(34 days)
The SmartStep™ System/ SmartStep™ Clinic System is intended to sense the amount of weight applied to the planter surface of the foot during rehabilitation. The System alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep™ System/ SmartStep™ Clinic System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
The SmartStep™ System is a monitoring & biofeedback system for gait. The device is a tool, which is intended to assist the clinicians to accurately assess patients who are undergoing weight bearing restrictions and gait therapy training. The SmartStep™ is used to measure the amount of weight being applied to an affected limb, to teach and promote specific weight bearing skills and to test patient's ability to maintain a weight bearing range. The SmartStep™ system is to be used under the supervision of physician or licensed health care provider such as physiotherapist. The SmartStep™ System is comprised of the following three main subelements: Flexible Insole that is placed in the patient's shoe, acting as a pressure-sensing element. Control Unit, connected to PC Software. PC Software that acts as a patient medical record and patient assessment tool. A Manual Pump is used to inflate the Insole compartments.
This document is a 510(k) Summary for the SmartStep™ System, comparing it to a previously cleared SmartStep™ System (K023161). The core of this submission is to demonstrate substantial equivalence, rather than a de novo performance study against defined acceptance criteria. Therefore, much of the requested information regarding a new study proving the device meets acceptance criteria cannot be extracted from this document.
However, based on the provided text, here's what can be gathered regarding performance and equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a new performance study with results against those criteria. Instead, it states that "Electrical and electromagnetic testing and verification and validation testing of the Software were performed to ensure that the modified SmartStep™ System does not raise any new questions of safety and efficacy." The general performance claim is substantial equivalence to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly defined in the document as new quantitative criteria for the modified device for this 510(k) submission.) | "Electrical and electromagnetic testing and verification and validation testing of the Software were performed to ensure that the modified SmartStep™ System does not raise any new questions of safety and efficacy." |
| Continued compliance with voluntary standards (IEC 60601-1, IEC 60601-1-2, AAMI/ISO 14971-1, FCC requirements). | The SmartStep™ System complies with these voluntary standards. |
| Substantial equivalence in technological characteristics, mode of operation, performance characteristics, and intended use to the predicate SmartStep™ System (K023161). | Andante Medical devices Ltd. believes the modified SmartStep™ System is substantially equivalent to the cleared SmartStep™ System, without raising new safety and/or effectiveness issues. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a new clinical or performance test set for the modified device with specific sample sizes. The testing mentioned is primarily electrical, electromagnetic, and software verification/validation, indicating laboratory or engineering testing rather than patient-based data. Therefore, details like data provenance (country of origin, retrospective/prospective) are not applicable to the type of testing described here.
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. The document does not describe a clinical study or diagnostic performance evaluation requiring expert-established ground truth. The testing detailed relates to device function and safety, without clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.
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. The SmartStep™ System is a monitoring and biofeedback system for gait, not an AI-assisted diagnostic or interpretation tool. The document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the sense of an "algorithm only" performance for a diagnostic or interpretive AI device. The SmartStep™ System inherently involves human interaction (patient wearing the insole, therapist supervising, clinician using PC software). The "performance data" mentioned refers to the device's functional and safety compliance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the engineering and software testing mentioned, the "ground truth" would be the expected functional behavior and safety specifications, rather than clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. The document does not describe a machine learning or AI algorithm development that would involve a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.
§ 890.5575 Powered external limb overload warning device.
(a)
Identification. A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.