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icotec Cervical Cage: The icotec Cervical Cage is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with degenerative cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment. When used with the icotec Anterior Cervical Plate System, the icotec Cervical Cage is intended to stabilize the cervical spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscits, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

icotec PLIF Cage: The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 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 without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g., pedicle screws). The device system is intended to be used with autograft. When used with the VADER® Pedicle System, the icotec PLIF Cage is intended to stabilize the lumbar spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

icotec ETurn® TLIF Cage: The icotec ETurn® TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in sketally mature patients who have had six months of nonoperative 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 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by radios. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g., pedicle screws). The device system is intended to be used with autograft. When used with the VADER® Pedicle System, the icotec ETurn TLIF Cage is intended to stabilize the lumbar spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

The icotec Interbody Cage System (i.e., icotec Cervical Cage, icotec PLIF Cage, and icotec ETurn® TLIF Cage) is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a rough titanium coating. The devices are intended to be used with supplemental spinal fixation. There is one type of cervical cage and two lumbar cages (i.e., PLIF and ETurn® TLIF) included in this portfolio. Each cage is provided sterile and is available in an assortment of heights, footprints, and/or lordosis angles to accommodate patient anatomy.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification clearance letter from the FDA for the icotec Interbody Cage System, which primarily focuses on device description, indications for use, and a statement of substantial equivalence to predicate devices. It mentions "Performance Testing" but only states that clinical data supports substantial equivalence and explicitly notes that the data did not support additional benefit for infection-related indications due to the specific material or technological characteristics. No specific acceptance criteria or details of a study (like sample size, ground truth, expert qualifications, etc.) are provided.

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icotec Cervical Cage: The icotec Cervical Cage is intended for spinal fusion procedures at one level (C2-T1) in skeltally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.

icotec PLIF Cage: The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 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 without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft.

icotec ETurn™ TLIF Cage: The icotec ETurn™ TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative 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 1 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 without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft.

The icotec Interbody Cage System (i.e., icotec Cervical Cage, icotec PLIF Cage, and icotec ETurn TLIF Cage) is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a porous titanium coating. The devices are intended to be used with supplemental spinal fixation. There is one type of cervical cage and two lumbar cages (1.e., PLIF and ETurn TLIF) included in this portfolio. Each cage is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.

This is a 510(k) premarket notification for a medical device (icotec Interbody Cage System), not a study describing acceptance criteria for an AI/ML powered device. Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or expert involvement for an AI medical device.

The document discusses the substantial equivalence of the icotec Interbody Cage System to legally marketed predicate devices based on indications, design, function, and performance, supported by preclinical testing according to ASTM standards. It does not involve any artificial intelligence or machine learning components.

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The InterForm Cervical Interbody Cage System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The device is intended to be implanted via an open, anterior approach and used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Cervical Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the cervical spine. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device.

Not Found

I am sorry, but the provided text from the FDA 510(k) K161608 document does not contain information about the acceptance criteria or a study that proves the device meets those criteria. The document is primarily an FDA clearance letter and an "Indications for Use" statement for the InterForm Cervical Interbody Cage System.

It states that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance, rather than a detailed report of a new study to establish acceptance criteria for the device's performance.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size and data provenance for a test set
3. Number and qualifications of experts for ground truth establishment
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. Ground truth establishment for the training set

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The Interbody Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Interbody Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK) or titanium alloy. The devices are intended to be implanted either one device per level when used in the ALIF, Banana, or Lateral styles, and one or two devices per level when used in the PLIF/TLIF style.

Tantalum pins are embedded in the PEEK versions of the implants to help allow for radiographic visualization.

This document is a 510(k) premarket notification for an Interbody Cage and does not contain the specific type of detailed acceptance criteria and study results typically found in performance studies for AI/ML-driven medical devices. The device is a physical implant, not a software algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission.

However, I can extract the relevant "performance data" that addresses the device's equivalence to predicates, which serves as the "acceptance criteria" and "study" in the context of this 510(k) submission.

Here's a summary of the information that can be extracted, adapting the request to the nature of the provided document:

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

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

• The document mentions "worst-case size testing submitted as part of K113478" and "Additional testing (compression) per ASTMF F2077." However, it does not specify the sample size for these tests for the current submission or the original K113478.
• Data Provenance: The tests are likely prospective mechanical tests conducted on the manufactured devices/materials, rather than clinical data from human subjects. The country of origin of the data is not specified but is implicitly tied to the manufacturer/testing labs involved in the 510(k) process.

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

• Not Applicable. This is a mechanical device submission. "Ground truth" in the sense of expert clinical annotation is not relevant here. Engineering standards and physical measurements are used.

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

• Not Applicable. Mechanical testing against industry standards (e.g., ASTM F2077) does not involve adjudication in this manner.

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 for a physical interbody fusion cage, not an AI-assisted diagnostic or therapeutic device.

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

• Not Applicable. This is for a physical interbody fusion cage.

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

• Based on engineering standards and physical properties: The "ground truth" for this device's performance evaluation lies in meeting established mechanical testing standards (e.g., ASTM F2077 for compression strength of intervertebral body fusion devices), material specifications (ASTM F2026, ASTM F560, ASTM F136), and demonstrating equivalence in design (geometry, footprint) to predicate devices. The goal is to show that the new variations (materials, sizes) do not introduce new safety or effectiveness concerns compared to already cleared devices.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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The Renovis S141 Lumbar Interbody Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Renovis S141 Lumbar Interbody Cage System consist of 3 designs and each design is available in either PEEK or titanium alloy. The PLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F650 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.

This document is a 510(k) summary for the Renovis S141 Lumbar Interbody Cage System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, materials, dimensions, function, and mechanical testing. It is not a study that proves a device meets acceptance criteria in the sense of a clinical trial or an AI/software performance study.

Therefore, many of the requested items related to AI/software performance, ground truth, expert adjudication, and clinical study details are not applicable or cannot be extracted from this type of regulatory submission. This document describes mechanical performance testing against established standards, not a clinical study with human subjects, AI algorithms, or expert readers.

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

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

Note: The document states the device was tested to these standards and found substantially equivalent, but it does not provide specific numerical acceptance criteria or performance metrics for each test (e.g., "subsidence must be less than X mm, and observed subsidence was Y mm"). It only states the overall conclusion of substantial equivalence.

Regarding the other requested information:

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

  • Not Applicable / Not Provided. This document describes mechanical testing of physical devices, not a study involving human patient data or software/AI. The "test set" here refers to the physical samples of the interbody cage system tested mechanically. The sample size for these mechanical tests is not specified, nor is data provenance in the context of clinical/patient data.

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

  • Not Applicable. Ground truth in the context of expert review applies to diagnostic devices or AI, not mechanical orthopedic implants. The "ground truth" for mechanical testing is defined by the physical properties and performance characteristics measured against engineering standards.

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

  • Not Applicable. Adjudication is relevant for expert review or clinical event assessment, not for mechanical testing of physical devices.

• 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 mechanical device, not an AI or diagnostic imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

  • Not Applicable. This is a physical medical device (lumbar interbody cage system), not an algorithm or software. No standalone algorithm performance was assessed.

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

  • Not Applicable. For mechanical testing, the "ground truth" is defined by the established engineering standards (ASTM F2077 and ASTM F2267) and the measured physical performance (axial compression, subsidence, expulsion).

• 8. The sample size for the training set

  • Not Applicable. This document does not describe a machine learning algorithm, so there is no "training set."

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

  • Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

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Lumbar System Indications: The Aurora Spine Interbody Fusion System devices are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

Cervical System Indications: The Aurora Spine Interbody Fusion System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.

The Aurora Spine Interbody Fusion System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights and lordotic configurations with an open architecture to accept packing of autograft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.

The Aurora Spine Interbody Fusion System is a medical device, and its acceptance criteria are based on mechanical testing to demonstrate substantial equivalence to a predicate device. There is no clinical study involving human patients or AI reported in this document.

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 applicable. The document describes non-clinical mechanical testing, not a test set of patient data.
• Data Provenance: Not applicable. The data is from mechanical testing performed on the device components, not from patient data.

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

• Not applicable. This device's acceptance is based on mechanical engineering standards, not expert clinical interpretation of data.

4. Adjudication method for the test set:

• Not applicable. As described, no human adjudication was involved in the mechanical testing for 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:

• No MRMC comparative effectiveness study was done. This document explicitly states, "Clinical data and conclusions were not needed for this device." There is no mention of AI.

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:

• The "ground truth" for this device's acceptance is adherence to established ASTM (American Society for Testing and Materials) standards for mechanical properties and the demonstration of substantial equivalence to a legally marketed predicate device (Tyber Medical Interbody System, K130573) based on these mechanical tests.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned or required for this type of device submission, as it involves mechanical testing and not machine learning or AI.

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 establishment process.

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When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The InterForm PLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm PLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior approach and used with supplemental fixation and autogenous bone graft.

The InterForm TLIF Interbody Fusion Implants consists of cage footprints widths of 9, 11, 13mm , lengths of 22, 24, 26, 28, 30, 32mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm TLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm OTLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30, 32, 34mm, ranging in height from 7mm to 14mm with lordosis of 0°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm OTLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior or transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm LLIF Interbody Fusion Implants consists of cage footprint widths of 18, 20, 22, 24mm, lengths of 40, 45, 50, 55, 60mm, ranging in height from 8mm to 18mm with lordosis of 0° or 7°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm LLIF Interbody Fusion devices are intended to be implant via a lateral approach and used with supplemental fixation and autogenous bone graft.

The InterForm ALIF Interbody Fusion Implants consists of cage footprints of 30x24mm, and 39x30mm (DxW), ranging in height from 10mm to 20mm with lordosis of 0°, 7° or 12° which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm ALIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, anterior approach and used with supplemental fixation and autogenous bone graft.

All implants are packaged non-sterile to be sterilized at the hospital.

Materials:

PEEK Optima LT1 conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:

Maintain adequate disc space until fusion occurs.

The InterForm Interbody Cage System is intended for spinal fusion procedures.
Here's a breakdown of the acceptance criteria and the study done:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states that the device is considered "substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances." The acceptance criteria, while not explicitly numerical, are therefore met by demonstrating performance comparable to the already legally marketed predicate devices. The study concludes that the results indicate the InterForm Interbody Cage System is equivalent.

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

This information is not provided in the document. The studies listed are non-clinical tests (mechanical testing), not studies involving human or animal subjects that would generate a "test set" of data in the typical sense of evaluating AI or clinical outcomes. The provenance of the samples (e.g., specific batches of PEEK and tantalum used in testing) is not detailed, nor is it relevant given the mechanical nature of the tests.

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 studies are non-clinical mechanical tests, not clinical evaluations requiring expert interpretation or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical mechanical tests.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This device is a physical medical implant, not an AI or imaging device that would typically involve human reader studies.

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

This information is not applicable as the device is a physical medical implant and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established mechanical properties and performance standards outlined in the ASTM F2077 and ASTM F2267 standards, and the performance characteristics of the predicate devices. For mechanical tests, the ground truth is objectively measured physical properties and behaviors of the material and device under specific conditions.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical implant and would not have a "training set" in the context of machine learning or AI. For mechanical testing, the "samples" would be the manufactured devices or materials subjected to the tests. The exact number of units tested for each non-clinical test (static compression, dynamic compression, subsidence, expulsion) is not specified, but it would typically be a statistically significant number of physical samples to ensure reliability and reproducibility of the results according to the ASTM standards.

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

This information is not applicable for the same reasons as #8. The "ground truth" for material and device properties in mechanical testing is established through standardized testing procedures and validated measurement techniques, as defined by organizations like ASTM.

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pezo™ 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. 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 pezo™ PEEK Cage Family is comprised of three principal interbody fusion cages. The pezo-P and pezo-T devices have a basic rectangular shape while the pezo-A devices have a basic kidney shape. All implants have a hollow center for placement of autograft. The pezo implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The information provided describes a medical device called the "pezo™ PEEK Cage Family," an intervertebral body fusion device. The submission outlines its technological characteristics and performance data in comparison to predicate devices, rather than a study involving human subjects or AI. Therefore, many of the requested elements for AI/human reader studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Intended Use
• Basic Design (hollow for autograft)
• Material (polymer)
• Sizes (comparable dimensions)
• Fundamental scientific technology | pezo™ possesses the same technological characteristics as one or more of the predicate devices including intended use, basic design, material (polymer), sizes, and the same fundamental scientific technology. |
  | Mechanical Performance equivalent to or better than predicate devices:
• Static and dynamic compression
• Subsidence | Mechanical test results demonstrate that pezo™ performs as well as or better than the predicate devices according to ASTM F2077 (static dynamic compression) and ASTM F2267 (subsidence). This indicates the device is as safe and effective as the predicates. |

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

• Sample Size: Not applicable. This study involves mechanical testing of the device, not a test set of data like in AI studies. The "worst case pezo™ device" was used, implying a single representative sample or a small number of samples, but specific numbers are not provided.
• Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing of the device itself.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F2077, ASTM F2267) and direct measurement, not expert consensus in the human assessment sense.
• Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians performing the mechanical tests.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined standards, not subject to adjudication by multiple human reviewers.

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

• MRMC Study Done: No. This submission does not describe an MRMC comparative effectiveness study involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study Done: No. This device is a physical intervertebral fusion cage, not an algorithm or AI system. Its performance is evaluated through mechanical testing, not a standalone algorithm study.

7. Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for device performance is based on established industry standards and objective material properties/mechanical strength measurements. Specifically, the device was tested according to ASTM F2077 (static and dynamic compression) and ASTM F2267 (subsidence). The performance of predicate devices against these same standards would form the basis for comparison.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI model, there is no corresponding ground truth to be established in that context.

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The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.

The Spinal USA Interbody Fusion Device ALIF, LLIF, T-PLIF and PLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device.

The Spinal USA Interbody Device Stabilizer RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The Stabilizer RPIF device is not meant for stand alone use.

The Spinal USA Interbody Fusion Device consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from Ti-6AI-4V titanium alloy (ASTM F136) or medical grade polyetheretherketone (Peek LT1). The products are supplied clean and "NON-STERILE".

This is a 510(k) summary for a Spinal USA Intervertebral Body Fusion Device. It outlines the device description, intended use, and equivalence to previously cleared devices. However, the provided document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is purely a regulatory submission stating the product's intended use and its substantial equivalence to other devices, which is the basis for its 510(k) clearance by the FDA. It does not include any performance data or clinical study results.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance studies based on the provided text. The requested information is not present in the given document.

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