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The FORTEZZA Spinal Stabilization System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the FORTEZZA Spinal Stabilization System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the FORTEZZA Spinal Stabilization System are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The FORTEZZA Spinal Stabilization System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

The FORTEZZA Spine Stabilization System consists of a variety of shapes and sizes of screws and 5.5 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy. Components of the system include straight and pre-bent rods, multi-axial screw.

This document is a 510(k) summary for the FORTEZZA Spinal Stabilization System, a medical device. It does not describe any clinical studies involving humans or AI. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical, bench testing.

Therefore, the requested information elements related to clinical studies, AI performance, ground truth, experts, and sample sizes for training/test sets are not applicable to this document.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a number of devices/tests, but implicitly refers to the number of samples required by ASTM F1717-14 for mechanical testing.
• Data Provenance: Not applicable for mechanical bench testing. The data is generated in a laboratory setting through controlled experiments.

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

• Not Applicable. No human experts were involved in establishing "ground truth" for these mechanical performance tests. The ground truth is determined by the physical properties and mechanical behavior of the device components under standardized test conditions specified by ASTM F1717-14.

4. Adjudication method for the test set

• Not Applicable. There is no adjudication method in the context of mechanical bench testing. Performance is measured against pre-defined engineering and material standards.

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 document describes a medical device for spinal stabilization, not an AI-powered diagnostic or interpretive tool. No MRMC studies were conducted.

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

• Not Applicable. This document describes a physical medical device, not a software algorithm.

7. The type of ground truth used

• The "ground truth" for the performance testing is based on engineering and material science standards and measurements. Specifically, the device's mechanical properties (static compression bending, static torsion, fatigue compression bending) are measured and compared against the properties of a predicate device, as required by ASTM F1717-14 and FDA guidance.

8. The sample size for the training set

• Not Applicable. There is no training set in the context of this type of medical device submission (mechanical testing for substantial equivalence).

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

• Not Applicable. As there is no training set, there is no ground truth for a training set.

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The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Fortex Pedicle Screw System is intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The purpose of this 510(k) submission is to add rods made of a different material to the Fortex Pedicle Screw System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared Fortex Pedicle Screw System.

Both the modified and predicate Fortex Pedicle Screw System consist of various screws, rods, and cross bar connectors that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion.

The components of the predicate Fortex.Pedicle Screw System are fabricated from medical grade titanium alloy per ASTM F136. The modified system includes components fabricated from medical grade cobalt chrome alloy per ASTM F1537, in addition to the titanium components. As documented within this premarket notification, the addition of cobalt chrome alloy rods does not raise new issues of safety or effectiveness. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The provided text describes a 510(k) submission for the Fortex Pedicle Screw System, specifically focusing on the addition of rods made from a different material (cobalt chrome alloy). The submission aims to demonstrate substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria for a device performance study in the way you've outlined, nor does it detail a study that proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy.

Instead, the performance data presented is for non-clinical mechanical testing to demonstrate the structural integrity and comparability of the modified device components.

Here's a breakdown based on the information available and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This table reflects mechanical performance, not clinical or diagnostic performance criteria as typically found in studies for AI/diagnostic devices.

Information Not Found in the Provided Text:

The following points are pertinent to studies of diagnostic or AI-driven medical devices, but are not applicable to this 510(k) submission, which focuses on a change in material for a spinal implant system. Therefore, the requested information for these points is not available in the provided text.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to physical components for mechanical testing, not patient data.
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. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to mechanical testing.
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 is a spinal implant, not an AI or diagnostic device designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is derived from the physical properties and performance metrics defined by ASTM F1717 standards.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Mechanical Testing):

The study involved non-clinical performance testing of the Fortex Pedicle Screw System. This included static and dynamic axial compression bending and static torsion tests. The tests were conducted according to ASTM F1717 standards. The performance of the modified system (with cobalt chrome alloy rods) was compared to the predicate system. The results demonstrated that the modified device functioned as intended and showed substantial equivalence in mechanical properties to the predicate devices. The purpose was to demonstrate that adding a new material (cobalt chrome alloy) for the rods does not introduce new safety or effectiveness concerns, and that its mechanical performance is comparable to an already cleared device.

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The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Fortex Pedicle Screw System is intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Fortex rods are 5.5 mm diameter solid cylinders with spherically rounded ends, provided in 40 mm, 60 mm, 70 mm, 80 mm, 120 mm, 120 mm, 160 mm, 180 mm, 200 mm, and 300 mm lengths.

Each Fortex pedicle screw assembly consists of a pedicle screw, yoke, and screw cap. Selftapping pedicle screw assemblies are provided in diameters of 4.75mm, 5.5 mm, 6.5 mm, 7.5 mm and 8.25mm. All screw assemblies are provided in lengths of 30 mm, 35 mm, 45 mm, 50 mm, and 55 mm. Screws are provided in canulated and non-canulated configurations.

The Fortex cross bar assembly is an optional component and can be used for additional stabilization. Cross bar assemblies are available in lengths from 25 mm to 81 mm.

The rods, pedicle screws and cross bars of the Fortex Pedicle Screw System are made of titanium alloy conforming to ASTM F136.

The provided text is a 510(k) summary for a medical device (Fortex Pedicle Screw System) which is a premarket notification to the FDA. It does not include information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment. This type of document focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing indications for use and technological characteristics, and typically relies on non-clinical (e.g., mechanical) testing rather than clinical studies with human subjects.

Therefore, I cannot fulfill your request for information about acceptance criteria and associated study details based on the provided text. The document does not contain this kind of data.

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The Forte Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

The modified Forte Gamma Camera System offers all the features of the existing Forte Gamma Camera System (K982911) while expanding the Concurrent Imaging feature for Multi-Energy/Multi-Isotope Imaging and the addition of DICOM to the acquisition system. The basic underlying algorithms for concurrent imaging remain the same. Software modifications to the Multi-Energy/Multi-Isotope application extend the current functionality to include acquisition of more image events simultaneously. Acquisition data can be exported to the Pegasys or any other processing station via DICOM by translating image data from the native XML format to a DICOM 3.0 complaint format. The addition of DICOM to the acquisition software will enhance workflow by providing DICOM Worklist and the capability to import patient information for scheduling purposes. The DOS-based user interface in Atlas acquisition system (predicate) is replaced by a Java based graphical user interface JETStream™. The Java graphical user interface provides a modern graphics presentation as opposed to the DOS text based interface of the predicate. In addition, P-scope (patient positioning/count rate) and gantry display information are now available on a touch screen for easy accessibility.

The Forte is designed to provide extended imaging functionality relative to a ring style gantry. The Forte is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes a gantry frame, display panel, two detectors, a collimator storage structure with an acquisition computer unit, a patient imaging table, and a remote hand controller. The gantry is "open" so that a high degree of imaging flexibility is available to image patients sitting, standing or lying down, with or without the included patient imaging table. The patient imaging tables are mechanized to allow for patient loading access and then raised to an imaging height. The imaging pallet includes removable arm, leg, breast, and headrest supports for patient positioning during studies that require support.

The Forte is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), Forte can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, coincidence studies, gated SPECT (circular and non-circular) studies, computerprogrammed protocol strings, and reference scans (dual detectors only). SPECT and total body acquisitions are routinely acquired with two detectors. There are some planar procedures such as bone statics and lung scan that also use two detectors. There are many additional nuclear medicine procedures that only use one detector at a time. These single detector procedures are typically renal, gastric emptying, hepatobiliary, flow studies, GI bleed, thyroid, and delayed static views.

This 510(k) submission (K033254) from ADAC Laboratories for the Forte™ Gamma Camera System focuses on modifications to an existing device (K982911), primarily in software, rather than presenting a de novo device with new acceptance criteria. Therefore, the traditional elements of acceptance criteria and a study proving a device meets them, particularly for performance metrics like sensitivity, specificity, accuracy, or reader improvement in AI contexts, are not present.

The submission claims substantial equivalence based on identical indications for use, technological comparison, and overall system performance. This implies that the device is expected to perform at least as well as the predicate device.

Here's an analysis based on the provided text, addressing the points where information is available or implicitly understood due to the nature of a 510(k) for a modified device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for device modifications, specific quantitative acceptance criteria (e.g., minimum sensitivity/specificity thresholds) and detailed performance data (e.g., clinical study results with these metrics) are not provided nor typically required in this format for substantial equivalence of software updates to an existing gamma camera. The focus is on demonstrating that the modifications do not adversely affect safety and effectiveness and that the overall system performance remains equivalent to the predicate.

The "performance" demonstrated for this type of submission is typically through:

• Verification and Validation Activities: (Implied) Ensuring the new software features function as intended and do not introduce new risks. These would likely include functional testing, performance testing (e.g., speed, data integrity, DICOM compliance), and possibly phantom studies to confirm image quality is maintained.
• Technological Comparison: The submission explicitly states: "The modified Forte™ Gamma Camera System and existing Forte Gamma Camera System have identical intended use and indications for use. The modified Forte and the existing Forte are technologically equivalent. They have the same main mechanical and electrical components. All the features provided on the existing Forte are provided on the modified Forte."

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

• Sample Size: Not applicable/not provided in this document as it's not a clinical trial for diagnostic performance. The "test set" would refer to testing environments for software and system functionality.
• Data Provenance: Not applicable.

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

• Not applicable/not provided. Ground truth in the context of a 510(k) for software updates to an imaging system usually relates to functional correctness and image quality, often verified by engineers and potentially nuclear medicine physicians during internal testing, rather than complex diagnostic ground truth.

4. Adjudication Method for the Test Set

• Not applicable/not provided.

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

• No MRMC study was done. This is not an AI-assisted diagnostic device where human reader improvement would be measured. It's a gamma camera system with software updates.

6. Standalone Performance Study (Algorithm Only)

• No standalone performance study of an algorithm was done in the context of comparing diagnostic accuracy. The "algorithms for concurrent imaging remain the same." The software modifications are largely about extending functionality (e.g., more simultaneous image events) and user interface (Java GUI, DICOM). The performance metrics would be related to the proper functioning of these software features and maintenance of image acquisition quality, not diagnostic accuracy of an AI algorithm.

7. Type of Ground Truth Used

• Functional correctness and image acquisition quality. For a gamma camera, ground truth would relate to the physical properties of the acquired images (e.g., spatial resolution, energy resolution, uniformity) using phantoms, and the correct operation of the software interface and data export. It's not typically "expert consensus" on disease diagnosis, pathology, or outcomes data for this type of submission.

8. Sample Size for the Training Set

• Not applicable/not provided. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, no training set for an AI algorithm is mentioned or implied.

Summary of Acceptance Criteria and Reported Performance (Based on Implied Substantial Equivalence):

In conclusion, the K033254 submission is a demonstration of substantial equivalence for software and user interface modifications to an existing gamma camera system. It does not contain the typical "acceptance criteria" and detailed study results found in submissions for novel AI/CAD devices or devices with novel diagnostic claims. Instead, the "study" is the comparison against the predicate device to ensure that the modifications do not negatively impact the established safety and effectiveness of the device.

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Vertex Ultra is intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

Vertex Ultra is a gantry (ring type) device designed for single- or dual-detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, two detectors, a collimator storage cabinet with acquisition computer unit, a patient imaging table, and a remote hand controller. The Vertex Ultra gantry is an "open" frame permitting easier access for imaging of standing, seated, and supine patients. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies; or the pallet may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys.

Vertex Ultra is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in relative 90° or relative 180° positions (as study appropriate), static, dynamic, gated, total body and ECT studies (circular orbit), non-circular orbital ECT, coincidence imaging, and gated SPECT (circular and non-circular orbit) imaging studies can be performed with or without a previously cleared ADAC attenuation correction option. In addition, Vertex Ultra acquisition software can be programmed to complete multiple imaging studies called protocol strings, which involve a combination of several imaging studies collected for use in customized clinical procedures.

The provided text describes the Vertex Ultra Gamma Camera System (K982911), which is a device intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving specific performance against clinical acceptance criteria with detailed studies and ground truth. Therefore, the information typically found in acceptance criteria tables and detailed study descriptions that you requested is not explicitly present in the provided document.

However, based on the Testing section, we can infer the types of tests performed and the general nature of what would constitute "acceptance."

Here's an attempt to structure the information based on the provided text, while acknowledging its limitations for filling out all requested fields:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document only mentions "Flood phantom images" and "center of rotation (COR) testing," implying the use of phantom data, not patient data for acceptance.
• Data Provenance: The 'data' (flood phantom images, COR test results) would be generated internally during the device's manufacturing and testing phases by ADAC Laboratories. It is not patient data from a specific country or collected retrospectively/prospectively in a clinical trial sense.

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

Not applicable in the context of the provided document. The "ground truth" for technical performance tests like field uniformity and COR alignment is determined by the physical properties of the phantom and the known geometric parameters of the system, not by clinical experts.

4. Adjudication method for the test set

Not applicable. Technical tests like field uniformity and COR alignment do not typically involve adjudication by multiple experts. The assessment is based on measured values and visual inspection against predetermined specifications.

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 MRMC comparative effectiveness study was done. The device described is a gamma camera system, not an AI-powered diagnostic algorithm.

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

No standalone algorithm performance study was done. This device is a hardware system for image acquisition, not an algorithm.

7. The type of ground truth used

For the described tests:

• Flood phantom images: The ground truth for field uniformity is the expected uniform distribution of radioactivity across the detector field, which is a physical characteristic of the phantom.
• Center of rotation (COR) testing: The ground truth for alignment is the known mechanical axis of rotation of the gantry and detector, used to verify the imaging system's accuracy in identifying this center.

8. The sample size for the training set

Not applicable. This device is a gamma camera hardware system, not a machine learning algorithm that requires a training set.

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

Not applicable (as above).

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Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. The CPS Ultrasound, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.

Not Found

The provided document is a 510(k) clearance letter from the FDA for several devices manufactured by Chattanooga Group, Inc., specifically the Forte CPS 400 Stim, Forte CPS 200 Stim, Forte CPS Ultrasound, Forte CPS 400 Combo, and Forte CPS 200 Combo. These are physical therapy devices, and the letter confirms that they are substantially equivalent to devices marketed prior to May 28, 1976.

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter is a regulatory approval document, not a scientific study report. It states that the FDA has reviewed the submission and found the devices substantially equivalent based on the indications for use provided.

Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving device performance from the provided text.

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For Ultrasound: Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis; bursitis with slight calcification, myositis and soft tissue injuries. The Forte CPS Combo, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.

For VMS. Russian, & Monophasic Hi-Volt:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Interferential, Microcurrent, and Premodulated:

• Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

Not Found

This document is a 510(k) clearance letter from the FDA for several medical devices manufactured by Chattanooga Group, Inc. It states that the devices (Forte CPS 400 Stim, Forte CPS 200 Stim, Forte CPS Ultrasound, Forte CPS 400 Combo, and Forte CPS 200 Combo) are substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory clearance based on substantial equivalence, not a detailed technical report of performance testing.

Therefore, I cannot provide the requested information based on the input text. The input text focuses on regulatory approval, product codes, trade names, and intended uses, not on performance metrics, study designs, or ground truth establishment.

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For VMS, Russian, Monophasic Hi-Volt:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Microcurrent. Interferential and Premodulated:

• Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for several medical devices. It does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide the requested information. The document primarily confirms the substantial equivalence of the listed devices to pre-amendment devices and outlines regulatory obligations for the manufacturer.

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