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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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The AccuTread™ Shoe System is intended for use as a limb load monitoring device to assist in the rehabilitation of patients with insults to their lower extremities. The AccuTread™ Shoe System is intended to be used in any situation in which a therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.

Not Found

This document is a 510(k) clearance letter from the FDA for the AccuTread Shoe System. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements and contact information for further questions.

Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text.

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The Foot Weight Alarm is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, such as malunion fracture, amputation, and cerebral vascular accident. The Foot Weight Alarm helps train patients by limiting the amount of force placed on the leg or helping a patient to reach a set amount of force in order to facilitate the return to normal gait pattern,

The Foot Weight Alarm is a foot shaped insole device to fit inside the patient's shoe to warn the patient when they are putting too little or too much weight on a limited weight bearing foot. It consists of an Insole, a Shoe Pouch which laces to the shoe, a foot unit which fits in the Shoe Pouch and connects to the Insole, a data cable that is used by a health care professional to program the Foot Weight Alarm unit; and Foot Weight Alarm Calibration System used by the health care professional to program the Foot Unit.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It describes a 510(k) summary for the "Foot Weight Alarm" device, focusing on:

• Submitter and Device Information: Name, address, contact, submission date, classification, common/proprietary name.
• Classification and Regulation: Class II, regulated as a powered external limb overload warning device.
• Substantial Equivalence: Claimed equivalence to the BarMed Pty. Ltd. Portable Limb Load Monitor BMLLM-100 (K915 326).
• Device Description: Foot-shaped insole with load sensors, shoe pouch, foot unit, data cable, and calibration system.
• Intended Use: Weight-bearing training for patients with orthopedic and neurological disabilities (malunion fracture, amputation, cerebral vascular accident) to limit or achieve a set amount of force on the leg.
• Summary of Safety and Effectiveness: States the device is similar in application and operation to the BarMed LLM-100, and that its safety and effectiveness are comparable. A table compares features like sensors, alarm, portability, and monitor dimensions.

The document lacks details on specific performance metrics, acceptance criteria, or any studies (standalone or comparative effectiveness) with data on accuracy, precision, sensitivity, specificity, or other quantitative measures. It does not mention sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the studies, as this information is not present in the provided text.

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The AccuTread™ Shoe is intended for use as a limb load monitoring device to monitor limited weight bearing during rehabilitation of patients with insults to their lower extremities.

The AccuTread™ Shoe is a shoe-like enclosure, worn by patients having insults to their lower extremities. The device is intended for use to achieve benefits such as:

• protection of the affected extremity during the healing process, .
• . ease of mind during initial ambulation, and
• documentation of compliance or non-compliance to a prescribed weight ● bearing program.
  These benefits derive from the patient's ability to know that he/she is not exceeding the correct amount of weight applied to the affected extremity as prescribed by their physician. The complete device consists of the following components:
• Shoe Body .
• Sensor Unit
• Transmitter .
• . Receiver

Here's a breakdown of the acceptance criteria and study information for the AccuTread™ Shoe, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain a formal "acceptance criteria" section with specific quantitative targets and results from a clinical study in the way a clinical trial report would. Instead, it highlights the device's technical specifications and how they compare to the predicate, with inherent performance claims embedded in the specifications, particularly in the "Precision" and "Load Sensitivity" sections.

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the given 510(k) summary. 510(k) submissions for devices like this, particularly in 1996 for a Class II device, often relied on bench testing and comparisons to predicate devices rather than extensive clinical studies with human participants. The document primarily describes the device's design and compares its features to the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the given 510(k) summary. Ground truth establishment with experts is typically part of a clinical validation study, which is not detailed here.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary. Adjudication methods are relevant to studies involving human interpretation or performance evaluation, which is not the focus of this document.

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

This information is not applicable/provided in the given 510(k) summary, as it describes a mechanical limb load monitor, not an AI-powered diagnostic imaging device that would involve human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/provided in the given 510(k) summary. The AccuTread™ Shoe is a physical device that provides feedback to a human user, not a standalone algorithm. Its performance is inherent in its measurement and alert capabilities.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For a device like the AccuTread™ Shoe, the "ground truth" would typically refer to the actual applied weight measured by a highly accurate (e.g., laboratory-grade) force sensor against which the device's readings are compared. This is implied by the "Precision" specification. The document speaks to its technical performance and comparison to a predicate, not clinical outcomes in the sense of pathology or long-term patient data.

8. The Sample Size for the Training Set

This information is not provided in the given 510(k) summary. The AccuTread™ Shoe is a physical measurement and alert device, not a machine learning model that would require a "training set" in the conventional sense. Its calibration process is likely based on engineering principles and bench testing.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable as the device is not an AI/ML model requiring a training set in the conventional sense. The "ground truth" for its calibration and precision would be established through physical force measurements on test equipment.

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ForceGuard is used to sense the amount of weight applied to the plantar surface of the foot. The device alerts the wearer and/or therapist with a repeating tone when the weight exceeds the pre-selected value.

ForceGuard will be used on patients who have bone, connective tissue or soft tissue damage who also have been instructed by a physician to limit the weight being placed on a lower limb.

ForceGuard Model 2090 consists of 3 components; footpad, electronics module, and leg band. The leg band is worn around the patient's ankle. The electronics module attaches to the leg band. The footpad, a flexible, fluid filled chamber, plugs into the electronics module and is worn under the plantar surface of the patient's foot inside suitable footwear.

The function of the leg band is to secure the electronics module to the patient's ankle. The function of the footpad is to sense the weight being placed through the patient's lower extremity. The electronics module functions as the user interface, processes information from the footpad and alarms when the weight on the footpad exceeds the selected weight.

The provided text describes a medical device, ForceGuard Model 2090, but it does not contain any information about a study that tests the device's performance against specific acceptance criteria in the context of AI or expert evaluation.

The document is a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It focuses on comparing the new device to existing predicate devices (Force Guard I and Pelimit) based on technological and performance characteristics.

Therefore, many of the requested information points, particularly those related to a study with acceptance criteria, sample sizes, expert involvement, and AI performance, cannot be extracted from this document.

However, I can extract information related to the device's specified performance characteristics (which can be considered de facto acceptance criteria based on the predicate device's performance).

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on predicate device comparison):

Note: The "acceptance criteria" here are inferred from the performance characteristics of the predicate device, which the new device is demonstrating substantial equivalence to or improvement upon. The document does not explicitly state "acceptance criteria" in a statistical or study-based sense.

Information NOT available in the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not 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, as this is not an AI device and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an algorithm-only device in the AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not described in terms of a formal study or ground truth establishment. The "ground truth" for performance is likely based on engineering measurements against specifications.
8. The sample size for the training set: Not applicable, this is not an AI device requiring a training set in that context.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not a study report detailing performance against specific acceptance criteria using a test set with expert-established ground truth or involving AI.

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