(182 days)
The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty.
The IBS is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis,
- -Avascular necrosis of the femoral head,
- Correction of functional deformity. ー
- -Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques,
- Revision procedures where other treatment or devices have failed. -
AND/OR
The IBS is indicated for cementless use only.
The IntraBlock™ BioBall™ Hip System (IBS) is composed of femoral stems, heads. taper adapter sleeves and acetabulum cups. The System is designed for uncemented use for either primary or revision hip arthroplasty.
The IBS stem is straight, collarless, and flat with a tapered design. The stem is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a proximal titanium plasma spray (TPS) coating. The stems are proportionally sized and shaped in sizes 6.25 mm to 15.00 mm to match the geometry of the femur. A lateralized version of the device is available. Both versions have a neck shaft angle of 135° and a 12/14 morse taper trunion. The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameter 28 mm.
The taper adapter sleeves are made from titanium alloy (Ti-6AI-4V ELI) with a 12/14 morse taper trunion in the four neck lengths S, M, L and XL.
The cementless MultiCup Locking PressFit is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a titanium plasma spray (TPS) coating on the outer surface. It is used with a UHMWPE inlay sized for Ø28 mm heads. 5 holes with threaded plugs give the option for an additional fixation with locking screws. The MultiCup is available in 9 different sizes ranged from 48mm up to 62mm outer diameter.
This document describes the 510(k) summary for the IntraBlock™ BioBall™ Hip System (IBS), a total hip replacement device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state specific acceptance criteria with numerical targets for device performance that would traditionally be found in a clinical study result table (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it describes a series of non-clinical tests conducted to demonstrate the device's mechanical integrity and material properties, aligning with established FDA guidance documents for orthopedic implants.
| Acceptance Criteria Category | Reported Device Performance Summary (from text) |
|---|---|
| Mechanical Testing | - Distal and proximal fatigue testing of the worst case performed, consistent with "Guidance for Industry and FDA staff Non-Clinical Information for Femoral Stem Prostheses." |
- Static compression testing performed, consistent with "Guidance document for the preparation of premarket notifications for ceramic ball hip systems."
- Connections between the stem, the adapter, and the head, as well as the liner locking mechanism, were tested.
- Range of Motion analysis was performed. |
| Coating Characterization | - TPS coating underwent characterization per FDA's "Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopaedic Implants to support reconsideration of Post Market Surveillance Requirements." |
| Modular Connection Analysis | - Fretting and corrosion analysis performed. |
It's important to note that the document states these tests were performed and were consistent with guidance documents, which implies they met the inherent "acceptance criteria" defined within those guidances for demonstrating safety and efficacy for substantial equivalence, rather than detailing the specific numerical outcomes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document refers to "non-clinical testing and analysis" which typically involves physical samples or prototypes of the device, rather than patient data. No specific sample sizes (e.g., number of stems, cups, or heads tested) are explicitly mentioned for each mechanical test.
- Data Provenance: The tests are non-clinical (laboratory-based). There is no patient data, so "country of origin" or "retrospective/prospective" are not applicable in the human data sense. The manufacturer is Merete Medical GmbH, based in Berlin, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a submission for a mechanical implant based on non-clinical testing, not a diagnostic or prognostic device requiring expert-established ground truth from medical images or patient data. The "ground truth" here is the adherence to mechanical and material standards established by recognized guidance documents.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As noted above, this involves non-clinical mechanical testing against predefined standards, not a review of clinical cases by experts.
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 total hip replacement system, an implantable medical device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this submission are the established mechanical and material standards and performance requirements outlined in referenced FDA guidance documents (e.g., "Guidance for Industry and FDA staff Non-Clinical Information for femoral Stem Prostheses", "Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopaedic Implants", "Guidance document for the preparation of premarket notifications for ceramic ball hip systems"). The device's performance in battery of non-clinical tests is compared against these engineering standards.
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this type of device. The design and manufacturing processes are developed based on engineering principles and existing knowledge of materials science and biomechanics, not machine learning training.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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.