(244 days)
The indications for use of the Implex Hedrocel® Acetabular Cage are as follows:
• For cemented or cementless use.
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
The Hedrocel® Acetabular Cage System consists of the Hedrocel® Acetabular Cage configured with an Implex All-Poly Cup. The Hedrocel® Acetabular Cage System, cemented and cementless, is available in OD sizes from 52 mm to 70 mm in 2 mm increments. The Hedrocel Acetabular Cage (Shell) is compatible with All-Poly Cups in OD sizes from 40 mm to 58 mm. The All-Poly Cups, cemented, are available with four ID size options (22 mm, 26 mm, 28 mm and 32 mm) and in 0° and 10° face angles. The All-Poly Cup is affixed to the Hedrocel® Acetabular Cage using acrylic bone cement.
The provided document is a 510(k) summary for the Implex Hedrocel® Acetabular Cage System. It is a premarket notification for a medical device aiming to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study demonstrating the device meets specific acceptance criteria through clinical performance metrics like sensitivity or specificity.
Therefore, many of the requested categories related to clinical study design (sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of regulatory submission. The document focuses on demonstrating that the device has comparable technological characteristics and intended use to existing devices.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in terms of technological characteristics. | "A comparison of technical characteristics [demonstrates] that the Hedrocel® Acetabular Cage System is substantially equivalent to commercially available reconstructive devices." |
| Device functions as intended. | "Testing conducted on the commercially available devices comprised wholly or in part of Hedrocel® and the Hedrocel Acetabular Cage System indicate that the device will function as intended." |
Note: For a 510(k) submission like this, "acceptance criteria" are typically met by demonstrating substantial equivalence to a legally marketed predicate device, rather than achieving specific performance metrics like those for a diagnostic algorithm. The "reported device performance" refers to the manufacturer's claim that testing supports the device's intended function and its equivalence.
Study Information
The document does not describe a clinical study of the type that would typically establish performance metrics for a diagnostic or AI device. Instead, it refers to "testing" to demonstrate substantial equivalence and intended function, common for orthopedic implants.
Here's a breakdown of the requested information, noting when it is not applicable:
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Sample size used for the test set and the data provenance: Not applicable. This document refers to technical characteristics and unspecified "testing" for substantial equivalence of an orthopedic implant, not a clinical trial with a test set of human subjects or data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic or AI studies is not relevant here. The "ground truth" for a 510(k) mechanical device is typically established through engineering and biomechanical testing demonstrating material properties, strength, and fit, compared against established standards or predicate devices. There's no mention of expert consensus on clinical cases.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept applies to clinical studies involving subjective interpretation, which is not the focus of this 510(k) for an orthopedic implant.
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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 device is an acetabular cage system (an orthopedic implant), not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an orthopedic implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a mechanical orthopedic device seeking 510(k) clearance, the "ground truth" is generally established through:
- Engineering specifications and material science: Ensuring the device meets design and material standards for strength, biocompatibility, and durability.
- Biomechanical testing: Demonstrating that the device can withstand expected physiological loads and perform its mechanical function comparably to predicate devices.
- Clinical experience with predicate devices: The "ground truth" for safety and effectiveness is largely drawn from the established performance and safety record of the legally marketed predicate devices to which this new device claims substantial equivalence.
The document mentions "Testing conducted on the commercially available devices" which would likely encompass these types of evaluations.
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The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable.
§ 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.