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The Karma® Fixation System is intended for bilateral facet stabilization for fusion as an adjunct to a 1-level interbody lumbar fusion from L1 to L5 with autogenous and/or allogenic bone graft. The Karma Fixation System must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The Karma Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L1 to L5 in skeletally mature patients who have failed conservative care.

The Karma® Fixation System is a system that provides adjunctive fixation. The system consists of a PEEK band. The Karma band consists of a strap manufactured from PEEK compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip of the device contains a tantalum insert for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taut by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the bony structures. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded. An instrument, Tensioner, is provided and can be used fully tension the implant.

The provided FDA 510(k) clearance letter and summary for the Karma® Fixation System is for a medical device (spinal fixation system), not a software device or AI-powered system that would typically have acceptance criteria focused on algorithm performance metrics like sensitivity, specificity, or AUC. Therefore, the questions related to AI performance, such as sample size for test sets, expert adjudication, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

The "acceptance criteria" for a medical device like the Karma® Fixation System are typically related to:

• Mechanical and Biomechanical Performance: Ensuring the device can withstand expected physiological loads and perform its intended structural function.
• Biocompatibility: Verifying that the materials used are safe for implantation in the human body.
• Sterilization: Confirming the device can be effectively sterilized.
• Labeling and Packaging: Ensuring proper information is provided.
• Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.

The study that proves the device meets its acceptance criteria (i.e., its safety and effectiveness compared to a predicate) is discussed under "Performance Data" and "Clinical Data."

Here's an interpretation based on the information provided, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a spinal fixation system, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to a predicate device in terms of safety and effectiveness. The "reported device performance" refers to the studies conducted to support this equivalence. Specific numerical acceptance criteria (e.g., minimum load-bearing capacity, fatigue life) are often part of the detailed testing protocols submitted to the FDA but are not explicitly listed in this summary.

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

• Sample Size for Test Set:
  • Biomechanical studies: Not specified, but typically involves a small number of cadaveric spines.
  • Clinical Data: Not specified, but includes CT evaluations, adverse event data, and patient-reported outcomes at 12 and 24 months. The specific number of patients is not mentioned.
• Data Provenance: Not explicitly stated (e.g., country of origin). The nature of the clinical data (CT evaluations, adverse events, patient-reported outcomes at specific follow-up points) suggests a prospective or retrospective clinical study, but this is not definitively stated.

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

This question is not applicable to this type of device submission. The "ground truth" for a spinal fixation system is typically established through objective measurements in mechanical/biomechanical testing and clinical outcomes, rather than expert consensus on image interpretation. Clinical assessments would be performed by qualified medical professionals (e.g., surgeons, radiologists), but their specific number or qualifications for "ground truth establishment" are not relevant in the context of AI model evaluation.

4. Adjudication Method for the Test Set

This question is not applicable as it pertains to expert disagreement resolution in AI model evaluation, which is not relevant for musculoskeletal implants.

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 question is not applicable. MRMC studies are specific to evaluating AI-assisted diagnostic or interpretative devices, not spinal fixation systems.

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

This question is not applicable. The Karma® Fixation System is a physical implant, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment relies on a combination of:

• Biomechanical Data: Objective measurements from cadaveric testing (e.g., stability, stiffness).
• Computational Modeling: Results from Finite Element Analysis (FEA) predicting stress distribution and fatigue.
• Clinical Outcomes Data:
  • Imaging: CT evaluations at 12 and 24 months.
  • Adverse Event Data: Reported complications.
  • Patient-Reported Outcomes (PROs): Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain.

8. The Sample Size for the Training Set

This question is not applicable. The Karma® Fixation System is a physical medical device, not an AI model that requires a "training set."

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

This question is not applicable. There is no "training set" for this type of device.

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The Primus Spinal Fixation System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is interior/ anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (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, pseudoarthrosis, and failed previous fusion.

The Spinal Elements Primus Spinal Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Primus or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Primus or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.

When used for posterior non-cervical pedicle screw fixation in pediative patients, the Primus and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

Spinal Elements' fenestrated screws are intended to be used with saline or radiopaque dye.

These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Spinal Elements' Navigated Instruments are intended to be used during the preparation and placements' Primus screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Spinal Elements' Primus Spinal Fixation System is comprised of a variety of screws, hooks, rods, and connectors that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws.

Navigation instruments are non-sterile and are intended to be used with the Medtronic StealthStation® S7 and S8 System.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria. Instead, the document is a 510(k) premarket notification letter from the FDA regarding the "Primus Spinal Fixation System," stating its substantial equivalence to a legally marketed predicate device.

The document discusses:

• The FDA's review and determination of substantial equivalence.
• General controls and additional controls applicable to the device.
• Requirements for quality systems, reporting adverse events, and unique device identification.
• The indications for use of the Primus Spinal Fixation System.
• A 510(k) summary, including:
  • Submitter and device information.
  • Device description (screws, hooks, rods, connectors, navigation instruments).
  • Detailed indications for use.
  • Technological characteristics and comparison to a predicate device (Mercury® II Spinal System K222516).
  • Performance Data: This section only mentions mechanical testing (Static and Dynamic Compression Bending, Static Torsion, Tensile Dissociation, Neutral and Max Angle testing per ASTM standards) to demonstrate substantial equivalence to the predicate device. It explicitly states, "The subject device has the same performance characteristics as the previously cleared predicate device..." and "Testing conducted demonstrates substantial equivalence to the predicate device."

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as this information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence, primarily supported by mechanical testing against established ASTM standards, not clinical performance studies with acceptance criteria as typically understood for AI/ML-driven medical devices (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement).

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Spinal Elements Navigated Instruments are intended to be used during the preparation and placements screws (Overwatch®, Savannah® and Mercury® Fixation Systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Spinal Elements Navigated instruments are non-sterile, reusable instruments designed to function with the the the Medtronic StealthStation® System. Spinal v Elements Navigated instruments are for use with Spinal Elements pedicle screw systems, specifically, Overwatch®, Mercury® and Savannah® pedicle screw systems. Instruments are manufactured from stainless steel.

The provided text describes a medical device, "Spinal Elements Navigated Instruments," which is designed to assist surgeons during spinal surgery. However, the document is a 510(k) summary for a premarket notification to the FDA, asserting substantial equivalence to predicate devices, rather than a detailed study report or clinical trial. Therefore, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria in the context of an AI/ML-driven device's performance.

The document primarily focuses on demonstrating substantial equivalence to previously cleared devices through technological characteristics and non-clinical performance testing. It does not describe a study involving AI, machine learning, or human readers.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it's absent due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the device was tested against a standard practice, but it does not explicitly state specific acceptance criteria (e.g., numerical thresholds for accuracy, precision) or numerical performance results (e.g., "device achieved X% accuracy"). It only provides a qualitative statement about the performance.

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

This information is not provided in the document. The testing described is "non-clinical testing" and refers to "Spinal Elements Navigated instruments" rather than a fixed test set of data or patient cases. The provenance of any underlying "data" (if referring to images or patient data) is not relevant for this type of non-clinical, instrument-centric 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 and therefore not provided. The device is a navigated instrument, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or patient data. The "ground truth" for instrument accuracy typically comes from metrological standards or precise measurements against known values, not expert consensus on medical images.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (like images) by multiple experts to establish a definitive ground truth. The testing mentioned in the document is non-clinical performance testing of an instrument.

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

A MRMC study was not done. This document describes the clearance of a "navigated instrument" for surgical guidance, not an AI/ML diagnostic or prognostic system. Therefore, there is no mention of human readers, AI assistance, or an effect size.

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

This information is not applicable. The device is an instrument designed to be used by a surgeon (human-in-the-loop) with a pre-existing navigation system (Medtronic StealthStation® System). It is not an algorithm that functions standalone.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For this navigated instrument, the "ground truth" would likely refer to the true physical position or trajectory relative to a known anatomical landmark, measured using highly accurate metrology equipment during the "non-clinical testing" (ASTM F2554). The document does not specify the exact methodology for establishing this ground truth, beyond referring to the ASTM F2554 standard. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The device is a surgical instrument, not an AI/ML model that requires a training set.

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

This information is not applicable and therefore not provided. As the device is not an AI/ML model, there is no training set and no ground truth for a training set.

Summary of Device and Study Type:

The "Spinal Elements Navigated Instruments" are physical, reusable surgical instruments designed to integrate with the Medtronic StealthStation® System for precise anatomical localization during spinal surgery. The FDA 510(k) clearance process described here focuses on demonstrating the substantial equivalence of these instruments to previously cleared predicate devices, primarily through non-clinical performance testing related to their mechanical and navigational accuracy. The document explicitly cites compliance with ASTM F2554 for "Measurement of Positional Accuracy of Computer Assisted Surgical Systems" as the basis for performance evaluation. This is not an AI/ML device, and therefore the questions related to AI/ML specific study designs (such as expert consensus, training/test sets for algorithms, MRMC studies) are not applicable.

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The Karma® Fixation System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternom following sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.

The Karma® Fixation System is a temporary implant to be used in orthopedic surgery. The Karma® implant is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Karma® Fixation System is designed for a posterior approach. The include the following applications:

1. Spinal trauma surgery: Karma® implants can be used in sublaminar wiring techniques;

2. Spinal degenerative surgery: Karma® implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.

The Karma® Fixation System consists of a strap manufactured from PEEK conforming to ASTM F2026 compounded with 7.5% barium sulphate for radiopacity and Tantalum conforming to ASTM F560. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap through or around the bony structures to be secured. Both the spherical tip and the head of the device contain a tantalum pin for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taught by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.

This document is an FDA 510(k) summary for a medical device called the Karma® Fixation System. It explicitly states: "No additional testing was performed in support for this 510(k) Premarket Notification. An engineering rationale was provided to demonstrate substantial equivalence when compared to the predicate device."

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in this document. The device's clearance is based on substantial equivalence to a predicate device (K180728) through an engineering rationale, rather than new performance testing.

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Lucent® intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The Lucent® device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

The provided text is a 510(k) summary for the Lucent® XP intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through technical comparisons and non-clinical testing. It explicitly states that no acceptance criteria or studies proving device performance against such criteria are presented in this document.

The document details the following about the device's evaluation:

1. Acceptance Criteria and Reported Device Performance:

   • No specific acceptance criteria (e.g., in terms of clinical outcomes, accuracy, or specific performance metrics) are mentioned in this 510(k) summary.
   • The document states: "All data indicates that the device will perform as intended." This is a general statement and not a specific performance metric against a defined acceptance criterion.

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

   • No clinical or standalone performance test sets are mentioned. The "non-clinical testing" refers to mechanical tests of the device itself (hardware). The sample sizes for these mechanical tests are not provided.
   • Data provenance is not applicable as no clinical or image-based studies are referenced.

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

   • Not applicable, as no expert-reviewed test sets (e.g., for image interpretation or diagnosis) were used. The evaluation was based on mechanical testing of the physical device.

4. Adjudication method for the test set:

   • Not applicable, as no expert-reviewed test sets were 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:

   • No MRMC or human-in-the-loop studies were performed. The device is a physical intervertebral body fusion device, not an AI or imaging diagnostic tool.

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:

   • For the mechanical testing, the "ground truth" would be the engineering specifications and recognized industry standards (ASTM F 2077-14) against which the device performance was measured.

8. The sample size for the training set:

   • Not applicable. 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.

Summary of Device Evaluation (based on the provided text):

The evaluation for the Lucent® XP intervertebral body fusion device primarily relied on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies or performance against specific acceptance criteria.

• Mechanical Testing:

  • Performed in accordance with the FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device."
  • Included:
    • Static and Dynamic Compression Testing per ASTM F 2077-14
    • Static and Dynamic Compression Shear Testing per ASTM F 2077-14
  • The document states: "All data indicates that the device will perform as intended."

• Biocompatibility Testing: The materials and manufacturing processes were stated to be identical to previously cleared devices (K152011), thus no new biocompatibility testing was reported.

• No Electrical Safety, Software Verification, Animal Studies, or Clinical Studies were performed.

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Lucent intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

Lucent Magnum+ is an intervertebral body fusion device intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s).

This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

Crystal devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach from the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

Vertu devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Spinal Elements' Ti-Bond® is an additive plasma sprayed coating of commercially pure titanium conforming to ASTM F1580. Spinal Elements' devices are coated with Ti-Bond®f on their surfaces. Spinal Elements Ti-Bond® coating presents a macro-, a micro and a nano-surface structure.

This document is a 510(k) Premarket Notification for Spinal Elements Ti-Bond coated devices, stating that the coating does not change the previously cleared devices or their indications for use. Therefore, it does not contain the information requested about acceptance criteria and a study proving a device meets those criteria because the device being reviewed is a coating applied to existing devices, and the submission argues for substantial equivalence based on the coating not changing the previously cleared devices.

Here's why the requested information cannot be extracted directly from this document:

1. Nature of the submission: This is a 510(k) for a coating (Ti-Bond) for already cleared intervertebral body fusion devices. The core argument is that applying this coating does not alter the fundamental safety or effectiveness of the devices, and thus they remain substantially equivalent to their predicates. It's not a submission for a new device with new performance claims requiring extensive new clinical or performance studies to establish standalone acceptance criteria.
2. No New Performance Claims: The document explicitly states: "The indications for use of the devices coated with Ti-Bond® are not being modified from the ones cleared in their respective 510(k)..." and "There are no changes to the predicate devices coating. All technical characteristics remain identical." This means that the device is relying on the previous clearances of the predicate devices for performance, rather than providing new performance data for this specific 510(k) submission that would require detailed acceptance criteria and a study proving they are met.
3. Performance Data Section: The "Performance Data" section merely states: "In support of this 510(k) Premarket Notification, Spinal Elements has conducted nonclinical testing demonstrating that the Spinal Elements Ti-Bond® coating present a surface topography at a macro, a micro and a nano scale." This describes a characterization of the coating's physical properties, not a study against specific acceptance criteria related to a device's clinical performance (e.g., fusion rates, pain reduction, etc.).

Therefore, the document does not provide the specific details regarding acceptance criteria and a study to prove they are met as you've requested. The information you're looking for (acceptance criteria for clinical performance, sample sizes for test/training sets, expert qualifications, etc.) would typically be found in the original 510(k) submissions for the predicate devices themselves, or in a 510(k) for a novel device where new performance claims are being made.

If this were a submission for a new device, the "Performance Data" section would be much more extensive and detail specific studies (e.g., biomechanical testing, clinical trials, animal studies) conducted to demonstrate safety and effectiveness against predefined acceptance criteria for that device.

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The Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.

The Spinal Elements Cerclage System is a temporary implant to be used in orthopedic surgery. The Spinal Elements Cerclage System is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Spinal Elements Cerclage System is designed for a posterior approach. The indications for use include the following applications:

1. Spinal trauma surgery: The Spinal Elements Cerclage implants can be used in sublaminar wiring techniques;
2. Spinal degenerative surgery: The Spinal Elements Cerclage implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.

The Spinal Elements Cerclage System consists of a strap manufactured from PEEK conforming to ASTM F2026 compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip contains a tantalum pin for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taught by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.

The provided text describes a 510(k) premarket notification for the "Spinal Elements Cerclage System," a medical device and does not contain information about an AI/ML device or a study involving acceptance criteria for an AI/ML product. The document is a regulatory submission for a physical medical implant, not a software algorithm. Therefore, I cannot extract the requested information related to AI/ML device performance, ground truth, sample sizes for test/training sets, expert adjudication, or MRMC studies.

The document discusses non-clinical testing to demonstrate mechanical strength and substantial equivalence to a predicate device, which are typical requirements for physical implants, but these are not related to AI/ML acceptance criteria.

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The Mercury® Spinal System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is intended for anterior/ateral nonpedicle fixation, posterior non-pedicle fixation pedicle fixation for the following indications: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion.

This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and into the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the screws to help distribute loads placed against the bone. Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136, ASTM F 1472 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.

This document describes the Mercury® Spinal System, a medical device, and its regulatory clearance. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for medical image analysis. Therefore, I cannot provide an answer that addresses the requested points regarding acceptance criteria, study details, expert involvement, or AI performance metrics.

The provided text details the following:

• Device Name: Mercury® Spinal System
• Manufacturer: Spinal Elements Inc.
• Regulatory Clearance: K172967
• Device Type: Thoracolumbosacral pedicle screw system
• Intended Use: Immobilization and stabilization of the spine as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Materials: Titanium alloy (Ti-6Al-4V) and Cobalt Chromium alloy (Co-Cr).
• Substantial Equivalence: Claimed to be substantially equivalent to previously cleared Mercury Spinal System predicate devices (K071914, K082353, K083230, K091587, K141372, K151215).
• Performance Data: States that performance testing included Static Axial Grip and Torsional Grip Interconnection Testing per ASTM F 1717 and ASTM F 1798, and Static and Dynamic Flexion/Extension Testing per ASTM F 1798. It concludes that "All data indicates that the device will perform as intended."

To reiterate, the original text does not contain the information required to answer your specific questions related to AI device performance evaluation.

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Lucent® intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The Lucent® device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

This document is a 510(k) summary for a medical device called Lucent®, an intervertebral body fusion device.

Here's an analysis of the provided text in the context of your request:

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

The document does not provide acceptance criteria or reported device performance in the typical sense of quantitative metrics for a study. This 510(k) pertains to line additions to an already cleared device, and the submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting new performance data against specific acceptance criteria.

The "Performance Data" section explicitly states: "No clinical testing was found to be necessary. Given the type of changes made to the Lucent device, no additional non-clinical testing was required or performed."

Therefore, I cannot generate a table of acceptance criteria and reported device performance from this document.

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

As stated above, no new performance data or clinical testing was conducted for this 510(k) submission. The device's substantial equivalence is based on its similarity to previously cleared devices. Therefore, there is no test set sample size or data provenance to report from this document.

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):

Since no new performance data or clinical testing was performed, there was no test set for which ground truth needed to be established by experts.

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

Not applicable, as no test set was used for new performance evaluation.

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 an intervertebral body fusion device (a physical implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable, as no new performance validation using a specific ground truth was conducted. The ground for substantial equivalence relies on comparison of design, materials, and indications for use with predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring 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.

Summary of Device Acceptance and Study proving criteria:

The document describes the device, Lucent®, as an intervertebral body fusion device. This 510(k) submission is for line additions to an already cleared device. The primary method of demonstrating acceptance and meeting criteria is through substantial equivalence to legally marketed predicate devices.

The study that "proves" the device meets acceptance criteria, in this context, is the comparison to predicate devices. The submission argues that:

• The subject device is identical in indications for use, manufacturing method, raw material and operating principles to the predicate devices cleared in K122967 and K150061.
• It has equivalent technological characteristics to its predicates in areas including labeling/indications for use, general design features, function, material, manufacturing process, and instrumentation.

Therefore, the "proof" is based on the argument that because the device is sufficiently similar to devices already found safe and effective, no new performance studies are required.

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Vertu® & Vertu® Ti-Bond devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/C3 disc space to the C7/T disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies) of the cervical spine. Implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Crystal® & Crystal® Ti-Bond devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach from the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The Vertu and Vertu Ti-Bond Cervical Interbody System is composed of an implant body made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or polyetheretherketone (PEEK-Optima®) conforming to ASTM F2026 or PEEK-Optima® coated with commercially pure titanium per ASTM F1580 and fixation screws made from Ti-6Al-4V per ASTM F136 or ISO 5832-3 with a Nitinol clip conforming to ASTM F2063. All implant bodies have a titanium insert lining the internal surface of the screw holes conforming to ASTM F136 or ISO 5832-3. The implant body is generally boxshaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. Each screw hole is lined in its internal surface with a titanium ring insert. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole.

The Crystal and Crystal Ti-Bond Cervical Interbody devices are generally a box-shaped device with various holes located throughout its geometry to allow for packing of bone graft material. The body of the implant is made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 or ISO 5832-3 or polyetheretherketone (PEEK-Optima®) conforming to ASTM F2026 or PEEK-Optima® coated with commercially pure titanium per ASTM F1580. Superior and inferior surfaces of the device have teeth that help keep the device from migrating once placed in its desired location.

This FDA 510(k) Premarket Notification document (K153352) describes the Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody Systems. Per the document, "No changes were made to the existing Vertu. Vertu Ti-Bond. Crystal Ti-Bond devices nor were any new components added to the system. Therefore, no additional testing was required or performed." This implies that new acceptance criteria and a study to prove these devices meet those criteria were not established for this specific submission. Instead, the document relies on the substantial equivalence to previously cleared predicate devices.

Therefore, the following information cannot be directly extracted from the provided text for this specific K153352 submission:

1. A table of acceptance criteria and the reported device performance: Not explicitly stated as new criteria or performance data were generated for this submission. The device is determined to be substantially equivalent based on existing data and characteristics of predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable as a new test set was not created for this submission. The submission references previous clearances (K122771, K133218, K073351) for the predicate devices, which would have had their own testing.
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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. These are interbody fusion devices, not AI-assisted diagnostic tools.
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.

Summary based on the provided document:

The provided document (K153352) is a 510(k) premarket notification for expanded indications for the Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody Systems. The FDA determined the device is substantially equivalent to legally marketed predicate devices. The basis for this determination is that no changes were made to the existing devices, and no new components were added, thus no additional testing was required or performed for this specific submission. The substantial equivalence is argued based on a comparison of indications for use, technological characteristics, surgical technique, design features, and instrumentation to established predicate devices.

The acceptance criteria and performance data for the original clearances of these devices and their predicates would be found in the associated 510(k) submissions (K122771, K133218, K073351, K150053, K142264, K133653), which are not included in this document.

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