(90 days)
The use of the Implex HEP Acetabular Cup System, Cemented, is indicated for:
a) Total Hip Replacement in severely disabled joints as a result of degenerative arthritis or avascular necrosis;
b) Secondary revision of a previously unsuccessful acetabular component;
c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results;
d) Fracture dislocation of the hip, or irreducible fractures in which adequate fixation cannot be obtained;
e) Non-union of femoral neck or head fractures; and
f) Salvage of a failed primary or secondary total or hemi hip.
Implex HEP Acetabular Cups, Cemented, are available in OD sizes from 40 mm to 70 mm (in 2 mm increments), and with four possible ID size options (22 mm, 26 mm, 28 mm, and 32 mm). Implex HEP Acetabular Cups are to be implanted using the Implex Acetabular Cup Instrumentation System.
The provided document is a 510(k) summary for the Implex HEP Acetabular Cup System, Cemented. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results. Therefore, much of the requested information cannot be extracted from this document.
Here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., strength, durability thresholds) for the device. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The reported device performance is implicitly that it meets the standard of being substantially equivalent to the predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Implex A-230 Porous Acetabular Cup System, Cemented, and Implex Hedrocel® Acetabular Restrictor) in terms of materials and performance characteristics. | "The surgical instrumentation and design geometry of the predicate Implex A-230 Porous Acetabular Cup System, Cemented, and the Implex HEP acetabular Cup System, Cemented, are equivalent. The primary difference between the two device systems is that the Implex HEP Acetabular Cup, Cemented shell is comprised of Hedrocel®, and the Implex A-230 Porous Acetabular Cup is comprised of porous coated titanium alloy. The Hedrocel® material used in the Implex HEP Acetabular Cup System, Cemented, is identical to the Hedrocel® material which comprises the Implex Hedrocel® Acetabular Restrictor." |
"Testing conducted to characterize the materials and the performance characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence." |
2. Sample size used for the test set and the data provenance:
- The document mentions "Testing conducted to characterize the materials and the performance characteristics of the device under defined laboratory conditions," but does not specify the sample size for this testing.
- Data provenance (country of origin, retrospective/prospective) is not mentioned. Likely, the testing was conducted in a laboratory setting, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical implant, not an AI/diagnostic software, so "ground truth" established by experts in the context of interpretation (e.g., radiologists reading images) is not relevant here. The evaluation relies on laboratory testing and material characterization.
4. Adjudication method for the test set:
- Not applicable. See point 3.
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 medical device (hip implant), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (hip implant), not an AI algorithm.
7. The type of ground truth used:
- For this type of device, the "ground truth" for performance is typically established through engineering specifications, material science standards, and established biomechanical testing protocols to ensure the device meets predefined physical and mechanical properties. The document states "Testing conducted to characterize the materials and the performance characteristics of the device under defined laboratory conditions." This implies physical testing against engineering standards.
8. The sample size for the training set:
- Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.