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Cryojet Plus is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Cryojet Plus is composed of main body (including power supply system, cooling system), power cable, supporting arm rod (a group of supporting rod, two support clips), wind tube, adapters, casters and other accessories. Control system consists of LCD screen display and control board, etc; Cooling system includes compressor, evaporator, radiator, fan, water tank; Power supply system is composed of power cable, filter and ON/OFF switch power.

The provided text describes a medical device called "Cryojet Plus" and its substantial equivalence to a predicate device "Cryo 7". However, it does not contain a study comparing the device's performance against specific acceptance criteria in a comparative effectiveness study involving human readers or standalone AI performance.

Therefore, many of the requested sections cannot be filled from the provided document.

Here's a breakdown of what information is available and what is not:

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

The document provides a comparison of technical specifications between the proposed device (Cryojet Plus) and the predicate device (Cryo 7). While these are performance characteristics, they are not explicitly presented as "acceptance criteria" met by a study designed to prove them. Instead, they are presented as part of a substantial equivalence comparison.

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. This device is not an AI/ML diagnostic or image analysis device, and no clinical testing was performed or reported. The submission focuses on substantial equivalence based on technical characteristics and non-clinical testing.

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. No clinical test set with ground truth established by experts was used.

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

Not applicable. No clinical test set 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 comparative effectiveness study was done. The device is a non-AI therapeutic cooling device.

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

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

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

Not applicable. No clinical ground truth was established or used for the purpose of this 510(k) submission. The "ground truth" for the device's technical performance would be engineering measurements as per the standards listed.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm and therefore does not have a training set.

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

Not applicable. This is not an AI/ML algorithm and therefore does not have a training set.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states that the Cryojet Plus has been considered to comply with several voluntary standards through investigation and test. These standards cover aspects like electrical safety, electromagnetic compatibility, usability, software lifecycle processes, risk management, biocompatibility assessment (lack of direct patient contact negates further testing), and quality management systems.

Specifically mentioned are:

• IEC 60601-1:2005;A1:2012;A2:2020 (Medical electrical equipment - General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (Medical electrical equipment – Electromagnetic disturbances - Requirements and tests)
• IEC 60601-1-6:2013 (Medical electrical equipment – Usability)
• IEC 62366-1:2015 (Medical devices – Application of usability engineering to medical devices)
• IEC 62304:2015 (Medical devices software – software life cycle processes) - Software verification and validation tests were performed successfully and met acceptance criteria.
• ISO 14971:2019-12 (Medical devices – Application of risk management to medical devices)
• ISO 15223-1:2016 (Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements)
• ISO 13485:2016 (Medical devices – Quality management systems--Requirements for regulatory purposes)
• ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) - Biocompatibility was assessed, and no additional testing was deemed necessary due to no direct patient contact.

Non-clinical testing for Cryojet Plus included:

• Electrical safety testing according to IEC 60601-1.
• Electromagnetic compatibility testing according to IEC 60601-1-2.
• Software verification and validation.

The conclusion is that the Cryojet Plus is substantially equivalent to the predicate device (Cryo 7) in intended use, device characteristics, and application parameters, based on these technical comparisons and non-clinical testing. No clinical testing was included in this 510(k).

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The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis

The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Pseudoarthrosis;
• Spondylolysis:
• Spondylolisthesis;
• Spinal stenosis;
• Tumors:
• Trauma (i.e. Fractures or Dislocation)
• Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
• Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The DynaTran™ Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis

The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine from C2 – T1. These systems are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal stenosis

The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and not intended for stand-alone use.

The previously cleared devices consist of a variety of plate systems designed to provide support across implanted levels in the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.

This document is a 510(k) summary for several spinal plate systems, primarily aimed at establishing an "MR Conditional" labeling claim. It describes a standalone performance study to demonstrate MR compatibility.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical or qualitative acceptance criteria defined by ASTM F2503 and applied for this submission are not detailed in the provided text. The document broadly states that the devices met these criteria.

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

• Sample Size: Not explicitly stated. The document refers to "the subject devices" which is a collection of 5 different plate systems, each with potentially various sizes and configurations.
• Data Provenance: Not explicitly stated. The study described is a laboratory performance test (MR Compatibility testing per ASTM F2503), not a clinical study involving patient data. Therefore, concepts like country of origin or retrospective/prospective don't directly apply in the same way they would for a clinical trial.

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

• Not applicable. This study is a technical performance test (MR Compatibility), not a clinical study requiring expert assessment for ground truth. The "ground truth" here is the physical property of MR compatibility as defined by the ASTM standard.

4. Adjudication Method for the Test Set

• Not applicable. As the study is a technical performance test, there is no adjudication process involving human reviewers. The assessment is based on objective measurements against the ASTM F2503 standard.

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

• No. This document describes a technical MR compatibility study, not a clinical MRMC comparative effectiveness study involving human readers and AI assistance.

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

• Yes. The described study is a standalone performance study focused on the physical properties of the devices themselves (MR compatibility) without any human-in-the-loop component. It's a laboratory test of the device's inherent characteristics.

7. The Type of Ground Truth Used

• Standardized Test Methods (ASTM F2503): The ground truth for MR compatibility is established by the specified industry standard (ASTM F2503), which outlines the methodologies and criteria for evaluating MR safety of medical implants. The "ground truth" is adherence to and performance within the limits defined by this standard.

8. The Sample Size for the Training Set

• Not applicable. This is a performance study for MR compatibility, not an AI/machine learning study. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described study.

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EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp.

EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans (from the age of 2) under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp. It acts as a conductor between the scalp and the cup electrodes to reduce impedance between the electrode surface and the skin. The reduction in impedance facilitates better recording of the signal. It is intended to be used for up to 10 hours after application to healthy, intact skin. After drying, it is self-adhesive and can be washed off with water. The cream is provided non-sterile and in a 100g aluminum tube. It is white and has no adverse smell. Its texture is smooth and creamy directly after withdrawal from the tube, and solid after drying. EEG-acp is intended to be used as an electroconductive medium between the electrode and the patient's skin, i.e., it amplifies the electrical signal and thereby improves the electrophysiological recording. The high salt content of the cream is responsible for its conductive properties. Its impedance is -1.9 kOhm and its conductivity is 20 mS/cm.

The provided text describes the 510(k) summary for the EEG-acp device. This document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. The information details the device, its intended use, and comparative data against a predicate device.

Here's an analysis of the acceptance criteria and study proving device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as typical performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML diagnostic device, because EEG-acp is an "Electroconductive Media" (a physical cream), not a diagnostic algorithm. Instead, the "acceptance criteria" for this device are established by demonstrating substantial equivalence to a legally marketed predicate device (SAC2 Electrode Cream, K192606) in terms of its physical and performance characteristics.

The table below summarizes the key comparisons made for "acceptance" of EEG-acp:

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

The document does not describe a clinical study in humans with a "test set" in the traditional sense of an AI/ML algorithm evaluation (i.e., a dataset of patient data used to evaluate algorithm performance). Instead, the studies performed are bench testing and biocompatibility testing of the physical cream itself.

• Bench Testing:
  • Impedance and Conductivity: Measured to confirm equivalence with the predicate device. The sample size for these measurements is not specified (e.g., number of cream samples, number of measurements).
  • Qualitative characteristics (Color, odor, adhesiveness, time to dry): Verified to be as specified and equivalent to the predicate device. Sample size not specified.
  • Shelf-life: Validated by accelerated aging testing in accordance with ASTM F1980-16. Sample size not specified (e.g., number of batches, number of samples tested over time).
• Biocompatibility Testing:
  • The tests performed were:
    • ISO 10993-5: Cytotoxicity in vitro Skin Irritation (Human Skin Model Test)
    • ISO 10993-10: Acute Dermal Irritation/Corrosion, Irritation/Skin Sensitization, Guinea Pig Maximization Test.
  • These are laboratory tests on cells/animal models, not human patient data. The sample sizes for these specific biological assays are not detailed in the summary.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective, though it implicitly describes prospective laboratory/bench testing.

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

This information is not applicable to the evaluation of this device. As EEG-acp is an electroconductive paste, its performance is assessed through physical and chemical property measurements and biocompatibility testing, not through expert interpretation of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" expert adjudication process in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable, as there is no expert adjudication of a diagnostic performance test set.

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 not an AI/ML algorithm designed to assist human readers (e.g., radiologists) in diagnostic interpretation. It is a physical medical device (conductive paste).

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

Not applicable. This is not an algorithm. Bench tests (e.g., impedance, conductivity, shelf-life) could be considered "standalone" in the sense that they evaluate the properties of the cream itself, independent of human application for diagnosis, but this term (standalone) is typically used for AI/ML algorithms.

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

The "ground truth" for this device's acceptance is based on:

• Physical and Chemical Properties: Measured values (e.g., impedance, conductivity, pH, time to dry, color, odor, adhesiveness, consistency) are compared against scientifically established standards or performance of the predicate device.
• Biocompatibility Standards: Results from tests defined by ISO 10993-1, -5, and -10 are used as "ground truth" for safety regarding biological compatibility (cytotoxicity, irritation, sensitization).
• Shelf-life Standards: Accelerated aging tests following ASTM F1980-16 provide the "ground truth" for shelf-life performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The ASPIRON™ S ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);

• · Spondylolisthesis
• · Trauma (including fractures, dislocation)
• · Spinal stenosis
• · Tumors
• · Deformity (defined as scoliosis, kyphosis, or lordosis)
• · Pseudoarthrosis
• · Failed previous fusion

The ASPIRON™ S ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM F136. All implants are single use only. The trade name is changed compared to the predicate devices (K182055, K190053).

The provided text is a 510(k) summary for the "ASPIRON™ S ACP System," an anterior cervical plate system intended for spinal fixation. It details the device's indications for use, its substantial equivalence to predicate devices, and the performance testing conducted.

However, the document does not describe any clinical study or specific acceptance criteria related to an AI/ML powered medical device's performance. It focuses on the substantial equivalence of a physical medical implant (an anterior cervical plate) to existing devices, primarily through mechanical performance testing (static compression bending, static torsion, and compression bending fatigue tests according to ASTM F1717).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria, as this information is not present in the provided text. The document is a regulatory filing for a traditional medical device, not an AI/ML product.

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The Admiral ACP System is intended for anterior cervical fixation (C2-T1) for the following indications:

• · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin 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.
  ·and failed previous fusion.

The Admiral ACP System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Admiral plates include locking pins that cover the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the Admiral ACP System implant components are made from titanium alloy per ASTM F136. Associated instruments are available to facilitate the implantation of the device.

This document is an FDA 510(k) clearance letter for a medical device called the "Admiral ACP System." It primarily focuses on the regulatory aspects of the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Key takeaway: This document explicitly states that the device demonstrated equivalent performance to the predicate system through mechanical testing and refers to ASTM F1717. It does NOT describe a study involving "human readers" or "AI assistance," nor does it present acceptance criteria related to diagnostic accuracy from image analysis.

Therefore, I cannot provide the information requested in terms of acceptance criteria and study details for an AI/human reader performance study because this document does not contain that information. The "study" referenced is a non-clinical mechanical test, not a clinical or diagnostic imaging study.

Here's an explanation based on the provided text, addressing why most of your requested points cannot be answered:

The provided document (K212139) is an FDA 510(k) clearance for the Admiral ACP System, which is a spinal intervertebral body fixation orthosis (a type of surgical implant for spinal fusion).

The "study that proves the device meets the acceptance criteria" in this context refers to mechanical (non-clinical) testing to demonstrate the structural integrity and performance of the implant, not an AI or diagnostic imaging study involving human readers or ground truth derived from image interpretation.

The document states:

• "The Admiral ACP System demonstrated equivalent performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717."

Given this, most of your specific questions are not applicable to the type of device and study described in this document.

However, I can extract what is relevant from the provided text:

Acceptance Criteria and Device Performance (Based on Mechanical Testing)

Information Not Available (as the document describes mechanical testing, not an AI/human reader study)

The following information cannot be extracted from the provided 510(k) clearance letter because it pertains to a mechanical medical device, not a diagnostic imaging AI and/or human reader study:

• Sample size used for the test set and data provenance: Not applicable. This refers to physical test specimens for mechanical properties, not clinical image datasets.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for mechanical testing would involve engineering specifications and direct measurement, not expert image interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is typically the established engineering standards (e.g., ASTM F1717) and the measured physical properties of the device compared to those standards and the predicate device.
• The sample size for the training set: Not applicable. This is for mechanical testing, not a machine learning model.
• How the ground truth for the training set was established: Not applicable.

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The FloSpine PANAMA™ Anterior Cervical Plate System is intended for anterior cervical screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative discase (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis), or scoliosis), pseudoarthrosis, and/or failed previous fusions.

The PANAMA™ Anterior Cervical Plate System is an anterior cervical spine fixation system that provides cervical spine fixation for intervertebral disk replacement procedures. The PANAMA™ ACP System is designed to stabilize and facilitate fusion in intervertebral disk replacement surgeries.

The PANAMA™ Anterior Cervical Plate (ACP) System consists of cervical plates that are 2.25 mm thick, 16 mm wide, and length options between 18 and 110 mm (end-to-end length) to accommodate 1 to 5 levels of fusion between C2 and T1. The PANAMA ACP System includes fixed and variable angle screws with 4.0mm and 4.5mm diameters and length options between 12mm and 20mm with self-tapping and self-drilling options. The screws and plates are made from Ti-6AI-4V ELI conforming to ASTM F-136.

The plates and screws of the PANAMA™ ACP System include a primary and secondary mechanism to mitigate screw backout. The primary mechanism consists of a cover plate that is rotated in-situ that partially covers the screw. The secondary mechanism consists of a number of radial teeth on the screw head and mating grooves on the underside of the cover plate. In the event that the screws start to back out, the teeth and grooves will engage, thereby preventing further counter-clockwise rotation of the screw. The screws in the system have a threaded hole at the bottom of the drive to provide easy insertion and positioning during surgery. The PANAMA™ ACP System of implants and instruments is provided clean and non-sterile in one sterilization case.

The provided text describes a medical device's 510(k) submission, focusing on its design, indications for use, and a comparison to predicate devices, including performance data. However, it does not contain information related to an AI/ML-driven device or diagnostic software.

Therefore, I cannot extract the specific details required to complete your request, such as:

• A table of acceptance criteria and the reported device performance for an AI/ML device. The document discusses performance testing (biomechanical testing) for a physical implant (spinal plate) per ASTM F1717, which measures properties like static axial compression bend, dynamic axial compression, and static torsion. These are engineering performance metrics for a physical device, not diagnostic performance metrics for an AI model.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI model.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is for a PANAMA™ Anterior Cervical Plate (ACP) System, which is a physical implant used for spinal fixation. The "performance data" section G explicitly refers to "Performance testing of the PANAMA™ ACP System was performed per ASTM F1717 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model'". This is mechanical testing of a medical device, not an algorithm.

To fulfill your request, you would need documentation pertaining to the regulatory submission of an AI/ML-driven medical device or diagnostic software.

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The APOLLO™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

• · Spondylolisthesis,
• · Trauma (including fractures or dislocations),
• · Tumors,
• · Deformity (defined as kyphosis, lordosis, or scoliosis),
• · Pseudarthrosis,
• · Failed previous fusion,
• · Spinal stenosis

The APOLLO™ Anterior Cervical Plate (ACP) System is comprised of cervical plates and bone screws constructed of titanium alloy as described by ASTM F136. Plates are available in multiple levels and lengths, and screws are available in multiple diameters, lengths, and tip configurations to accommodate variations in patient anatomy. The Integrated screw locking mechanism is used to block the screw heads after the device construct has been attached to the anterior cervical spine.

The provided text is a 510(k) summary for the APOLLO™ Anterior Cervical Plate (ACP) System. This document describes a medical device (an implanted plate and screws for spinal fusion), not an AI/ML-driven device or diagnostic system.

Therefore, the requested information (acceptance criteria for AI/ML performance, study details for AI/ML device validation, such as sample size, ground truth establishment, MRMC studies, etc.) is not applicable to this submission. The "Performance Data" section explicitly states:

• "Non-clinical mechanical testing was performed consisting of the following test modes: Static and dynamic compression bending per ASTM F1717 . Static torsion per ASTM F1717"
• "The results of this non-clinical testing show that the strength of APOLLO™ device is sufficient for its intended use."
• "Clinical data and conclusions were not needed for this device."

This indicates that the clearance was based on mechanical bench testing demonstrating the structural integrity and equivalence to a predicate device, rather than a study evaluating diagnostic or predictive performance using patient data, which would be the case for an AI/ML device.

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Cure™ 2.0 Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Deformity (defined as kyphosis, lordosis), Pseudarthrosis, and Failed previous fusions.

Cure™ 2.0 Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.

Cure™ 2.0 Anterior Cervical Plate (ACP) System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

I am sorry, but the provided text is a 510(k) summary for a medical device (Cure™ 2.0 Anterior Cervical Plate (ACP) System). This type of document focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing.

The information you requested, such as acceptance criteria, reported device performance (with specific metrics like sensitivity, specificity, or accuracy), details about test sets (sample size, data provenance), ground truth establishment (number of experts, qualifications, adjudication), MRMC studies, standalone algorithm performance, and training set details, are typically found in studies for AI/ML-enabled devices or diagnostic software.

The Cure™ 2.0 Anterior Cervical Plate (ACP) System is a physical implant, and its clearance is based on mechanical testing (ASTM F1717) to ensure it performs equivalently to an existing device. Therefore, the requested information about AI/ML device performance metrics and study design elements is not applicable to this document.

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The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The NuVasive ACP System is an anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3. The NuVasive ACP System was initially cleared in K191500, and lower static torsion test values were presented in K201078. The purpose of this submission is to introduce design changes to the ACP Self-Drilling Screws. Select changes implemented via the add to file process as well as additional design updates are also presented in this submission.

Here's an analysis of the provided FDA 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: NuVasive® ACP System (Anterior Cervical Plating System)

The provided document describes a spinal intervertebral body fixation orthosis and the review for its 510(k) premarket notification. This type of device is a physical implant, not an AI/ML-based diagnostic or assistive device. Therefore, the questions related to AI/ML performance metrics, ground truth, expert adjudication, and comparative effectiveness studies are not applicable to this submission.

The "acceptance criteria" for such a device are primarily based on demonstrating substantial equivalence to a predicate device through non-clinical performance data (e.g., mechanical testing).

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 "sample size" in the context of clinical studies. The testing performed is non-clinical (mechanical testing). The document does not specify the number of implants or test specimens used for the static torsion testing.
• Data Provenance: The data is generated from laboratory mechanical testing. The country of origin and whether it's retrospective or prospective are not applicable as it's not human subject data.

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

• This is not applicable. Ground truth, in the context of clinical interpretation by experts, is not relevant for this type of mechanical device submission. The "ground truth" for mechanical performance is established by standardized testing methods and material specifications (e.g., ASTM F1717 for static torsion, ASTM F136 for material).

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

• This is not applicable. Adjudication methods are used for expert consensus on clinical data. For mechanical testing, the results are quantitative and objective, typically requiring no adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable. This device is a physical implant, not an AI-assisted diagnostic or therapeutic system.

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

• This is not applicable. This device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance is established by objective, standardized mechanical testing results (e.g., torque at failure, deformation under load) compared against predetermined criteria derived from predicate device performance and relevant ASTM standards.

8. The sample size for the training set

• This is not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• This is not applicable. This is a physical device, not an AI/ML algorithm.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical performance study focused on mechanical testing.

• Purpose: To demonstrate that the NuVasive® ACP System is substantially equivalent to predicate devices, particularly regarding its mechanical performance and material composition.
• Key Test: Static torsion testing per ASTM F1717.
• Material Testing: The device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, ensuring material properties meet established standards.
• Results/Conclusion: "The results of these studies show that the subject NuVasive ACP System meets or exceeds the performance of the predicate device and does not introduce any new risks." This statement confirms that the device's mechanical performance, specifically in static torsion, was found to be acceptable and comparable or superior to the legally marketed predicate devices, thereby establishing substantial equivalence.

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The Admiral ACP System is intended for anterior cervical fixation (C2-T1) for the following indications:
• Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin 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,
·and failed previous fusion.

The Admiral ACP System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Admiral plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The Admiral ACP System implant components are made from titanium allov per ASTM F136. Associated instruments are available to facilitate the implantation of the device.

The provided text is a 510(k) summary for the Admiral ACP System, a spinal implant. It describes the device, its indications for use, and a summary of non-clinical testing. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria for software or AI-driven performance.

The document states:

• "The Admiral ACP System demonstrated equivalent performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717."
• "The submitted data demonstrate that the Admiral ACP System is substantially equivalent to the cited legally marketed predicate device."

This indicates that the "performance" referenced is mechanical performance of a physical implant (plates and screws), not the performance of an AI/software device. The regulatory submission (510(k)) is for a physical medical device, not a software as a medical device (SaMD) or an AI-powered diagnostic tool.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics for an AI/software device.
2. Sample sizes used for the test set and the data provenance: Not applicable, as there's no AI/software performance test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating mechanical equivalence to a predicate device, which is typical for physical orthopedic implants.

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