(83 days)
LimaCorporate Femoral modular heads are intended to be used in Total Hip arthroplasty with compatible femoral and acetabular components.
- Coupling of femoral modular heads with DELTA Acetabular System is indicated for use 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 and hip dysplasia;
- · Rheumatoid arthritis;
- · Post-traumatic arthritis,
- · Correction of functional deformity;
- · Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
- · Revisions in cases of good remaining bone stock.
- · Revision of previously failed total hip arthroplasty (DELTA Multihole TT Pro only)
The components are intended for use in cementless (press-fit) applications.
- Coupling of femoral modular heads with H-MAX S, Minima S, Master SL, C2, MODULUS femoral stems is indicated 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 and hip dysplasia;
- · rheumatoid arthritis;
- · osteoarthritis after femoral heads fractures (H-MAX S and Modulus stem);
- · treatment of femoral head and neck fractures (Minima S and MasterSL stems)
- · correction of functional deformity (MODULUS stems);
- · revisions in cases of good remaining femoral bone stock.
The components are intended for use in cementless (press-fit) applications.
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Coupling of femoral modular heads with Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. The components are intended for use in cementless (press-fit) applications.
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Coupling of femoral modular heads with Cemented Cup is intended applications in hip arthroplasty where the acetabular socket needs reconstruction.
LimaCorporate Lock Bipolar femoral heads are intended to be used in Partial Hip replacement with compatible femoral components (Minima S, Master SL, C2, MODULUS femoral stems) for cementless applications.
This procedure is intended for redict of pain and/or improved hip function in skeletally mature patients with the following conditions: treatment of non-union, femoral neck fracture and intertrochanteric fractures unmanageable by other techniques.
Biolox® Delta Revision heads consist of a Biolox® Delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the Biolox® Delta ceramic material (K141327, K182099) and come in various outer diameters. The ceramic Biolox® Delta ball head is assembled with the corresponding titanium sleeve and is then placed over the taper of an in-situ hip stem prosthesis, during revision of a previously implanted femoral head:
K170473, K112091, K160011, K140975, K151739, K161226, K141327, K143509, K150855
The titanium sleeve has an inner 12/14 taper which fits the dimensions of a metallic hip stem prosthesis, and the Biolox® Delta ball head has a 16/18 taper which fits to the dimensions of the outer diameter of the titanium sleeve. The ball head then articulates against an acetabular insert:
K112898, K141395, K182099, K181491, K191622, K200656
The titanium sleeves are available in sizes -3, 0, +4, and +7 (S, M, L, XL) and the ball heads of the Biolox® Delta Revision heads are available with outer diameters ranging from 28mm - 40 mm.
Based on the provided text, the device in question is Biolox® Delta Revision heads, which are components of hip joint prostheses. The document is a 510(k) summary from the FDA, indicating a premarket notification for a medical device.
It's important to clarify that this document describes the substantial equivalence of a physical medical device (hip joint components), not a software-based or AI-driven diagnostic device. Therefore, the questions related to AI performance, ground truth establishment for AI, human reader improvement with AI assistance, and specific AI-related acceptance criteria are not applicable to this submission.
The "study that proves the device meets the acceptance criteria" in this context refers to mechanical testing of the physical hip replacement components to demonstrate their performance and substantial equivalence to predicate devices, rather than a clinical study evaluating an AI algorithm's diagnostic accuracy.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not present performance in a typical "acceptance criteria vs. reported performance" table format for a diagnostic device. Instead, it states that "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."
The acceptance criteria are implied by the standards chosen for testing, and the performance is implicitly meeting those standards.
| Acceptance Criteria (Implied by Test Standards) | Reported Device Performance |
|---|---|
| Ability to withstand burst forces (ISO 7206-10) | Fulfilled intended use & substantially equivalent to predicate |
| Resistance to fatigue failure (ISO 7206-10, ISO 7206-4, ISO 7206-6) | Fulfilled intended use & substantially equivalent to predicate |
| Resistance to pull-off forces (ISO 7206-10, ASTM F2009) | Fulfilled intended use & substantially equivalent to predicate |
| Resistance to fretting corrosion (ASTM F1875) | Fulfilled intended use & substantially equivalent to predicate |
| Resistance to torque-off (ISO 7206-13) | Fulfilled intended use & substantially equivalent to predicate |
2. Sample size used for the test set and the data provenance
The document states, "Mechanical testing was performed on worst case components or constructs." It does not specify the exact number of samples tested (e.g., how many heads or constructs were subjected to each test). This is typical for mechanical testing where a representative "worst case" sample or a small batch is tested to ensure compliance with engineering standards.
- Sample Size: Not explicitly stated as a number of units, but "worst case components or constructs."
- Data Provenance: Not specified (e.g., country of origin). The mechanical testing is conducted by the manufacturer, Limacorporate S.p.A., based in Italy. The data is generated from laboratory testing of manufactured components, not patient data.
- Retrospective or Prospective: Not applicable in the context of mechanical testing of physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical hip implant component, not an AI or diagnostic software. Ground truth in this context would be related to material properties and mechanical integrity, established by engineering specifications and physical testing methods, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or clinical diagnoses, which is not relevant for mechanical testing of a medical device component. The "ground truth" for mechanical testing is derived from the physical properties and performance of the device under stress, measured by instruments according to established standards.
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 device is a physical medical implant (hip replacement component), not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question refers to AI algorithm performance. The device is a physical hip implant component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on engineering standards and specifications for mechanical integrity and durability. This is established by:
- Physical measurements and material properties of the components.
- Performance of the components when subjected to standardized mechanical loading (e.g., burst, fatigue, pull-off, fretting, torque-off tests) as defined by ISO and ASTM standards.
- Comparison to the performance of legally marketed predicate devices, which have a history of safe and effective use.
8. The sample size for the training set
Not applicable. This question refers to machine learning. This device does not involve a training set for an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. As above, no AI "training set" is involved. The "ground truth" for the device's design and mechanical properties is based on established biomechanical and material science principles, engineering design standards, and the performance characteristics of previously cleared predicate devices.
§ 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.