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The AposTherapy System is intended to be used by trained professionals for adjusting the distribution of weight/force(s) that is being applied to a lower limb. The AposTherapy System is intended for patients with knee osteoarthritis, to help temporarily reduce knee pain and improve lower extremity function during activities of daily living.

The AposTherapy System consists of a pair of shoe-like uppers with two convex units (Pertupods) on the sole of each shoe, a screw fixation mechanism for securely attaching the Pertupod to the track and, if required, soft spacers, weight discs, hard spacers, and wedge spacers. Legally marketed gait analysis software may be used by practitioners to help inform their calibration of the biomechanical device, but the software is not supplied with the device.

The device is worn over socks, so it has no direct contact with the patient. Based on a preliminary evaluation of pain, function, and quality of life, a personalized therapy program is created to meet the patient's treatment needs using the personally calibrated device. Practitioners may use basic, legally marketed gait analysis software (not provided with the device) to collect measurements from various movements (e.g., velocity, step length, single limb support) as part of the treatment program. The patient's progress is assessed periodically; the device is then further adjusted and the therapy program updated as needed to achieve the pre-defined goals. The device is intended to be worn only during the time scheduled by the practitioner (e.g., 30 minutes a day).

The provided text describes the AposTherapy System, a limb orthosis intended for patients with knee osteoarthritis to temporarily reduce knee pain and improve lower extremity function during activities of daily living. Here's a breakdown of the acceptance criteria and study information:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size: 220 knee OA patients (110 in AposTherapy arm, 110 in sham arm, assuming equal distribution based on text).
• Data provenance: Prospective, randomized, sham-controlled clinical trial. The country of origin is not explicitly stated in the provided text.

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 text. The study design described is a clinical trial assessing patient-reported outcomes (WOMAC scores) rather than an evaluation by experts.

4. Adjudication method for the test set:

• This information is not applicable/provided in the context of this clinical trial focusing on patient-reported outcomes. Adjudication methods are typically used for expert review of images or clinical events, not for standardized questionnaire results.

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. The device is a physical orthosis, not an AI-powered diagnostic or assistive tool, and the study did not involve human readers interpreting cases.

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

• This information is not applicable. The AposTherapy System is a physical medical device, not a standalone algorithm.

7. The type of ground truth used:

• The ground truth in this study was based on patient-reported outcomes, specifically the WOMAC (Western Ontario and McMaster Universities Arthritis Index) global scores, which is a widely accepted measure for assessing pain, stiffness, and physical function in patients with osteoarthritis.

8. The sample size for the training set:

• This information is not applicable/provided. This was a clinical trial validating a physical device, not an AI/machine learning model that typically has a "training set."

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

• This information is not applicable/provided for the same reasons as point 8.

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The Beactive Brace is applied to the upper calf just below the knee such that the pressure pad presses against the soleus muscle located just to the outside of the back of the knee for the purposes of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is intended for over-the-counter distribution.

The Beactive® Brace is a brace intended to temporarily reduce lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is an adjustable, cylindrically-shaped band that fits over the upper calf on either leg. Integrated into the wall of the brace is a disk-shaped protrusion (pressure pad) that projects inward the leg. The pressure pad presses against the soleus muscle located just to the back of the knee. The pressure pad exerts even pressure on the soleus muscle near its origin at the fibula. The Velcro strap is designed to focus the pressure on the pressure pad on the calf. As a soleus muscle compression brace, it uses both compression as well as anterior glide forces onto the proximal tibiofibular joint to temporarily reduce low back pain.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Beactive® Brace:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a numerical or pass/fail threshold manner. Instead, it describes general effectiveness and safety observations. Based on the provided "Effectiveness" and "Safety" sections, we can infer the following:

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

The document does not explicitly state the exact sample size for the clinical study. It refers to "a majority of subjects," "52% of subjects," and "12% of subjects," which indicates a quantitative study, but the total 'N' is missing.

• Sample Size: Not specified (referred to as "subjects").
• Data Provenance: Not explicitly stated (e.g., country of origin). It's a clinical study conducted as part of a 510(k) submission, suggesting it was likely conducted in accordance with FDA regulations, but whether it was prospective or retrospective is also not stated. However, the design of "before using," "while performing motion," "while at rest," and "after a week" suggests a prospective design.

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

The document does not mention the use of experts to establish ground truth independently for the clinical study. The "ground truth" for pain reduction and disability improvement was based on self-reported patient outcomes using established scales (10-point pain scale, Oswestry Disability Index Questionnaire).

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for the clinical study data or for establishing ground truth. The data appears to rely on direct patient reporting.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was performed or mentioned. The clinical study evaluated the Beactive® Brace itself, not its impact on human reader performance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Beactive® Brace is a physical medical device (limb orthosis), not an algorithm or AI system. Therefore, the concept of an "algorithm only" or "standalone" study does not apply.

7. The Type of Ground Truth Used

• For Clinical Study: Patient self-reported pain levels (10-point pain scale) and disability index scores (Oswestry Disability Index Questionnaire). This is considered outcomes data / patient-reported outcomes.
• For Biocompatibility: Laboratory testing results (Cytotoxicity, Sensitization, Irritation). This is laboratory-based evidence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable, as it's not an AI/ML model.

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An orthosis worn on the wrist

With rigid insert:
to limit wrist motion while worn, allowing the body to recover from the damage of repetitive motion or other injuries
to immobilize and / or support for functional improvement following, repetitive motion-type of injuries such as carpal tunnel syndrome (CTS), wrist strains or sprains, and similar injuries of the wrist

Without rigid insert:

• . to provide wrist support
• . to provide temporary relief of associated symptoms of some repetitive motion wrist conditions
• to provide feedback to the user when the wrist reaches maximal flexion or extension

An orthosis worn on the wrist

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter for a device called "Neurosplint," outlining its indications for use and regulatory information. It does not include details about device performance metrics, study designs, sample sizes, or expert involvement as requested.

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Foot raising paresis.

The Musmate uses six out of eight components, depending on whether it is for a single leg or both legs.

• A shoulder harness for a single leg (left or right) which holds the elastic assembly in place and is available in two mirror-image designs (for the left leg and for the right leg), four sizes, and a range of colours. It is made from polypropylene webbing and plastic components. There are adjusters to alter the length of the harness to suit the individual. It has a length-adjusting strap which controls the height of the foot lift. This has a triangle on one end which connects to the upper hook on the elastic cord assembly, and a square ring grip which the person pulls on to adjust. The strap passes through a ladderloc control which prevents the strap moving in use. The shoulder harness has two front release clips which connect to the waist belt (or which can be clipped together if the belt is not used);
• An optional waist belt made from polypropylene webbing. This features two adjusters so that it is adjustable in length to suit each person and clips for attaching to the shoulder harness. This is available in three lengths and a range of colours;
• A shoulder harness for both legs. This is made from polypropylene webbing. Its function is to hold the elastic assembly in place and it is available in one design, four sizes, and a range of colours. This features triglide adjusters to alter the length of the harness to suit the individual. There is a steel ring on the rear which brings the different parts together. It has a length-adjusting strap which controls the height of the foot lift. This has a triangle on one end which connects to the upper hook on the elastic cord assembly, and a square ring grip which the person pulls on to adjust. The strap passes through a ladderloc control which prevents the strap moving in use. The shoulder harness has two front release clips which connect to the waist belt (or which can be clipped together if the belt is not used);
• Optional polypropylene webbing waist half-belts for the shoulder harness for both legs which help balance the harness if the loads applied are different on each leg. Two are used out of the four supplied (there are two short and two long). These feature an adjuster so that it is adjustable in length to suit each person. There are two front release clips which connect to the shoulder harness. These are available in six lengths and a range of colours;
• An optional foam shoulder pad which can be used to cushion the load of the shoulder harness until the muscles become accustomed to the additional effort. This is made from leatherette with a foam insert and hook and loop fastenings. It is available in two sizes and a range of colours;
• An elastic cord assembly. This is made from 8mm shock cord, which has a rubber core and polypropylene sheathing. It has a nylon peg adjuster which can be used to adjust the elastic cord for length to optimise the support offered by the Musmate. There is a hook at the top for connecting to the shoulder harness, and one at the bottom for connecting to either the shoe harness or shoelace connector as required. The cord is only available in black, and the nylon adjuster and hooks are available in black and white;
• A shoe harness made from shoe soling which wraps under and over the shoe. This is secured with hook and loop fittings. There is a polypropylene strap which is sewn onto this which goes around the back of the shoe to hold it in place. This is adjustable in length with a triglide adjuster. This also has a front-release clip for ease of removal, and a short length of elastic tape for tensioning the harness on the shoe. There is a triangle on top of the shoe which is used to connect to the elastic cord assembly. The position of the triangle which connects to the elastic cord assembly can be adjusted to suit the person's requirements;
• A shoelace connector which goes round either shoelaces or a sandal strap for a discreet but secure fit. This is made from polypropylene webbing with a plastic triangle and a front release clip.

The Musmate works in the following manner. When you place your foot on the ground during the gait cycle, you stretch the elastic cord. Then, when you lift your leg to walk forward, the shoulder harness acts as an anchor, the tension on the cord is reduced by the lifting of the leg and so contracts. This lifts your foot up. The length of the elastic cord is adjustable so that the amount of support is altered to best meet your needs. A shorter cord has a stronger action, because it has to be stretched further to reach the ground and also because more of the elastic cord is doubled over by the adjusting nylon peg. The height of the foot lift is adjustable by changing the length of the length-adjusting strap on the shoulder harness. A shorter strap will lead to a higher lift because the effective end of the elastic cord assembly is raised higher up.

The person using the Musmate puts the shoulder harness, shoulder pad (if used), and waist belt on first. They then attach the desired shoe harness or shoelace connector onto their shoes and then connect the two with the elastic cord assembly. They stand up and then adjust the tension in the elastic cord to their satisfaction.

The provided text describes the Musmate Walking Aid and its comparison to a predicate device, the Foot-Up. Here's an analysis of the acceptance criteria and study details based solely on the provided input:

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

The document does not explicitly state formal "acceptance criteria" for the Musmate device in terms of specific performance thresholds that must be met for clearance. Instead, the study aims to demonstrate "substantial equivalence" to a predicate device and highlight clinical benefit.

However, based on the clinical test data presented, we can infer a primary performance metric: walking speed improvement.

2. Sample size used for the test set and the data provenance

• Sample size for the test set: The "Degrees of Freedom" for the Musmate in Table 5.3 is 15. For a T-test, Degrees of Freedom (df) is typically n-1. Therefore, the sample size (n) for the Musmate clinical test was 16.
• Data provenance: The document states "Musmate Ltd is a company registered in England & Wales" and provides UK contact details. It also mentions "The company is not yet registered with the FDA., but will do so once clearance is obtained." This suggests the study was conducted in the United Kingdom.
• Retrospective or prospective: The description "When the test started, the mean walking speed..." and "After one month, the walking speed..." indicates a prospective study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. The primary metric measured (walking speed) is objective and does not inherently require expert interpretation for ground truth.

4. Adjudication method for the test set

The document does not mention any adjudication method for the test set. Given that walking speed is an objective measurement, a formal adjudication process may not have been deemed necessary.

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

• Was an MRMC study done? No, this device is a walking aid, not an imaging device or diagnostic tool that would typically involve "human readers" or AI assistance in a diagnostic context. The study focuses on direct physiological/functional improvement.
• Effect size of human readers with AI vs without AI assistance: This is not applicable to the Musmate device.

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

The Musmate is a physical medical device (walking aid), not an algorithm or AI system. Therefore, a "standalone algorithm-only" performance study is not applicable. The device itself is the "standalone" component being tested for its effect on human performance (walking).

7. The type of ground truth used

The ground truth used was objective physiological/functional measurement, specifically mean walking speed (in m/s).

8. The sample size for the training set

The document does not mention a training set. This is a physical device, not a machine learning model, so the concept of a "training set" in the context of AI/ML is not applicable. The clinical study described serves as the evaluation or validation study for the device's performance.

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

As there is no mention of a "training set" for an AI/ML model, this question is not applicable.

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The Myomo e100 is indicated for use by stroke patients undergoing rehabilitation to facilitate the following:
. Stroke rehabilitation by muscle re-education
. Maintaining or increasing range of motion .

The Myomo e100 is an electromechanically powered device intended to facilitate movement and increase range of motion for stroke patients. This device would be included as part of prescribed physical therapy to enable stroke patients to exercise that would otherwise be unable to independently do so. The Myomo e100 is an automatic strength amplifier using the detected electromyograph (EMG) as an indication of residual muscle strength. In the case of a patient who is unable to move his/her arm, the addition of strength amplification allows him/her to perform standard physical therapy exercises.
The Myomo e100 is available in left and right arm configurations. Foam pad inserts of various shapes are provided for fitting the brace for individual patients. Placement of the EMG sensors is configured for the individual patient allowing placement on either the tricep or bicep depending on the prescribed exercise. Optional adjustments for bicep and tricep gain are set and stored as part of the customization.
As pictured in Figure 1, adjustable straps are used to attach the brace to the arm. Once the brace is properly fitted to the arm the Myomo e100 is turned on using the "Control User Interface". The EMG signals are calibrated in the resting position and then the brace is ready for operation. The battery pack attaches to the "Control User Interface" and is not in contact with the patient.
The prescribing health care provider incorporates use of the Myomo e100 as part of a patient's physical therapy regimen. Progress can be monitored through the prescribed therapy using a goniometer, Fugl-Meyer testing, or other conventional evaluation techniques.
The Myomo e100 consists of three main elements:

• Brace: provides support for the forearm during lift. 4.1
• 4.2 EMG Sensors: B & L Electrodes
• Control User Interface: provides the signal processing function and the motor 4.3 mechanism and controls for operation of the Myomo e100.

The Myomo e100 510(k) submission (K062631) does not contain the type of acceptance criteria and performance study details typically associated with AI/ML-based medical devices or diagnostics. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technical characteristics, and compliance with general safety and performance standards.

The document explicitly states: "Neither bench, animal nor clinical testing were assessed." and "Performance Testing: Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30." This means a formal clinical performance study, as would be expected for AI/ML devices, was not required or submitted for this particular device.

Therefore, many of the requested categories in your prompt cannot be answered from the provided text. I will provide the information that is available.

Description of Acceptance Criteria and Reported Device Performance

The submission for the Myomo e100 does not present a table of specific acceptance criteria for a diagnostic or AI/ML performance study, nor does it report device performance in terms of metrics like sensitivity, specificity, or accuracy.

Instead, the "Performance Data" section primarily addresses:

1. Compliance with recognized standards:

   • IEC 60601-1-1 (Thermal, Electrical, Mechanical Safety)
   • IEC 60601-1-2 (Electromagnetic Compatibility)
   • FDA's "Reviewer Guidance for the Content of Premarket Submission for Software Contained in Medical Devices", May 11, 2005
   • FDA's "Guidance for Off-The-Shelf Software Use in Medical Devices"
   • ISO 14971:2000 (Risk Analysis)
   • ISO 10993-1:2003 (Biocompatibility)
   • Title 21 CFR Part 898 Performance Standard for Electrode Lead (demonstrated by conformity to IEC 60601-1-1).

2. Design Verification and Validation: Bench testing was performed according to FDA's Design Control Requirements (Title 21 Code of Federal Regulations, Part 820.30).

The conclusion states that the Myomo e100 is "substantially equivalent to the afore-mentioned predicate devices with respect to indications for use/intended use, and technical characteristics." This is the primary "acceptance criterion" for a 510(k) premarket notification when formal clinical performance data is not deemed necessary by the FDA.

Information Not Available (and why)

The following information cannot be extracted from the provided text because the submission did not include a clinical performance study as typically seen for AI/ML devices:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of this 510(k) submission.
2. Sample size used for the test set and the data provenance: No test set (clinical data) was used or reported in this submission for device performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set with expert-established ground truth was reported.
4. Adjudication method for the test set: Not applicable.
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/ML diagnostic device and no human reader study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable, as no AI model training was mentioned.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is available from the text:

• Device: Myomo e100, an electromechanically powered device for stroke patients undergoing rehabilitation to facilitate muscle re-education and maintain/increase range of motion. It uses detected electromyograph (EMG) as an indication of residual muscle strength to amplify movement.
• Regulatory Pathway: 510(k) Premarket Notification (K062631).
• Basis for Clearance: Substantial equivalence to predicate devices (Kinetec 6080 CPM for Elbow, Biomove 3000, Boston Digital Arm System) based on indications for use/intended use and technical characteristics.
• Performance Data: Focuses on compliance with recognized safety, electrical, EMC, software, risk management, and biocompatibility standards (e.g., IEC 60601-1-1, IEC 60601-1-2, ISO 14971, ISO 10993). Bench testing for design verification and validation was performed as per FDA Design Control Requirements (21 CFR Part 820.30).
• Absence of Clinical Studies: The submission explicitly states that "Neither bench, animal nor clinical testing were assessed" for the comparison of the Myomo e100 to predicate devices. This indicates that a separate, formal clinical performance study was not required by the FDA for this particular 510(k) clearance, as the device was deemed substantially equivalent through other means (design documentation, technical characteristics, and standards compliance).

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The SensorWalk is intended to lock the knee joint during the stance phase and to unlock the knee joint during the swing phase when walking forward on level surfaces. It is intended solely for the orthotic fitting of the lower limbs of patients who are community ambulators and who:

• Exhibit knee instability in the sagittal plane while bearing weight during the stance phase of their gait cycle;
• Have hip extensor strength of at least grade 3 (against gravity);
• Have the muscle strength in their torso or pelvis required to swing the SensorWalk forward while they are walking;
• Have a gait in which the step length on level ground exceeds the length of the opposing foot;
• Weigh 300 pounds or less; and
• Are able to understand and carry out the instructions.

The Sensor Walk is a microprocessor-controlled Knee Ankle Foot Orthosis (KAFO) designed to help wearers achieve a safer, more physiologically correct gait. It does this by unlocking the knee joint when the wearer is ready for swing phase and locking it again for stability during stance phase.

The Sensor Walk system includes an onboard microprocessor, a clutch spring knee joint, foot pressure sensors, a knee angle sensor, a battery, and a battery charger. When the sound limb has been loaded during walking and the affected side is about to enter swing phase (with the toe still on the ground) the microprocessor reads signal information from the foot and knee sensors and allows the knee to go into flexion. When the orthosis begins to extend again, the knee will enter a stable phase, preventing any flexion while allowing full extension for stance phase. The Sensor Walk will support the wearer if they load it at any point while it is extending, offering them exceptional stability. Wearers can disengage the knee joint, such as for sitting, simply by pressing the manual release switch.

The Sensor Walk offers 12 hours of continuous use before it needs to be recharged, and contains an audible warning to alert the use if the battery is running low.

When the Sensor Walk is turned off, it offers the stability of a traditional locked KAFO throughout the gait cycle.

The Sensor Walk has Manual Release Function. A control collar at the knee joint can be manually pushed back to temporarily override the locking mechanism and put the joint into free swing mode. As soon as the collar is reling meetialism und be able to lock.

To override the Sensor Walk's locking mechanism for a longer period, a Manual Release Rocker Switch can be pressed to lock the control collar in the free swing mode. When the Manual Release Rocker Switch is pressed and the joint is in free-swing mode, the switch will show an amber dot to indicate that caution should be used. In normal operating mode, the switch will show a green dot indicating that the locking feature will function normally.

The Sensor Walk™ is comprised of the following parts: a traditional, doubleupright KAFO with a free-articulating medial knee joint; a lateral mechanical clutch, 6 spring knee joint, microprocessor-controlled electronics, foot sensors, a battery, and a battery charger.

The foot sensor plate includes 4 sensors arranged in a straight line on the bottom of the foot plate. They are numbered from 1 to 4, beginning with the most posterior. The sensors overlap by 3/8 inch (10mm), and are wired to a sensor selection switch located in the electronics of the Sensor Walk. The Sensor Walk comes delivered with sensors 1 and 2 activated, but, if necessary, other sensors can be selected to optimize patient fitting.

The Sensor Walk is delivered with the following components:

• Fabricated KAFO with Sensor Walk (17B500) knee joint and foot sensor (520E500)
• Battery (517B20) and Charger (517L20)
• Sensor Walk Instructions for Use

The Sensor Walk comes in either a right or left, laminated or thermoplastic. The Order Numbers are as follows:

• 17B500 == R-L300 == Laminated Right
• 17B500 = L-L300 Laminated Left
• 17B59() = R-T300 Thermoplastic Right
• 178500 -- L-T300 -- Thermoplastic Left

The provided text describes the "Sensor Walk" device, a microprocessor-controlled Knee Ankle Foot Orthosis (KAFO). However, it is a 510(k) summary for a medical device and not a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (OTTO BOCK FreeWalk), not on reporting specific performance against acceptance criteria from a standalone study. Therefore, the requested information about acceptance criteria, detailed study parameters, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is largely not present in the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The 510(k) summary focuses on comparing the Sensor Walk to a predicate device and outlining its intended use and technological characteristics, rather than reporting performance against specific, quantifiable acceptance criteria.

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

This information is not provided. The document does not describe any specific test set or study conducted for the Sensor Walk. It mentions that "None of the differences [between Sensor Walk and FreeWalk] raise any new questions of safety or effectiveness that have not been addressed by the developers (OTTO BOCK and Mayo Clinic)," which implies reliance on existing knowledge or internal assessments rather than a specific clinical trial detailed here.

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. No test set is described, so no ground truth establishment by experts is detailed.

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

This information is not provided. No test set is described, so no adjudication method is mentioned.

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 is not applicable as the Sensor Walk is a physical orthotic device, not an AI diagnostic or image analysis tool that would involve human readers.

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

This is not directly applicable in the context of a standalone algorithm performance in the way it's usually asked for AI/software devices. The entire device is the "standalone" unit in terms of its function (microprocessor-controlled KAFO). However, no specific performance metrics for the device are reported that could be compared to typical "standalone algorithm" evaluations.

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

This information is not provided. As no specific test data or study with ground truth is described, the type of ground truth used is unknown.

8. The sample size for the training set:

This information is not provided. The document does not mention any training set for an algorithm. While the device is microprocessor-controlled, the text does not describe a machine learning algorithm that undergoes a training phase.

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

This information is not provided. As no training set is mentioned, the method of establishing its ground truth is also not described.

Summary of what is available from the document (related to acceptance/testing):

• The device (Sensor Walk) aims to provide a safer, more physiologically correct gait by unlocking the knee joint for swing phase and locking it for stability during stance phase.
• Intended Use & Indications for Use: These outline the specific conditions and patient characteristics for which the device is designed. These act as high-level "acceptance criteria" for the device's application.
  • Intended Use: Orthotic fitting of lower limbs, for community ambulators, forward walking on level surfaces, with power turned on. Not for sports or aggressive use.
  • Indications for Use (Patient Criteria):
    • Knee instability in the sagittal plane during stance phase.
    • Hip extensor strength of at least grade 3 (against gravity).
    • Muscle strength in torso/pelvis to swing KAFO forward.
    • Gait where step length on level ground exceeds length of opposing foot.
    • Weigh 300 pounds or less.
    • Able to understand and carry out instructions.
• Functional Features: The document describes the device's operation (e.g., 12 hours continuous use, audible low battery warning, manual release function). Implied "acceptance" is that these features function as described.
• Substantial Equivalence: The key "study" or basis for clearance is the demonstration of substantial equivalence to the OTTO BOCK FreeWalk, a Class I exempt device. This comparison focuses on technological characteristics and intended use rather than specific endpoint performance data from a clinical trial. The developers (OTTO BOCK and Mayo Clinic) have attested that differences do not raise new safety or effectiveness questions.

Therefore, while the document explains the purpose and features of the Sensor Walk, it does not provide the detailed study information typically requested when evaluating acceptance criteria for a device, particularly one involving advanced algorithms or diagnostic capabilities. The 510(k) process for this Class I device relied on demonstrating similarity to a legally marketed predicate, rather than an independent clinical performance study with defined acceptance criteria.

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An orthosis worn on the wrist for medical purposes:

• to support and/or immobilize for functional improvement.
• for conservative treatment of symptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist.
• to keep wrist motion to a minimum while worn allowing the body to recover from the damage of repetitive motion or other injuries.
• to provide temporary relief of associated symptoms of some wrist conditions.

Not Found

I am sorry, but the provided text from K031576 does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance for the Spartan Orthopaedic Wrist Brace, Model SCT-1.

This document is an FDA 510(k) clearance letter, which means the device was found substantially equivalent to a predicate device already on the market. This type of clearance typically relies on demonstrating similarity to existing devices rather than extensive new clinical studies with detailed acceptance criteria and performance reports as would be expected for novel or higher-risk devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness study.
6. Information on standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states the device's indications for use and confirms its substantial equivalence to a legally marketed predicate device. It does not include performance data or studies defining and meeting specific acceptance criteria.

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