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The Mega Plus MIS Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus MIS Spine System can be used in an open approach and percutaneous approach.

The Mega Plus MIS Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking bolts, and a transverse (cross) link. Various sizes of these implants are available. Mega Plus MIS Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Mega Plus MIS Spine System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. All products are made of titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) approved for medical use. The implants will be provided non-sterile. The locking bolts utilized as part of the proposed system are identical to those of the Mega Plus Spine System (K173180, K183080). The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously for the Mega Plus Spine System (K173180, K183080).

The provided text describes a 510(k) premarket notification for the "Mega Plus MIS Spine System," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data or acceptance criteria for AI/ML performance.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as you've outlined, is not present in this document.

The document primarily focuses on:

• Device Description: What the device is and its components.
• Intended Use/Indications for Use: For what medical conditions and patient populations the device is intended.
• Technological Characteristics: How it compares to predicate devices.
• Performance Data: This section mentions non-clinical testing (mechanical tests) per ASTM F1717, but it does not provide acceptance criteria or specific results in the form of a table. It simply states that "The results of this non-clinical testing show that the strength of the Mega Plus MIS Spine System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

In summary, this document does not contain the information needed to answer your questions because it pertains to a traditional medical device (spinal fixation system) and its mechanical performance testing for substantial equivalence, not an AI/ML-driven device requiring clinical performance criteria, expert adjudication, or separate training/test sets as described in your request.

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The Mega Plus Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chromic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws (multi-axial, multi-axial long arm, mono and long-arm), iliac screws, rods, locking bolts, cross-links, and connectors. The Mega Plus Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mega Plus Spine implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt chromium alloy (Co28-Cr6-Mo) that conform to ASTM F1537. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the Mega Plus Spine System. Modifications to the Mega Plus Spine System from the clearance in K173180 include the addition of CoCr rods, the addition of LED and deformity type rods, and the inclusion of non-anodized screws for all screw types and sizes.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) summary for a medical device (Mega Plus Spine System) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific performance criteria or a study designed to prove those criteria.

Therefore, I cannot generate the table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

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The Mega Plus Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws (multi-axial, multi-axial long-arm, mono and long-arm), iliac screws, rods, locking bolts, cross-links and connectors. The Mega Plus Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mega Plus Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the Mega Plus Spine System.

This document is a 510(k) summary for the "Mega Plus Spine System," a medical device intended for spinal fusion. The FDA has determined it is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information, focusing on the absence of information rather than its presence, as this is a mechanical device, not an AI/software device.

1. Table of acceptance criteria and the reported device performance

The document lists performance tests conducted for the Mega Plus Spine System, all based on ASTM standards. However, it does not explicitly state specific quantitative acceptance criteria or detailed numerical results for these tests. It only makes a general concluding statement about the sufficiency of the device's strength.

2. Sample sized 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 any of the performance tests.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. It only mentions that BK MEDITECH Co., Ltd. is based in the Republic of Korea.

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

This question is not applicable to this document. The Mega Plus Spine System is a mechanical spinal implant, not a diagnostic or AI device that requires expert-established ground truth from medical imaging or clinical assessment for its performance evaluation (beyond internal engineering validation). The "ground truth" for this type of device is its mechanical integrity and compliance with engineering standards.

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

This question is not applicable as there is no mention of human observation or assessment of the performance data that would require an adjudication method. The performance data seems to be derived from objective mechanical testing.

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

This question is not applicable. The Mega Plus Spine System is a mechanical implant, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC comparative effectiveness studies involving human readers and AI assistance are irrelevant to this device.

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

This question is not applicable. The Mega Plus Spine System is a mechanical implant; there is no algorithm or software component that operates in a standalone manner.

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

The "ground truth" for this device's performance is established by conformance to recognized engineering and material standards (ASTM F1717-15 and ASTM F1798-13) and the mechanical properties of its constituent materials (titanium alloy Ti-6Al-4V ELI). These standards implicitly define what constitutes acceptable mechanical performance for spinal fixation devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical device testing for a spinal implant. Training sets are relevant for machine learning algorithms or AI models.

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

This question is not applicable for the same reason as point 8.

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The INNESIS PEEK TL Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The INNESIS PEEK TL Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The INNESIS PEEK TL Cages are offered in a variety of heights, footprints and curved shapes. The device has ridges on both its inferior and superior surfaces, and two large graft windows which help facilitate bony integration. The device includes marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage. The INNESIS PEEK TL Cage components are manufactured from Polyetheretherketone (VESTAKEEP® 14 R, ASTM F2026). They contain marker made of medical grade titanium alloy (Ti6Al4V-ELI, ASTM F136). The INNESIS PEEK TL Cage and instrumentation set is sold non-sterile.

This document is a 510(k) premarket notification for a medical device, the INNESIS PEEK TL CAGE. It does not contain information about the acceptance criteria and study proving device performance in the context of an AI/human-in-the-loop study. Instead, it details the substantial equivalence of this intervertebral body fusion device to predicate devices based on materials, design, indications for use, operational principles, and mechanical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for device performance related to AI or multi-reader multi-case studies, as that information is not present in the provided text.

The closest relevant information, regarding device performance in a general sense, is about mechanical testing to demonstrate substantial equivalence:

Summary of Mechanical Testing:

• Test Standards:
  • Static and dynamic axial compression test: ASTM F2077-11
  • Static compression shear test: ASTM F2077-11
  • Static and dynamic torsion test: ASTM F2077-11
  • Static subsidence test: ASTM F2267-04
  • Expulsion test: ASTM Draft Standard F04.25.02.02.
• Conclusion: The tests performed demonstrated that the INNESIS PEEK TL Cage met required mechanical strengths and that any minor geometric differences from predicate devices did not impact performance. The device was found substantially equivalent to the predicate devices.

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The INNESIS PEEK Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The INNESIS PEEK Cervical Cage is an implant for the anterior stabilization of the cervical spinal column using an Anterior Cervical Desectorny and Fusion (ACDF) surgery. The INNESIS PEEK Cervical Cages are offered in a variety of heights, footprints and curved shapes. The INNESIS PEEK Cervical Cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The INNESIS PEEK Cervical Cage includes spikes and marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage

Here's a breakdown of the acceptance criteria and study information for the INNESIS PEEK Cervical Cage, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and the mechanical performance of the INNESIS PEEK Cervical Cage. The acceptance criteria are based on established ASTM standards for intervertebral body fusion devices.

Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Testing results are for the following:" followed by the list of tests and standards. It then concludes by saying "These materials are both recognized as suitable biomaterials for this intended use and predicate devices have previously been cleared by FDA for this same intended use. Endotoxin testing has demonstrated that the process does not introduce endotoxins as a bi-product of the manufacturing and cleaning process." While it directly states biocompatibility and endotoxin results, for the mechanical tests, it implicitly suggests that the device met the requirements of the standards by stating testing was conducted in accordance with them, which is the typical approach for demonstrating substantial equivalence for mechanical properties.

Study Details

The provided text describes pre-clinical, often benchtop, testing rather than a clinical study. Therefore, some of the requested information regarding clinical study design (e.g., sample size for test sets, expert ground truth, MRMC studies) is not applicable.

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

   • Sample Size: Not specified for individual tests. For mechanical testing of medical devices, samples are typically physical units of the device tested under controlled laboratory conditions.
   • Data Provenance: Not explicitly stated, but implied to be from laboratory testing performed by BK Meditech Co, Ltd. or a contracted testing facility, likely in the Republic of Korea given the company's origin. The data is retrospective in the sense that it's generated for regulatory submission after device development.

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

   • This is not applicable as the testing described is mechanical, material, and chemical (endotoxin) in nature, not based on expert interpretation of clinical data or images. The "ground truth" here is the adherence to the specified ASTM standards and the validated properties of the materials.

3. Adjudication method for the test set:

   • Not applicable for the type of testing performed. Mechanical and material tests have objective pass/fail criteria based on quantitative measurements against a standard.

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

   • Not applicable. This device is an implantable medical device (cervical cage), not an AI diagnostic or image interpretation tool. Therefore, no MRMC study or AI assistance is relevant.

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

   • Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used:

   • For mechanical, material, and chemical tests: The ground truth is the performance specification defined by recognized industry standards (ASTM) and accepted material properties for biomaterials. For endotoxin testing, the ground truth is the absence of endotoxins at or below detectable levels.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/machine learning model for this type of device submission. The device design and materials are based on established engineering principles and prior art (predicate devices), not machine learning.

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

   • Not applicable, as there is no training set for an AI/machine learning model. The analogous "ground truth" for the device's design and manufacturing is based on established engineering and materials science principles, industry standards, and the performance history of similar predicate devices.

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The INNESIS PEEK Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level 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. INNESIS PEEK Cages are to be used with autogenous bone graft and implanted via a posterior approach. The INNESIS PEEK Cages are 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 INNESIS PEEK Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The INNESIS PEEK implant incorporates ridges on both its superior and inférior surfaces to help eliminate migration. A graft space help facilitate bony integration once implanted. The implants are made of polyether-ether-ketone (PEEK) body with the x-ray markers made of Titanium alloy (Ti-6A1-4V).

The provided document is a 510(k) summary for the INNESIS PEEK CAGE, an intervertebral body fusion device. It primarily details the device's information, indications for use, and substantial equivalence to predicate devices, along with performance testing conducted. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical or diagnostic performance, as might be expected for an AI/ML medical device.

The "Performance Testing" section refers to benchtop engineering tests performed according to ASTM standards for intervertebral body fusion devices, focusing on mechanical properties such as:

• ASTM F2077-11: "Test Methods for Intervertebral Body Fusion Devices."
• ASTM F2267-04: "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression."
• ASTM Draft Standard F-04.25.02.02: "Static Push-out Test Method for Intervertebral Body Fusion Devices," Draft #2 - August 29, 2000.

These tests evaluate the physical integrity, load-bearing capacity, and resistance to migration of the implant itself, not its performance in a diagnostic or AI-assisted scenario.

Therefore, the requested information elements related to AI/ML device performance (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable and not present in this document.

The document describes the acceptance criteria in terms of meeting the specifications defined by the ASTM standards for structural and mechanical performance of the implant. The "study" proving this involves the execution of these specific ASTM test methods.

Given the nature of the device (a PEEK cage implant) and the provided 510(k) summary, I cannot fill out the requested table or answer the questions related to AI/ML device performance. This document pertains to a physical medical implant, not a diagnostic or AI-powered technology.

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The Dyna-EXTOR(L) II and Dyna-EXTOR(M) II external fixation systems are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

The Dyna-EXTOR(SM) II external fixation system is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

Dyna-EXTOR(ST) II external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.

The Dyna-EXTOR II is unilateral external fixation device. The system has 4 detailed systems according to the intended use. The Dyna-EXTOR 11 external fixation system is composed of pins or wires inserted into the bone, above and below the fracture or surgery site. These pins are then attached to a strong external frame. This allows the bone to be held relatively firmly, while some mobility and weight bearing can take place.

The provided 510(k) summary for the Dyna-EXTOR® II External Fixation System does not contain specific acceptance criteria or a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy, which are typical for AI/ML-based devices.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on materials, configuration, indications for use, and through comparative testing to established standards.

Therefore, many of the requested details (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study, standalone performance, type of ground truth) are not applicable to this type of submission, which is for a physical medical device (an external fixation system) and not an AI/ML diagnostic or prognostic tool.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For physical devices like this external fixation system, "acceptance criteria" and "device performance" primarily revolve around meeting recognized industry standards (like ASTM F1541-02) and demonstrating equivalence in design and function to devices already on the market. There are no performance metrics like sensitivity or specificity because it's not a diagnostic or AI/ML device.

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 submission references "testing conducted according to ASTM F1541-02." This typically involves laboratory mechanical testing of device prototypes or production samples, not clinical data sets with "test sets" in the context of AI/ML. The provenance of such mechanical testing data is usually the manufacturer's R&D or an accredited testing lab.

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. "Ground truth" in the context of this device would refer to the physical and mechanical properties of the materials and component designs, which are verified through engineering tests against established standards, not expert clinical consensus on a "test set."

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

• Not applicable. As there is no clinical "test set" requiring human interpretation or consensus, no adjudication method is relevant here.

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

• Not applicable. This device is an external fixation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI performance metrics are not relevant.

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

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

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

• The "ground truth" for this device's performance is compliance with mechanical and material specifications as defined by engineering standards (e.g., ASTM F1541-02) and demonstrated equivalence to physically manufactured predicate devices. This is established through laboratory testing and engineering analysis.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an external fixation system.

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

• Not applicable. There is no "training set" for this device.

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The DVX 5.5 Spine System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

The DVX 5.5 Spine System (like the predicate The DVX Spine System) consists of four or more pedicle screws and two solid rods in a symmetric. bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX5.5 Spine System ( See Figure 1) is made of components for fixation of the spine: multi-axial pedicle screws, locking cap, rod and cross-link . The materials, sterilization and packaging are the same as those in DVX Spine System, the predicate.

The provided text is a 510(k) summary for the DVX 5.5 Spinal System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical testing. It does not contain information typically associated with clinical studies involving human patients or complex data analysis for acceptance criteria related to diagnostic or AI devices. Therefore, many of the requested categories (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to the information contained in this document.

Here's the information that can be extracted and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of number of devices tested, but the testing was for the DVX 5.5 Spine System components.
• Data Provenance: The testing was conducted for the specific device by the manufacturer (BK MEDITECH Co., Ltd.). It is a laboratory, mechanical test, not derived from patient data.

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

• Not Applicable. Ground truth, in this context, refers to clinical or diagnostic accuracy. For a mechanical device, performance is evaluated against engineering standards (ASTM F1717-04). No human experts are used to establish "ground truth" for mechanical performance in the way they would for medical image interpretation.

4. Adjudication Method for the Test Set

• Not Applicable. Mechanical testing against an ASTM standard does not involve an adjudication method. The results are quantitative measurements interpreted against the standard's specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• Not Applicable. This is a mechanical spinal implant. It is not an AI-assisted diagnostic or treatment device, and no MRMC studies were conducted as part of this submission.

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

• Not Applicable. This is a mechanical device, not an algorithm, and does not involve human-in-the-loop performance.

7. The Type of Ground Truth Used

• Mechanical performance standards. Specifically, ASTM F1717-04, which outlines standard test methods for spinal implant constructs in a corpectomy model. The "ground truth" is adherence to the specified mechanical properties and performance characteristics defined by this standard.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The DVX Spine System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal turnor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attaimment of solid fusion.

The DVX Spine System consists of four or more pedicle screws and two DVX solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The DVX rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX Spine System is fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136 -02a, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications (UNS R56401

The provided text describes a 510(k) submission for the DVX Spinal System, a medical device for spinal fusion. However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the context of device performance, clinical efficacy, or AI system-specific metrics.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices (NFix Fusion System, K053623, and MEGA Spine System, K072436). The basis for substantial equivalence is the similarity in materials, design, indications for use, operational principles, and source manufacturer.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not detail specific acceptance criteria for a new performance study or report new device performance metrics. Its claim is based on substantial equivalence to predicate devices, implying that the predicate devices' performance (which met their own acceptance criteria) is sufficient.

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

Not applicable. No new performance testing in a "test set" (clinical or otherwise) is described for the DVX Spinal System. The evaluation relies on the equivalence to existing devices.

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

Not applicable. No new test set requiring expert ground truth establishment is mentioned.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is mentioned.

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

No. The document does not describe any MRMC study, nor does it refer to an AI device that would typically be evaluated in such a study.

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

No. The document describes a physical medical device (spinal system) and does not refer to an algorithm or AI system for which a standalone performance study would be relevant.

7. Type of Ground Truth Used

Not applicable. Since no new performance studies are detailed, there is no mention of ground truth (expert consensus, pathology, or outcomes data) being used for the DVX Spinal System itself. The evaluation is based on the characteristics of the device and its predicate devices.

8. Sample Size for the Training Set

Not applicable. The DVX Spine System is a physical medical device. It does not involve machine learning or AI, and therefore, there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary of the Study (and its absence) described in the document:

The provided document describes a 510(k) submission for substantial equivalence. The "study" in this context is primarily a design and materials comparison between the DVX Spinal System and its predicate devices (NFix Fusion System and MEGA Spine System).

The key statement is: "No additional testing is required because the test results applicable to the N SPINE System and MEGA spinal system components are directly applicable to the DVX Spine System since they are virtually identical in design and materials. Designs are directly compared to demonstrate equivalence."

This means that:

• The acceptance criteria for the DVX Spinal System are implicitly those that were met by the predicate devices during their own clearance processes.
• No new study data is presented for the DVX Spinal System, as it is considered substantially equivalent based on design and material identity to already cleared devices.

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The MEGA Spine System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the MEGA Spine System is intended to provide immobilization and stabilization 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The MEGA Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking bolt, and a cross(transverse) linking mechanism.

The MEGA Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA Spine System.

The provided document is a 510(k) summary for the MEGA Spine System, a medical device for spinal fixation. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on mechanical testing. However, it does not contain the specific information required to complete the table and answer the study-related questions as it is not a study report on device performance but a premarket notification for regulatory approval.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Mechanical testing as listed in APPENDIX 9 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." However, it does not provide the specific acceptance criteria or the reported device performance metrics. Therefore, this table cannot be filled with the requested level of detail.

Missing Information for Complete Answer:

The following information is not present in the provided 510(k) summary:

2. Sample size used for the test set and the data provenance: This document does not detail specific sample sizes for mechanical testing or the origin of any data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This document is about mechanical testing of a medical device, not a performance study involving human interpretation or ground truth establishment by experts.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for mechanical testing. The "ground truth" would be the ASTM standard and predicate device performance.
8. The sample size for the training set: Not applicable to this type of device and study.
9. How the ground truth for the training set was established: Not applicable to this type of device and study.

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