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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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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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MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal 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 I Spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

UNID® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device consists of one single implant with specific heights, footprint, lordosis and coronal angle. Patient matched endplates can be added to the implant. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following ASTM F3001 standard, a radio opaque material. As any orthopaedic implants should not be reused. For a complete quide of the system, please refer to the surgical technique manual for specific instructions.

The UNiD® IB3D ALIF cage is designed for a specific patient, it must not be used for another patient.

MATERIALS: Components are manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.

Function:
The UNiD® IB3D ALIF was developed as an implant:

• to provide immobilization and stabilization of posterior spinal segments .
• to augment the development of a solid spinal fusion ●
• . to provide stability to ease fusion
• to be mechanically resistant to allow the fusion of the operated level

I apologize, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (UNiD® IB3D ALIF), an intervertebral body fusion device.

It focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than an AI/ML-driven device's performance study against specific acceptance criteria.

The text does not include:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Details about sample sizes used for test sets or data provenance.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Types of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The document discusses mechanical testing (Finite Element Analysis - FEA) of the physical implant, concluding that no new worst-case implant was created, thus no additional physical testing was deemed necessary. This is typical for a physical medical device clearance, not an AI/ML software.

Therefore, I cannot fulfill your request based on the provided input.

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MEDICREA® INTERNATIONAL IB3D ALIF device is indicated for spinal 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 I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IB3D ALIF Device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

MEDICREA® INTERNATIONAL IB3D ALIF device consists of one single implant available in several heights, lengths, lordosis and footprints. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6Al-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.

The provided text is a 510(k) premarket notification for a medical device called "IB3D ALIF," an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical trial with defined acceptance criteria and human reader studies (MRMC studies).

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, and other specifics typically found in studies proving a device meets such criteria (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types, training set details).

The requested information is not available in the provided text because this is a 510(k) submission for a physical implant (an intervertebral body fusion device), not a software or AI-driven diagnostic device.

Here's an explanation of why the requested information is absent and what is typically provided in a 510(k) for a physical device:

• Acceptance Criteria and Device Performance (Table): Not applicable in the context of AI software. For this device, "performance" relates to mechanical strength, biocompatibility, and intended function as an intervertebral body fusion device, which are tested against standards like ASTM F2077 and F2267. The document states "no new worse-case implant was created" by FEA, and expulsion testing was conducted, but specific pass/fail criteria or detailed results are not explicitly listed in this summary.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type (for test set), Training Set Details: These questions are specifically relevant to the evaluation of AI or imaging diagnostic software. The IB3D ALIF is a physical implant. Its evaluation for 510(k) clearance primarily involves:
  • Mechanical Testing: Such as finite element analysis (FEA) and expulsion testing to ensure the device can withstand forces and maintain placement.
  • Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
  • Materials Comparability: Demonstrating the materials are the same as previously cleared predicate devices.
  • Indications for Use Comparability: Showing the device is intended for the same patient population and conditions as predicate devices.
  • Sterilization Validation: Ensuring the device can be sterilized effectively.

In summary, the provided document relates to a physical medical device (an implant) and not an AI or software-based diagnostic tool. As such, the concept of "acceptance criteria" and "studies" as understood for AI/software in the prompt are not relevant to this 510(k) submission.

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UNiD Patient-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels form 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 I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with bone graff.

UNiD Patient-matched PLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The UNiD patient-matched PLIF cage is an intervertebral lumbar device, designed to match the anatomy of an individual patient from patient imaging data (X-Ray, MRI, CT). The implant is manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.

This looks like a 510(k) summary for a medical device called "UNiD Patient-matched PLIF cage". The provided text describes the device, its intended use, and compares it to predicate devices. It also mentions non-clinical testing but explicitly states that no clinical studies were performed.

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria in the way you've requested, as this submission indicates clinical performance data is not available. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

If you have a different document that details clinical studies and acceptance criteria, please provide that. Otherwise, based only on the provided text, the answer is that no such study was performed to demonstrate performance against acceptance criteria.

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UNiD Patient specific 3D printed TLIF cage 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 I spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

UNiD Patient specific 3D printed TLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

MEDICREA® INTERNATIONAL UNiD Patient specific 3D Printed TLIF cage consists of one single implant with specific heights, length and lordosis angle to the patient. It is intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.

MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.

Function:
The UNiD Patient specific 3D printed TLIF cage was developed as an implant:

• To provide immobilization and stabilization of posterior spinal segments ●
• to augment the development of a solid spinal fusion
• to provide stability to ease fusion ●
• to be mechanically resistant to allow the fusion of the operated level

The given text describes a 510(k) summary for the UNiD Patient specific 3D printed TLIF cage, which is an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about studies involving acceptance criteria related to device performance in an AI/algorithm context, nor does it detail a study that proves the device meets such criteria through clinical trials or performance metrics typically associated with AI-driven devices.

Therefore, many of the requested categories of information cannot be extracted from the provided text as they pertain to AI/algorithm performance and clinical study designs which are not present in this regulatory submission for a physical medical device.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria for the device performance that would typically be seen for an AI or algorithm-driven device. Instead, it relies on demonstrating substantial equivalence through material properties and mechanical testing comparisons to predicate devices. The "reported device performance" is essentially that it meets the same mechanical and biocompatibility standards as its predicates.

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

Not applicable. The "test set" and "data provenance" refer to data used in evaluating AI/algorithm performance. This document describes mechanical and biocompatibility testing of a physical implant. The mechanical testing involved evaluating a "worst-case device," but the sample size for these specific tests is not provided.

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, as this relates to expert-labeled data for AI/algorithm performance.

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

Not applicable, as this relates to expert adjudication for AI/algorithm ground truth.

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

Not applicable. This is a physical medical device (intervertebral cage), not an AI/algorithm.

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

Not applicable. This is a physical medical device.

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

For the mechanical testing, the "ground truth" would be the established engineering standards (ASTM F2077, ASTM F2267) which define acceptable mechanical properties and behaviors of intervertebral body fusion devices. For biocompatibility, the ground truth would be established international standards for the biocompatibility of medical device materials.

8. The sample size for the training set:

Not applicable. There is no AI/algorithm training set.

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

Not applicable. There is no AI/algorithm training set.

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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 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 pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scollosis. 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 PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3.

A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP range, with the addition of those new components:

• TULIP GENESIS Non-cannulated Pedicle Screws
• TULIP GENESIS Non-cannulated Iliac Screws
• TULIP GENESIS Cannulated Pedicle Screws
• TULIP GENESIS Cannulated Iliac Screws
• TULIP GENESIS Breakable Setscrew

This document is a 510(k) Pre-Market Notification from the FDA for the PASS LP Spinal System. It is an approval letter and a summary of the device and its intended use, not a study evaluating its performance against acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information as the document does not contain details about:

1. Acceptance criteria and reported device performance related to an AI/ML model. This document is for a medical implant (spinal fixation system), not a software device that relies on performance metrics like accuracy, sensitivity, or specificity.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Stand-alone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
8. Sample size for a training set.
9. How ground truth for the training set was established.

The "Performance Data" section (g) only mentions mechanical testing according to ASTM F1717-18 for static compression bending, static torsion, and dynamic compression bending tests, concluding that the products are "as mechanically sound as other devices commercially available." This refers to the physical properties of the spinal implants, not the performance of an AI or Machine Learning algorithm.

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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, when used for posterior 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 pediatic patients diagnosed with the following conditions: spondylolistis 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 PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP, with the addition of new components: 'Dominoes & Iliac Connectors'.

The provided document is a 510(k) summary for the Medicrea International S.A. PASS LP Spinal System, specifically for the addition of new components ('Dominoes & Iliac Connectors'). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel performance against acceptance criteria in the context of an AI/ML medical device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product. Specifically:

• No AI/ML device: The PASS LP Spinal System is a physical spinal implant system, not an AI/ML-driven medical device.
• No acceptance criteria for AI/ML performance: The "acceptance criteria" discussed in the document relate to biocompatibility and mechanical engineering standards for physical implants (e.g., ASTM F1717-15, ISO 10993).
• No study demonstrating AI/ML performance: The document explicitly states "No clinical studies were performed" and "No animal studies were performed." The "performance data" section refers to engineering and biocompatibility testing of the physical components.
• No data provenance, expert panels, or MRMC studies: These concepts are relevant to the evaluation of AI/ML diagnostic or prognostic devices, which is not what this 510(k) submission addresses.

In summary, the provided text describes a medical device approval pathway for a physical orthopedic implant and does not contain any of the information requested about AI/ML device acceptance criteria or performance studies.

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UNiD 3D printed interbody system 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 I spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

UNiD 3D printed interbody system device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The UNiD 3D printed cage is an intervertebral lumbar device, which consists of various implant sizes to adapt the implant to the patient anatomy. The implants are manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.

This document is a 510(k) premarket notification for the UNiD Patient Specific 3D printed cage. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and performance against those criteria as would be found for a novel device requiring extensive clinical trials.

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

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

The document does not explicitly state "acceptance criteria" for performance in a clinical sense. Instead, it describes mechanical tests performed following established ASTM standards to ensure the device's physical and mechanical properties are comparable to legally marketed predicate devices. The performance reported is that these tests were "conducted" and presumably met the requirements of these standards for substantial equivalence.

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

• Sample Size: The document does not specify the sample size for the non-clinical mechanical tests. Typically, these tests would involve a small number of device samples (e.g., 3-6 per test condition).
• Data Provenance: The tests were non-clinical (mechanical). There is no patient data or country of origin mentioned.

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. This device is an intervertebral fusion cage, and the testing described is mechanical, not involving human interpretation or clinical ground truth establishment by medical experts.

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

Not applicable. There was no clinical test set requiring adjudication.

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

Not applicable. This is not an AI/imaging device. No MRMC study was conducted.

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

Not applicable. This is not an algorithmic device.

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

For the non-clinical mechanical tests, the "ground truth" would be the established performance requirements and thresholds defined within the ASTM standards (F2077 and F2267). The device's performance is compared against these industry-accepted mechanical benchmarks.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

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The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

-Spinal trauma, used in sublaminar, or facet wiring techniques

-Spinal reconstruction 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, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions;

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 LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

The purpose of this submission is to introduce the LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010.

MATERIALS: Components in these bands are manufactured from pure titanium that conforms to ASTM F67 and biocompatible Polyethylene Terephthalate (PET).

Function: The LigaPASS spinal system was developed as an implant:

• To provide temporary stabilization as bone anchor during the development of solid bony fusion.

• To aid the repair of bone fracture.

This document is a 510(k) summary for the Medica International's LigaPASS additional components (LigaPASS 2.0 Band - B08110005 and LigaPASS 2.0 Dual Band - B08110010). It focuses on establishing substantial equivalence to previously cleared LigaPASS devices (K172021). The information provided primarily pertains to the design and material comparisons, and non-clinical testing. It does not include data from a study that typically measures specific performance metrics against pre-defined acceptance criteria in the context of medical device AI or diagnostic accuracy, nor does it involve human readers, ground truth establishment by experts, or training/test sets for an algorithm.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert qualifications, and AI-related studies are not applicable to the content of this 510(k) summary.

However, I can extract the relevant information from the provided text regarding the non-clinical testing and the basis for substantial equivalence.

Here's an interpretation based on the provided document, acknowledging the limitations:

This document is a 510(k) Summary, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. In such cases, the "acceptance criteria" are generally that the new device performs at least as well as, or is technologically similar to, the predicate device in terms of safety and effectiveness, supported by non-clinical (and sometimes clinical) data. There isn't a table of numerical "acceptance criteria" against which a new device's performance is explicitly measured in the way one might expect for a diagnostic or AI-driven device's sensitivity/specificity.

The "study" undertaken here is a comparative analysis and non-clinical testing to demonstrate substantial equivalence.

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

As this is a 510(k) for device modifications (additional components to an existing system) and not a novel diagnostic AI product, there aren't explicit numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity). The "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, particularly regarding material properties and mechanical performance.

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

For the mechanical testing:

• Sample Size: Not explicitly stated in terms of number of units tested, but the document refers to "the LigaPASS 2.0 Dual Band – B08110010" being tested. Typically, mechanical tests would involve a statistically relevant number of samples, but this specific number is not provided in the summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is non-clinical laboratory testing, not human data.

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

Not applicable. This device is a mechanical implant, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. There is no "test set" requiring adjudication by experts in this context.

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 or imaging device.

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

Not applicable. This device is a mechanical implant.

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

Not applicable. For mechanical non-clinical testing, the "ground truth" is typically the physical and material properties measured against established engineering standards (e.g., ASTM F67 for titanium, NF EN ISO 13934-1 for static traction) and comparison to the predicate device's known performance.

8. The sample size for the training set

Not applicable. This is a mechanical implant, not an AI-driven device requiring a training set.

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

Not applicable.

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