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The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

The UNiD™ Spine Analyzer is a web-based application developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. It aims to make measurements on a patient image, simulate a surgical strategy, draw patient-specific rods or choose from a pre-selection of standard implants. The UNiD™ Spine Analyzer allows the user to:

1. Measure radiological images using generic tools and "specialty" tools
2. Plan and simulate aspects of surgical procedures
3. Estimate the compensatory effects of the simulated surgical procedure on the patient's spine

The planning of surgical procedures is done by Medtronic as part of the service of pre-operative planning. The surgical plan may then be used to assist in designing patient-specific implants. Surgeons will have to validate the surgical plan before Medtronic manufactures any implant.

The UNiD™ Spine Analyzer interface is accessible in either standalone mode or connected mode.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for the UNiD™ Spine Analyzer:

Overview of Device and Study Focus:

The UNiD™ Spine Analyzer is a web-based application designed to assist healthcare professionals in viewing, measuring, and planning orthopedic spine surgeries. This 510(k) submission primarily focuses on the update to the AI-enabled degenerative predictive model (Degenerative Predictive model). The study aims to demonstrate that this new version is non-inferior to the previous version (predicate device).

1. Table of Acceptance Criteria and Reported Device Performance

The core of the performance evaluation for this AI-enabled software function is focused on demonstrating non-inferiority of the updated "Degenerative Predictive model" to the predicate version.

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

• Test Set Sample Size: 274 patient surgery cases.
• Data Provenance:
  • Country of Origin: US only.
  • Retrospective/Prospective: The document states "Preoperative and post operative images from 1050 patient surgery cases were collected." This implies existing data, making it a retrospective collection.

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

• Number of Experts: Not explicitly stated as "experts." Instead, the document mentions "highly trained Medtronic measurement technicians."
• Qualifications of Experts: "Highly trained Medtronic measurement technicians, operating within a quality-controlled environment." The specific professional background (e.g., radiologist, orthopedist) or years of experience are not provided. They were responsible for vetting image viability and performing measurements.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1 for consensus). It states that "After the images were collected, they were then provided to and measured by highly trained Medtronic measurement technicians, operating within a quality-controlled environment." This suggests a single evaluation per case by these technicians, which then forms the basis for the ground truth. There's no mention of multiple technicians independently measuring and then adjudicating discrepancies.

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

• No, a formal MRMC comparative effectiveness study involving human readers assisting with AI vs. without AI assistance was not mentioned or described in this document. The study specifically focused on the AI model's performance (algorithm only) compared to its previous version, not the impact on human reader performance.

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

• Yes, a standalone (algorithm only) performance study was done. The entire "AI-enabled device software functions (AI-DSF)" section describes the evaluation of the new Degenerative Predictive model's output against the ground truth, comparing its performance (MAEs) directly to the predicate AI model. This evaluates the algorithm itself.

7. The Type of Ground Truth Used

• Derived from Measured Images by Technicians: "Ground truth was derived from the measured images." These measurements were performed by the "highly trained Medtronic measurement technicians." This is a form of expert consensus/review, albeit by technicians rather than clinicians, and described as measurements on images. It is not pathology or outcomes data.

8. The Sample Size for the Training Set

• Training Set Sample Size: 776 patient surgery cases.

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

• The document implies the ground truth for the training set was established in the same manner as the test set: through measurements performed by "highly trained Medtronic measurement technicians." The statement "Ground truth was derived from the measured images" applies to the overall data collection process before splitting into training and testing sets.

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The MediYag is indicated for:

532nm wavelength: treatment of benign pigmented lesions (Lentigines, Birthmark: Cafe-Au-Lait).

1064nm wavelength: treatment of acne scars, benign pigmented lesions (Nevus of Ota), and removal of dark ink tattoos (black, blue).

The MediYag is a laser system which delivers a laser at a wavelength of 1064nm or 532nm.

The provided document is a 510(k) summary for the MediYag laser surgical instrument. It states that no clinical study was included in this submission (Section 8, page 6). Therefore, there is no information in the document to describe acceptance criteria or a study that proves the device meets such criteria based on clinical performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical specifications.

Here's a breakdown of the requested information based on the provided text, highlighting the absence of clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical study was performed, there are no acceptance criteria for clinical performance or reported device performance in terms of clinical outcomes. The device performance listed below is based on non-clinical technical specifications outlined for comparison to predicate devices.

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

Not applicable. No clinical test set data is provided. Non-clinical testing involved validating design specifications, but a "sample size" in the context of patient data is not relevant here.

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

Not applicable. No clinical test set and thus no "ground truth" derived from expert review of patient data is described.

4. Adjudication method for the test set

Not applicable. No clinical test set is described.

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 MediYag is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a laser surgical instrument, not an algorithm, and intrinsically requires human operation (human-in-the-loop).

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

Not applicable. No clinical "ground truth" data is referenced as no clinical study was performed. For non-clinical testing, the "ground truth" would be the device's design specifications and performance parameters, verified through engineering tests.

8. The sample size for the training set

Not applicable. No training set is mentioned as no clinical study or machine learning algorithm development (in the sense of a dataset) is described.

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

Not applicable. As no training set or clinical study is described, there's no information on how any "ground truth" for a training set would have been established.

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IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain 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. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

The IB3D™ PL Spinal System implants are inter-somatic spacers manufactured by additive manufacturing (Direct Laser Metal Sintering) from Titanium alloy Ti-6Al-4V ELI powder, according to ASTM F3001 and ASTM F136.

The IB3D™ PL Spinal System implants are intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach on the lumbar spine only.

The subject IB3D™ PL Spinal System interbody devices are available in a variety of heights and lordosis angles for treatment of lumbar interbody fusion procedure. The implant is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The design incorporates hexalock macro-rough surface on the superior and inferior surfaces of the device along with angular teeth to prevent expulsion from the interbody space.

This is a medical device submission, not an AI/ML device submission. Therefore, it does not contain information about acceptance criteria, test sets, ground truth, or training sets typical for AI/ML performance evaluation.

The provided document describes the IB3D™ PL Spinal System, an intervertebral body fusion device. The acceptance criteria and supporting studies for this type of device focus on mechanical performance, biocompatibility, and manufacturing quality, not diagnostic accuracy or AI algorithm performance.

Here's a breakdown of the relevant information from the document:

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

The document mentions several non-clinical tests performed to support substantial equivalence. These tests serve as the basis for demonstrating the device meets certain performance criteria. However, explicit "acceptance criteria" presented in a table format with corresponding "reported device performance" values are not detailed in this summary.

Non-clinical tests performed in support of substantial equivalence:

The summary states that these tests were performed on "worst-case constructs" of the IB3D™ PL Spinal System. The implication is that the device met the performance requirements of these standards, demonstrating substantial equivalence to its predicates.

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

For mechanical and material tests of this nature, "sample size" typically refers to the number of test articles (implants) subjected to testing. This information is not specified in the provided 510(k) summary. The document does not describe patient data (e.g., country of origin, retrospective/prospective) because no clinical testing was used to support the submission.

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

This information is not applicable as the submission is for a medical device (intervertebral body fusion device) and does not involve diagnostic interpretation or AI algorithm evaluation requiring human experts to establish ground truth from medical images or clinical data.

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

This information is not applicable for the same reasons as point 3.

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

This information is not applicable as this is not an AI-assisted device. The submission explicitly states: "No clinical testing was used in order to support this submission."

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

This information is not applicable as this is not an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the specified test standards (ASTM, ISO). Meeting the criteria outlined in these standards for mechanical strength, fatigue, wear, and biocompatibility constitutes the "ground truth" for proving the device's performance characteristics and safety.

8. The sample size for the training set:

This information is not applicable as this is a medical device, not an AI/ML product that requires a training set.

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

This information is not applicable as this is not an AI/ML product.

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The MediDiode is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hair regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Medidiode." This letter indicates that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain the specific information required to answer your request about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The letter primarily outlines regulatory compliance and does not describe the technical performance evaluation or clinical study results in detail.

Therefore, I cannot extract the requested information from the provided text.

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The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and id in the repair of bone fractures. The indications for use are as follows:

· Spinal trauma surgery, used in sublaminar or facet wiring techniques;

· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adults scoliosis and kyphosis;

· Spine degenerative surgery as an adjunct to spinal fusions.

· Intended for use with a posterior spinal instrumentation construct when ligamentation is needed.

The LigaPASS™ system may also be used in conjunction with other medical implants made of titanium or cobalt-chrome alloy whenever "wiring" may help secure the attachment of other implants.

The purpose of this submission is to expand the indications of the LigaPASS™ system to include the use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The LigaPASS™ 2.0 Ligament Augmentation System provides surgeons the ability to mimic anatomical muscle and ligament functionality and stabilization between vertebrae that are collapsed during surgery before fusion. The LigaPASS™ 2.0 Ligament Augmentation System is designed to restore balance and stability as a complement to a posterior thoracolumbar fixation system. Ergonomic instrumentation provides smooth assembly with self-stabilizing tensioners and torque-limiting locking tools. The LigaPASS™ 2.0 Ligament Augmentation System consists of a polyester (PET) band and titanium alloy medial open connector with 2 set screws.

LigaPASS™ bands allow the surgeon to create a posterior vertebra anchorage without theuse of a pedicle screw or hook. Instead of a pedicle screw or hook, the LigaPASS™ bands are laced around the vertebra independently of the vertebra anatomy and then connected to a LigaPASSTM connector to make the rod-bone connection.

The LigaPASS™ 2.0 bands are comprised of a PET braid and pure titanium (T40) malleable leads at the ends of the bands. The malleable tips help the surgeon to lace the band around the vertebra. They can be bent by the surgeon to make it pass under and through the vertebral body easier.

The LigaPASS™ connectors allow surgeons to attach a rod to a vertebral body without the use of the pedicle. Instead of a pedicle screw, the LigaPASS™ connector use a facet band to make the rod-bone connection. The connectors are comprised of a connector body, a rod set screw, a locking set screw for the band and a polyester band. The body of these connectors is manufactured from titanium allov (Ti-6Al-4V). The part is compatible with any rods made of titanium or cobalt chromium alloys between diameters 5.5 mm and 6.0 mm.

The provided text is a 510(k) premarket notification decision letter and summary for the LigaPASS™ 2.0 Ligament Augmentation System. It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria.

The document pertains to a physical medical device (ligament augmentation system) used in orthopedic surgery, not a diagnostic or AI-powered device. The "Performance Testing Summary" explicitly states:

"No additional bench or animal testing was completed for the purpose of this 510(k) submission. The non-clinical performance of the LigaPASS™ 2.0 Medial System has been validated through a series of 510(k) submissions (K172021, K173506). Clinical data published in the literature were provided to support the use of ligament augmentation with the LigaPASS™ system in adult spinal deformity surgery."

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from this document.

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The Infinity™ OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:

• Traumatic spinal fractures and/or traumatic dislocations.
• Instability or deformity.
• Failed previous fusions (e.g. pseudarthrosis).
• Tumors involving the cervical spine.
• Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Infinity™ OCT System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT Rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and VertexTM Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert and Vertex™ Reconstruction System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) reguires the use of MAS Crosslink™ at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offiset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

The PASS OCT spinal system is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT spinal system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the PASS OCT spinal system may be connected to the PASS LP spinal system with the dual diameter rods. Refer to the PASS LP spinal system package insert for a list of the PASS LP spinal system indications of use.

The Infinity™ OCT System and PASS OCT Spinal System (including UNID™ OCT Patient-Specific Rods) are posterior systems, which consist of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, Cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO 5832-12 and ASTM F1537.

The purpose of this submission is to add titanium alloy and cobalt chrome 3.5/4.75 mm transition rods to the line of UNID™ OCT Patient-Specific Rods. The subject rods are designed and manufactured for one specific patient and are compatible with Infinity™ OCT System and PASS OCT Spinal Systems (cranially) and the CD Horizon Spinal System (caudally). The UNID™ OCT Patient-Specific Rods must be used during surgery for this patient only and must not be reused (single use only).

This document describes a spinal system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for AI/ML models is not applicable and cannot be extracted from the provided text.

The document pertains to the 510(k) premarket notification for the "Infinity™ OCT System and PASS OCT Spinal System," which are posterior cervical screw systems intended to provide immobilization of spinal segments. The purpose of the specific submission is to add titanium alloy and cobalt chrome 3.5/4.75 mm transition rods to the line of UNiD™ OCT Patient-Specific Rods.

The "Performance Data (Non-Clinical Test Summary)" section mentions that "Medicrea has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices." The tests performed were "static and dynamic compression bending, and static torsion" per ASTM F1717, to confirm the compatibility of the caudal 4.75 mm portion of the subject rods with the CD Horizon Spinal System. This describes mechanical testing of a medical device, not a study of an AI/ML algorithm.

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The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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), tumor, pseudarthrosis, and or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™M Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications

The PASS LP™ Spinal System is a pedicle screw fixation system intended for 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon Spinal System and PASS LP™ Spinal System (including UNiD™ Patient Specific Rods) consist of a variety of shapes and size of rods, hooks, screws, crosslink, plates, staples and connecting components, as well as implants components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The purposes of this submission are to:

• Add the UNiD™ Patient Specific Rods (new diameter 4.75mm) to the previously cleared CD Horizon™ Spinal System (K113174, cleared 11/21/2011) and PASS LP™ Spinal System (K140738, cleared 11/04/2014)
• Change the propriety Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient י Specific Rods"

UNiD™ Patient Specific Rods are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, or in cobalt chrome alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications.

UNiD™ Patient Specific Rods are differentiated in two subgroups: UNiD™ Patient Specific Standard Rods (UNiD ROD) and UNiD™ Patient Specific Percutaneous Rods (UNiD™ Patient Specific Rods have been designed and manufactured for one specific patient. UNiD™ Patient Specific Rods must be used during surgery for this patient only and must not be reused (single use only). The UNiD™ Patient Specific Rods 4.75 diameter rods are not compatible with the PASS LP system. For a complete guide to the system, it is important to refer to the surgical technique.

Please find the information regarding the acceptance criteria and study for the device below.

The provided text is a 510(k) Summary for the CD Horizon™ Spinal System and PASS LP™ Spinal System, which are pedicle screw fixation systems. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly for UNiD™ Patient Specific Rods. The primary purpose of this submission is to add UNiD™ Patient Specific Rods (new diameter 4.75mm) and to change the proprietary Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient Specific Rods."

The testing conducted is for mechanical equivalence, not clinical performance or diagnostic accuracy. Therefore, concepts like sensitivity, specificity, accuracy, and reader studies (MRMC, standalone algorithm performance) are not applicable to this type of device submission. The acceptance criteria and "performance" here refer to mechanical strength and durability.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (implantable spinal system), the acceptance criteria are based on mechanical properties as per a recognized standard. The document does not provide specific numerical acceptance criteria (e.g., minimum load values) but rather states that testing was conducted in accordance with a standard and demonstrated mechanical equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. Mechanical testing typically involves a sufficient number of samples (e.g., typically n=5 or n=6 per test condition for medical device mechanical testing) to provide statistically significant results according to the chosen standard (ASTM F1717-18).
• Data Provenance: The testing was conducted by Medicrea (Medtronic). It's scientific/engineering test data, not patient data, so 'country of origin' of data or 'retrospective/prospective' doesn't apply in the common clinical sense. The manufacturer is based in France.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by recognized engineering standards (ASTM F1717-18) and measured physical properties, not expert consensus.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is mechanical testing data, not human-interpreted data. Results are quantified using laboratory equipment.

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

• MRMC Study Done: No. This type of study is for evaluating the impact of a diagnostic or assistive AI device on human reader performance. This submission is for an implantable medical device, not a diagnostic or AI-driven system.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Standalone Study Done: No. This also refers to AI algorithm performance, which is not relevant to this mechanical device submission.

7. Type of Ground Truth Used

• Type of Ground Truth: Engineering standards and measurements of mechanical properties. The "ground truth" is adherence to established, validated mechanical test methods (ASTM F1717-18) that ensure the device is "substantially equivalent" in performance to predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This concept applies to machine learning models. The manufacturing process of UNiD™ Patient Specific Rods involves patient-specific design (i.e., custom bending for one specific patient based on their anatomy), but this is not an AI "training set."

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

• How Ground Truth for Training Set Was Established: Not applicable. No "training set" in the machine learning sense is used here. For the patient-specific rods, the "ground truth" for each rod's design is the specific patient's anatomical requirements, which are determined via medical imaging and planning, not a training set.

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The UNID™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

The MEDICREA UNiD Spine Analyzer was developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. This web-based, Software as a Medical Device (SaMD) application aims to simulate a surgical strategy, make measurements on a patient image, and draw patient-specific rods or choose from a pre-selection of standard implants and ordering the patient-specific rods. The UNiD Spine Analyzer allows the user to:

• 1. Measure radiological images using generic tools and "specialty" tools
• 2. Plan and simulate aspects of surgical procedures

The purpose of this submission is to request clearance for the UNiD Spine Analyzer v4.0. The changes introduced are as follows:

• . Addition of the Degenerative Predictive Model, which corresponds to a type of adult spinal fusion degenerative construct, trained with a retrospective longitudinal patient dataset.
• . Update to the existing Adult Predictive Model consisting of three predictive model modules trained with retrospective longitudinal patient datasets, where one was included in Adult Deformity Model 1 (TKA-12) and two included in Adult Deformity Model 2 (PTA-12 and PTA-34).
• Update to the existing Pediatric Predictive Model consisting of two predictive model modules trained with retrospective longitudinal patient datasets (PediaLL and PediaPT),
• Addition of the display of a Predicted Value derived from a static machine-learning based model . when the user views simulated quantitative radiographic parameters of a planned surgery, generated when the Degenerative, Adult or Pediatric Predictive Models are used.
• . The subject device update also includes the addition of implant templates among a preselected database of Medtronic standard implants cleared in in the following 510(k)s: K073291, K083026, K091813, K110543, K113528, K120368, K150135, K152277, K172199, K172328, and K201267.

The provided text describes the UNiD™ Spine Analyzer, a medical image management and processing system, and its submission for FDA 510(k) clearance. Here's information extracted regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner for the "Predictive Models" (Degenerative Predictive Model, Adult Predictive Model, Pediatric Predictive Model). Instead, it states that these additions are "similar to the display of reference and normative data, and does not raise new questions of safety and effectiveness when considered with existing methods of managing spinal compensation."

For the software as a whole, the acceptance criteria are described indirectly through the validation activities:

• Comprehension of the Health Care professional with the UNiD Spine Analyzer,
• Appropriate human factors related to the UNiD Spine Analyzer, and
• Ease of use of the UNiD Spine Analyzer. |

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

• Predictive Models: The predictive models (Degenerative, Adult, and Pediatric) were "trained with retrospective longitudinal patient datasets." No specific sample size for these datasets or their provenance (country of origin) is provided.
• Software Validation/Verification: The document does not specify a separate "test set" sample size for the software validation activities beyond stating that "the software was tested against the established Software Design Specifications."
• Usability Study: No specific sample size (number of users) is mentioned for the usability study.

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

This information is not provided in the document. The document refers to the predictive models being "trained with retrospective longitudinal patient datasets" but does not detail how the ground truth for these training sets or any potential test sets was established, nor does it mention the involvement or qualifications of experts in this process for external validation. The clinical judgment of healthcare professionals is explicitly stated as required for proper software use, but not for ground truth establishment.

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

This information is not provided in the document.

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 multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or reported for this submission. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is identical to the predicate device." The new features (predictive models) are presented as an "additional tool" similar to "display of reference and normative data" and are not claimed to improve human reader performance with a measurable effect size.

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

The document mentions "Addition of the display of a Predicted Value derived from a static machine-learning based model" when the user views simulated quantitative radiographic parameters. This implies a standalone algorithmic prediction output. However, there are no specific performance metrics or a standalone study reported for the algorithm itself (e.g., accuracy of predictions against ground truth without human intervention).

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

For the predictive models, the ground truth for the training data was derived from "retrospective longitudinal patient datasets." The specific nature of this ground truth (e.g., direct surgical measurements, post-operative imaging, clinical outcomes) is not explicitly stated, beyond it being used to train models for "predicted spinal compensation."

8. The sample size for the training set:

The document states that the predictive models were "trained with retrospective longitudinal patient datasets" but does not specify the sample size for these training sets.

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

The document states the predictive models were trained using "retrospective longitudinal patient datasets." However, it does not detail the specific methodology for how the ground truth within these datasets was established (e.g., whether it was based on expert review of images, surgical records, or patient outcomes).

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The PASS LP™ Spinal System is a pedicle screw fixation system intended for 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediative patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LPTM Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ Spinal System without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications.

The PASS LP" Spinal System is composed of screws, hooks, rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, with the exception of the rods intended for in situ bending which are manufactured in non-alloyed titanium (CP titanium) conforming to ISO 5832-2 specifications and ASTM F67 specifications.

CoCr rods and implants are manufactured in Cobalt-Chromium Molybdenum alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications. Under no circumstances are the implants reusable.

The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The purpose of this submission following:

• introduce new PASS LP™ Spinal System 'Universal Crosslinks' components
• expand use of the previously cleared CD Horizon™ Spinal System rods with the subject PASS LP™ Universal Crosslinks
• expand use of previously cleared CD Horizon™ Spinal System hooks with previously cleared PASS LP™ Spinal System components

The provided text is an FDA 510(k) summary for a spinal system device. It does not describe or contain information about a study that proves a device meets acceptance criteria related to AI/ML device performance, which is what the prompt is asking for when it refers to "acceptance criteria," "sample size for test set," "data provenance," "experts," "adjudication," "MRMC study," "standalone performance," "ground truth," and "training set."

This document describes a spinal fixation system, its components, indications for use, and a comparison to predicate devices, primarily focusing on mechanical testing to demonstrate substantial equivalence for a physical medical device. The "acceptance criteria" mentioned in this document refer to the mechanical performance of the spinal system components (e.g., dynamic compression bending) as per ASTM F1717, to ensure the device is safe and effective when compared to existing devices.

Therefore, it's impossible to extract the requested information (related to AI/ML device performance studies) from the provided text.

The closest relevant information from the text to the prompt's structure is:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria (Mechanical): Mechanical equivalence of the subject PASS LP™ universal crosslinks when used with the CD Horizon™ 5.5/6.0 Spinal System, as demonstrated by testing in accordance with ASTM F1717.
* Reported Device Performance: "The performance testing demonstrates mechanical equivalence of the subject PASS LP™ universal crosslinks when used with the CD Horizon™ 5.5/6.0 Spinal System." and "The mechanical testing (e.g., dynamic compression bending) and an engineering analysis were performed to demonstrate substantial equivalence."
* Note: No specific numerical values for performance are provided in this summary.

The following information cannot be found in the provided text as it pertains to AI/ML device validation, not mechanical device testing:

• Sample sized used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

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