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The Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the biliary system.

The Single-use Extraction Baskets is a single-use, sterile, disposable device. It is intended for the endoscopic removal of stones and stone fragments in the biliary system. The device consists of basket, sheath, and handle components. The basket component is constructed of stainless steel/nitinol wires. And the basket is connected to the handle of the operating portion through the insertion portion. Activating the handle allows the basket to open or close. This device is not compatible with any mechanical lithotripter.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Single-use Extraction Baskets." This type of document is concerned with demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing. It is not a document that details the rigorous clinical validation of an AI-powered diagnostic device, which is what your request implies by asking about acceptance criteria, ground truth, training sets, and MRMC studies.

Therefore, most of the information you requested regarding acceptance criteria and a study proving device performance (especially for an AI device) cannot be found in this document because the device in question is a mechanical medical device (extraction baskets), not an AI diagnostic tool, and the review process outlined here focuses on substantial equivalence through non-clinical and mechanical performance testing.

However, I can extract information related to what was used to demonstrate the device's performance for this specific 510(k) submission:

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

The document does not provide a formal table of acceptance criteria with numerical performance metrics for an AI device. Instead, it lists the types of performance tests conducted and states that the "test results demonstrated that the subject device complies with the standard requirements." "Compliance with standard requirements" is the implicit acceptance criterion for these non-clinical tests.

• Dimensions Testing
• Tensile Pull Testing
• Simulated-Use Functionality & Durability Testing
• Stone Capture Testing
• Deflection Testing | Demonstrates basic performance and performs as intended. | Confirmed that the subject device performs as intended. |
  | Comparative Testing | Performance comparable to the predicate device (K203322). | Demonstrated that the subject is as safe and effective as the predicate. |

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

• Sample Size for Test Set: Not specified in terms of numbers of devices or specific test runs for each mechanical test. The document states "The following performance data were provided..." without quantifying the test samples.
• Data Provenance: Not explicitly stated, given that these are non-clinical bench tests rather than patient data. These tests would typically be performed in a lab setting by the manufacturer.

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

• This information is not applicable and not provided in this document. Since the device is a mechanical extraction basket, there is no "ground truth" in the diagnostic sense or expert interpretation required for these performance tests. The ground truth for mechanical performance is typically defined by engineering specifications and objective measurements.

4. Adjudication method for the test set

• This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for human expert review processes, typically in clinical studies or for establishing ground truth in diagnostic AI datasets. This document describes non-clinical engineering and performance tests.

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. This type of study is specifically for evaluating the impact of AI on human reader performance, usually in image-based diagnostics. This document is for a mechanical medical device, not an AI diagnostic tool.
• The document explicitly states: "The clinical data is not applicable."

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

• No, this is not applicable. The device is a "Single-use Extraction Basket," a physical tool, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The type of ground truth used

• For mechanical performance tests: The "ground truth" is established by engineering specifications, physical measurements, and industry standards (e.g., ISO, ASTM). For example, "Dimensions Testing" would verify that the device's dimensions meet pre-defined specifications. "Stone Capture Testing" would evaluate the basket's ability to capture stones under simulated conditions, with the "truth" being whether it successfully performed the action based on defined criteria.
• Not applicable for clinical or diagnostic "ground truth" derived from expert consensus, pathology, or outcomes data, as this is not an AI diagnostic device.

8. The sample size for the training set

• Not applicable. This device is a mechanical one and does not involve AI or machine learning that requires a "training set."

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

• Not applicable. As a mechanical device, there is no AI training set.

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NewPort Spinal System: The NewPort Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis, and/or failed previous fusion.

Daytona Small Stature Spinal System: The Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine. The indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the Daytona Small Stature Spinal System may be used for the above indications as an adjunct to fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is also indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The Daytona Small Stature Spinal System can be attached to other cleared SeaSpine posterior fixation systems (e.g., Atoll OCT, Sierra, Malibu, Daytona, and Mariner Spinal Systems) using the rod connectors. Refer to the package inserts for the indications for use for those systems.

Daytona Small Stature Growth Rod Conversion Set: The Daytona Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The extended axial connectors may be used with any cleared Daytona Small Stature Spinal System rod construct. The Daytona Small Stature Growth Rod Conversion Set is not intended to be used in conjunction with staples.

Malibu Spinal System (including with the Daytona Deformity System): The intended use of the Malibu Spinal System. when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis, and/or failed previous fusion. The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

Mariner Pedicle Screw System, Mariner MIS Pedicle Screw System, Mariner Deformity System, and Mariner RDX System: The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis, and/or failed previous fusion.

Mariner Outrigger Revision System: When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Systems: The Mariner Outrigger Revision System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/ilium) in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis (i.e., failed previous fusions). When used with Daytona Small Stature Spinal System for posterior non-cervical pedicle screw fixation in pediatric patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Mariner Outrigger Revision System is intended to be used with autograft.

NewPort Spinal System: The NewPort Spinal System. which consists of non-sterile pedicle screws. locking caps, rods. and cap/rod combos, is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The implants are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136), with the screws having a cobalt washer (Co-28Cr-6Mo per ASTM F1537).

Daytona Small Stature Spinal System: The Daytona Small Stature Spinal System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, as a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants, including monoaxial, and uniplanar screws, rods, locking caps, crossbars, hooks, and connectors. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562).

Daytona Small Stature Growth Rod Conversion Set: The Daytona Small Stature Growth Rod Conversion Set is a non-cervical spinal device intended to convert a traditional fusion construct into a non-fusion, growth- enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The system consists of single use extended axial connectors designed to interact with constructs consisting of hooks, screws, connectors, and rods. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

Malibu Spinal System (including with the Daytona Deformity System): The Malibu Spinal System, which consists of non-sterile implants and the associated instruments, is used to build constructs within the body to act as temporary or permanent posterior, non-cervical spinal fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The system consists of a variety of titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome allov (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) implants. including uni-planar and polyaxial pedicle screws, rods, locking caps, hooks, connectors, crossbars, set screws, and sublaminar wire.

Mariner Pedicle Screw System: The Mariner Pedicle Screw System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, a posterior nonpedicle fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The Mariner Pedicle Screw System includes a variety of non-sterile implants manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of fixed, uni-axial, uni-planar, polyaxial, and motion-limiting modular pedicle screws, as well as connecting spinal rods, hooks, connectors, crossbars, and a separate locking element. The Mariner Pedicle Screw System is comprised of several sub-systems whose components are compatible with one another and may be designed for use together, depending on the type of procedure and surgical approach. The sub-systems are as follows:

Mariner Outrigger Revision System: The Mariner Outrigger Revision System is a thoracolumbar revision system designed to help reduce the trauma associated with revision surgeries by allowing the user the option to leave the existing hardware in and extend the construct or remove and replace with new SeaSpine hardware. The system includes closed polyaxial heads, Z-rods, and a variety of connectors, including axial, parallel, and L-shaped connectors. The Mariner Outrigger Revision System is compatible with other SeaSpine posterior spinal fixation systems (e.g., Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems) which offer titanium and/or cobalt chrome alloy rods ranging in sizes from Ø4.5mm to Ø6.35mm.

Mariner MIS Pedicle Screw System: The Mariner MIS Pedicle Screw System includes instruments and implants designed to facilitate the placement of the Mariner system through a minimally invasive surgical approach. providing an additional surgical approach option for surgeons. The system includes additional rods and extended tab modular screw heads that provide access for instrumentation and implant placement via a minimally invasive surgical approach.

Mariner Deformity System: The Mariner Deformity System provides additional implants and instruments designed to expand the functionality of Mariner to address adult deformity applications. The system is comprised of a range of implants, such as pre-contoured and constrained rods, uni-planar, uni-axial, and fenestrated screws, hooks, lateral connectors, and modular screw heads, including those with a rigidly attached rod connector, as well as instruments for pedicle subtraction osteotomy, iliac fixation, reduction, derotation, and correction.

Mariner RDX System: The Mariner RDX System provides additional implants and instruments that are designed to facilitate implant-based reduction techniques with an open or minimally invasive approach. The system is comprised of a locking cap and a variety of standard tab, extended tab, and MIS screw heads, as well as associated instruments.

This FDA 510(k) premarket notification describes the addition of MR Conditional labeling to several spinal systems manufactured by SeaSpine Orthopedics Corporation. It is not an AI/ML device, therefore many of the requested categories are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of implants tested) for each ASTM standard. However, the testing was conducted in accordance with the specified ASTM standards, which inherently include methodologies for appropriate sample selection for validating specific physical properties. The data provenance is related to in-vitro testing of the devices themselves, not patient data (retrospective or prospective). The country of origin for the data (where the testing was performed) is not explicitly stated.

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

Not applicable. This submission is for the addition of MR Conditional labeling based on physical performance testing of the device components according to recognized ASTM standards, not on clinical or image-based ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. The evaluation relies on standardized physical testing protocols, not expert adjudication of clinical outcomes or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined limits and acceptable ranges specified within the ASTM consensus standards for each tested parameter (e.g., maximum allowable displacement force, torque, temperature rise, and characteristics of artifacts). Compliance with these limits, as determined by laboratory measurements, constitutes meeting the acceptance criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The Espire Elbow processes user's input signals to activate and control elbow movement.

The Espire Elbow is an advanced upper extremity prosthetic component that when paired with other manufacturers' devices can create a complete upper extremity prosthetic system. Control means of the Espire Elbow include cutaneous electrodes, linear transducers, touchpads and/or switches. The manual control methods (linear transducer, touchpads, and switches) only require that the patient can press/touch the buttons as well as provide a pull type activation. The cutaneous electrodes offer an advanced method of control that uses the patient's muscle signals to govern the movement of the upper extremity prosthetic system. Depending on patient preferences the Espire Elbow comes in two configurations, Pro and Hybrid. The Espire Elbow (Pro) is designed to provide natural flexion and extension through a powered elbow joint which is activated by the input signals from the user. The Espire Elbow (Hybrid) contains an auto-forearm balance mechanism that assists the user with manually moving the elbow into different positions. use the same battery, electronics, inputs, and outputs.

At the time of the fitting a certified prosthetist uses the set-up application to program the device with custom criteria specific for each patient's needs. The setup is completed over a secure Bluetooth connection, no patient information is kept within the application. The Espire Elbow is designed to work seamlessly with most major manufacturers' wrist and hand devices. The Espire Elbow provides the control signals and battery power to these terminal devices.

The Espire Elbow is suitable for adult patients that are unilateral above elbow upper limb amputees. The device can be administered via prescription by a licensed and certified prosthetist only. For the prosthetist fitting the arm, CPI does not require any specific training related to the technology. The prosthetist will determine the combination of control means to be used with the Espire Elbow. The Espire Elbow is to be used for assistance in daily living; this includes normal daily routine type activities, as well as returning to work. The Espire Elbow is not indicated for use while driving any motorized vehicle or operation of heavy machinery. The device is also not to be used in any extremely warm or cold environments; this is primarily determined by the battery pack requirements. The battery pack must be removed in order to charge the device, using the supplied wall charger. Use in very wet environments, showering or swimming with the device is also outside the system capabilities.

The provided text describes the 510(k) premarket notification for the Espire Elbow prosthetic device. It outlines the device's characteristics and its comparison to a predicate device to establish substantial equivalence. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically seen in AI/ML medical device submissions.

The Espire Elbow is a physical medical device (an elbow prosthetic), not a software-driven AI/ML diagnostic or prognostic system. Therefore, the types of acceptance criteria and performance studies requested in the prompt (e.g., related to AI performance metrics like sensitivity, specificity, types of data, expert ground truth, MRMC studies) are not applicable to this device.

The "Non-Clinical Performance Data" section mentions various testing performed (biocompatibility, electrical safety, EMC, usability, battery safety, software verification, mechanical testing), all of which are standard validations for physical medical devices to ensure they meet their design inputs and safety standards. The "Clinical Performance Data" section explicitly states that "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

Therefore, I cannot fulfill the request for a table of acceptance criteria and AI/ML-specific study details because the provided text is for a physical medical device, not an AI/ML-driven one.

To answer your prompt, I would need a document describing an AI/ML medical device submission.

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The COMPLETE CONTROL System is to be used exclusively for external prosthetic fittings of the upper limbs.

The COMPLETE CONTROL System is an advanced control solution designed to enhance the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System employs Pattern Recognition technology to acquire, non-invasively, the rich information in muscle signals to enhance the control of industry standard upper extremity prostheses. Patients can achieve intuitive control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. COMPLETE CONTROL simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.

The COMPLETE CONTROL System is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on. COMPLETE CONTROL does not require an additional battery.

The COMPLETE CONTROL System is an embedded system that is used in conjunction with an upper-limb prosthetic device. This device can include any combination of an elbow, wrist, hand or terminal device. It contains several modules, including one for processing surface EMG (CO-AMP), processing and translating the signals (CONTROLLER), along with a controlling training routine (CALIBRATE). Finally, a wireless adapter (COMMUNICATOR) is included with the system setup and is used to provision the entire system.

The COMPLETE CONTROL System contains the following components.

• 1. Device Interface Cable (clinician-specified termination type)
• 2. COMPLETE CONTROLLER main processor
• 3. COMPLETE CALIBRATE patient interface button
• 4. COMPLETE CO-AMP consolidated EMG amplifier
• 5. EMG Interface Cable
• 6. Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
• 7. Socket cut-out template for the COMPLETE CALIBRATE button
• 8. COMPLETE COMMUNICATOR USB dongle
• 9. COMPLETE CONTROLROOM software installation USB dongle

This document, a 510(k) summary for the "COMPLETE CONTROL System" by Coapt, LLC, outlines the device's characteristics and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It focuses on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision, latency) for the device's core function (pattern recognition for myoelectric control). Instead, the "acceptance criteria" are implied to be conformance to various standards and the successful completion of internal validation tests.

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

The document does not mention a test set with a specific sample size used for performance evaluation related to the device's primary function of pattern recognition for myoelectric control. The non-clinical performance data described relates to engineering verification and validation testing of the hardware and software components.

The data provenance for these engineering tests would typically be internal laboratory testing conducted by Coapt, LLC or a contracted testing facility. No information about country of origin of data or retrospective/prospective nature is provided for these engineering tests.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable and not provided in the document because the performance evaluation relies on engineering tests and conformance to standards, not on clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as there was no test set requiring expert adjudication for clinical or performance outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done and is not mentioned in the document. The device is a "Cutaneous Electrode" (Class II, Product Code GXY) that enhances the control of existing prosthetic devices; it's not a diagnostic imaging device where MRMC studies are typically performed. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

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

The document describes "Calibration and Pattern Recognition Test" and "Feature Extraction Test" which would involve the algorithm operating in a standalone manner, processing signals and performing its designated function. However, the exact methodology, metrics, and quantitative results of these algorithm-only tests are not detailed beyond stating they "Passed."

7. The Type of Ground Truth Used

For the engineering tests (e.g., cabling, power, wireless), the ground truth is simply the expected operational output or state of the system (e.g., cable connected correctly, power on, wireless connected). For the "Calibration and Pattern Recognition Test" and "Feature Extraction Test," the ground truth would be the expected or correct pattern recognition output based on the input EMG signals, but the specifics of how this ground truth was defined or evaluated are not elaborated. There is no mention of expert consensus, pathology, or outcomes data as ground truth for these tests.

8. The Sample Size for the Training Set

The document does not mention the sample size for a training set. While the device utilizes "Pattern Recognition technology," the details of its development and training, including the dataset size, are not provided in this 510(k) summary.

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

This information is not provided in the document. Given the use of "Pattern Recognition technology," a training set with associated ground truth (e.g., specific muscle movements or intentions linked to EMG patterns) would typically be required, but the document does not elaborate on this aspect of the device's development.

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The DEKA Arm System consists of a prosthetic arm and accessories, which are used by a certified prosthetist to create a full upper extremity prosthesis indicated for individuals, age 18 years and older, who have partial or full upper limb amputations or congenital defects. The device is used to assist in activities of daily living (ADLs).

The DEKA Arm System is a lithium-ion battery operated upper limb prosthesis intended to restore limb functions in individuals who lost all (i.e., shoulder disarticulations) or part of either upper limb (e.g., trans-radial amputation). Three configurations may exist, depending on the level of amputation or congenital defect: shoulder configuration (SC), humeral configuration (HC), and radial configuration (RC). It can provide up to 10 active degrees of freedom. Main components consist of Mechanical limb hardware, Arm Control Interfaces (ACI) that record user input signals (myoelectric recording electrodes, discrete bump switches, linear transducers, Inertial Measurement Units (IMUs), and force sensing resistors), Inertial Measurement Units (IMU) that record arm and foot movements, Master Arm Controller (MAC) that is the main processor, Arm Control Modules (ACM)/Hand Control Module (HCM) that control movement and are used for each respective limb component, and One or more battery modules and holsters. These components communicate via the Controller Area Network (CAN). The device is powered through a separate power bus. The system, not including the IMUs, is IP52 rated. The MAC controls wrist movement only, but oversees all actuators. There is afferent and efferent communication between the MAC and ACMs, HCM, IMUs, ACIs and battery module. The ACMs control actuators above the wrist while the HCM controls actuators below the wrist. The battery module may be embedded inside the arm, or worn outside the arm. IMUs do have a Power Control Module for the battery and are IP57 liquid/particle ingress rated. The hand has a grip release button that will release the grip in emergencies. The arm communicates wirelessly via 2 RF channels to a personal computer (PC) for configuration, as well as up to two IMUs. Signal acquisition from the user may be derived from cutaneous myoelectric recording electrodes, discrete bump switches, linear transducers, IMUs, and force sensing resistors, with the ability to accommodate 4 inputs (including up to 2 wireless inputs). Each of the 4 input methods may use up to 4 channels each. Wireless input comes only from the IMUs. Wired input is acquired through the ACIs and transmitted to the MAC. Modes are used to control the 10 degrees of freedom, including Standby, Hand, and Arm modes. Feedback will be provided by a tactor and an LED control display on the arm.

Here's a breakdown of the acceptance criteria and the study information for the DEKA Arm System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "SPECIAL CONTROLS" section and the "Basic Safety and Essential Performance" section within the Electrical Testing. The reported device performance is gathered from the "SUMMARY OF NONCLINICAL/BENCH STUDIES" and "SUMMARY OF CLINICAL INFORMATION" sections.

Table of Acceptance Criteria and Reported Device Performance:

• Leakage current tests within specification.
• During operation, a failure in communication between control modules shall result in the prosthesis reverting to a safe state.
• During operation, a detectable failure or out of range reading of any sensor or motor shall result in the prosthesis reverting to a safe state.
• When power is removed, system shall revert to a safe state.
• Means to turn power on/off. | - Leakage current tests (IEC 60601-1: Sec. 8.7) were within specification and acceptable.
• EMC testing performed to IEC 60601-1-2 and additional FDA RF Wireless Guidance, all tests passed for various configurations.
• Software/firmware review (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005) determined moderate level of concern.
• Wireless communications with PC are checksummed to maintain safety.
• Fault Safety: During fault/shutdown, arm slows/stops, hand stops; sensory input ignored (except hand open button).
• Sudden power loss testing ensured defined safe state is reached.
• Arm is limited in joint speed and further reduced when moving towards face.
• Hand has a grip release button (two for redundancy) that releases grip in emergencies.
• System provides ON/OFF switches (soft Off 1-2s, hard Off 8s). |
  | Software Performance | - Appropriate software verification, validation, and hazard analysis must be performed. | - All software (Luke Arm Software, Prosthetist Interface (PI) Software) was appropriately validated.
• PI Software allows configuration of arm movements in response to EMG/other inputs, with a virtual reality environment for testing. |
  | Non-clinical Performance | - Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use.
• Mechanical bench data, including durability testing, to demonstrate that the device will withstand forces, conditions, and environments encountered during use.
• Simulated use testing to demonstrate performance of arm commands and safeguard(s) under worst-case conditions and after durability testing.
• Verification and validation of force sensors and hand release button.
• Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor/actuator performance, motor/brake performance.
• Accuracy of device features and safeguards. | - Durability testing (2 samples, simulated 3 years of usage by cycling arm 4,000-28,000 times) found some components required maintenance after 18 months, leading to updated labeling. Tests were acceptable, criteria met.
• Mechanical strength testing (IEC 60601-1:2005 Sec. 15.3) conducted.
• IP52 testing documented (IMU is IP57 rated) in accordance with IEC 60529.
• Testing of face approach velocity slowdown done (from various initial positions).
• ACI and IMU communication loss testing performed.
• Hand open button tested with different grips.
• Device reverts to safe state if joint is overloaded (prevents whipping).
• Can carry payload of up to 3.9 kg.
• Biocompatibility evaluation of patient-contacting materials performed (electrodes cleared in K032833; socket materials tested per ISO 10993). Materials well-characterized.
• Abuse testing (shock and impact) done per IEC 60601-1-11 2010 and IEC 60601-1:2005 Sec. 15.3.
• Device passed all identified non-clinical tests. |
  | Clinical Performance | - Non-clinical and clinical performance testing must demonstrate the accuracy of device features and safeguards.
• Documented clinical experience and human factors testing must demonstrate safe and effective use, capture any adverse events observed during clinical use and demonstrate the accuracy of device features and safeguards. | VA Study (Study 1):
• Evaluated usability, dexterity, prosthetic skill, spontaneity, daily activities, and satisfaction.
• 29 subjects completed objective testing.
• Comparison of DEKA Arm (Gen3) vs. current prosthesis showed DEKA Arm outperformed current prosthesis in most activities (Figure 3), and was preferred by 83% of users (Table 2).
• Two of four self-report measures (UEFS Use, Patient Specific Functional Scale) were significantly better with the DEKA Arm.
• 77% of participants wanted a DEKA Arm in the future.
  DEKA Study (Study 2):
• 10 arm users.
• Participants found Gen2 and Gen3 comfortable, wore them 7 hrs/day and 6 hrs/day respectively.
• Reported DEKA Arm was better at performing tasks than existing prosthesis.
• Reliability reported as fair, improving to near excellent for later Gen3 subjects.
• Feedback from heavy users led to design changes.
  Overall: Studies "reasonably demonstrate the safety and effectiveness of the DEKA arm system during the completion of predefined tasks and spontaneous activities in both the laboratory and home settings." |
  | Biocompatibility | - Elements of the device that may contact the patient must be demonstrated to be biocompatible. | - Electrodes previously cleared (K032833) and passed biocompatibility testing.
• Socket materials (prolonged contact) tested per ISO 10993 for skin irritation, sensitization, and cytotoxicity.
• Materials well characterized in prosthetic applications. |
  | Labeling | - Labeling for Prosthetist and User Guide must include:
  a. appropriate instructions, warnings, cautions, limitations, info on safeguards (e.g., driving).
  b. specific instructions and clinical training (assembling, fitting, programming, controls, modes, safety features, maintenance).
  c. information on patient population for which device effective.
  d. detailed summary of non-clinical and clinical testing. | - Patient labeling written according to "Guidance on Medical Device Patient Labeling" (2001), readable and understandable.
• Definitions of symbols described.
• Labeling checked according to IEC 60601-1:2005 Clause 7.
• Indications for Use in User and Prosthetist guides.
• Contraindications in Prosthetists Guide are general and appropriate.
• User/Prosthetist Guides provide clear and understandable instructions, warnings, cautions.
• Contact info provided for electrode replacement.
• Labeling updated for maintenance needs based on durability testing. |

Study Details:

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

• Study 1 (VA Study):
  • Test Set Sample Size: 36 arm users enrolled, 29 completed all objective testing.
  • Data Provenance: Retrospective and prospective. The study was described as an "iterative usability and optimization study with repeated measures collected prior to and after users received the DEKA Arm." It was conducted in the US (Veterans Affairs).
• Study 2 (DEKA Study):
  • Test Set Sample Size: 10 arm users.
  • Data Provenance: Retrospective and prospective. The study involved daily interviews during a home use portion (two-week interval), suggesting a prospective data collection approach. Conducted by the sponsor, likely in the US.

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

The studies primarily used a mixed-methodology approach involving performance-based tests (objective measures) and self-report measures (subjective from users). There isn't an explicit mention of a panel of independent experts establishing a "ground truth" in the sense of diagnostic imaging (e.g., radiologists interpreting images). Instead, the "ground truth" for performance was based on:

• Clinical Assessments: Administered by study personnel/therapists using standardized tests (e.g., Modified Box and Blocks Test, Jebsen-Taylor Hand Function Test). These individuals would be qualified in rehabilitation and prosthetics.
• Prosthetist Ratings: Evaluations of ease of fitting and setup.
• Therapist Ratings: Evaluations of ease of training and aspects of the arm's function.
• User Reports: Self-reported ease of use, satisfaction, and ability to perform tasks.

The number and specific qualifications (e.g., years of experience) of the prosthetists, therapists, or other clinical personnel involved in administering these tests or providing ratings are not specified in the provided text.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for the test set. For performance-based tests, scores are derived from direct observation or timed tasks. For self-report measures, user responses are directly collected. The study design does not suggest a need for "adjudication" in the typical sense of resolving conflicting expert opinions on a specific diagnosis or finding.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• Yes, a comparative effectiveness study was done, comparing the DEKA Arm to the subjects' existing prostheses. However, it was not an MRMC study in the traditional sense of multiple "readers" (e.g., radiologists) evaluating cases.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: This specific metric (human reader improvement with/without AI assistance) is not applicable here as the DEKA Arm is a prosthetic device for physical function, not an AI diagnostic tool primarily assisting human interpretation.
  • Instead, the studies compared the human user's performance with the DEKA Arm to their performance with their existing prosthesis.
  • Study 1 (VA Study) results:
    • The DEKA Arm (Gen3) outperformed current prostheses in most activities (Figure 3, where DEKA Arm, black bars, are generally longer).
    • 83% of users preferred the DEKA Arm for specific activities (Table 2).
    • Two of four self-report measures were significantly better with the DEKA Arm.
    • Performance was significantly slower on 2 measures (Box and Block and Jebsen feeding tests) with the DEKA Arm.
  • Study 2 (DEKA Study) results: Participants reported the arm system was better at performing tasks than their existing prosthesis.

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

This question is not applicable to the DEKA Arm System. The DEKA Arm is a prosthetic device designed for human use and controlled directly by the user. It does not operate as a standalone algorithm or AI model in a diagnostic or interpretive capacity. Its "performance" is inherently human-in-the-loop. The non-clinical bench testing does evaluate the device's technical functions independently, but this is not a standalone "algorithm" performance test.

7. The Type of Ground Truth Used

The "ground truth" was established through a combination of:

• Performance-based tests: Objective measures of dexterity and functional activities (e.g., number of blocks moved, tasks completed in time, observation of successful completion).
• Self-report measures: Subjective assessment of satisfaction, ease of use, and perceived difficulty from the users themselves.
• Professional ratings: Evaluations by prosthetists and therapists.

This is a clinical "ground truth" based on observed functional performance and user experience, rather than a pathological or outcomes-based "ground truth" derived from a definitive diagnostic test.

8. The Sample Size for the Training Set

The provided document describes clinical studies and non-clinical/bench studies. There is no explicit mention of a "training set" in the context of machine learning model development for the DEKA Arm System's operation or evaluation. The studies focus on testing the finished device.

The development process for the DEKA Arm involved iterative design based on feedback, especially from the Gen2 to Gen3 versions ("changes listed above are improvements made based on feedback received during device testing"). This feedback loop could be considered a form of "training" or refinement for the device design, but not a "training set" for a separate AI model within the device in the sense of deep learning.

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

As there is no distinct "training set" for a machine learning model identified in the document, this question is not applicable. The "ground truth" for the device's development was likely established through engineering specifications, user requirements, and iterative testing and feedback during the design phases.

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