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510(k) Data Aggregation
(28 days)
LINEAR HIP STEM, SIZE 5
The indications for use of the total hip replacement prosthesis include: noninflammatory 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. This stem is to be press-fit.
The Linear Porous Coated Hip Stem is fabricated from wrought/forged Ti-6Al-4V. It is collarless and has a Morse type taper to receive modular heads. This stem is available with a standard offset and a lateralized offset version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°. This change will add an alternate porous coating.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Linear Porous Coated Hip Stem:
No clinical studies were provided or conducted to prove the device meets acceptance criteria. The document explicitly states under "Clinical Testing: None provided." This submission relies solely on non-clinical testing and comparison to predicate devices for substantial equivalence.
Therefore, many of the requested sections (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets, and how ground truth was established) are not applicable as they pertain to clinical or human-reader studies.
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)
The approval for this device is based on demonstrating substantial equivalence to predicate devices and showing mechanical functionality through non-clinical testing. The "acceptance criteria" in this context are not defined as specific performance metrics on patient outcomes, but rather as successful completion of required engineering tests to ensure device integrity and safety.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance & Evidence |
|---|---|
| Mechanical Integrity (Fatigue) | "Fatigue testing of the size 5 stem demonstrated the device's ability to perform under expected conditions." (Non-clinical testing, specific results not detailed but implied to meet internal thresholds for "performing under expected conditions"). |
| Porous Coating Performance | "Prior testing of the alternate porous coating in K081679 included shear strength, tensile strength, shear fatigue strength, and rotating beam fatigue." (Non-clinical testing, performance of the coating on a predicate device, implies this coating meets design and safety requirements). This indicates the alternate coating passed these mechanical tests. |
| Equivalence to Predicate Devices | "Features comparable to predicate devices include the same design features, materials, indications sterilization, packaging and intended use." (A qualitative assessment of similarity to K991325 and K081679). |
| Biocompatibility/Material Safety | Implied through the use of Ti-6Al-4V, a generally recognized safe material for implants, and comparison to predicate devices using similar materials. |
| Sterilization Efficacy | Implied through "sterilization" being listed as comparable to predicate devices, meaning the chosen sterilization method is validated and effective. |
Study Details (Where Applicable, Based on Provided Information)
Since no clinical studies were performed, many sections are N/A.
- Sample size used for the test set and the data provenance: N/A (No clinical test set was used). The non-clinical fatigue testing would have involved a sample of manufactured devices (e.g., a certain number of stems of size 5) but the exact sample size is not stated in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No clinical test set requiring expert ground truth).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set requiring adjudication).
- 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: N/A (No MRMC study was done, nor is this an AI device).
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an algorithm or AI device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (No clinical ground truth established). For non-clinical testing, the "ground truth" would be the engineering specifications and performance limits for fatigue, shear strength, etc.
- The sample size for the training set: N/A (No training set was used, as this is not an AI device or a clinical study).
- How the ground truth for the training set was established: N/A (No training set was used).
Summary:
This 510(k) submission for the Linear® Porous Coated Hip Stem, Size 5, relies solely on non-clinical mechanical testing and comparison to predicate devices to demonstrate substantial equivalence. No clinical studies, human reader studies, or AI-related performance evaluations were conducted or are documented in this summary. The "acceptance criteria" are implied by the successful completion of the described non-clinical tests (fatigue, porous coating properties) and the determination of substantial equivalence by the FDA.
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