(266 days)
Indications for use in total hip replacement include: degenerative joint disease including osteoarthritis and avascular necrosis; 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, which is unmanageable using other techniques.
The metal/metal hip system consists of metal femoral heads and an acetabular cup. The acetabular cup is a metal shell with a polyethylene liner that has a machined feature to accept a metal articulating inlay. The polyethylene components are manufactured from materials conforming to ISO 5834-2 and the metal components are manufactured from materials conforming to ASTM F799. The design features of these parts are identical to those previously cleared under K003250.The metal shells are available with outside diameters of 48mm to 66mm (in 2mm increments). The shells accept a nolyethylene liner with a metal articulating inlay with inner diameters of 28mm, 32mm, 34mm, and 38mm. The femoral heads are available in diameters of 28mm, 32mm, 34mm, and 38mm. The size changes referenced in this 510(k) are the additional 32mm, 34mm, and 38mm components.
The provided text is a 510(k) premarket notification for a medical device: Encore Medical, L.P.'s Metal/Metal Hip System. This submission focuses on establishing substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance in the way a clinical trial for a novel device would.
Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, and training set details will not be explicitly found in this type of regulatory document. This document primarily details the device's description, intended use, and comparison to existing products.
Here's an analysis based on the provided text, highlighting what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical study. The "acceptance criteria" in this context are for regulatory approval, primarily demonstrating substantial equivalence to a legally marketed predicate device (K003250). This means the device must share the same materials, design features, and indications for use as the predicate.
- Reported Device Performance: No clinical performance metrics are reported in this summary. The focus is on the physical characteristics and intended use.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Device materials conform to ISO 5834-2 (polyethylene) and ASTM F799 (metal). | Polyethylene components manufactured from materials conforming to ISO 5834-2. Metal components manufactured from materials conforming to ASTM F799. |
| Design features are identical to predicate device K003250. | Design features are identical to those previously cleared under K003250. |
| Indications for Use are consistent with predicate. | Indications for Use provided are for total hip replacement for specified conditions (degenerative joint disease, rheumatoid arthritis, etc.). (These are comparable to the predicate). |
| Device dimensions (e.g., diameters) are within specified range. | Metal shells: 48mm to 66mm (2mm increments). Polyethylene liner with metal inlay inner diameters: 28mm, 32mm, 34mm, 38mm. Femoral heads: 28mm, 32mm, 34mm, 38mm. (Note: The 32mm, 34mm, and 38mm components are the additional sizes in this 510(k)). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not provided. This is a 510(k) summary, not a clinical study report. There is no mention of a "test set" in the context of clinical performance data.
- Data Provenance: Not applicable/Not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts/Qualifications: Not applicable/Not provided. There is no mention of a "test set" requiring ground truth established by experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, this type of study is not mentioned or described in the document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable/Not provided in the context of clinical performance data. The "ground truth" for this submission would be adherence to material specifications, design similarity to the predicate, and established indications for use.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. This is not a machine learning or algorithm-based device.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable/Not provided.
In summary: The provided document is a 510(k) premarket notification for a Class III medical device (Metal/Metal Hip System). Its purpose is to demonstrate substantial equivalence to a predicate device already on the market (K003250). This process does not typically involve extensive clinical performance studies with acceptance criteria, test/training sets, or expert ground truth as would be required for novel devices or AI/software as a medical device (SaMD) clearances. The "proof" is in meeting the design, material, and intended use specifications that are identical or highly similar to the predicate device.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.