(157 days)
Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital eiphysis, fused hip, fracture of the pelveis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteoeomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
HA Coated Reflection Acetabular Shells and HA Coated Reflection InterFit Acetabular Shells are for single use only and are intended for cementless fixation.
The Reflection acctabular shells are hemispherical in shape. Shells are available with and without holes. Multi-hole shells are designed to accommodate metallic cancellous screws. HA Reflection Acetabular Shells and HA Reflection InterFit Shells are used with existing Reflection UHMWPE liners.
This document describes a 510(k) premarket notification for Hydroxyapatite (HA) Coated Reflection® Acetabular Shells and HA Coated Reflection InterFit® Shells. This submission outlines the substantial equivalence to existing devices, primarily focusing on materials and intended use rather than specific performance studies against acceptance criteria.
Therefore, many of the requested sections regarding acceptance criteria, study data, sample sizes, and expert review are not explicitly present in the provided text. The document refers to "Performance characteristics: Data indicate that HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are substantially equivalent to predicate devices," but does not detail the specific performance data or the acceptance criteria used to establish this substantial equivalence.
Here's a breakdown of the information that can be extracted or inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document.
The submission asserts "substantial equivalence" based on similar materials and technological characteristics to legally marketed predicate devices. It states: "Performance characteristics: Data indicate that HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are substantially equivalent to predicate devices."
However, specific quantitative acceptance criteria for performance (e.g., mechanical strength thresholds, adhesion values, wear rates) and the actual reported device performance values against these criteria are not detailed in the provided text. The two ASTM standards (F1472, F67) are identified as "materials' specification only," implying they relate to the composition and properties of the HA coating and/or core material, but not necessarily to the device's functional performance as a whole.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Substantial Equivalence | Device is as safe and effective as predicate devices based on similar technological characteristics and materials. | "Data indicate that HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are substantially equivalent to predicate devices." |
| Material Specifications (ASTM F1472, F67) | Material properties meet specified ASTM standards for the materials used (e.g., composition, mechanical properties of HA coating and/or core material). | Conformity to ASTM F1472 and F67 is declared (implied by listing the standards). |
| Biocompatibility | Device materials are biocompatible. (Implicit for implantable devices) | No specific data provided, but implied by regulatory clearance and use of established materials. |
| Mechanical Performance (e.g., strength, durability, fixation) | Device meets mechanical performance appropriate for an acetabular shell in total hip replacement. (Implicit for implantable devices) | No specific data provided, but implied by substantial equivalence claim. |
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly provided in the document.
The text mentions "Data indicate" but does not specify any clinical or non-clinical test sets used, their sample sizes, or their provenance (e.g., country of origin, retrospective/prospective). As this is a 510(k) for substantial equivalence, it's possible the data relied heavily on existing literature for the predicate devices and general material properties, rather than a specific new clinical study with a defined test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided in the document.
Since no specific test set or clinical study requiring ground truth establishment by experts is detailed, this information is not present. The regulatory review process involves FDA experts, but this is distinct from experts establishing ground truth for a device's performance study.
4. Adjudication Method for the Test Set
Not applicable/Not provided in the document.
Without a described test set or study involving human readers/assessors, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable.
This device (a hip implant component) is not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human performance with and without AI assistance is irrelevant and not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable.
As this is a physical medical device (hip implant), not a software algorithm, standalone performance (in the context of AI) is not relevant.
7. The Type of Ground Truth Used
Implicit: Substantial Equivalence to Predicate Devices
For this 510(k), the "ground truth" for demonstrating the device's safety and effectiveness is largely based on its substantial equivalence to legally marketed predicate devices, whose safety and effectiveness are already established. This means that if the materials, technological characteristics, and intended use are sufficiently similar to approved predicates, specific new clinical "ground truth" data for every performance aspect might not be required. The "data indicate" statement likely refers to engineering analyses, material testing (as per ASTM standards), and potentially preclinical animal or bench testing that supports the equivalence claim.
8. The Sample Size for the Training Set
Not applicable/Not provided in the document.
As this is a physical medical device and not an AI/machine learning system, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in the document.
As this is a physical medical device and not an AI/machine learning system, the concept of a "training set" and its ground truth establishment is not applicable.
§ 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.