabular shell/liner, bone screws). The acceptance criteria were implicitly defined by relevant engineering standards for orthopedic implants and by demonstrating equivalence to the predicate device, NovoSource NovoHip Total Hip System (K132158). The document states that all devices met the required performance specifications for testing, leading to the conclusion that the device is substantially equivalent to the predicate. No clinical testing was required for this 510(k) submission.

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