(261 days)
Total Hip Replacement: Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-Hip Replacement: Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated: irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
The hydroxyapatite tricalcium phosphate coated HGP Total Hip System is modular in design and consists of four basic components: The hip stem, the femoral head, the acetabular component and the liner. The Acetabular Components also have an HA/TCP coating. The HGP Total Hip is a femoral component made from Tivanium® Ti-6A1-4V Alloy. The femoral stem is straight and similar to that of other conventional total hip stems. In addition, commercially pure titanium fiber pads of approximately 2 mm thickness are metallurgically bonded to the anterior, posterior, lateral and medial aspects of the stem body. The proximal one-third of the stem is coated with HA/TCP which is applied by a plasma spraying process. This coating is approximately 20 to 50 microns in thickness. The plasma spray feedstock and resultant coating consists predominantly of calcium hydroxyapatite with minor components of betatricalcium phosphate and other calcium phosphates. The modular connection of the femoral stem is a Morse type 6° taper designed to mate with the corresponding 6° bore of a femoral head component. The femoral heads are available in 22, 26, 28, and 32 mm diameters. The modular nature of the system allows for the use of a variety of neck lengths, offsets, and femoral head diameters. The devices may also be used with endoprostheses. This ceramic is colorless. The measurement of a calcium phosphate ceramic's chemical composition involves determination of the calcium/phosphorus ratio and trace metals content by elemental analysis. The distribution among different crystalline phases is determined by powder X-ray diffraction, which has an accuracy of approximately 10 percent for any given phase in a multiphasic, moderately crystalline calcium phosphate ceramic. The device is designed to fit the upper end of the femur and provide an interference fit with intimate contact between the porous titànium pads and the surrounding bone. This fibrous titanium mesh HA/TCP sufface has a porous morphology which provides a scaffold-like structure into which biological tissues may ingrow, thus fixing or anchoring the prosthesis.
This document is a 510(k) summary for the Harris/Galante Porous Hip Prosthesis With HA/TCP Coating. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., a formal clinical trial with quantitative performance metrics).
The FDA's review for a 510(k) submission determines substantial equivalence to a legally marketed predicate device, rather than establishing new acceptance criteria or conducting a study to prove performance against predetermined metrics. The summary focuses on comparing the new device to existing predicate devices based on design, materials, and intended use.
However, I can extract information related to the device description, intended use, and comparison to predicate devices, which implicitly address safety and effectiveness as judged by substantial equivalence.
Here's an analysis based on the provided text, addressing the points where possible:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported device performance against such metrics. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is indirectly assured by the history of successful clinical use of the materials and design principles in predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study assessing performance of the device against a test set in the traditional sense of a clinical trial for diagnostic devices or AI algorithms. The submission is for a medical implant and relies on "clinical and nonclinical data" that support the principle of biologic fixation through bone ingrowth (Page 2). Specific clinical study data with sample sizes, data provenance, or study design (retrospective/prospective) are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of "ground truth" establishment by experts in the context of a test set for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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 device is a hip prosthesis, not a diagnostic imaging aid or an AI-powered system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (hip prosthesis), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as applied to diagnostic algorithms is not relevant here. The "truth" for this device's safety and effectiveness is established by its substantial equivalence to existing, legally marketed predicate devices that have a history of successful clinical use. The "clinical and nonclinical data" mentioned are used to support this equivalence, particularly regarding biologic fixation. The FDA specifically states: "The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation, only)." (Page 3-4)
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an algorithm or machine learning as this is a physical medical device.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Evidence Presented in the 510(k):
Device Name: Harris/Galante Porous Hip Prosthesis With HA/TCP Coating
Intended Use/Indications:
- Total Hip Replacement: Severe hip pain and disability due to various conditions including rheumatoid arthritis, osteoarthritis, traumatic arthritis, avascular necrosis, nonunion of fractures, congenital hip dysplasia, etc. Also for previously failed endoprostheses and acute femoral neck fractures.
- Hemi-Hip Replacement: Fracture dislocation of the hip, irreducible fractures, certain high subcapital and comminuted femoral neck fractures in the aged, nonunion of femoral neck fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis primarily affecting the femoral head, especially in elderly, debilitated patients where total hip replacement is contraindicated.
Basis for Acceptance (Substantial Equivalence):
The submission demonstrates substantial equivalence to previously cleared predicate devices, including:
- Harris/Galante Porous Hip Prosthesis (K-840643, cleared April 17, 1984)
- TCP-Coated Porocoat AML Femoral Hip Prosthesis (K-964650, cleared June 6, 1997)
- HGP II Acetabular Stem (K-921308, cleared February 22, 1994)
- Inter-Op HA Porous Acetabular System (K-972393, cleared September 19, 1997)
Key arguments for substantial equivalence:
- Intended Use: All predicate devices and the HGP Hip Prosthesis are intended for cementless fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum.
- Design/Technology: All feature a porous or roughened surface and are modular in design. Each has a Morse-type proximal neck taper that mates with a femoral head, which articulates with a UHMWPE bearing surface.
- Materials: All predicate devices and the HGP Hip Prosthesis are manufactured from metal alloys (Tivanium® Ti-6A1-4V Alloy) that have a history of successful clinical use in orthopedic applications. The HGP features a HA/TCP coating applied by plasma spraying, with specific composition and thickness described.
- Performance Claim: The device is designed to achieve biologic fixation to bone through bone ingrowth. The FDA limited the claims to "biological fixation, only," emphasizing that the data supported equivalence without additional claims of "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation."
In essence, the "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which provides a comparative analysis to predicate devices and asserts that the new device is as safe and effective as those already on the market. The FDA's clearance (NOV 1 2 1998) confirms this finding of substantial equivalence.
§ 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.