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The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are 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 long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system instruments. Current cleared Spineart® Navigation reusable instruments (K241644, K210472 & K183630) feature a connecting area for the tracker compatible with the Navlock Tracker to be navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spineart's Brainlab® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the Brainlab® Spine & Trauma Navigation System to the cleared range of SPINEART® Navigation Instrument System.

The provided FDA 510(k) clearance letter describes the "SPINEART Navigation Instrument System." This document is a clearance letter and a 510(k) summary, which may not always detail the full extent of the testing that would typically be found in a full submission. However, based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document states: "Performance data showed the addition of the SPINEART Brainlab® Navigation Adaptor (Subject device) on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System, provides an accuracy at least equivalent to the initial intended use defined for Brainlab® and provides results in simulated use more accurate than the acceptance criteria."

However, specific numerical acceptance criteria for accuracy are not explicitly stated in the provided text. The performance is reported as meeting or exceeding unspecified acceptance criteria.

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

The document does not specify the sample size used for the test set. It mentions "Comparison of accuracy between the Brainlab® tracker and clamps directly attached on the SPINEART Navigation Reusable Instruments and the Brainlab® tracker and clamps attached on the SPINEART Navigation Reusable Instrument using the SPINEART Brainlab® Navigation Adaptor (subject device)" and "Accuracy in simulated use (protocol adapted from ASTM F2554-22)."

The data provenance is not explicitly stated as originating from a specific country or as retrospective/prospective. The testing appears to be non-clinical performance bench testing conducted by the manufacturer, Spineart SA, located in Switzerland.

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

The document does not mention the use of experts or their qualifications for establishing ground truth in the non-clinical testing. The ground truth (or reference standard) in this type of accuracy testing is typically established through precise metrological instruments and methods.

4. Adjudication method for the test set

Not applicable. The described testing is non-clinical performance testing (bench testing for accuracy), not a study involving human interpretation that would typically require an adjudication method.

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. The device is a "Navigation Instrument System" intended to assist surgeons in precisely locating anatomical structures. It is not an AI-assisted diagnostic device that would typically involve human readers interpreting images, therefore, an MRMC study is not relevant to this device.

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

This device appears to be an instrument system and not an algorithm in the traditional sense of AI. The "standalone" performance tested was the accuracy of the navigation system components (specifically the new adapter with the instruments and Brainlab system), which is essentially the performance of the technical system without direct human variability in judgment as the primary outcome. The testing performed was a "Comparison of accuracy" and "Accuracy in simulated use," which are standalone technical evaluations.

7. The type of ground truth used

The ground truth for the accuracy testing would typically be established by highly precise measurement systems (e.g., coordinate measuring machines, optical tracking systems) that can determine the true position and orientation of instruments with sub-millimeter accuracy in a controlled testing environment. The document mentions "dimensional analysis" as also confirming accuracy.

8. The sample size for the training set

Not applicable. This device is not described as an AI/ML device that requires a training set. It is a navigation instrument system, and its performance is evaluated based on its mechanical and optical tracking accuracy.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

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The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the eCential Op.n PERLA® TL Nav System. It is indicated for population with medical conditions requiring the placement of spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The quidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nav Software and based on intraoperative 3D images provided by a compatible imaging system.

The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. Currently cleared Spineart® Navigation reusable instruments (K210472) feature a connecting area for the tracker compatible with the Navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spinear's eCential® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the eCential® Op.nº Navigation System to the cleared range of SPINEART® Natrument System.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state the numerical acceptance criteria from the ASTM F2554 protocol or the eCential protocol. However, it indicates that the device met these criteria.

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

The document does not specify the sample size for the test set used in the ASTM F2554 verification or the eCential protocol accuracy verification.
The data provenance is not explicitly stated in terms of country of origin, but the company (Spineart SA) is based in Switzerland. The studies are non-clinical (verification and accuracy testing), so concepts like "retrospective" or "prospective" are not applicable in the same way they would be for clinical trials.

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

The document does not mention the use of experts to establish a ground truth for the test set. The testing described (ASTM F2554 verification and eCential protocol accuracy verification) appears to be objective, physical testing of the device's accuracy and performance against defined technical standards and internal protocols, rather than relying on human expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the testing described does not involve human interpretation or subjective assessment that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The testing mentioned is non-clinical performance and accuracy verification of the device itself.

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

Yes, the testing described appears to be a standalone study of the device's performance. The "Verification of the eCential Navigation Adaptor designed by Spineart used in a worst case scenario, with the eCential® Op.n® Perla TL Nav system, according to the ASTM F2554 protocole" and "Accuracy Verification: Verification of the SPINEART Navigation reusable instruments with the eCential® Op.nº Peda TL Nav system, according a Protocole defined by eCential®" describe the device's inherent accuracy and technical performance without human intervention as part of the measured outcome. The device itself assists in navigation, but the testing focuses on the accuracy of the navigation system and instruments, not the accuracy of a human using it.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing would be the established technical specifications and measurements outlined in the ASTM F2554 standard and the eCential protocol. It's based on objective, measurable physical parameters such as precision, accuracy, and mechanical performance under specific test conditions.

8. The Sample Size for the Training Set

Not applicable. The described device is a navigation instrument system, not an AI/ML algorithm that requires a training set. The "eCential Op.n PERLA TL Nav System" includes software, but the provided text focuses on the instruments and adaptor and their performance with the navigation system, not the training of an AI component within the software itself.

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

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

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The SCARLET® AL-T system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous and /or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

When used with the integrated fixation by the mean of the bone screws provided, the SCARLET® AL-T is a stand-alone system and requires no additional supplemental fixation system.

When used as a lumbar intervertebral fusion device (i.e. without the bone screws provided), the SCARLET® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.

The SCARLET® AL-T spinal system is an anterior lumbar interbody fusion device with integrated fixation intended to provide mechanical support to the lumbar spine and maintain adequate disc space until fusion occurs. The SCARLET® AL-T system comprises a range of intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints and lordosis so as to adapt individual pathology and different patient's anatomical conditions. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The SCARLET® AL-T spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The Scarlet® AL-T interbody spacer has a monolithic design that incorporates solid, lattice and porous structures along with superior and inferior rough surfaces intended to increase implant stability into the intervertebral space and bony integration throughout the implant. When used with its integrated fixation, the spacer is crossed by three (3) bone screws protruding into the vertebral endplates. The bone screws are secured by the mean of two (2) cam locks that prevent backing out. The SCARLET® AL-T spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.The purpose of this submission is to add a 5° range of lordotic intervertebral spacers in 3 footprints (small, medium, a 20mm height to the existing 10° and 15° footprints to the previously cleared SCARLET® AL-T range of devices (K1818) K192993). The solid, lattice and porous structures of the same. No modifications have been made to the intended use, indications for use, materials, manufacturing process, sterilization process.

This document is a 510(k) premarket notification decision letter from the FDA to Spineart SA regarding their Scarlet® AL-T intervertebral body fusion device. It primarily focuses on the substantial equivalence determination for additional lordotic intervertebral spacers to their previously cleared devices.

Based on the provided text, there is no information available regarding the acceptance criteria, the specific study that proves the device meets acceptance criteria, or any of the detailed aspects of a clinical or analytical study as requested in the prompt.

The document states:

• "The present submission introduces only additional references for the interbody spacer and trials." (Page 5)
• "The engineering analysis has demonstrated that SCARLET® AL-T line extension (present submission) does not introduce new worst cases regarding the mechanical testing, so the tests performed on SCARLET® AL-T predicatedevices (K181818 / K192993) are still valid and cover the added cage references." (Page 6)
• "There is no significant difference between the SCARLET® AL-T line extension) and the previously cleared SCARLET® AL-T predicate devices (K1818 / K192993) which would adversely affect the use and performances of the product or raise any issue of safety and effectiveness. Consequently, no new mechanical tests were carried out." (Page 6)

This implies that the current submission relies on the testing and acceptance criteria established for the predicate devices (K181818 and K192993). The document does not provide details about those previous tests or acceptance criteria. It only lists a summary of non-clinical tests conducted on the predicate devices, such as:

• Static and dynamic axial compression (per ASTM F2077)
• Static and dynamic shear compression (per ASTM F2077)
• Static and dynamic torsion (per ASTM F2077)
• Expulsion
• Subsidence (per ASTM F2267)
• Mass loss determination after dynamic testing that passed 5 million cycles.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details because this information is not contained within the provided FDA 510(k) summary. The document is for a "line extension" of an already cleared device, asserting substantial equivalence based on prior testing, rather than presenting new comprehensive study data for the current submission.

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The Spineart Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Spineart Navigation Instrument System reusable instruments are specifically 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 a long bone or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.

The SPINEART® Navigation system includes the following instruments dedicated to screw placement: Screwdrivers, Taps, Drills.
The SPINEART® Navigation Instrument System is to be used with the following Spineart Systems:
RomeoⓇ2 Romeo®2 MIS PerlaⓇ Perla® TL Perla® TL MIS All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided non sterile.

The SPINEART® Navigation Instrument System instruments are not compatible with implants from other manufacturers.

The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation® System (V2.1.0) and the Medtronic NavLock® Tracker System.

This document (K241644) is an FDA 510(k) premarket notification for the "SPINEART Navigation Instrument System." This is a Class II medical device (Orthopedic Stereotaxic Instrument) with product code OLO, which includes surgical instruments intended to assist surgeons in precisely locating anatomical structures during spinal surgery for the placement of Spineart screws.

Based on the provided text, the submission is a "Special 510k" for a line extension, indicating that the device in question is a modification of a previously cleared device. The "Discussion of Testing" section explicitly states: "Addition of navigated instruments to SPINEART® Navigation Instrument System (K183630, K210472) does not require testing. An Engineering Analysis has been submitted to support substantial equivalence."

This clearly indicates that no new clinical study or performance study demonstrating the device meets specific acceptance criteria was conducted or submitted for this particular 510(k). Instead, the manufacturer relied on an engineering analysis to demonstrate substantial equivalence to previously cleared predicate devices (K183630 and K210472).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, because this specific 510(k) submission states that no testing was required or performed for the new instrument additions.

The manufacturer's argument for clearance here is based on the new instruments having the same technological characteristics, indications for use, function, material composition, design, range of sizes, and presumed accuracy performance as the predicate devices that were previously cleared. The "engineering analysis" would have focused on demonstrating that these new instruments do not introduce new questions of safety or effectiveness.

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JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The JULIET® Ti LL Lumbar Interbody Device are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Implants with 15-degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least two integrated fixation screws. The JULIET® Ti LL implants must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.

Spineart Juliet® Ti LL spinal implants consist of a range of titanium intervertebral body spacers, with various sizes and footprints so as to adapt different patient's conditions. The Juliet® Ti LL spinal implants are made of Titanium alloy Ti6A4V ELI conforming to ASTM F136. The Juliet® TilL spinal implants are additively manufactured and porous structures. The Juliet® Ti LL spinal implants are delivered sterilization). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The purpose of this submission is to add a new height (10mm) for the hyperlordotic spacers (five footprints) with a lordosis of 15° to the previously cleared Juliet® Ti LL range of devices (K190877, K173702).

The design of the connection interface of the plates and the screws are not modified. The solid, lattice and porous structures are the same. No modifications have been made to the indications for use, materials, manufacturing process, sterilization process.

Previously cleared (K190877, K173702) and added Juliet® Ti LL implants conform to Class II special controls established for Sec 888.3080 Intervertebral body fusion device.

Additionally, the Juliet Ti LL package insert has been updated to describe the conditions under which patients an MR environment.

This document describes a 510(k) premarket notification for the "Juliet® Ti LL Lumbar Interbody Device". The acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to previously cleared predicate devices, primarily K190877 and K173702, following a product line extension to include a new height (10mm) for hyperlordotic spacers with a 15° lordosis.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical performance data in the typical sense of a diagnostic AI device. Instead, the "acceptance criteria" are implied by the demonstration that the modified device (new height) is substantially equivalent to predicates, particularly for the mechanical and MR environment performance. The performance is assessed by confirming that existing predicate device testing covers the new device, and by conducting new MR assessments where applicable.

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

The document focuses on mechanical and MR testing of the device itself, rather than human clinical or imaging data (which would typically have a "test set" and "data provenance").

• Mechanical Testing: Performed on physical device samples (the predicate devices). The exact sample size for mechanical tests (e.g., how many devices were tested for compression, shear, etc.) is not specified in the provided text, but it refers to "assemblies (spacer + plate + fixation screws) that passed 5 million cycles."
• MR Testing: Performed on physical device samples. No specific sample size is mentioned, but typical MR testing involves a limited number of device samples.
• Data Provenance: Not applicable in the context of clinical patient data, as this is a device modification submission based on benchmarking against predicates and engineering analysis, not a new clinical study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The submission relies on engineering analysis and testing against established mechanical and material standards (ASTM, USP), rather than expert assessment of a clinical "test set" for ground truth.

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

Not applicable, as there is no clinical "test set" requiring expert adjudication of diagnoses or findings.

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

Not applicable. This is for an intervertebral body fusion device, not an AI-powered diagnostic device, so no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" here is defined by existing performance standards and the mechanical properties of the device materials and design validated through established testing protocols (e.g., ASTM standards for mechanical properties, USP for endotoxin, ASTM/FDA guidance for MR safety). The comparison is against the performance of the legally marketed predicate devices.

8. The sample size for the training set

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

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

Not applicable. No training set is involved for this device submission.

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SCARLET® AC-Ti cages are indicated for use 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. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. SCARLET® AC-Ti cages are intended to be used at one or two contiguous levels from C2-T1 to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used with two bone screws, the SCARLET® AC-Ti Secured Anterior Cervical Cage is intended to be used as a standalone system and requires no additional supplementary fixation systems.

When used with two anchors or without two bone screws, the SCARLET® AC-Ti cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.

The SCARLET® AC-Ti hyperlordotic (12° lordosis) cages are to be used with bone screws and/or anchors and additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine.

Spineart SCARLET® AC-Ti system is a Cervical Intervertebral Body Fusion device with integrated fixation intended to provide mechanical support and stabilization to the cervical spine and maintain adequate disc space until fusion occurs. The system comprises a range of intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints, and lordosis to adapt individual pathology and different patients' anatomical conditions. The interbody device is a box-shaped spacer with a central cavity that can receive bone graft, which is intended to promote intervertebral fusion. It has a monolithic design and is crossed by two tunnels that guide the bone screws and/or the anchors insertion into the vertebral endplates. Moreover, SCARLET® AC-Ti comprises integrated fixation by the mean of bone screws and/or anchors that come in various diameters and lengths. The SCARLET® AC-Ti spacers are all made from medical grade titanium alloy conforming to ASTM F136 and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is polished and thread tapping is machined. The screws and anchors are made from Ti-6AI-4V ELI conforming to ASTM F136. The SCARLET® AC-Ti spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile). Bacterial endotoxin testing on final, finished devices as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The provided text does not contain information about acceptance criteria or specific studies proving a device meets them. Instead, it is a 510(k) premarket notification summary for a medical device called SCARLET® AC-Ti, an intervertebral body fusion device.

The document discusses the device's indications for use, description, technological characteristics, and various types of non-clinical performance testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.

Here's a breakdown of the information that is available in the text regarding testing:

• Mechanical testing:

  • Tests Conducted: Static and dynamic Axial Compression, Static and dynamic Shear-compression, Static and dynamic Torsion (according to ASTM F2077-22), and Subsidence (according to ASTM F2267-22).
  • Purpose: To demonstrate comparable mechanical properties to identified predicate devices.
  • Additional Measurements: Mass loss was measured on post-test run-out of SCARLET® AC-Ti worst-case specimens dynamically tested. Expulsion characterization was also conducted.

• MRI Safety Evaluation:

  • Guidance Used: FDA guidance “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment” (Issued October 2023).
  • Testing Completed:
    • ASTM F2052-2021: Measurement of Magnetically Induced Displacement Force
    • ASTM F2213-17: Measurement of Magnetically Induced Torque
    • ASTM F2119-07: Evaluation of MR Image Artifacts from Passive Implants
    • ASTM F2182-19e2: Measurement of Radio Frequency Induced Heating
    • ASTM F2503-23e1: "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment"
  • Conclusion: The device was determined to be MR conditional.

• Human cadaveric testing:

  • Activity: Cadaver lab trials were conducted. (No specific details about metrics or outcomes are provided in this summary).

Based on the provided text, the following information you requested is NOT available:

• A table of acceptance criteria and the reported device performance: The document states that "Results demonstrate comparable mechanical properties to the identified predicate devices," but it does not provide specific numerical acceptance criteria or performance values.
• Sample size used for the test set and the data provenance: No information on sample sizes (e.g., number of units tested for mechanical properties, number of cadavers) or data provenance (country, retrospective/prospective) is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the studies described are non-clinical, mechanical, and safety evaluations, not expert-based diagnostic performance studies.
• Adjudication method for the test set: Not applicable for the types of tests described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This device is an implant, and the studies described are for physical and safety performance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI algorithm.
• The type of ground truth used: For mechanical testing, the "ground truth" would be established engineering standards (ASTM). For MRI safety, it's the physical interaction with MRI fields.
• The sample size for the training set: Not applicable, as there is no mention of a training set for an AI/algorithm.
• How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical implant and focuses on demonstrating its safety and performance based on engineering standards and comparison to existing devices, rather than clinical efficacy studies with specific acceptance criteria as you might see for a diagnostic device or a drug.

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The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the PERLA® TL Posterior Thoraco-lumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL Posterior Thoraco-lumbar Fixation System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL Posterior Thoraco-lumbar Fixation System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL Posterior Thoraco-lumbar Fixation System implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The provided text describes a 510(k) premarket notification for the PERLA® TL Posterior Thoraco-lumbar Fixation System. This submission is an "Extension of the range" and an "MRI update" for an already cleared device.

Crucially, the document explicitly states that this is an extension of an existing device and focuses on mechanical testing of new components (rods, rod connectors) and MRI safety evaluations. It does NOT describe a study evaluating the clinical performance or diagnostic accuracy of an AI or software device. Therefore, many of the requested points related to AI performance, such as sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this specific device extension.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria for this device extension are primarily focused on the safety and performance of the added mechanical components and their compatibility with MRI environments, as well as adherence to material and manufacturing standards.

Regarding the points not applicable to this specific submission (as it's a hardware extension and MRI update, not an AI/software performance study):

• 2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document describes mechanical and MRI safety testing, not clinical data analysis. For mechanical testing, samples are typically physical devices.
• 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 expert ground truth was established as this is not a diagnostic AI device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method was used as this is not a diagnostic AI device.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for diagnostic accuracy is not relevant here. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.

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The PERLA® TL system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• · degenerative disc disease;
• · spondylolisthesis;
• · fracture;
• · dislocation;
• scoliosis;
• · kyphosis;
• spinal tumor:
• · and failed previous fusion (pseudarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with TEKTONA® HV US bone cement system, the PERLA®TL system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time, in patients whom life expectancy is of insufficient duration to permit achievement of fusion in advanced stage of thoracic and lumbar spine tumors. The PERLA®TL 35mm to 60mm lengths Screws augmented used with TEKTONA® HV US bone cement system are intended to be used at spinal levels where the structural integrity is not severely compromised.

TEKTONA® HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

When used in conjunction with PERLA®TL system, TEKTONA® HV US Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. PERLA®TL Screws augmented with TEKTONA® HV US Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The PERLA® TL System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537.

The PERLA® TL System is identical to the previously cleared version, however this submission includes the additional option to use bone cement with the fenestrated screws.

Mendec Spine HV System (TEKTONA HV US Bone Cement) is highly viscous, radio-opaque acrylic resins (PMMA based) for percutaneous vertebroplasty or kyphoplasty. Mendec Spine HV System holds the powder and liquid components separately within a closed syringe-like device that serves as a mixing chamber. The device is packaged in unitary PVC-blister with tray, sealed with Tyvek lid, which is placed in an aluminum bag. The device is sold disposable and sterile.

The provided FDA 510(k) summary (K230774) describes a medical device, the PERLA® TL System, and its use in conjunction with TEKTONA® HV US Bone Cement. However, this document does not contain acceptance criteria or a study describing the device's performance against such criteria for the PERLA® TL System with bone cement augmentation for thoracic and lumbar spine tumors.

The document states that:

"Bone cement usability testing (Usability Testing, Cement Injection Time Testing, and Cement Flow, Bolus Formation, and Screw Removal from Bone Cement Testing) was conducted to validate the use of the Perla® TL System used with bone cement."

And:

"The non-clinical tests performed by the company included bone cement usability testing and screw removal testing was conducted to validate the use of the Perla® TL System used with bone cement."

This indicates that testing was performed, but the details required to answer your specific questions (acceptance criteria, performance results, sample size, type of ground truth, expert qualifications, etc.) are not present in this document. The provided text focuses on establishing substantial equivalence to predicate devices based on indications, design, materials, manufacturing, and performance based on these "usability" and "screw removal" tests, but it does not quantify their results or define specific acceptance criteria they met.

Therefore, I cannot provide the requested table or detailed information about the study from the given text.

In summary, the provided document lacks the specific information about acceptance criteria and detailed study results that you are requesting.

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TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. TRYPTIK®Ti cages are used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages are to be used with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Spineart Tryptik® Ti spinal implants consist in a range of intervertebral body spacers with various shapes and designs so as to be implanted via an anterior cervical approach and to adapt different patient's conditions. The Tryptik® Ti spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The subject implants Tryptik® Ti will extend the previously cleared Tryptik® Ti range of implants (K200312) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM), and join the previously cleared Tryptik® Ti range of implants (K200312) which addresses the same indications and utilize the same instrumentation designed purposely. The Tryptik® Ti spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile).

This is a 510(k) premarket notification for a medical device called Tryptik® Ti, an intervertebral body fusion device. The document states that "No additional testing has been performed for the Spineart Tryptik® Ti line extension spinal implants." and relies on an "engineering rationale" to support substantial equivalence to a previously cleared version of the same device and other predicate devices.

Therefore, the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It explicitly states that no additional testing was performed for this particular submission.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

1. Technological characteristics: The device uses the same manufacturing technology (additive manufacturing - SLM) and material (medical grade titanium alloy conforming to ASTM F136 and ASTM F3001) as the primary predicate device.
2. Design features: The device presents similar design features and range of devices, and is designed for the same anterior approach as the previously cleared Tryptik® Ti spinal implants.
3. Indications for use: The indications for use are identical to the predicate device.

The document also mentions that non-clinical tests (Static axial compression, Static shear compression, Static torsion according to ASTM F2077 and subsidence testing according to ASTM F2267) were conducted on the predicate devices, not this current submission.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established**

as this information is not present in the provided text. The submission relies on prior testing of predicate devices and an engineering rationale for substantial equivalence.

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The PERLA® TL Posterior Osteosynthesis System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the PERLA® TL Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL posterior osteosynthesis system consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The Perla®TL system is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL posterior osteosynthesis implants are delivered either non-sterile or sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. The subject product line extension of the PERLA® TL Posterior Osteosynthesis System manufactured by Spineart (K193396; K203222; K203506) consists of addition of cannulated fenestrated sagittal screws in various sizes and designs to accommodate different patient anatomies or surgeon's techniques.

The provided text describes a 510(k) premarket notification for a medical device called the "PERLA® TL Posterior Osteosynthesis System." This document primarily discusses the substantial equivalence of the new components (cannulated fenestrated sagittal screws) to previously cleared predicate devices based on mechanical performance and design.

However, the provided text DOES NOT contain information regarding the acceptance criteria for an AI/ML powered medical device, nor does it describe a study involving human readers or AI performance metrics such as sensitivity, specificity, or AUC.

The document details the FDA's acknowledgement of the 510(k) submission, the indications for use of the device, and a summary of the technical characteristics and non-clinical performance testing (mechanical testing like static and dynamic compression bending) to demonstrate substantial equivalence to predicate devices. It states:

• "Static compression bending, static torsion and dynamic compression bending testing were conducted in conformance to ASTM F1717-18. Results demonstrated substantial equivalence between Cannulated Fenestrated Sagittal Screw added component to the PerlaⓇTL system and the identified predicate devices."
• "As was established in this submission, the PERLA® TL added components are substantially equivalent and have the same technological characteristics to predicate devices in areas including indications for use, function, material composition, design, range of sizes and mechanical performance."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI-powered device meets the acceptance criteria based on the provided text. The device described (PERLA® TL Posterior Osteosynthesis System) is a physical medical implant (pedicle screw system), not an AI/ML-powered software device.

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