(217 days)
The Hintermann Series H2 Total Ankle Replacement (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint.
The Hintermann Series H2 is indicated as a total ankle replacement in primary or revision surgery of ankle joints damaged by:
· Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis)
· Primary arthritis (e.g., degenerative disease)
· Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant)
The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union of the ankle arthrodesis, provided sufficient bone stock is present.
Note: In the United States, this device is intended for cemented use only.
The Hintermann Series H2 Total Ankle System includes a metal tibial component, polyethylene inlay, and metal talar component. The tibial and talar components are coated with plasma spray titanium on the bone contacting surfaces. The system is a semiconstrained device used for the indications as follows.
This document is a 510(k) summary for the Hintermann Series H2 Total Ankle System, asserting its substantial equivalence to previously marketed predicate devices. It focuses on the device's design, materials, and nonclinical testing to demonstrate safety and effectiveness.
Here's an analysis of the provided text in relation to your request about acceptance criteria and supportive studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a clear table of specific, quantitative acceptance criteria with corresponding reported device performance values. Instead, it lists types of non-clinical tests performed and states that the comparisons confirmed substantial equivalence to predicate devices. It implies that meeting the standards of ASTM F2665 and FDA guidance constitutes the acceptance criteria, but doesn't quantify results against specific thresholds.
Here's a conceptual representation, though explicit numeric values are missing from the text:
| Acceptance Criterion (Implied Standard) | Reported Device Performance |
|---|---|
| Coating characterization per FDA Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants (Feb 2, 2000) | Testing conducted; confirmed substantial equivalence. |
| Range of motion analysis per ASTM F2665 | Testing conducted; confirmed substantial equivalence. |
| Fatigue testing per ASTM F2665 | Testing conducted; confirmed substantial equivalence. |
| Contact area/contact stress analysis per ASTM F2665 | Testing conducted; confirmed substantial equivalence. |
| Constraint testing per ASTM F2665 | Testing conducted; confirmed substantial equivalence. |
| Tibial Component locking mechanism testing | Testing conducted; confirmed substantial equivalence. |
| Wear testing per ASTM F2665 | Testing conducted; confirmed substantial equivalence. |
| Endotoxin testing per FDA guidance | Testing conducted; confirmed substantial equivalence. |
| Overall safety, effectiveness, and performance compared to predicate devices, regarding intended use, product technical characteristics, and performance characteristics as defined by ASTM F2665. | "Confirmed that the Hintermann Series H2 Total Ankle System is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document details non-clinical testing, which refers to laboratory or bench testing, not human-subject clinical trials. Therefore, concepts like "test set" in the context of patient data, data provenance (e.g., country of origin), or retrospective/prospective studies are not applicable to the information provided. The "sample size" for the non-clinical tests would refer to the number of physical device units or components tested for each specific test (e.g., 5 units for fatigue testing), but this information is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since this is a non-clinical device clearance based on substantial equivalence, there is no "test set" of patient data and therefore no experts used to establish ground truth in the way you might find in an AI/diagnostic device submission. The "ground truth" here is adherence to engineering standards and material specifications, verified through laboratory testing.
4. Adjudication Method for the Test Set
As there is no patient data test set or expert review, an adjudication method is not applicable to this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. The Hintermann Series H2 Total Ankle System is an implantable medical device, and its clearance is based on non-clinical engineering and material performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the Hintermann Series H2 Total Ankle System is a physical implant, not an algorithm or AI-powered device.
7. The Type of Ground Truth Used
For this non-clinical submission, the "ground truth" is defined by:
- Established engineering standards: Specifically, ASTM F2665 ("Standard Specification for Total Ankle Replacement Prosthesis").
- FDA guidance documents: Such as the "FDA Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements dated February 2, 2000" and general FDA guidance for endotoxin testing.
- Material specifications: For titanium alloy, UHMWPE, and CoCr alloy.
The "ground truth" is that the device, when subjected to these tests, performs within the acceptable parameters defined by these standards and demonstrates properties comparable to legally marketed predicate devices.
8. The Sample Size for the Training Set
This question is not applicable. The device is an implant and does not involve machine learning or AI, and therefore has no "training set."
9. How the Ground Truth for the Training Set was Established
This question is not applicable as no training set exists for this device.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.