(117 days)
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainagefree period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Echelon Hip Stems are designed for single use only.
The Echelon Hip Stems are manufactured from cobalt chrome (CoCr) material, either forged or cast and are designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.
The provided text is a 510(k) summary for the Echelon Hip Stems, a medical device for hip replacement. As such, it's focused on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance criteria through a standalone study with acceptance criteria in the way an AI/ML device submission might.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of document because the regulatory pathway is different.
Here's an analysis based on the information provided and what can be inferred about this type of submission:
1. A table of acceptance criteria and the reported device performance:
This document does not present a table with specific, quantifiable "acceptance criteria" and "reported device performance" in the way one would for a new AI/ML algorithm measuring a specific metric (e.g., sensitivity, specificity). The acceptance criterion for a 510(k) submission is typically substantial equivalence to a predicate device.
The document states: "Data indicate that the Echelon Hip Stems are substantially equivalent to legally marketed devices." This is the overarching "performance" claim.
2. Sample sized used for the test set and the data provenance:
Not applicable in the context of this 510(k) submission. This is a traditional medical device (hip implant), not a diagnostic algorithm that processes a "test set" of data. The "data" referred to in this submission would relate to engineering tests (e.g., mechanical strength, wear), materials testing, and comparisons to predicate device specifications. These are not typically presented as a "test set" for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no "ground truth" establishment in the context of evaluating an algorithm. The "ground truth" for a hip stem would be its physical properties, biocompatibility, and clinical outcomes, evaluated through various means (bench testing, clinical experience with similar devices, literature).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No "test set" in the AI/ML sense exists for this traditional medical device.
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 is not an AI-assisted device, and no MRMC study or human reader improvement with AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not explicitly stated in terms of a "ground truth" study in the provided text. For a hip implant, the "ground truth" for its performance and safety would be based on:
- Engineering specifications and testing (e.g., fatigue strength, pull-out strength, material composition)
- Biocompatibility data
- Clinical history and performance of the predicate devices
- Clinical experience and literature supporting similar designs and materials.
8. The sample size for the training set:
Not applicable. There is no "training set" for this traditional medical device.
9. How the ground truth for the training set was established:
Not applicable.
Summary for the Echelon Hip Stems (K983834):
- Acceptance Criteria & Reported Performance: The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to legally marketed predicate devices. The "reported performance" is that "Data indicate that the Echelon Hip Stems are substantially equivalent to legally marketed devices." The specific details of the data (e.g., mechanical test results, material comparisons) are not included in this summary but would have been part of the full 510(k) submission.
- Study Type: This is a 510(k) premarket notification based on substantial equivalence, not a performance study of an AI/ML algorithm. The "study" involves comparing the technological characteristics and performance characteristics (e.g., design, materials, intended use, mechanical properties) of the Echelon Hip Stems to predicate devices.
- Predicate Devices:
- Echelon Revision Hip Stem (Smith & Nephew)
- DePuy AML® Hip Stem (DePuy)
- DePuy Replica™ Hip Stem (DePuy)
This 510(k) summary is typical for a traditional medical device, where the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving a specific performance metric against a benchmark.
§ 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.