(60 days)
The SUMMIT™ Acetabular 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 revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.
The SUMMIT™ Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, an outer shell composed of titanium alloy (Ti-6Al-4V) with a commercially pure titanium porous coating and a liner of ultrahigh molecular weight polyethylene (UHMWPE), which locks into the outer shell. The acetabular component articulates with a femoral head of an appropriate diameter.
The acetabular shell has a porous-coated surface and is provided No-Hole, Cluster Hole, Multi-Hole, Spiked and Deep Profile configurations that accept liners for 22.225, 26, 28 and 32mm femoral head sizes; as well as 0°, 10°, and 15° face angles.
Also available for use with the SUMMIT™ Acetabular System are an apical hole plug and a variety of bone screws, all composed of titanium alloy.
This document is a 510(k) summary for the SUMMIT™ Acetabular System, a medical device for total hip replacement. It outlines the device's information, indications for use, and a statement of substantial equivalence to predicate devices. It does not describe acceptance criteria, performance data, or a study to prove the device meets acceptance criteria in the way typically expected for an AI/software as a medical device (SaMD).
Therefore, I cannot populate the requested table and answer many of the questions as the provided text pertains to a hardware medical device (an acetabular system) and its regulatory clearance as substantially equivalent to existing devices, not a software or AI-based device's performance study.
However, I can extract information related to the device and its regulatory clearance:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a mechanical medical device, not an AI/SaMD, specific "acceptance criteria" and "reported device performance" are not presented in the format of metrics like sensitivity, specificity, or accuracy. The "acceptance criteria" for regulatory clearance were met through demonstrating substantial equivalence to predicate devices. "Device performance" in this context refers to its mechanical integrity and biocompatibility, as demonstrated through materials and design.
| Criterion Type | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as basis for substantial equivalence) |
|---|---|---|
| Intended Use | Must be the same or very similar to predicate devices. | "The SUMMIT™ Acetabular System is substantially equivalent in terms of intended use..." when compared to ZTT™ I and II Acetabular Cup (K951000), Arthopor™ I and II (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301). |
| Materials | Must be comparable to predicate devices in terms of biocompatibility and mechanical properties. (e.g., Titanium alloy (Ti-6Al-4V) for the shell, commercially pure titanium porous coating, UHMWPE for the liner, titanium alloy for screws/plugs) | "...materials..." were deemed substantially equivalent. Conformance with voluntary performance standards: ASTM F-67 (Standard Specification for Unalloyed Titanium for Surgical Implant Applications) and ASTM F136 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications). |
| Design | Must be comparable to predicate devices. (e.g., modular system with an outer shell and a liner, various head sizes and face angles, porous coating) | "...design..." was deemed substantially equivalent. |
| Sterilization Method | Must be a validated sterilization method commonly used for medical devices and comparable to predicate devices. | "...sterilization method..." was deemed substantially equivalent. |
| Packaging | Must be appropriate for maintaining sterility and device integrity, and comparable to predicate devices. | "...packaging..." was deemed substantially equivalent. |
| Performance Testing | Mechanical and material performance testing to ensure safety and effectiveness, conforming to relevant standards. (Though specific tests are not detailed, ASTM standards imply certain mechanical properties and biocompatibility requirements were met). | "performance testing" was conducted and contributed to the determination of substantial equivalence. Specifically mentioned: ASTM F1044 (Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Interfacially Attached to Metallic Substrates). |
Regarding the remaining questions:
- 2. Sample sized used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" in the context of an AI/SaMD. The "data" here refers to device specifications, materials, design, and performance testing results which are compared to predicate devices and standards.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established for this type of device submission. The "ground truth" for regulatory clearance is based on established engineering principles, material science, and the safety and effectiveness record of predicate devices.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 for a mechanical implant, not an AI system assisting human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware medical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this medical device's clearance is adherence to recognized industry standards (e.g., ASTM F-67, ASTM F136, ASTM F1044), material specifications, and comparison to the known safety and efficacy profiles of legally marketed predicate devices through the 510(k) Substantial Equivalence pathway. It relies on scientific and engineering principles rather than clinical 'ground truth' in the sense of diagnostic accuracy.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical hip implant. It demonstrates substantial equivalence to existing devices based on traditional engineering and material science evaluations, rather than a clinical performance study with "acceptance criteria" and "test sets" as understood for AI/SaMD.
§ 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.