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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.

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.

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The SmartStep System is intended to sense the amount of weight applied to the plantar surface of the foot during rehabilitation. The device alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep 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 biofeedback system for gait training and reeducation. The device is a tool to assist clinicians 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 rang. A patient's weight bearing status is important to know because it is an indicator of overall progress, and with certain conditions, under-weight bearing or over-weight bearing can lead to complication in the rehabilitation process.

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 three sub elements:

Flexible Foot force insole that is placed on the inside of a shoe worn by the patient over a sock.

Central Processing Unit (CPU)- the unit is connected to computer software.

Computer software that acts as a patient medical record and patient assessment tool.

This document, a 510(k) summary for the SmartStep System, references performance testing but does not provide specific acceptance criteria or detailed study results. Therefore, I cannot fully answer all parts of your request.

However, based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Explanation: The document states, "Based on validations and performance testing results, Andante Medical Devices Ltd. believes that the SmartStep System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues." However, it does not provide any specific quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) or the numerical results of this performance testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. (The applicant is based in Israel, but the origin of the data is not mentioned).
• Retrospective or Prospective: Not specified.

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 specified. The document does not describe the establishment of a ground truth by experts in the context of performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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

• No, an MRMC comparative effectiveness study was not done or reported. The SmartStep System is a biofeedback device that senses and alerts based on weight applied, not an AI-assisted diagnostic tool that would involve "human readers" interpreting data. Therefore, this type of study is not applicable to this device as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, implied. The device itself senses and alerts, which is an algorithmic standalone function. The "study" mentioned ("validations and performance testing results") would have assessed this standalone performance, although the details are not provided. The system is designed to "objectively assessing the amount of weight."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not explicitly stated. Given the device's function (sensing weight), the "ground truth" for its performance testing would likely be derived from a highly accurate and calibrated weight measurement system, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable/Not specified. This device is described as a biofeedback system that senses and alerts. There is no mention of a "training set" in the context of machine learning, as this is not an AI/ML-based diagnostic system that would require such a set.

9. How the ground truth for the training set was established

• Not applicable/Not specified, as there is no mention of a training set.

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