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This system 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 either one level or two contiguous 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 patient history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Lumbar Interbody Fusion System consists of instruments and Titanium Alloy (Ti-6Al-4V per ASTM F136) implants which will be offered in twenty-four (24) size configurations to accommodate individual patient anatomy. The implants are designed to facilitate a specific surgical technique, the Oblique Lateral Lumbar approach (OLLIF). The implants are single use and the system is provided non-sterile.

This document is a 510(k) premarket notification for a medical device called the "Lumbar Interbody Fusion System (OLLIF)". It primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, indications for use, materials, technological characteristics, and labeling, supported by pre-clinical performance data.

Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device, which would typically involve human-in-the-loop or standalone performance metrics, ground truth establishment, expert adjudication, and sample sizes for training and testing.

The document details:

• Device Name: Lumbar Interbody Fusion System (OLLIF)
• Regulatory Class: Class II
• Product Code: MAX (Intervertebral Body Fusion Device, Lumbar)
• Indications for Use: Intervertebral body fusion of the lumbar spine (L2 to S1) in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis, after six months of non-operative treatment, for one or two contiguous levels. It requires supplemental fixation and autograft.
• Predicate Devices: Python Interbody Fusion Device (K090064) and Buttress (Fang) Plate System (K090415)
• Performance Data: Static and dynamic axial compression testing following ASTM F2077-14, and subsidence testing following ASTM F2267-04. These are bench tests of the physical device's mechanical properties, not clinical performance or AI/ML algorithm performance.

In summary, this document is for a traditional medical device (spinal implant), not an AI/ML device. Therefore, the requested information about acceptance criteria for AI algorithm performance, study design (e.g., MRMC, standalone), ground truth derivation, and sample sizes for AI model training/testing is not present in this document.

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This system 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. 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 Lumbar Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) implants which will be offered in four (4) configurations of various sizes to accommodate individual patient anatomy. The configurations are designed pursuant to a specific surgical approach, and consist of the following: 1) Anterior Lumbar Approach (ALIF); 2) Posterior Lumbar Approach (PLIF); 3) Lateral Lumbar Approach (LLIF) and 4) Transforaminal Posterior Lumbar Approach (TPLIF). The implants are single use and the system is provided non-sterile.

This document is a 510(k) Premarket Notification for a Lumbar Interbody Fusion System. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device submission. This document is for a traditional medical device (an implant) and the performance data described are related to mechanical testing, not a clinical study to evaluate diagnostic accuracy or human reader performance.

Therefore, many of your requested points are not applicable to the information provided in this document. I will fill in what I can and note where the information is not present.

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

Note: The document states that "The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to its predicate device(s)." This means the performance met the thresholds demonstrated by the predicate devices or relevant standards. Specific numerical acceptance values and actual measured performance data are not provided in this summary.

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. This document describes mechanical bench testing of an implant, not a clinical study with a "test set" of patient data. The "sample size" would refer to the number of devices tested, which is not specified but would be dictated by the ASTM standards.
• Data Provenance: Not applicable. The data comes from bench testing in a laboratory setting, not clinical data from patients.

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

• Not applicable. This device is an implant, and its performance is evaluated based on engineering and mechanical standards, not expert interpretation of diagnostic images or clinical outcomes in the context of an AI/ML device.

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

• Not applicable. No expert adjudication method is mentioned as this is not an AI/ML device or a diagnostic study.

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 is not an AI/ML medical device. No MRMC study was conducted.

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

• No. This is not an AI/ML medical device.

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

• Not applicable in the sense of clinical ground truth for an AI/ML device. The "ground truth" for this device's performance is defined by established engineering and mechanical testing standards (ASTM F2077-14 for mechanical properties, ASTM F2267-04 for subsidence, and a "widely accepted and validated methodology" for expulsion).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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The Integrity Spine Lumbar Interbody Fusion 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) may be implanted:

• bi-laterally in pairs via a posterior (PLIF) approach;
• as a single device via an oblique (OLIF) approach:
• as a single device via a transforaminal (TLIF) approach; or
• as as a single device via an anterior or anterolateral (ALIF) approach.
  The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
  The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

This document is a 510(k) premarket notification for the Integrity Spine Lumbar Interbody Fusion System. It is an FDA clearance letter and a 510(k) summary, not a study report proving a device meets acceptance criteria. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, ground truth, or expert involvement for evaluating device performance in the context of AI or diagnostic accuracy studies.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical mechanical testing for safety and performance in a physical device context (interbody fusion).

Therefore, I cannot extract the requested information from this document. The document discusses:

• Device Name: Integrity Spine Lumbar Interbody Fusion System (Page 2)
• Intended Use: Intervertebral body fusion of the lumbar spine, from L2 to S1, for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, for skeletally mature patients who have had six months of non-operative treatment. (Page 2)
• Testing: Non-clinical mechanical testing including static and dynamic compression, static and dynamic torsion, subsidence, and expulsion testing. These tests were conducted according to ASTM standards (F2077-11, F2267-04, and a Draft Standard F-04.25.02.02). (Page 5)
• Conclusion: The device is substantially equivalent to predicate devices based on shared intended use, implant design, material, and non-clinical mechanical test results. (Page 5)

The prompt asks for acceptance criteria and study details that are typically found in studies evaluating diagnostic devices, AI algorithms, or clinical performance. This document pertains to a surgical implant and its mechanical properties.

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When used as a cervical intervertebral fusion device, the GPS™ Cervical Spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.
When used as a lumbar intervertebral fusion device, the GPS™ PLIF and TLIF Spacers are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). The device is to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

The basic shape of the Cervical and Lumbar GPS™ devices is a structural column having upper and lower implant openings and a central cavity for autograft bone. The cervical devices have a "B" shaped cross-section. The PLIF devices are rectangular having a pyramidal anterior surface. The TLIF device cross-section is curved having a wedged leading face. For all devices, surface teeth assist in the seating the implant between the vertebral bodies. Each device type is available in a variety of size and angulation combinations to accommodate the diversity in patient anatomy.

The provided document is a 510(k) summary for the GPS™ Spacers, an intervertebral body fusion device. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and performance data.

However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The "Performance Data" section specifically states: "Mechanical testing of the worst case GPS™ Spacers was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267. Expulsion testing was performed. The mechanical test results demonstrate that the GPS™ Spacer performance is substantially equivalent to the predicate devices."

This indicates that the performance data presented is related to mechanical and material properties of the physical intervertebral fusion device, not the performance of an AI/ML algorithm. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, ground truth establishment, or sample sizes relevant to an AI/ML device study, as that information is not present in the provided text.

Based on the nature of the device (intervertebral body fusion device), it is a physical implant and not an AI/ML-driven diagnostic or therapeutic device. The typical metrics, study designs, and ground truth methodologies for AI/ML devices (like sensitivity, specificity, MRMC studies, expert adjudication for image analysis) are not applicable here.

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The K7 Lumbar Spacers are 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

The K7 Lumbar Spacers are a collection of radiolucent interbody devices having variously shaped cross-sections. The superior and inferior surfaces are open with parallel serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The provided text describes the K7 Lumbar Spacers, a medical device for intervertebral body fusion. The study presented focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than a clinical study evaluating the device's performance in a human population.

Therefore, many of the requested categories related to clinical performance metrics, ground truth establishment, expert involvement, and reader studies are not applicable or cannot be extracted from this document, as the FDA 510(k) submission for this device type typically relies on demonstrating engineering and material equivalence for clearance.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The mechanical testing was likely performed on a representative sample of K7 Lumbar Spacers of the "worst case" configuration. The specific number of units tested for static, dynamic compression, and subsidence is not provided.
• Data Provenance: The data is from mechanical testing of the device itself (K7 Lumbar Spacers) in a laboratory setting, not from human subjects. Therefore, country of origin or retrospective/prospective clinical data is not applicable.

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

• This is not applicable. The "ground truth" for this device's regulatory clearance is established by engineering standards (ASTM F2077, ASTM F2267) and comparison to predicate device characteristics, not by expert clinical consensus on a "test set" of patient data.

4. Adjudication Method for the Test Set

• This is not applicable, as there was no clinical "test set" involving human interpretation or adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a spinal implant, and its regulatory clearance here is based on mechanical performance and material equivalence, not on the interpretative performance of a diagnostic algorithm or image analysis by human readers.

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

• No, a standalone study in the context of AI algorithm performance was not done. This device is a physical implant, not an AI algorithm.

7. Type of Ground Truth Used

• For the mechanical performance, the "ground truth" is defined by engineering standards (ASTM F2077 for compression, ASTM F2267 for subsidence) and the established performance/characteristics of legally marketed predicate devices. The goal was to demonstrate that the K7 Lumbar Spacers met or were equivalent to these benchmarks.

8. Sample Size for the Training Set

• This is not applicable. There is no "training set" in the context of machine learning or AI as this is a physical medical device.

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

• This is not applicable. See point 8.

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When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain 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. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Integrity Spine Core System is a cervical intervertebral body fusion system comprised of parallel and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

The provided text describes a 510(k) Premarket Notification for the Integrity Spine Core System, an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing, rather than a clinical study evaluating device performance in humans.

Therefore, many of the requested items related to clinical study design, such as acceptance criteria based on human performance, sample size for test sets (in a clinical context), expert ground truth establishment for diagnostic performance, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable to this 510(k) submission.

This submission primarily relies on bench testing to show mechanical equivalence.

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

1. Table of acceptance criteria and the reported device performance

Explanation of Acceptance Criteria: The acceptance criteria for this 510(k) submission are implicitly defined as demonstrating "substantially equivalent results" in non-clinical mechanical testing compared to the identified predicate devices. This means the Integrity Spine Core System's mechanical performance in these standardized tests must fall within expected ranges relative to the predicates, indicating no new questions of safety or effectiveness are raised.

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

• Sample Size for Test Set: Not applicable in the context of human data. For the mechanical tests, the sample sizes would be determined by the ASTM standards (e.g., number of constructs tested for compression, torsion, subsidence, and expulsion). The document does not specify these exact numbers, but it states the tests were "conducted in accordance with" the respective ASTM standards.
• Data Provenance: Not applicable as this submission is based on non-clinical (bench) testing, not human data. The tests were performed in a lab setting to assess the device's physical properties.

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

• Not Applicable. Ground truth, in the sense of expert diagnosis or outcome labeling from human data, is not established for this type of non-clinical mechanical testing. The "ground truth" here is the adherence to mechanical performance standards and comparison to predicate devices.

4. Adjudication method for the test set

• Not Applicable. This is relevant for studies involving human data where there might be disagreements in interpretation (e.g., reading medical images). For mechanical testing, outcomes are typically measured objectively based on physical properties.

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 intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance 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 implant, not an algorithm or AI system.

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

• Not Applicable / Bench Test Standards. The "ground truth" for this submission are the established ASTM standards for mechanical testing of spinal implants (F2077-11 for static and dynamic mechanical testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion) and the performance characteristics of the predicate devices. The aim is to demonstrate that the new device performs equivalently in these controlled mechanical environments.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this 510(k) submission for a physical implant device. This concept applies to machine learning algorithms.

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

• Not Applicable. As there is no training set, there is no corresponding ground truth to establish.

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The Cezanne II Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade l spondylolisthesis or retrolisthesis at the involved level(s). DOD 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 Cezanne II Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Cezanne II System consists of XLIF, TLIF and ALIF implants.

The System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

Note: The provided text describes a 510(k) premarket notification for a medical device, the "Accel Spine Cezanne II Interbody Fusion System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing (mechanical tests). It does not involve clinical studies or AI algorithm performance, which are the typical contexts for the acceptance criteria and study design questions you've posed.

Therefore, many of the requested fields are not applicable to the information provided in this 510(k) summary. I will answer based only on the information present in the document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The study involved non-clinical mechanical testing of the device, not a test set of data such as images or patient records.
• Data Provenance: Not applicable. The "data" comes from engineering tests performed according to specific ASTM standards in a lab setting, not from patients or a specific country of origin. The tests were "non-clinical."

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

• Not applicable. Ground truth, in the context of expert review, is not relevant for this type of non-clinical mechanical testing. The "ground truth" for these tests is defined by the objective physical properties and performance measured according to the specified ASTM standards.

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

• Not applicable. Adjudication methods are used in studies involving expert review or subjective interpretation of data, which is not the case 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 is a 510(k) submission for an interbody fusion system, not an AI-powered diagnostic device. No MRMC study was conducted.

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

• Not applicable. This is a physical medical device (interbody fusion system), not an algorithm or AI.

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

• The "ground truth" for the non-clinical testing is defined by the objective measurements and pass/fail criteria established by the specific ASTM standards (F2077-11, F2267-04, F-04.25.02.02, F2026, F560, F899). It is a form of empirical measurement against established engineering standards.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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The Helena System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). 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 Helena System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of: Lumbar interbody fusion device(s), which may be implanted bi-laterally via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach - as a single device via an anterior (ALIF) approach; or The Helena System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The Helena System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

The Helena System is an intervertebral body fusion device made of PEEK Optima LT1 with tantalum markers, designed for lumbar spine fusion from L2 to S1.

1. Acceptance Criteria and Device Performance

The acceptance criteria for the Helena System are based on non-clinical mechanical testing standards, demonstrating substantial equivalence to predicate devices. The device performance, as reported, met these criteria.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided documents. The testing was non-clinical, involving mechanical tests of the device itself rather than patient data.
• Data Provenance: The data is based on laboratory non-clinical testing of the Helena System implants, following specified ASTM standards. No human or animal data provenance (e.g., country of origin, retrospective/prospective) is applicable to this type of testing.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The ground truth for the non-clinical mechanical tests is based on the performance standards defined by ASTM (American Society for Testing and Materials) specifications, not expert interpretation of medical images or patient data.

4. Adjudication Method for the Test Set

Not applicable. As the testing involved mechanical measurements against predefined standards, there was no need for expert adjudication. The results are quantitative and objective.

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

No MRMC study was performed or mentioned. This type of study is relevant for imaging-based diagnostic or prognostic AI tools that involve human interpretation, not for mechanical orthopedic implants.

6. Standalone Performance Study

A standalone performance study was done in the sense that the device's mechanical properties were tested independently against established standards (ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F-04.25.02.02). The "algorithm only" concept is not applicable here as it's a physical medical device. The tests evaluated the device's ability to withstand various forces encountered in the body.

7. Type of Ground Truth Used

The ground truth used was objective engineering standards and performance criteria as defined by the ASTM standards (ASTM F2077-03 for static and dynamic compression, ASTM F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion).

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for a physical medical device like this. Machine learning algorithms require training sets, but this regulatory submission concerns a physical implant.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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The NobelProcera Zi Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare's NobelProcera Zi Abutment is an endosseous dental implant abutment. The Nobel Biocare's NobelProcera Zi Abutment attaches directly to endosseous dental implants and provides a platform for restoration.

Nobel Biccare's NobelProcera ZI Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study designs (such as sample sizes, data provenance, expert qualifications, or adjudication methods), or any details regarding a comparative effectiveness study or standalone algorithm performance. The document appears to be a 510(k) summary for a dental implant abutment, primarily focusing on its regulatory classification and indications for use, rather than a performance study report. Therefore, I cannot fulfill your request based on the given input.

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The Integrity Spine Lumbar Interbody Fusion System 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) mav be implanted:

• bi-laterally in pairs via a posterior (PLIF) approach;
• as a single device via an oblique (OLIF) approach: a
• as a single device via a transforaminal (TLIF) approach: or -
• as as a single device via an anterior or anterolateral (ALIF) approach.
  The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
  The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

Since the extracted text refers to a 510(k) summary for a medical device (Integrity Spine Lumbar Interbody Fusion System), the "acceptance criteria" and "device performance" would typically relate to comparisons to predicate devices based on non-clinical testing, rather than explicit numerical performance metrics like sensitivity or specificity often seen in AI/diagnostic device contexts. Also, there's no mention of a "study that proves the device meets the acceptance criteria" in terms of clinical trials or AI performance evaluations with ground truth. The summary focuses on substantiating substantial equivalence through non-clinical testing.

Here's an attempt to answer your questions based solely on the provided text, acknowledging that many of your points are not directly addressed due to the nature of this particular 510(k) summary:

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

Based on the provided text, the "acceptance criteria" for this device are primarily met by demonstrating substantial equivalence to predicate devices through non-clinical testing. The "reported device performance" is the successful completion of these tests with results deemed equivalent. There are no explicit numerical acceptance criteria for performance provided in the document in the way one might see for diagnostic AI (e.g., sensitivity > X%, specificity > Y%).

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

The document describes non-clinical mechanical testing rather than testing on patient data. Therefore, the concept of "test set" in terms of patient data, data provenance, or retrospective/prospective studies does not apply here. The "samples" used were physical devices subjected to the specified ASTM tests. The sample sizes for these specific mechanical tests are not detailed in this summary.

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 the provided document. The ground truth for this device's evaluation (substantial equivalence) is established through adherence to recognized international standards for mechanical testing (ASTM standards) and comparison to legally marketed predicate devices, not through human expert interpretation of clinical data in a diagnostic context.

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

This question is not applicable to the provided document, as it pertains to clinical data interpretation and not mechanical device 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

There is no mention of a multi-reader multi-case (MRMC) study. This document describes a medical device (spinal implant) and its substantial equivalence determination, not an AI or diagnostic tool that would involve human readers or AI assistance.

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

This question is not applicable. The device is a physical spinal implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" is established by the specified ASTM (American Society for Testing and Materials) standards for mechanical performance (e.g., F2077-11 for static and dynamic testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion). The performance of the predicate devices under these same standards also serves as a comparative benchmark.

8. The sample size for the training set

This question is not applicable to the provided document. There is no concept of a "training set" for a physical medical device like a spinal implant in the context of this 510(k) summary.

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

This question is not applicable to the provided document for the same reasons as point 8.

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