(67 days)
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.
When viewed in the mediolateral plane the Linear™ Porous Coated Hip Stem tapers slightly proximal to distal beginning at the distal border of the porous coating. Proximal to this point the stem flares approximately 6°. The stem has a rectangular cross-sectional geometry to provide rotational stability. The Linear™ Porous Coated Hip Stem is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136 or F620, respectively. The outside surface of the stern is porous coated with commercially pure titanium (ASTM F67 grade 2) to provide a porous surface for enhanced fixation. The stem is intended to be press-fit. The Linear™ Porous Coated Hip Stem is collarless and has a Morse type taper to receive modular heads. This stem is available with a standard head/stem offset and a lateralized version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°.
The provided text describes a medical device, the Linear™ Porous Coated Hip Stem, and its regulatory approval (K991325). It details the device's characteristics, materials, and intended use. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on:
- Device Description: Physical attributes, materials, and manufacturing standards.
- Intended Use/Indications For Use: Clinical conditions for which the device is designed to be used.
- Comparable Features to Predicate Device(s): How it is similar to previously approved devices.
- Test Results (Limited): It mentions "Finite element analysis of the fatigue stem strength and laboratory testing of the Morse type taper was conducted," but provides no specific results, acceptance criteria for these tests, or detailed methodology.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary data is not present in the provided text.
Here's how I would answer based on the absence of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | Not specified in the provided text |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document mentions "Finite element analysis" and "laboratory testing," but no sample sizes for these tests are provided.
- Data provenance: Not applicable, as there are no detailed test results or clinical data presented to determine provenance (e.g., country of origin, retrospective/prospective). The tests mentioned appear to be mechanical/simulation-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes a hip stem, a physical implant. The "ground truth" concept (e.g., for diagnostic algorithms) does not apply here. The "tests" mentioned are mechanical stress analysis and taper quality, which would have engineering standards as their basis, not expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is mentioned or relevant for the types of tests alluded to (finite element analysis, lab testing of taper).
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:
- No. This is a hip implant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study and AI performance metrics are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hip implant, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic AI. For the mechanical tests mentioned, the "ground truth" would be established engineering standards and physical properties of the materials and design, against which the results of the finite element analysis and laboratory testing would be compared. These standards are not detailed.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.