(90 days)
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The PRO-FEMUR Hip with plasma spray coating is a modular prosthesis comprising of four principal parts:
- Distal Stem
- Proximal Body
- Extension Adapter
- Modular Neck
The PRO-FEMUR distal stem with plasma spray coating will be available in three different lengths, namely SHORT, MEDIUM, and LONG, in increments of Irum from 10mm to 22mm in diameter. The SHORT distal stem (135mm) is straight, and the MEDIUM (175mm) and LONG (215mm) are both anatomically curved. All distal stems are cylindrical with plasma spray coating and a bullet shaped distal tip.
The PRO-FEMUR Proximal Body with plasma spray coating will be available in seven different sizes: Extra Small, Small, 4x Standard, and Large. The four standard components have the same length but became progressively wider.
The distal stem is secured to the proximal body by a morse taper and secondly by a fixation screw.
To further lengthen the implant by either 26 or 52 mm, extension adapters are available. They are positioned between the selected proximal body and distal stem and secured by morse taper and a longer fixation screw.
The proximal body has a specific oblong housing for the insertion of the twelve modular necks.
The design features of PRO-FEMUR Hip System with plasma spray coating are substantially equivalent to the design features of competitive devices previously cleared for market.
The provided document, a 510(k) summary for the PRO-FEMUR Hip System, does not describe the acceptance criteria, or a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic device.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the primary mechanism for clearance under a 510(k) premarket notification. The "study" in this context is the submission itself, which primarily relies on comparative analysis and materials testing rather than clinical performance data against predefined acceptance criteria for accuracy, sensitivity, or specificity.
Here's why the structured information cannot be fully provided based on the input:
- No "acceptance criteria" for performance metrics: The 510(k) pathway does not typically require the device manufacturer to establish and meet specific performance acceptance criteria (like sensitivity, specificity, accuracy percentages) from a clinical study for Class II devices. Instead, the focus is on showing the device is as safe and effective as a predicate device.
- No "study" in the traditional sense: There isn't a prospective or retrospective clinical study of the PRO-FEMUR Hip System described with patient outcomes, expert ground truth, or statistical analysis of performance against a benchmark. The "study" is the submission of materials data and a comparison to predicate devices, which are deemed safe and effective.
- No AI component: The PRO-FEMUR Hip System is a physical orthopedic implant, not an AI/ML-driven device. Therefore, questions about human-in-the-loop performance, standalone algorithm performance, or training set details are not applicable.
However, I can extract information related to the demonstration of safety and effectiveness as presented in the document, framed within the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Requirement (Implied for 510(k)) | Device Performance/Demonstration (PRO-FEMUR Hip System) |
|---|---|
| Intended Use Equivalence | Indicated for total hip arthroplasty for similar conditions (non-inflammatory/inflammatory degenerative joint disease, deformity correction, revision, proximal femur fractures) as predicate devices. |
| Material Equivalence | Utilizes materials comparable to predicate devices (metal/polymer, metal/ceramic/polymer, plasma spray coating). Specific material data mentioned as provided. |
| Type of Interface Equivalence | Designed for uncemented total hip arthroplasty, similar to predicate devices. Features modular components (distal stem, proximal body, extension adapter, modular neck). |
| Design Features Equivalence | Design features (e.g., modularity, tapering, sizing, plasma spray coating) are "substantially equivalent to the design features of competitive devices previously cleared for market." |
| Safety and Effectiveness | "Adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." (Implies the testing and comparison demonstrate equivalent safety/effectiveness). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a 510(k) submission for an orthopedic implant. There is no "test set" of patient data in the sense of a diagnostic algorithm or image analysis. The "testing results" refer to material and mechanical tests (e.g., fatigue, wear) on the device components, not clinical performance on a patient cohort. The document does not specify the number of units tested.
- Data Provenance: Not applicable in the context of clinical patient data. The "data" primarily refers to engineering and material testing data, and comparative design analyses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth in the clinical diagnostic sense is established by external experts for this type of submission. The safety and effectiveness are established by the manufacturer through comparison to predicate devices and mechanical testing, and then reviewed by FDA scientific/regulatory experts.
4. Adjudication method for the test set
- Not Applicable. No clinical test set or adjudication process for interpreting patient outcomes is described in this 510(k) summary.
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. The PRO-FEMUR Hip System is a physical orthopedic implant, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The PRO-FEMUR Hip System is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used
- Not Applicable in the clinical diagnostic sense (e.g., expert consensus, pathology, outcomes data). The "ground truth" for this device's clearance is its demonstrated substantial equivalence to legally marketed predicate devices, supported by engineering design specifications, material properties, and mechanical testing data that confirm its performance characteristics (e.g., strength, durability, wear resistance) are comparable to those predicates.
8. The sample size for the training set
- Not Applicable. The device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. The device is not an AI/ML system.
In summary, the provided document is a 510(k) summary for a physical medical device. The "acceptance criteria" are regulatory requirements for demonstrating substantial equivalence to a predicate device, primarily through comparative analysis of intended use, technology, materials, and design features, along with non-clinical testing (e.g., mechanical testing). It does not involve performance metrics like sensitivity/specificity derived from a clinical study with patient data and expert-established ground truth.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.