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The Reliance Spinal Screw System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 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.

When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis, and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Reliance Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS Instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Posterior Reliance Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors. The Anterior Reliance Spinal Screw System consists of spinal rods, monoaxial screws. staples, and set screws. The Anterior Reliance staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section)

The Reliance Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications.

Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The provided document is a 510(k) premarket notification from the FDA for the Reliance Spinal Screw System. It details the device's indications for use, its description, and its substantial equivalence to previously marketed devices. However, it does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document discusses "Non-Clinical Testing" which includes "Static Compressive and Dynamic Compressive in accordance with ASTM F1717." This refers to mechanical testing standards for spinal implant constructs, not a clinical study involving human patients or a study validating an AI algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving an AI device meets them using the provided text. The document is about a traditional mechanical spinal implant, not an AI/ML medical device.

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The CastleLoc Spinal Fixation 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 CastleLoc Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

The CastleLoc Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism.

The CastleLoc Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. CastleLoc Spinal Fixation System implants components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The purpose of this submission is to add components of the type2 pedicle screw in CastleLoc Spinal Fixation System. Various sizes of these implants are available.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them, in the format you specified. The document is an FDA 510(k) premarket notification for a spinal fixation system, primarily focusing on establishing substantial equivalence to a predicate device.

Specifically, the text is a letter from the FDA to L&K Biomed Co., Ltd., regarding their CastleLoc Spinal Fixation System. It confirms that the device is substantially equivalent to a legally marketed predicate device. The "510(k) Summary" section outlines the device's identification, purpose, predicate devices, description, and indications for use.

While it mentions "Performance Testing" by stating: "Additional components of this system are not worst case. To verify worst case, we have performed mechanical test followed below standard. ASTM F 543", this is a very high-level statement indicating that mechanical tests were performed according to a specific ASTM standard.

The document does NOT provide the following crucial details that you requested:

• A table of acceptance criteria and reported device performance: It only generally refers to mechanical testing per ASTM F 543 but doesn't list specific criteria (e.g., pull-out strength, fatigue life) or the actual results achieved.
• Sample size used for the test set and data provenance: No information about the number of devices tested or if the data was retrospective/prospective or geographical origin.
• Number of experts used to establish ground truth and their qualifications: This is irrelevant for a mechanical device test, as "ground truth" typically refers to clinical or diagnostic accuracy, not mechanical performance.
• Adjudication method: Again, not applicable to mechanical testing.
• Multi reader multi case (MRMC) comparative effectiveness study: This type of study is for evaluating diagnostic devices where human readers interpret results, not for mechanical implants.
• Standalone performance: While mechanical tests are standalone in a sense, the document doesn't provide specific performance metrics.
• Type of ground truth used: Not applicable for a mechanical device.
• Sample size for the training set: Not applicable as this is a mechanical device, not an AI/ML algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory communication for a medical device and describes its equivalence to an existing product, but it does not contain the detailed performance study information with the specific criteria you requested.

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The SpineWorks™ FixxSure® X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:

• i) Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra;
• ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
• iii) Fracture;
• Dislocation; iv)
• Scoliosis: v)
• vi) Kyphosis;
• vii) Spinal tumor; and
• viii) Previous failed fusion (pseudarthrosis).

The SpineWorks™ FixxSure® X-Link can also be used with the Talon® Pedicle Screw System.*

The SpineWorks FixxSure X-Link is a transverse stabilizing device utilized to increase the strength of a pedicle screw instrumentation construct in posterior spinal fusion. The FixxSure implant comes in multiple lengths and has the capability of being manipulated into various planes of anqulation. The FixxSure implant has a proprietary dual locking mechanism allowing maximum cross-Link/rod connection while maintaining ease of insertion/use.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Two Excella II pedicle screw constructs with the FixxSure X-Link were tested.
• Data Provenance: The document does not specify the country of origin for the data. The testing was non-clinical, implying it was conducted as part of the device development and validation by Innovasis, Inc. or a contracted testing facility. It is retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.

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

This information is not applicable as the "test set" in this context refers to physical device constructs undergoing mechanical testing, not a dataset requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" in this context refers to physical device constructs undergoing mechanical testing, not a dataset requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable. The document describes a mechanical performance (non-clinical) study, not a clinical effectiveness study involving human readers or AI.

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

This information is not applicable. The device, FixxSure® X-Link, is a physical medical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective mechanical performance metrics as defined by the ASTM F1717-14 standard. The standard itself provides the criteria for evaluating the device's ability to withstand dynamic compression bending without failure for a specified number of cycles.

8. The Sample Size for the Training Set

This information is not applicable. As a physical implant, there is no "training set" in the context of machine learning or algorithm development. The device's design is based on engineering principles and previous successful designs (predicates).

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

This information is not applicable for the reasons stated above. The device's design and manufacturing rely on validated engineering specifications and quality control, not on a "ground truth" derived from a training dataset.

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Spinal fixation system is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

Spinal fixation system is mainly constituted by pedicle screw, reduction pedicle screw, Set screw, Spine Hook, Rod and Transverse linking pole assembly. Through using the assembly of the screws, rods and/or poles, there will be established a firm frame structure on the Spinal (conforming to the bio-mechanics principle). The components of the system include: pedicle screw, reduction pedicle screw, set screw, spine hook, rod and transverse linking pole assembly and so on. According to the different specification of the rod's diameter and the different usage on the spinal segments, the system is classified: J2X03, J2X04, J2X07..

Here's an analysis of the provided text regarding the acceptance criteria and study for the described medical device:

The provided document (K161151) is a 510(k) summary for a "Spinal fixation system." It describes a traditional clearance pathway where the device is shown to be substantially equivalent to a legally marketed predicate device (Devine Spinal System K111690). This type of submission relies heavily on similarity in design, materials, and performance data to the predicate, rather than establishing de novo safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study provided to demonstrate the device meets acceptance criteria is primarily a non-clinical bench testing study focused on mechanical and material properties, along with a rationale for biocompatibility based on material standards and prior use.

• Mechanical Testing:

  • Tests conducted: Static compression bending test, Dynamic compression bending test, Static torsion test.
  • Standard followed: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
  • Results: For all mechanical tests, the reported performance is that the testing results show "no statistically significant difference" between the proposed device and the predicate device's performance. This implies the acceptance criterion was equivalence or non-inferiority to the predicate device's established mechanical properties.

• Biocompatibility Testing:

  • Rationale provided: The device is made of Ti-6Al-4V, a material conforming to ASTM F136. The document states this material has been "employed successfully in human implant applications in contact with soft tissue and bone for over a decade" and has been used as a "control material in Practice F 981." This serves as the "proof" that the material is biocompatible, rather than new primary biocompatibility testing specifically for this device.

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

• Sample Size for Test Set: The document does not explicitly state the exact sample size for the mechanical tests (e.g., how many screws, rods, or construct assemblies were tested for each mechanical property). It refers to "two sample groups" (presumably proposed device vs. predicate) for comparison.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the testing itself, but the manufacturer (CANWELL MEDICAL CO., LTD.) is based in China. The predicate device manufacturer (Changzhou Orthmed Medical Instrument Co., Ltd) is also likely Chinese.
  • Retrospective or Prospective: The bench testing would be considered prospective for the specific tests performed on the proposed device, but the comparison relies on established data/performance of the predicate device.

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

Given this is a 510(k) submission for a physical implant (spinal fixation system) based on substantial equivalence and primarily on bench testing, the concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus on image interpretation) is not applicable in the same way.

• Ground Truth for Mechanical Tests: The "ground truth" is effectively adherence to established ASTM standards and the performance characteristics of the predicate device. The experts involved would be engineers or testing personnel qualified to conduct and interpret the mechanical tests and compare them to the predicate's specifications/performance data. Their specific number or qualifications are not detailed in this document.
• Ground Truth for Biocompatibility: The "ground truth" is the established biocompatibility of the ASTM F136 Titanium alloy, as recognized by regulatory bodies and scientific literature.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of mechanical and material testing. Adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in expert interpretations (e.g., in diagnostic studies). Here, the comparison is objective (numerical results from mechanical tests) and against a known standard or predicate performance.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study assesses human performance, often with and without AI assistance, and is common in diagnostic imaging devices. This device is a physical implant, not a diagnostic tool with human interpretation.

6. Standalone (Algorithm Only) Performance Study

• No standalone (algorithm only) performance study was done. This concept is relevant for AI algorithms. The device described is a physical medical implant (spinal fixation system).

7. Type of Ground Truth Used

• For Mechanical Performance: The ground truth is established through industry-recognized ASTM standards (ASTM F1717) and the established performance characteristics of the legally marketed predicate device (K111690).
• For Biocompatibility: The ground truth is based on material standards (ASTM F136) and the documented history of safe use of the material in medical implants.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles, material science, and the existing predicate device, but not through a "training set" of data for an algorithm.

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

• Not Applicable (as there is no training set for an algorithm). The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science knowledge, and the performance history and specifications of the predicate device.

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The ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

Spondylolithesis (Grade 3 and 4) Degenerative spondylolisthesis with objective evidence of neurological impairment Trauma (i.e., fracture or dislocation) Spinal stenosis Defomities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Tumor Pseudoarthrosis Failed previous fusion

The ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors and a transverse (cross) linking mechanism. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All pedicle screws have self-tapping function in ANAX™ 5.5 spinal System. The double lead thread is applied to the all pedicle screws to shorten the operation time. ANAX™ 5.5 Spinal System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities) The product life time of ANAX™ 5.5 SPINAL SYSTEM is 2 years based on mechanical test result.

MIS Extended Screw, Set Screw for MIS, and Straight and Curved MIS Rod have newly added in the system and they are intended for use in minimally invasive surgery (MIS).

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of ANAX™ 5.5 Spinal System implants.

The provided document is a 510(k) premarket notification from the FDA regarding a spinal system, not an AI/ML device. Therefore, it does not contain the information required to answer the specific questions about acceptance criteria for an AI/ML device's performance study.

The document discusses the substantial equivalence of the ANAX™ 5.5 Spinal System to previously cleared predicate devices based on design, material, mechanical performance, function, and intended use. It mentions that "mechanical performance of ANAX™ 5.5 Spinal System met the acceptance criteria which have been established from the predicate devices" and that "Additional mechanical testing (bench testing) was not conducted on the ANAX™ 5.5 Spinal System. However, the justification report was conducted to compare data of modified device to the ANAX™ 5.5 Spinal System (K132101, K143417) and determined no new worst case was introduced."

This statement refers to mechanical performance for a physical implant, not the diagnostic performance of an AI/ML algorithm. Consequently, I cannot extract details such as:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth relevant to an AI/ML diagnostic study.
• Training set details for an AI/ML model.

The document focuses on the regulatory clearance for a medical device (a spinal implant system) based on substantial equivalence to existing devices, primarily through engineering and mechanical testing or justification, rather than a clinical performance study of an AI/ML algorithm.

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The HC Spinal System is intended for posterior noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients for the following indications: severe spondylolisthesis (i.e., Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The HC Spinal System offers a comprehensive solution for immobilizing and stabilizing spinal deformities in patients as an adjunct to fusion. The HC Spinal System consists of monoaxial and polyaxial pedicle screws, set screw and rods. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile and will be used for either posterior or anterolateral non cervical fixation.

The provided text is a 510(k) summary for the HC Spinal System, a medical device. It does not describe a study involving an AI algorithm or human-in-the-loop performance. Instead, it details the non-clinical testing performed on a physical spinal implant system to demonstrate its substantial equivalence to a predicate device.

Therefore, most of the requested information regarding AI performance, sample sizes for test/training sets in an AI context, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document.

Here's the relevant information that can be extracted:

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

The document states that a series of non-clinical tests were performed. The "reported device performance" is a general statement that the device met the requirements. Specific numerical acceptance criteria and performance values are not provided in this summary.

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

• Sample sizes for test set: Not specified in the document. The tests performed are engineering/materials tests on physical devices, not clinical studies with human participants.
• Data provenance: Taiwan (R.O.C.) (where the submitter is located), for the device manufacturing/testing.

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

Not applicable. The "ground truth" for this type of device (spinal implant) is established through engineering and material testing standards (e.g., ASTM F1717). No human expert consensus for a "test set" in the context of interpretation of medical data is described.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of interpretations.

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 document does not describe an AI device or an MRMC study.

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

Not applicable. This document does not describe an AI algorithm.

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

The "ground truth" or standard for evaluation is based on pre-defined acceptance criteria derived from established engineering and material testing standards, such as ASTM F1717 for mechanical performance, and general biological safety standards for cytotoxicity, irritation, etc. These are objective measures rather than expert consensus on medical image interpretation or pathology.

8. The sample size for the training set

Not applicable. There is no AI algorithm, so no training set.

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

Not applicable. There is no AI algorithm, so no training set or associated ground truth establishment.

Summary of the study that proves the device meets the acceptance criteria:

The study described is a series of non-clinical tests performed on the HC Spinal System. These tests are outlined in Section 8 ("Non-clinical Testing") and include:

• Shelf Life Test
• In vitro Cytotoxicity Test
• Intracutaneous Irritation Study
• Skin Sensitization Study
• Pyrogen Test
• Acute Intravenous Systemic Toxicity Study
• Acute Intraperitoneal Systemic Toxicity Study
• Salmonella Reverse Mutation Test
• In Vitro Mammalian Chromosomal Aberration Test
• Rodent Micronucleus Test
• Bone Implantation Study
• Subchronic Intravenous Systemic Toxicity Study
• Static and Dynamic axial Compress Bending Testing
• Static Torsional Test

The document states that "All the test results demonstrate that HC Spinal system meets the requirements of its pre-defined acceptance criteria and intended uses." Specifically, for performance, it notes compliance with ASTM F1717. The purpose of these tests was to demonstrate the safety and performance of the device and to establish substantial equivalence to the predicate device (Xia® 4.5 Spinal System) under 510(k) regulations. No clinical test data was used to support this decision.

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The Zavation Spinal System is a pedicle screw system 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 Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 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.

The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance as one would typically find for an AI/ML medical device.

Instead, this document describes the Zavation Spinal System, its intended use, materials, predicate devices, and the basis for its substantial equivalence to those predicate devices. The "Performance Data" section specifically states:

"Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. The mechanical test results demonstrated that the Zavation Spinal System performs as well as or better than the predicate devices."

This indicates a mechanical performance study for a spinal implant, which is a different type of evaluation from what is typically done for AI/ML devices regarding diagnostic accuracy or clinical effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance in the context of an AI/ML device from this document. The document primarily focuses on:

• Mechanical Safety/Performance: Comparing the mechanical strength of the Zavation Spinal System to predicate devices according to a specific ASTM standard (F1717). The acceptance criterion here is implicit: the device must perform "as well as or better than" the predicate devices in these mechanical tests.
• Substantial Equivalence: Arguing that the device is substantially equivalent to legally marketed predicate devices based on technological characteristics, performance, and intended use.

To answer your specific questions in the context of an AI/ML device, I would need a document detailing a clinical performance study or an AI algorithm validation study.

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The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

When used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), or who are having the device removed after the attainment of a solid fusion.

The CapLOX II/TowerLOX Pedicle Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-100mm. Rods are available in 5.5mm diameter in lengths from 30-600mm and in an array of configurations including, straight and pre- lordosed configurations. The system includes set screws, pedicle screws, and rods along with the associated instrumentation to complete the procedure and implant construct.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (CapLOX II/TowerLOX Pedicle Screw System) and does not contain any information about acceptance criteria or a study proving that a device meets such criteria related to AI or software performance.

The document states:

• "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." This is a regulatory clearance based on equivalence to existing devices, not performance against specific acceptance criteria for a new type of study (like those you've inquired about).
• "Performance testing was not conducted as part of this submission." This explicitly indicates that the type of performance study you're asking for was not done for this particular submission. The changes being submitted are additions of new pedicle screw sizes and associated instruments, which do not represent a new worst-case for mechanical integrity and are within clinically accepted size ranges, thus not requiring new performance testing for substantial equivalence.

Therefore, I cannot provide the requested information from this document.

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Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Spinal inner fixation system consists of a variety of shapes and sizes of pedicle screws, rods, hooks, transverse linking pole assembly, and connecting components (side, domino, and axial), which can be rigidly locked into a variety of configurations. These components are made of titanium alloy per ASTM F136.

This document is a 510(k) premarket notification for a medical device, the "Spinal Inner Fixation System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets a specific set of acceptance criteria for diagnostic performance or treatment efficacy in the way an AI/ML device would.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance for AI/ML systems is not applicable or present in this document.

However, I can extract the information relevant to the mechanical performance testing conducted for this orthopedic device.

Here's the breakdown of the available information:

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

The document does not explicitly state numerical acceptance criteria for mechanical tests. Instead, it compares the proposed device's performance to that of the predicate device within the context of the testing standard ASTM F1717. The acceptance is based on the results showing no statistically significant difference between the proposed device and the predicate device for various mechanical properties.

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

The document refers to "two samples groups" for the mechanical testing, but the specific numerical sample sizes are not provided. The data provenance is testing conducted by the applicant, Changzhou Dingjian Medical Appliance Co., Ltd., likely in China, as it is the country of origin for the submitter. This is a bench test, not clinical data, so the concepts of retrospective or prospective data as typically applied to patient studies are not applicable.

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 is not applicable as this is a mechanical testing study, not a study involving human interpretation or ground truth establishment by experts in the context of diagnostic performance.

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

This is 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

This is not applicable as this is a mechanical orthopedic device, not an AI/ML diagnostic or assistive device.

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

This is not applicable as this is a mechanical orthopedic device.

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

For mechanical testing, the "ground truth" or reference standard would be the established testing methodology and performance characteristics defined by the ASTM F1717 standard and the performance of the legally marketed predicate device. The comparison is made against the predicate device's measured performance in these standardized tests.

8. The sample size for the training set

This is not applicable as this is a mechanical testing study, not an AI/ML study involving a training set.

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

This is not applicable as this is a mechanical testing study.

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Romeo® posterior osteosynthesis system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw fixation system, Romeo® posterior osteosynthesis system is intended 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Romeo posterior fixation system comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and various connectors. The Romeo screws come in various lengths (from 25 to 90 mm) and diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient anatomies. Romeo components are delivered sterile (gamma sterilization) in a dedicated packaging or not sterile upon request. The Romeo posterior fixation system is supplied with a set of surgical instruments.

The provided text is a 510(k) summary for a medical device called the Romeo® posterior osteosynthesis system. It describes the device, its indications for use, and a comparison to predicate devices, including performance testing. However, it does not contain the specific information required to complete all sections of your request regarding clinical study details, such as acceptance criteria based on clinical performance metrics, expert reader studies, or detailed ground truth establishment methods for large datasets.

The document primarily focuses on demonstrating substantial equivalence through non-clinical performance testing, comparing the new components (Setscrew with modified hexalobe imprint, Parallel Rod Connector, and T Rod Connector) to previously cleared predicate devices.

Here's the information that can be extracted and what is missing:

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

Missing: Specific quantitative acceptance criteria (e.g., minimum torque values, maximum displacement, etc.) and quantitative performance data for the device components are not provided in this summary. The summary only states that the results "demonstrate comparable mechanical properties to the predicate devices."

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 for Test Set: Not applicable as this is a non-clinical, mechanical performance study. The "test set" here refers to the actual device components tested. The number of components tested is not specified, but typically these tests involve several samples to ensure reproducibility and statistical power.
• Data Provenance: Not applicable for non-clinical mechanical testing of physical device components.

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 submission relies on non-clinical, mechanical testing, not clinical data or expert interpretation of medical images.

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

Not applicable. This was non-clinical mechanical testing, not a study requiring adjudication of expert opinions.

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

No. This document does not mention any multi-reader, multi-case clinical studies, nor does it describe an AI-powered device.

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

No. This document is for a physical orthopedic implant system, not a software algorithm.

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

The "ground truth" for this submission is based on established engineering and biomechanical standards and measurements. The performance of the new components is compared against the known performance of predicate devices through standardized mechanical tests.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

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