(426 days)
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.
| Screw Sizes | 6.5mm OD x 15-45mm Length |
|---|---|
| Material | Ti6Al4V per ASTM 1472 |
| Apical Hole Plug OD | Ø 8.52mm OD |
| Apical Hole Plug Thread | 5/16 X 24 UNF 2A |
| Material | Ti6Al4V |
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
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Mechanical characterization | Equivalent to predicate devices |
| Torsion Resistance | Equivalent to predicate devices |
| Driving Torque | Equivalent to predicate devices |
| Pull Out Strength | Equivalent to predicate devices |
| Material Equivalence | Equivalent to predicate devices |
| Construction Equivalence | Equivalent to predicate devices |
| Performance Characteristics Equivalence | Equivalent to predicate devices |
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.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.