(57 days)
The device 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.
Porous-coated ASR™ 300 Acetabular Cups are indicated for cementless application.
The subject DePuy ASR™ 300 Acetabular Cup System is part of a modular system for use in total hip replacement. The acetabular cup is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface features a porous coating with the addition of a plece cup. The outer suring. The cups feature three spikes for adjunct fixation and are available in ten sizes. The subject device is identical in design to the acetabular cups available in the DEPuy ASR™ Modular Acetabular Cup System in K040627 on August 5, 2005 with the addition of spikes on the outer surface of the cup.
This document describes a 510(k) premarket notification for the DePuy ASR™ 300 Acetabular Cup System. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study with acceptance criteria and performance data in the same way one would for a novel device requiring a PMA.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, reported device performance, specific study details (sample sizes, expert involvement, adjudication, MRMC, standalone performance), or the method for establishing ground truth for training or test sets.
Instead, the submission states:
- Basis of Substantial Equivalence: The device is considered substantially equivalent to previously cleared devices (DePuy ASR™ Modular Acetabular Cup System (K040627), Pinnacle Acetabular System (K000306), and Porocoat Lunceford Acetabulum (K823145)) based on "similarities in design, material, fabrication and intended use/indications for use."
- Safety and Effectiveness: "The subject device does not raise any new issues of safety or effectiveness."
This means that DePuy Orthopaedics, Inc. asserted that since their new device is substantially equivalent to already approved devices, detailed performance studies with pre-defined acceptance criteria were not necessary for FDA clearance under the 510(k) pathway. The FDA's letter confirms this, stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent..."
To answer your request directly based only on the provided text:
- Table of acceptance criteria and reported device performance: Not provided. The submission focuses on substantial equivalence rather than meeting specific performance criteria demonstrated by a new study.
- Sample sizes used for the test set and the data provenance: Not applicable/provided. No new test set study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. No new test set study data is presented.
- Adjudication method for the test set: Not applicable/provided. No new test set study data is presented.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done and is not mentioned. This part of the submission relies on substantial equivalence.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical acetabular cup system, not an AI algorithm.
- The type of ground truth used: Not applicable/provided. No new test set or training set data is presented. The "ground truth" for this submission is the established performance and safety of the predicate devices.
- The sample size for the training set: Not applicable/provided. This device is a physical acetabular cup system, not an AI algorithm that undergoes training.
- How the ground truth for the training set was established: Not applicable/provided. This device is a physical acetabular cup system, not an AI algorithm.
§ 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.