(514 days)
The DePuy ASR™ Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The DePuy ASR™ Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter.
The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy onepiece cup with Porocoat® porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups.
The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy The femoral heads articulate with corresponding one-piece metal 12/14 or 11/13 tapers. acetabular cups.
The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima" Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12.
The provided document is a 510(k) summary for the DePuy ASR™ Modular Acetabular Cup System. It outlines the device description, indications for use, and a claim of substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, or clinical trial data.
Therefore, I cannot provide the requested information in the table or answer most of the specific questions. The 510(k) summary is generally a regulatory submission that focuses on demonstrating equivalence to existing marketed devices rather than presenting novel performance study data.
Here's what I can extract based on the provided document, even though it doesn't directly answer your questions about acceptance criteria and study details:
Missing Information:
- Acceptance Criteria and Reported Device Performance Table: Not available in this 510(k) summary. These summaries typically do not include detailed performance metrics or "acceptance criteria" in the way you might find in a clinical study report.
- Sample size for the test set and data provenance: No performance study data is presented.
- Number of experts used to establish the ground truth for the test set and their qualifications: No performance study data is presented.
- Adjudication method for the test set: No performance study data is presented.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable; no such study is reported in this document.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable; no performance study data is presented.
- Sample size for the training set: Not applicable; no algorithm is being trained.
- How the ground truth for the training set was established: Not applicable; no algorithm is being trained.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.