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The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical procedures such as: arthroplasty, nucleotomy, discectomy, and foraminotomy. These manual surgical instruments are hand-held devices intended to manipulate tissue in spinal surgery.

The rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column.

The Integra Spine Instrument System for Endoscopic Spinal Surgery is an assembled, comprehensive set of instruments for use in endoscopic decompression techniques. The instrument set includes guide wires, pituitaries, ronguers, trephines, trocar / dilators, cannulas, reamers, dural elevator, nerve hook, mallet, forceps, chisels, and associated handles. The instrument set will be used with an FDA cleared endoscope with a length of no more than 254mm and working channel of at least 4.1mm.

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved verification of individual instrument functions and a cadaver study.
• Data Provenance: The cadaver study was performed with a cadaver (human cadaver), indicating a form of retrospective human anatomical testing in a controlled environment. The country of origin for the cadaver or the specific institution is not given.

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

• Number of Experts: One surgeon.
• Qualifications of Experts: The surgeon was described as "skilled in percutaneous and endoscopic spinal procedures." No further details on years of experience or specific board certifications are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Implicitly, "none" in the traditional sense of multiple reviewers. The evaluation of instrument performance was conducted by a single "skilled surgeon" in the cadaver setting. There is no mention of a consensus process between multiple experts.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument system, not an imaging or diagnostic device that typically undergoes MRMC studies.

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

• Standalone Study: Yes, in a manner applicable to a surgical instrument. "Mechanical testing consisted of verification testing of the individual instrument functions." This can be considered a standalone evaluation of the instruments' physical properties and operational capabilities without direct human surgical interaction beyond the test setup. The cadaver study then integrated human users, but the mechanical testing itself was standalone.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was based on the design specifications and intended functionality of the physical instruments. In the cadaver study, the ground truth was essentially the successful and satisfactory performance of the instruments during simulated surgical procedures as observed and judged by a skilled surgeon. It is a functional efficacy ground truth within a simulated surgical environment.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a manual surgical instrument system, not an AI/ML-based device that would typically have a "training set" in the computational sense. The device's design is based on established surgical principles and predicate devices, refined through engineering and testing, not machine learning.

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

• Ground Truth for Training Set: Not applicable. As mentioned, there is no "training set" in the context of an AI/ML device. The "ground truth" for the development and design of these instruments would stem from anatomical and physiological knowledge, surgical best practices, and the performance characteristics of existing predicate devices. This would have been established through years of medical knowledge development and engineering experience, not through a specific formal "ground truth establishment" for a data set.

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When used with the bone screws, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material.

When used with the SpinPlate, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation.

The Integra Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand alone device. If the Integra Spine Vu aPod Intervertebral Body Fusion Device is used only with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The Vu aPOD Intervertebral Body Fusion Device consists of lumbar spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu aPOD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026 while the bone screws and SpinPlate are comprised of Titanium alloy (Ti-6AI-4V ELI) per ASTM F136. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu aPOD Intervertebral Body Fusion Device is for lumbar spinal use at one or two contiguous levels from the L2-L3 to L5-S1 disc levels.

This document is a 510(k) summary for a medical device called the "Integra Vu aPOD Intervertebral Body Fusion Device." It describes the device, its intended use, material composition, and how it compares to a predicate device. Importantly, it includes information about performance standards but explicitly states that no clinical or animal testing was performed.

Therefore, based on the provided text, I cannot answer the requested questions about acceptance criteria, actual device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth for a study proving the device meets acceptance criteria.

The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and similarity in design, materials, and other characteristics, rather than through performance in a clinical study.

Here's what I can extract and rephrase from the document regarding "acceptance criteria" and "performance" in the context of this 510(k) submission:

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

Explanation: The performance criteria here are the compliance with specific ASTM mechanical testing standards. The "reported device performance" is the conclusion that the device passed these tests to a degree that demonstrated substantial equivalence to the legally marketed predicate device (K101310). The 510(k) process relies on demonstrating equivalence rather than establishing new clinical safety and effectiveness through a full clinical trial.

For the remaining questions (2-9), the document explicitly states:

"Clinical Testing: There was no clinical or animal testing performed for this submission."

Therefore, I cannot provide answers for the following points as they relate to clinical or AI-based performance studies:

• 2. Sample size used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 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
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

This device falls under a category where mechanical testing for substantial equivalence to an existing device is typically sufficient for 510(k) clearance, rather than extensive clinical studies or AI performance evaluations.

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The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of alternative varieties of pedicle screws and surgical instruments to provide surgeons with further options for implant placement and deformity correction. The Stainless Steel Spinal System components can be rigidly locked together creating a construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F 138 and ISO 5832-1.

The provided text describes a medical device, the Stainless Steel Spinal System, and its substantial equivalence to a predicate device based on performance tests. However, it does not include information about AI or machine learning. Therefore, I cannot answer most of your detailed questions regarding acceptance criteria, study design, expert involvement, or ground truth establishment in the context of an AI device.

Here's what I can extract from the provided text regarding the device's performance based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not Available in the Provided Text for AI-related questions):

• Sample size used for the test set and the data provenance: Not applicable as this is a mechanical device, not an AI system using a test set of data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Explanation of the Provided Information:

The Stainless Steel Spinal System is a physical medical device. The "acceptance criteria" for this device are based on mechanical performance standards (ASTM F-1717 and ASTM F-1798) for spinal implant constructs. The study performed involved conducting these mechanical tests on the device. The reported performance is that the "construct performed as designed and met or exceeded all product specifications," which indicates successful fulfillment of the acceptance criteria based on these mechanical standards.

The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device, primarily through material composition, design concept, indications for use, manufacturing, and performance testing for physical, non-AI devices. There is no mention of AI, machine learning, or software components that would require the kind of data-driven performance analysis you've asked about (e.g., test sets, ground truth, expert review).

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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of the Malibu adjustable cross connector from SeaSpine Inc. to the Coral™ Spinal System. Cross connectors are used to connect the bi-lateral rods of a spinal construct to add torsional rigidity. The cross connectors are available in two styles, straight and contoured, the different styles offer the surgeon options intraoperatively. The straight cross connector offers the surgeon a low profile compared to the surrounding construct. The contoured cross connector offers surgeons an option that is slightly higher in profile but provides additional clearance between the cross connector and the spinal construct.

The information provided describes a medical device submission (K120047) for the Coral™ Spinal System and its expansion with the Malibu adjustable cross connector. It focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and mechanical testing, rather than presenting a study of device performance against specific clinical acceptance criteria.

Therefore, many of the requested categories for acceptance criteria and the study proving adherence cannot be directly addressed from the provided text, as they pertain to clinical or functional performance. The document primarily describes mechanical performance tests to establish substantial equivalence.

Here's the breakdown based on the provided text, with "N/A" for information not present in the document:

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

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

• Sample Size: Not specified for the mechanical tests.
• Data Provenance: N/A (mechanical tests, not clinical data)

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

• N/A (Ground truth is not relevant for mechanical performance testing establishing substantial equivalence.)

4. Adjudication method for the test set

• N/A (Adjudication is not relevant for mechanical performance testing establishing substantial equivalence.)

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

• MRMC Study: No.
• Effect Size: N/A (This device is a spinal fixation system, not an AI-assisted diagnostic tool.)

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

• No. (This device is a spinal fixation system, not an algorithm.)

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

• The "ground truth" for the device's performance is its ability to meet the mechanical standards outlined in ASTM F-1717. This is based on engineering and physical testing standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• N/A (This pertains to mechanical testing and substantial equivalence, not a machine learning model's training set.)

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

• N/A (Not applicable for this type of submission.)

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The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c.POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Spine Manta Ray or the Theken Spine Tether systems.

The Vu c POD Intervertebral Body Fusion Device consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu c POD Intervertebral Body Fusion Device is manufactured from PEEK OPTIMA LT1 polymer. The Vu c·POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

The provided text describes the Integra Spine Vu c-POD Intervertebral Body Fusion Device. It outlines its indications for use and states that preclinical testing was performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific acceptance criteria and detailed study that proves the device meets those criteria, as typically found in a clinical trial report or a performance goal document.

The information provided is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a previously marketed device rather than proving performance against detailed acceptance criteria from a new study.

Therefore, I cannot fulfill your request for the comprehensive table and detailed study information as it is not present in the provided text.

Here's what I can extract based on the information given, noting where data is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not specified. The testing mentioned is "preclinical testing" per ASTM standards, which typically involves a number of samples for mechanical tests, but the exact count is not provided.
• Data provenance (country of origin, retrospective/prospective): Not specified. Preclinical testing data is usually generated in laboratories, but the location is not mentioned.

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 and not provided. The "ground truth" concept is typically used in AI/diagnostic studies to assess human expert performance against a reference standard. Here, the "truth" is established by adherence to ASTM mechanical testing standards.

4. Adjudication method for the test set

• Not applicable and not provided. Adjudication methods are typically used in clinical studies or AI performance evaluations involving human readers.

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 MRMC study was done or mentioned. This device is an implant, not an AI diagnostic tool.

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

• For the preclinical testing, the "ground truth" would be the established methods and expected outcomes defined by the ASTM F2077 and ASTM F2267 standards for spinal intervertebral body fusion devices.

8. The sample size for the training set

• Not applicable/Not specified. This device did not involve machine learning or AI training datasets.

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

• Not applicable.

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The Cervical Standalone Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cervical Standalone Intervertebral Body Fusion Device implants are to be used with autogenous bone graft and implanted via an anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical Standalone Intervertebral Body Fusion Device is to be used with two titanium alloy screws which accompany the implant.

The Cervical Standalone Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which are available in a variety of sizes. The cages include toothed spikes on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cage shape and open center allow for bony in-growth in and around the implant. A single cage is sufficient to be used at each intervertebral level. Screws are inserted through the anterior titanium face and screwed into the vertebral bodies for bony fixation.

The acceptance criteria for the Cervical Standalone Intervertebral Body Fusion Device are based on demonstrating substantial equivalence to a predicate device, the COALITION™ Spacer Intervertebral Body Fusion Device (K083389). The study proving the device meets these criteria involved mechanical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or
  clinical samples. The testing described is primarily mechanical and wear testing of the device itself.
• Data Provenance: Not applicable as the testing is non-clinical, mechanical testing of the device.

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 device's acceptance is based on adherence to engineering standards (ASTM F-2077 and F-2267) and comparison to a predicate device, not on expert clinical review of test data.

4. Adjudication method for the test set

• Not applicable. This was a non-clinical, mechanical testing study against established ASTM standards and
  predicate device equivalence.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a
  physical implant, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a physical implant, not an algorithm. The "standalone" in the device name refers to its design as an intervertebral fusion device that does not require an anterior plate.

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

• For the mechanical testing, the ground truth was defined by established engineering standards (ASTM F-2077 and F-2267) and the performance specifications of the device itself, with the aim of demonstrating that the device performed "as designed" and met/exceeded these specifications.
• For substantial equivalence, the ground truth was based on the characteristics and performance of the legally marketed predicate device (K083389).

8. The sample size for the training set

• Not applicable. This is a physical medical device undergoing mechanical validation, not a machine
  learning model requiring a training set.

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

• Not applicable, as there was no training set for a machine learning model.

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When used with the bone screws, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material.

When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.

The Theken Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws, is a stand alone device. If the Theken Spine Vu aPod Intervertebral Body Fusion Device is used with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. The SpinPlate and bone screws are not intended to be used together. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The Vu aPOD Intervertebral Body Fusion Device consists of lumbar spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu aPOD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026 while the bone screws and SpinMate are comprised of Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu aPOD Intervertebral Body Fusion Device is for lumbar spinal use at one or two contiguous levels from the L2-L3 to L5-S1 disc levels.

This document pertains to the 510(k) summary for the Theken Spine Vu aPOD Intervertebral Body Fusion Device, a spinal implant, not an AI/ML powered device. As such, concepts like "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (e.g., sensitivity, specificity, F1 score) are not directly applicable.

The document describes the preclinical testing performed to demonstrate the device's substantial equivalence to predicate devices, focusing on mechanical performance.

Here's an interpretation of the requested information based on the provided text, re-framing "acceptance criteria" to refer to the mechanical performance standards:

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

Explanation: The document states that "Preclinical testing has been performed per ASTM F2077 (static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, expulsion) and ASTM F2267 (static subsidence) indicating that the Vu aPOD Intervertebral Body Fusion Device is substantially equivalent to predicate devices." This implies that the device successfully met the performance requirements outlined in these ASTM standards, thus proving its mechanical integrity and equivalence to existing, cleared devices.

Regarding the remaining points (2-9), these are relevant to AI/ML device evaluations and are not applicable to this physical medical device. The document does not contain information on:

• Sample size used for a test set (as there is no "test set" in the AI/ML sense)
• Data provenance for a test set
• Number of experts used to establish ground truth or their qualifications
• Adjudication method for a test set
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth (e.g., pathology, outcomes data) for an AI/ML model
• Sample size for a training set
• How ground truth for a training set was established

This 510(k) summary focuses on demonstrating mechanical and material equivalence of a surgical implant to previously cleared devices through preclinical bench testing, rather than evaluating the performance of an AI/ML algorithm.

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The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Stainless Steel Spinal System consists of a variety of shapes and sizes of screws, rods, hooks, and cross-connectors. The Stainless Steel Spinal System components can be rigidly locked together creating a rigid construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F-138 and ISO 5832-1.

Here's a summary of the acceptance criteria and study information for the Stainless Steel Spinal System (K100970) based on the provided text, formatted to address your specific points:

Since the provided text describes a spinal implant system and its mechanical testing, not a diagnostic AI device, many of the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable. I will specify "N/A" for these fields.

Acceptance Criteria and Device Performance for Stainless Steel Spinal System (K100970)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The construct performed as designed and met or exceeded all product specifications." This implies that the specific numerical criteria were met, but the exact numerical thresholds for "product specifications" and the measured performance values are not detailed in this summary.

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

• Sample Size for Test Set: Not specified. (The study involves mechanical testing of device constructs, not data from human subjects or images.)
• Data Provenance: N/A (Mechanical tests are conducted on manufactured devices, not patient data.)

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

• Number of Experts: N/A (Ground truth for mechanical performance is established by engineering standards and test results, not expert consensus.)
• Qualifications of Experts: N/A

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

• Adjudication Method: N/A (Not relevant 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

• MRMC Study: No, this is not an AI/diagnostic device.

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

• Standalone Performance: No, this is not an AI/diagnostic device.

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

• Type of Ground Truth: Engineering standards and design specifications as defined by ASTM F-1717.

8. The sample size for the training set

• Sample Size for Training Set: N/A (This is not an AI/machine learning device that requires a training set.)

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

• Ground Truth for Training Set: N/A

Study Summary:

The study conducted for the Stainless Steel Spinal System involved mechanical testing to demonstrate its performance and substantial equivalence to predicate devices. The tests performed were:

• Static axial compression
• Static torsion
• Dynamic axial compression

These tests were performed in accordance with ASTM F-1717. The results indicated that the device performed as designed and met or exceeded all specified product requirements, supporting its substantial equivalence to the predicate devices.

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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of cobalt chrome rods to the Coral™ Spinal System. The Coral™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.

I am sorry, but the provided text from K091266 does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that are typically found in a clinical study report.

The document is a 510(k) summary for the Coral™ Spinal System, which focuses on demonstrating substantial equivalence to previously cleared predicate devices for the addition of cobalt chrome rods to the system. It primarily discusses:

• Device Description: The components and their materials.
• Intended Use: The medical conditions the device is designed to treat.
• Predicate Devices: Previously cleared devices it is similar to.
• Substantial Equivalence Argument: How the new components are similar to existing ones in terms of indications for use, operating principle, biocompatible materials, surgical techniques, manufacturing, sterilization, and packaging.
• Regulatory Information: Classification and product codes.

The key phrase "sufficient evidence exists to reasonably conclude that the additional components are substantially equivalent to the predicate device...This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, preproduction quality assurance planning and engineering analysis" indicates that the evaluation was based on bench testing (mechanical testing) and a comparison of design and materials, rather than clinical efficacy studies with patient data.

Therefore, I cannot provide the requested table or answer the questions related to clinical study design, acceptance criteria, sample sizes, ground truth establishment, or human reader performance. This type of information is not typically part of a 510(k) submission focused on substantial equivalence for a device modification where prior clinical data on the predicate device is assumed to be sufficient.

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