(77 days)
AcuMatch Integrated Hip System - M-Series Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis, and/or post-traumatic degenerative problems. M-Series components are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.
AcuMatch M-Series components are intended to be used in press-fit and cemented applications.
The Exactech Modular Stem is a four-piece system consisting of a proximal neck segment, metaphyseal segment, diaphyseal segment and a locking screw. All of the components are interchangeable, therefore allowing for many sizing combinations to meet varying anatomical situations. The components are composed of titanium alloy.
The neck segment is available in four heights and has a male taper for attachment to the metaphyseal segment. The anteversion/retroversion adjustment of the neck is completely independent of the rest of the construction.
There are 24 sizes of plasma-coated metaphyseal segments. The bone is prepared to receive the implant using a series of milling instruments specifically designed to match the system. The proximal cross-section of this segment is trapezoidal in order to contribute torsional stability to the device. The metaphyseal segments are available in small, medium and large flare designs. A calcar version is also available.
The distal stems have parabolic distal tips, biting flutes and coronal slots. The end of the stem is polished. The stems are available in various diameters in both straight and curved designs. Each stem is interchangeable with any metaphyseal segment.
The provided document (K993736) is a 510(k) Pre-Market Notification for a medical device: an Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing a new, comprehensive study proving safety and effectiveness from scratch.
Therefore, the document does not contain information about specific acceptance criteria for device performance in an AI/Software as a Medical Device (SaMD) context, nor does it describe a study in the format of an AI model's performance evaluation as requested. The "acceptance criteria" discussed in this document relate to the FDA's regulatory process for demonstrating substantial equivalence for a medical implant, primarily through design comparisons, material comparisons, and general performance testing (e.g., endurance, rotational stability) against established standards and predicate devices.
Here's an attempt to answer your questions based on the available information, noting where the requested details are not present for this type of submission:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a hip implant, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and adherence to relevant standards. The "reported device performance" is largely based on material properties, design features, and specific mechanical tests.
| Acceptance Criteria (Implied from Substantial Equivalence and Standards) | Reported Device Performance |
|---|---|
| Primary Goal: Substantial Equivalence to Legally Marketed Predicates | The M-Series is stated to be "equivalent in materials and design" to the "S-ROM" by Joint Medical Products Corporation and "similar" to Biomet's "Impact", Biomet's "Mallory-Head", and the "Link MP" by Link America. |
| Material Compatibility/Equivalence | All components are composed of titanium alloy, similar to predicate stems. Predicate stems also use Titanium Alloy. |
| Design Features (for function and stability) | Similar to predicate devices in:Use of tapered junctions for intra-operative flexibility.Accommodation of proximal/distal mismatch.Use of a screw (like Mallory-Head and Impact) for positive lock between stem components. (Link uses a toothed sleeve)Distal flutes for rotational stability.Coronal slot to reduce distal stem stiffness (like S-ROM, Mallory Head, Impact). |
| Mechanical Endurance (e.g., fatigue life) | In-house endurance testing (ISO 7206-4) along with fatigue analysis by a contract testing facility shows the M-Series to be "comparable to current clinically successful implants." |
| Rotational Stability | Rotational stability testing revealed that the M-Series was "able to consistently withstand the torsional loads expected in vivo." |
| Proximal Fixation Mechanism | Uses plasma-coated metaphyseal segments (24 sizes). Similar to Mallory-Head and Impact using proximal plasma coating, and S-ROM using sintered titanium beads. |
Since this is not an AI/SaMD study, the following questions are largely not applicable or the information is not present within this 510(k) summary. I will state if the information is unavailable or not relevant to this type of device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Information Not Provided for this Device Type: This document does not describe a clinical study with a test set of patient data, as would be relevant for an AI/SaMD product. The "testing" mentioned is mechanical testing of the physical implant components (e.g., "In-house endurance testing," "rotational stability testing").
- For Mechanical Tests: The sample sizes for these mechanical tests are not specified in this summary. Data provenance would be from the Exactech facility and/or a contract testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: There is no "ground truth for a test set" in the context of an AI/SaMD evaluation described here. The "experts" involved would be the engineers performing the mechanical testing and potentially hip surgeons providing input on design, but this is not framed as an "expert consensus" for ground truth in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No adjudication method for a test set is described, as there is no diagnostic or classification performance being evaluated in this submission.
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 a physical hip implant, not an AI-assisted diagnostic or decision support tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical hip implant. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Mechanical Testing: For the mechanical tests (endurance, rotational stability), the "ground truth" would be established by engineering standards (e.g., ISO 7206-4 for endurance) and the physical properties and performance characteristics of the predicate devices. There is no pathology or outcomes data discussed for the performance evaluation in this 510(k) summary, though clinical outcomes are the ultimate measure of success for such implants.
8. The sample size for the training set
- Not Applicable: There is no AI model or "training set" for this physical device.
9. How the ground truth for the training set was established
- Not Applicable: As there is no AI model, there is no training set or ground truth for it.
§ 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.