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The DRX9000-SL True Non-Surgical Spinal Decompression System provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome and sciatica.

The DRX9000-SL True Non-Surgical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. The user interface provided by the treatment computer constantly updates a servo-amplifier controlling a servo-motor to immediately and safely apply forces as determined by qualified healthcare personnel. Load-cell feedback is utilized to further verify and adjust tensile forces, allowing for variations in patient posture and outside forces such that continuous and smooth tension is experienced by the patient.

An upper chest harness and a lower pelvic harness are used to help distribute the applied forces evenly. Once in place, the patient is slowly reclined to a horizontal position. Following the physician's orders, the therapist localizes the pain, makes any adjustments and directs the treatment to the proper area. The DRX9000-SL True Non-Surgical Spinal Decompression System helps to mobilize the troubled disc segment without introducing further damage to the spine.

The patient safety switch is held by the patient who at any time and for any reason may quickly pause any tensile forces. The patient safety switch is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.

The emergency stop button is accessible to the operator who at any time and for any reason may quickly pause any tensile forces. The emergency stop button is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.

Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, dedicated and matched servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), two segment (upper and lower) textile patient harness, patient safety switch, and free-floating lower body mattress. The free-floating lower body mattress allows the interdiscal segments of the lumbar spine to decompress at their own rate. As tension is cycled, the lower body can extend independent of the upper body which is held in place via an upper body textile patient harness. The treatment bed and textile harness allow the patient to relax completely and require no conscious exertion on the part of the patient. Total patient relaxation encourages paraspinal muscle relaxation from both a physical and psychological standpoint and is a key to spinal decompression.

The provided FDA 510(k) clearance letter and summary for the DRX9000-SL True Non-Surgical Spinal Decompression System do not contain information related to acceptance criteria for an AI device, nor any study that proves an AI device meets such criteria.

The submission is for a medical device that applies spinal decompressive forces, and it primarily focuses on demonstrating substantial equivalence to a predicate device (DRX9000 True Non-Surgical Spinal Decompression System) through non-clinical testing of electrical safety, EMC, usability, risk management, biocompatibility, and software.

Therefore, I cannot provide the requested information, as the input document does not pertain to an AI device or a study with typical AI-related acceptance criteria.

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The DRX9000C-SL Cervical Spinal Decompression System provides a program of treatments for relief from pain for those patients suffering with neck pain. It is designed to apply spinal decompressive forces to the spine. Conditions that may be treated include neck pain associated with herniated discs, protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome.

The DRX9000C-SL Cervical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. The user interface provided by the treatment computer constantly updates a servo-amplifier controlling a servo-motor to immediately and safely apply forces as determined by qualified healthcare personnel. Load-cell feedback is utilized to further verify and adjust tensile forces, allowing for variations in patient posture and outside forces such that continuous and smooth tension is experienced by the patient.

A headpiece harness is used to help distribute the applied forces evenly. Once in place, the patient is slowly reclined to a horizontal position. Following the physician's orders, the therapist localizes the pain, makes any adjustments and directs the treatment to the proper area. The DRX9000C-SL Cervical Spinal Decompression System helps to mobilize the troubled disc segment without introducing further damage to the spine.

The patient safety switch is held by the patient who at any time and for any reason may quickly pause any tensile forces. The patient safety switch is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.

The emergency stop button is accessible to the operator who at any time and for any reason may quickly pause any tensile forces. The emergency stop button is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.

Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), headpiece harness, patient safety switch, and mattress.

The provided FDA clearance letter for the DRX9000C-SL Cervical Spinal Decompression System does not contain information regarding detailed acceptance criteria for device performance with specific metrics, nor does it describe a clinical study of the device proving it meets acceptance criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DRX5000) primarily through non-clinical testing and comparison of technical characteristics.

Here's a breakdown of the requested information based on the provided text, highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantifiable acceptance criteria for device performance (e.g., specific pain reduction percentages, success rates, or ranges of therapeutic effectiveness). It broadly states the device "provides a program of treatments for relief from pain" and is "designed to apply spinal decompressive forces."

The most direct "performance" metrics described relate to the device's capabilities rather than clinical outcomes:

• Traction Force: Can be varied between 0 – 50lbs pull. (This is a capability, not a clinical outcome or acceptance criterion).
• Treatment Time: Up to 30 – 45 minutes. (Again, a capability).

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

No clinical test set is described or utilized for proving device performance. The submission explicitly states: "Clinical testing is not required for this submission. The non-clinical performance testing described above is sufficient to support substantial equivalence of the subject device to the predicate device."

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

Not applicable. No clinical test set requiring expert ground truth establishment was conducted or referenced.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was conducted or referenced.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document explicitly states clinical testing was not required. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be provided. This device is a mechanical traction system, not an AI-assisted diagnostic or treatment planning tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a mechanical device, not an algorithm, so a "standalone" or "algorithm only" performance assessment is irrelevant in this context. Its function is to apply physical forces, controlled by software, but not to provide diagnostic or interpretative output like an algorithm.

7. Type of Ground Truth Used

Not applicable in the sense of clinical outcome ground truth. The "ground truth" for this submission revolves around demonstrating that the device's technical specifications and safety standards meet regulatory requirements and are substantially equivalent to a predicate device. This is achieved through:

• Engineering and Safety Standard Conformance: Verification that the device adheres to standards like IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 & IEC 62366-1 (usability), ISO 14971 (risk management), ISO 10993-1 (biocompatibility), and IEC 62304 (software life cycle processes).
• Predicate Device Comparison: Establishing substantial equivalence by comparing technological characteristics and intended use to the DRX5000 (K023160).

8. Sample Size for the Training Set

Not applicable. This device undergoes non-clinical engineering and safety testing, not machine learning model training.

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

Not applicable. No training set for a machine learning model is involved.

In summary, the FDA clearance for the DRX9000C-SL Cervical Spinal Decompression System was based on non-clinical testing demonstrating conformance to recognized safety and performance standards, and a comparison of its technological characteristics and intended use to a legally marketed predicate device (DRX5000) to establish substantial equivalence. The submission explicitly states that clinical testing was not required.

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The Back on Trac (BOTGEN1) and Cervi-Trac Systems are in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder).

Back on Trac
The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)". The device may be used to manage and reduce pain associated with the following conditions:

• facet syndrome,
• herniated disc,
• protruding disc,
• extruded disc,
• sciatica,
• spondylosis (degenerative disc disease & facet syndrome),
• joint pain.

Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back.

Cervi-Trac
The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.

The Ergo-Flex Technologies Systems that are the subject of this premarket notification are prescription use only and are intended for use by licensed, qualified healthcare professionals, such as physicians, chiropractors, physical therapists, etc.

Ergo-Flex Back on Trac System:
The (BOTGEN1) is comprised of a reclinable therapeutic cushioned chair with back support portion and a second lower back, upper and lower leg support section that is movable in an axial direction with respect to the back support section and is also arcuately movable about a pivot axis that is perpendicular to the axial direction. The chair includes remotely controlled linear actuators to control the relative movement of the different sections of the device.

Ergo-Flex Cervi-Trac:
The Cervi-Trac (CT) is an accessory to the Back on Trac (BOTGEN1) that focuses specifically on the cervical region. The patient is not restrained by the Back on Trac arm bolsters, therefore lumbar traction is not activated by the Cervi-Trac during this therapy.

This document is a 510(k) summary for the Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac devices. It demonstrates substantial equivalence to a predicate device, as opposed to proving the device meets specific performance criteria through a clinical study. Therefore, the information requested regarding acceptance criteria, study design, ground truth establishment, and expert involvement is not applicable in the context of this document.

Here's why and what information is provided:

• 510(k) Premarket Notification: This is a regulatory pathway used to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. It generally relies on non-clinical performance data and a comparison of technological characteristics, rather than de novo clinical efficacy studies with specific acceptance criteria that would typically be required for novel devices or those seeking a new indication.

Based on the provided document, here's what can be stated regarding the requested categories:

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

   • Not Applicable. This document does not present a table of acceptance criteria and reported device performance in the way a clinical trial or performance study would. The acceptance is based on demonstrating "substantial equivalence" to a predicate device, which is achieved by showing similar intended use and technical/functional characteristics, and adherence to relevant consensus standards.
   • Instead, the document provides a "Comparison of the IFU and Technical Specifications and Performance Characteristics" (Table 1 on page 9) between the subject device and the predicate device. This table highlights similarities and differences in parameters like intended use, environment, treatment areas, electrical safety, EMC, and traction mechanism.
   • For performance, it states: "Performance testing on the Back on Trac (BOTGEN1) and Cervi-Trac Systems demonstrated the design, operational and functional parameters and safety features met the established specifications for each device and demonstrate performance substantial that is equivalent to the predicate device." However, specific numerical performance metrics are not listed as "acceptance criteria" but rather as "specifications" met.

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

   • Not Applicable. The submission did not involve clinical testing to demonstrate substantial equivalence. Therefore, there are no "test sets" of patient data in the typical sense for clinical performance.
   • The "testing" mentioned refers to non-clinical performance testing and compliance with recognized consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 14971 for risk management). These are tests on the device itself, not on patient samples.
   • Data provenance for such non-clinical testing is typically internal company data or reports from certified testing facilities, not patient data from specific countries or study designs.

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. Since no clinical test set with patient data was used to establish "ground truth" for efficacy or diagnostic performance, there were no experts establishing such ground truth.

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

   • Not Applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was conducted. This device is "Power traction equipment," which is a physical therapy device, not an AI or diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.

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

   • Not Applicable. This is not an algorithm-based device.

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

   • Not Applicable. No ground truth for clinical efficacy or diagnostic accuracy was established as part of this 510(k) submission. Substantial equivalence is based on engineering and performance characteristics compared to a predicate device, and compliance with safety standards.

8. The sample size for the training set:

   • Not Applicable. As this is not an AI/machine learning device, there is no "training set."

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

   • Not Applicable. There is no training set for an AI/machine learning model.

In summary, the document states:

• Clinical Performance: "Not applicable. Clinical testing was not provided to demonstrate the substantial equivalence of the Back on Trac (BOTGEN1) and Cervi-Trac." (Page 12)
• Non-Clinical Performance: The devices underwent "100% performance testing and Quality Assurance inspection" by the manufacturer, and "Performance testing...demonstrated the design, operational and functional parameters and safety features met the established specifications for each device and demonstrate performance substantial that is equivalent to the predicate device." (Page 12).
• The device was evaluated and tested by independent certified testing facilities in conformance with various consensus standards related to electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366-1), risk management (ISO 14971), and biocompatibility (IEC 10993). (Page 13)

This 510(k) clearance is based on the comparison to a legally marketed predicate device (Chattanooga Group's Triton/Tru-Trac/TX/Triton DTS Traction, K053223) and compliance with relevant safety and performance standards for mechanical devices, not on the demonstration of clinical efficacy through formal acceptance criteria and studies with human data.

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The Titus Titanium Cervical by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Titus Titanium Cervical by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The Titus Titanium Cervical by SAGICO is designed in a manner to be used with additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

The Titus Titanium Cervical by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The Titanium Cervical by SAGICO, is intended to be used at one disc level from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Titus Titanium Cervical by SAGICO incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The Titus Titanium Cervical by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device. The Titus Titanium Cervical by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Titus Titanium Cervical by SAGICO." This document is a regulatory filing for a medical device and describes its intended use, design, and comparison to legally marketed predicate devices to establish substantial equivalence.

**Crucially, this document does not describe:

• A study proving the device meets acceptance criteria.** Instead, it lists non-clinical performance data testing (like ASTM standards for static and dynamic compression, torsion, and pullout tests) that was conducted to support the claim of substantial equivalence. These are engineering and material tests, not clinical studies with patients or image-based diagnostic performance studies.
• Acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC). The "acceptance criteria" discussed implicitly are related to the mechanical and material properties of the implant, ensuring it functions safely and effectively as an intervertebral body fusion device.
• Any human-in-the-loop (MRMC) studies or standalone algorithm performance. This is an implantable medical device, not an AI/ML-based diagnostic software.
• Ground truth establishment for diagnostic purposes or expert review processes.

Therefore, I cannot extract the information requested as it pertains to AI/ML diagnostic device performance studies. The document describes a physical medical device (an intervertebral body fusion device), not an imaging or diagnostic AI. The "K221138" is a 510(k) clearance number for an implant, not for a diagnostic algorithm.

If the request was for a different type of document (e.g., an FDA clearance for an AI-powered diagnostic device), I would be able to provide the requested information, assuming it was present in that document.

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The SAGICO Spinal System - Lucas Expandable Lumbar by SAGICO are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO are to be filled with autogenous bone graft material. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO is intended to be used with supplemental fixation cleared by the FDA to properly utilize this device.

The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO must be used with the additional internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

LUMBAR: The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO implants are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral and can expand to the desired height. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO implants are to be filled with autogenous bone graft material. Protrusions are located on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

CERVICAL: The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO implant is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implants are comprised of PEEK Optima LT1 and include large central hollow window to be filled with autogenous bone graft material. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implants features protrusions located on the top and bottom surfaces of PEEK spacers to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO includes internal titanium spin blade offering internal fixation and expansion of 1mm in height allowing low profile insertion. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device.

MATERIALS: The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implants, and Carney Expandable Cervical Spinal Implants by SAGICO, are implants that are manufactured from medical Grade PEEK (Polyetheretherketone) OPTIMAT LT I (InvibioTM) per ISO 10993-1 USP Class VI, and ASTM F2026, Titanium Alloy per ASTM F136 and Tantalum beads /rods to be Grade IJNS R05200, IJNS R05400 according to ASTM F560.

FUNCTION: The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implants, and Carney Expandable Cervical Spinal Implants by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical and lumbar regions.

The provided text describes a 510(k) premarket notification for the "SAGICO Spinal System" and focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data. It does not contain information about a study that proves the device meets acceptance criteria related to an AI/ML-based medical device.

The document details:

• Device Type: Intervertebral Body Fusion Device (implants for spinal fusion).
• Purpose of filing: 510(k) premarket notification to demonstrate substantial equivalence to legally marketed predicate devices.
• Study described: Non-clinical (benchtop) testing to evaluate the mechanical performance of the spinal implants against established ASTM standards. This is done to show the physical device's safety and performance, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device's performance, as the document concerns a physical medical implant and its non-clinical testing for 510(k) clearance.

If you have a different document or context related to an AI/ML medical device, please provide it, and I will do my best to answer your questions.

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clTrac is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. clTrac may be used to treat pain and symptoms associated with the following conditions: herniated discs, bulging or protruding intervertebral disc disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.

The clTrac is powered traction equipment that offers both static and intermittent traction. Spinal traction is a form of decompression that relieves the pressure on the spine. Traction is a non-surgical, non-invasive and non-pharmaceutical treatment for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The clTrac is intended to be used by healthcare professionals (HCP) on their patients. When device is operational, the applied force shall not exceed +/-10% of the target force as set by the operator. clTrac applies a specific force onto the traction cord. The applied force is set by the operator by means of the touch screen and rotary knob. A patient interrupt button is available for the patient to pause the therapy. The cl Trac is a non-invasive therapeutic device. The device consists of a console with ABS housing. The console consists of an aluminium ground plate, an ABS outer shell, a 7" touch screen and a steel central control knob. A 2.9m long cord with a plastic patient interrupt button is plugged into the console. The console is intended to be fastened to a standardized traction table using screws that are tightly screwed into its aluminium ground plate, with holes in a standardized pattern. The implemented motor-gear unit applies traction via a traction cord that is fixed into the console with a 360° swivel head with guide pulley. The traction cord is intended to be attached to hip and thoracic traction belts that are sold separately.

The provided document is an FDA 510(k) clearance letter for the clTrac device, a powered traction equipment. It focuses on demonstrating substantial equivalence to a predicate device (Eltrac 471) rather than a deep dive into specific performance study details with acceptance criteria for an AI/ML-based medical device.

Therefore, many of the requested details regarding acceptance criteria, specific study types (MRMC, standalone), sample sizes for test and training sets, expert qualifications, and ground truth establishment methods for an AI/ML device are NOT present in this document.

The document details the device's indications for use, technological characteristics, and compliance with various voluntary general and electrical safety standards. It explicitly states:

• Clinical Performance: Not applicable. This device does not require clinical testing for demonstration of substantial equivalence and safety/effectiveness."

This means the 510(k) clearance was based on non-clinical performance (bench testing, electrical safety, software validation, usability, risk management, and biocompatibility) and comparison to a predicate, not on a study demonstrating clinical performance with specific metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML device clearances.

Here's a breakdown of what can be extracted or inferred based on the provided text, and where the information is missing:

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

The document doesn't present "acceptance criteria" in the way one would for an AI/ML diagnostic or prognostic device (e.g., target specificity, sensitivity thresholds). Instead, it refers to compliance with established medical device standards and the device's operational specifications.

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

• Sample Size: Not applicable. No clinical test set. The performance testing was primarily bench testing and engineering verification/validation against standards.
• Data Provenance: Not applicable for clinical data. The testing mentioned (electrical safety, EMC, usability, software, risk, biocompatibility) would 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

• Not applicable. There was no clinical test set requiring expert-established ground truth.

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

• No. This device is a powered traction equipment, not an AI/ML diagnostic aid for human readers.

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

• No. This device is electro-mechanical, not an AI/ML algorithm. Its "performance" refers to its physical operation and safety, not an intelligent diagnostic output.

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

• Not applicable. Ground truth for an AI/ML algorithm is not relevant here. The "ground truth" for the device's functionality would be engineering specifications and measurements (e.g., force output measured by a calibrated sensor, electrical safety limits).

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

• Not applicable.

In summary, the provided document is for a medical device clearance (clTrac, a powered traction equipment) that relies on demonstrating substantial equivalence to a predicate device and compliance with general device safety and performance standards. It explicitly states that clinical testing was "not applicable." As such, the detailed requirements for AI/ML device clearances (like test set/training set sizes, expert ground truth establishment, MRMC studies) are not relevant to this specific FDA submission and are not found in this document.

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The ELTRAC 471 Traction device, with its accessories, is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The ELTRAC 471 Traction device may be used to treat pain and symptoms associated with the following conditions: hermiated discs, bulging or protruding intervertebral discs, degenerative disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.

The Eltrac 471 traction device applies forces to the spine to alleviate pain caused by a variety of pressure on muscular or skeletal structures. It exerts defined forces on the human body to alleviate pain and utilizes computer technology for programming of different kinds of traction.

This device is intended for use by professional users only, such as qualified personnel in physiotherapy, rehabilitation and adjacent areas. The device is designed with a plastic housing that holds the motor and has a full color touch screen interface on which the professional user can enter various parameters by touch. The forces from the motor are transferred to the patient by cords and connected accessories. Sequential programming is possible for programming combinations of traction which can be stored as favorites for later use.

The provided text describes the regulatory clearance for the "Eltrac 471 Traction device" based on substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria through performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance against those criteria are not present.

However, I can extract the information that is available regarding regulatory requirements and the non-clinical performance evaluation.

Here's a breakdown of the available information based on your request:

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

The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) against which the Eltrac 471 was compared. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized non-clinical standards.

The "performance" is generally described as meeting safety and functionality requirements through verification and validation tests against these standards.

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 in the document. The non-clinical performance refers to "Verification and validation tests" conducted by Enraf-Nonius, B.V., but details about specific test sets, sample sizes, or data provenance (e.g., retrospective/prospective, country of origin) are absent. This is typical for submissions based on substantial equivalence for non-clinical devices where the "test set" would be the device itself subject to engineering and safety tests.

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)

This information is not provided. Clinical ground truth, experts, or their qualifications are not mentioned, as no clinical testing was performed or required. The "ground truth" for non-clinical tests would typically be defined by engineering specifications and standard requirements.

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

This information is not provided. Adjudication methods are relevant for clinical studies, which were explicitly stated as "Not applicable" for this device.

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 and not provided. This device is a physical therapy traction device, not an AI-assisted diagnostic or imaging device used by human readers/interpreters. No MRMC study was conducted.

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

This information is not applicable in the context of typical AI algorithm-only performance. The "device" itself, the Eltrac 471, performs its function (applying traction) independently to the extent of its programming. The "non-clinical performance" section describes tests on the device's electrical, safety, and software functionality, which could be considered a form of standalone testing for the device's inherent design.

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

For the non-clinical performance, the "ground truth" implicitly used would be engineering specifications, design requirements, and the pass/fail criteria defined by the cited international standards (ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304). This does not involve clinical "ground truth" like pathology or outcomes data, as no clinical studies were performed.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "software" component refers to control software, not a learned model.

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

This information is not applicable and not provided for the reasons stated in point 8.

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Modpod cervical traction provides mobilization of skeletal structures and muscles in static, intermittent, progressive, and regressive distraction forces to relieve pressures that may be causing pain of skeletal or muscular origin. These effects are achieved through decompression of intervertebral discs, that is, unloading due to distraction and positioning, and may be used to relieve peripheral radiation/sciatica and pain associated with:
• Protruding discs
• Bulging discs
• Herniated discs
• Degenerative disc disease
• Posterior facet syndrome
• Acute facet problems
• Radicular pain
• Prolapsed discs
• Spinal root impingement
• Hypomobility
• Degenerative joint disease
• Facet syndrome
• Compressions fracture
• Joint pain
• Discogenic pain

The Modpod™ Cervical Traction Device provides static and intermittent distraction forces to the cervical spine to relieve pressures on structures that may be causing pain of skeletal or muscular origin. Therapeutic distraction can be applied in a variety of programmable patterns and functions.

The device design allows a clinician access to a patients head and neck when hands-on interaction and positioning is needed. Use of the device reduces the level of exertion experienced by the clinician when compared to manual traction therapy techniques. Additionally, hands-on interaction and positioning by the clinician may occur before or after treatment.

Painted sheet metal and ABS plastic encasement housing electronic circuitry; software and electronics engage a gear driven motor with load sensors; slide mechanism, and patient head harness to apply cervical traction.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a 510(k) premarket notification letter from the FDA to Hollywog, LLC, regarding their device called "Modpod".

This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices (K051938 and K053223). It details:

• Indications for Use: The medical conditions the device is intended to treat.
• Technical Specifications: Information about the device's design, power supply, components, and operational characteristics.
• Comparison to Predicate Devices: A comprehensive table comparing the Modpod to the predicate devices across various parameters like regulation, product class, intended use, anatomical site, maximum traction force, electrical standards, etc.

However, the document does not contain information about specific acceptance criteria (performance metrics) or a study report with associated data and statistical analysis that proves the device meets such criteria. It states that "The Modpod cervical traction device is as safe and effective, and performs as well or better than the claimed predicate devices," which is a conclusion based on the comparison provided, but not a detailed study report with results against predefined acceptance criteria.

Therefore, I cannot extract the requested information regarding:

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

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The iTrac c2i cervical traction system is intended for use as a conservative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

The iTrac™ c2i cervical traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis/extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

Operational software controls the exertion and release of the pulling forces, operation cycle, and treatment times prescribed by the physician. The iTrac's operational components consist of software, an air compressor, three pneumatic cylinders, two electro-pneumatic regulators, a traction line and pullev system, head halter, fulcrum strap, magnetic safety release, backup flow controls, and mechanical pressure relief valves.

All accessories necessary to provide the traction to the patient are included with the device making it a ready to use traction device. A head halter captures the patient's chin during treatment and is connected to an adjustable overhead traction bar that can be manually adjusted by the doctor to the doctor-prescribed traction angle. A fulcrum strap rests on the back of the patient's neck and may be used to provide an additional anterior force. During setup, an electric lift column allows the fulcrum/traction section to be raised or lowered by the doctor to the height doctor prescribed for each patient.

For each treatment session the Doctor commands the software to implement a specific treatment time, traction force, and fulcrum force. Utilizing a piecewise linear function calculation the software generates an output signal causing the electro-pneumatic pressure controllers to adjust pressure, delivering the doctor prescribed forces to the fulcrum and traction cylinders. For safety, limits are hard coded in the software to prevent traction and fulcrum forces from exceeding the allowable limits. The software is loaded on a standard personal computer which interfaces with the device via a standard network connection; this standard connection is limited to connection only with the iTrac.

A Patient Stop Switch provides additional protection to the patient by operating independent of software to relieve all forces when pressed. When activated, the patient stop switch triggers a relay which, in turn, triggers a solenoid-controlled pneumatic valve causing a quick stop and venting of all pneumatic pressure to the cylinders. This action immediately relieves the patient of traction forces and sends a discrete output from the relay to the I/O Module, placing the treatment session into 'Pause' within the software. As an added safety measure the software requires the patient stop switch to be pressed before the start of each treatment during the treatment start protocol to ensure its functionality.

The provided document is a 510(k) summary for the iTrac c2i Cervical Traction System. It focuses on demonstrating substantial equivalence to a predicate device, the CTBox Cervical/Lumbar Traction System, rather than presenting a clinical study to prove device performance against specific acceptance criteria in the manner usually seen for AI/ML-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. The document primarily details technical specifications and safety features compared to a predicate device.

Here's an attempt to answer the questions based on the available information, noting when information is not present in the document.

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

Since this is a substantial equivalence submission for a physical medical device (traction system), "acceptance criteria" here refers to demonstrating that the new device's technical characteristics and safety features are equivalent to or better than a legally marketed predicate device. There aren't "performance metrics" in the typical sense of accuracy, sensitivity, specificity, etc., as would be the case for AI/ML diagnostic tools.

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The Integrity Spinal Care System 3.0 provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica.

The Integrity Spinal Care System 3.0 incorporates the same principles and working characteristics of the predicate devices, the DRX9000 True Non Surgical Decompression System (K060735) and is same in size, shape and function. The components of The Integrity Spinal Care System 3.0 are substantially equivalent in form, fit, function and configuration to its predicate device the DRX9000 True Non Surgical Decompression System (K060735).There are similar key design technical characteristics; multi-function table designed to applied distraction forces and controlled by a computer console, same/similar components for treatment and measurement; similar size, power source, and performance.

The Integrity Spinal Care System 3.0 is a spinal decompression device. The provided text indicates that no clinical data was required for its 510(k) clearance, as non-clinical comparisons to its predicate device, the DRX9000 True Non Surgical Decompression System (K060735), demonstrated substantial equivalence. Therefore, the information regarding acceptance criteria and a study proving the device meets these criteria is limited to non-clinical testing.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of clinical data for this 510(k). The non-clinical testing involved a "calibrated dynamometer" to stimulate a patient, implying a hardware-based test rather than a patient dataset. The sample size for this non-clinical test is not specified, but it refers to a device-to-device comparison and standard compliance tests.
• Data Provenance: Not applicable for clinical data. For non-clinical tests, the data was generated internally by the applicant (Integrity Life Sciences) and/or by an "independent party" for evaluation of modifications to appearance.

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

• Not applicable as no clinical ground truth was established for the 510(k) clearance. The determination of substantial equivalence was based on non-clinical engineering and performance comparisons.

4. Adjudication Method for the Test Set

• Not applicable as no clinical ground truth was established.

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. This device is a physical traction system, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical traction system, not an algorithm, and its performance is inherently "standalone" in the sense that its mechanical operation is evaluated independently of a human interpreter.

7. The Type of Ground Truth Used

• For functional and performance characteristics, the "ground truth" was established by comparison to the predicate device (DRX9000 True Non Surgical Decompression System) and compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 14971). The accuracy of tension display was verified against a calibrated dynamometer.

8. The Sample Size for the Training Set

• Not applicable as no machine learning algorithm was involved, and thus no training set was used.

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

• Not applicable as no machine learning algorithm was involved.

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