(64 days)
The Salto Talaris Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. All components are intended for cemented use only.
The goal of total ankle replacement is to restore function and relieve pain. The Salto Talaris Total Ankle Prosthesis is intended to accomplish these goals. The Salto Talaris Total Ankle Prosthesis is a semi-constrained anatomical design, which reproduces the kinematics of the ankle joint. The Tornier Salto Talaris Total Ankle Prosthesis consists of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.
This document is a 510(k) premarket notification for the Salto Talaris Total Ankle Prosthesis, not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving the device meets them in the format requested.
Specifically, the document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with performance metrics, sample sizes, expert involvement, or statistical analysis.
However, based on the provided text, here's what can be inferred or stated about the device's intended use and regulatory status:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria or reported device performance in terms of clinical outcomes or specific metrics (e.g., success rates, pain reduction scores, range of motion improvements). The regulatory approval process for this type of device (510(k)) is based on demonstrating substantial equivalence to existing, legally marketed predicate devices, not on meeting predefined clinical performance acceptance criteria from a new clinical study.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a test set of patients.
- Data Provenance: Not applicable. The document references predicate devices (K060544, K920802, K020541, K051023) as a basis for substantial equivalence, but it doesn't provide new clinical data from a prospective or retrospective study for the Salto Talaris Total Ankle Prosthesis to evaluate its performance against specific criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new clinical test set is described, and therefore no ground truth established by experts for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No new clinical test set 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 is a medical device (prosthesis), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (prosthesis), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of a new clinical study for this 510(k). The "ground truth" for the device's approvability is its substantial equivalence to predicate devices, which implies that the predicate devices have established safety and effectiveness.
8. The sample size for the training set:
Not applicable. No training set for an algorithm is discussed.
9. How the ground truth for the training set was established:
Not applicable. No training set for an algorithm is discussed.
Summary based on the provided text:
The document is a regulatory submission demonstrating the substantial equivalence of the Salto Talaris Total Ankle Prosthesis to previously marketed devices. The "acceptance criteria" in this context are primarily regulatory – demonstrating that the device has similar technological characteristics and indications for use as existing predicate devices and does not raise new questions of safety or effectiveness. The "study" that "proves" this is the comparative analysis against the predicate devices presented in the 510(k) submission (though the details of this comparison are not elaborated in the provided excerpts beyond listing the predicates).
§ 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.