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Peridot-PT Anterior Cervical Intervertebral body fusion System: The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Perior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The Peridot-PT Anterior Cervical body fusion system is designed for use with autogenous and or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-PT Intervertebral body fusion system: The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Peridot-TD Anterior Cervical Intervertebral body fusion system: The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Peridot-TD Intervertebral body fusion system: The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fussion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system: The Peridot-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. The Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft comprised of Cancellous and/or corticocancellous bone graft. The hyperlordotic lumbar cages (>20 degree) the form of supplement fixation should be an anterior plate system.

The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system: This product is intervertebral fusion device manufactured from poly-ether-ether -ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The implants have a 0.5 ~ 1.0 micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cage holders are made of titanium alloy as per ASTM F136. The device have a central canal for receiving autogenous bone graft and offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. Designed to treat cervical and lumbar degenerative disc disease, the platform consists of Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. Tantalum marker on the cage permits the identification of cage position and allows post-operative assessment. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are intended to be used with supplement spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665. The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system. The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and non-sterile.

The provided text describes a 510(k) premarket notification for various intervertebral body fusion systems. It outlines the device identification, indications for use, comparison to predicate devices, and performance testing. However, it does not contain specific acceptance criteria, reported device performance values, details of a study proving compliance, sample sizes for test or training sets, data provenance, information on expert ground truth establishment, adjudication methods, or MRMC study results.

The "Performance Testing" section lists the types of mechanical tests performed according to ASTM standards for static compression, shear, torsion, and fatigue, as well as subsidence and wear. It states that "The worst-case devices were tested," but does not provide any results from these tests or the acceptance criteria used to evaluate them.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other numbered questions related to study details, as this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices (K232822 and K233084) based on similar indications for use, technological characteristics (materials, design principles), and the use of established ASTM mechanical testing standards. The conclusion explicitly states: "Based on the information provided in this premarket notification... concludes that Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system, The Peridot-TD Intervertebral body fusion system, The Peridot-TD Anterior Cervical Intervertebral body fusion system are substantially equivalent to predicate devices." This implies that the device meets the same performance benchmarks as the predicate devices, but the specific numerical targets and results are not disclosed in this summary.

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Peridot-PT Anterior Cervical Intervertebral body fusion System

The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Perior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment.

The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-PT Intervertebral body fusion system

The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Peridot-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).

Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of Cancellous and/or corticocancellous bone graft. The hyperlordotic lumbar cages (>20 decree) the form of supplemental fixation should be an anterior plate system.

The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.

The provided document is a 510(k) premarket notification for "Peridot-PT Anterior Cervical Intervertebral body fusion System" and "Peridot-PT Intervertebral body fusion system." This document focuses on demonstrating substantial equivalence to previously cleared devices, primarily through technological comparison and mechanical performance testing, rather than clinical efficacy studies often associated with AI/software devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to clinical performance, human expert analysis, and multi-reader studies) are not applicable to this type of device and submission.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" as one might see for clinical accuracy metrics. Instead, the performance testing focuses on mechanical characteristics, and the implicit acceptance criterion is that the device performs comparably to the predicate device and meets established ASTM standards.

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 does not specify a "sample size" in the context of clinical data or patient studies. The testing described is mechanical (benchtop) in nature. The data provenance is implicit; the tests were conducted as part of the submission process, likely by the manufacturer or a contract testing lab. There is no information regarding country of origin for mechanical testing 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. This submission concerns a physical implantable device, not a diagnostic or AI-powered software device requiring expert-established ground truth from medical images or clinical outcomes.

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

Not applicable. There is no mention of adjudication for clinical or image-based data.

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 not an AI/software device, and no MRMC study was performed.

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

Not applicable. This is not an algorithmic or software device.

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

For the mechanical testing, the "ground truth" would be the established ASTM standards and the expected performance of the predicate devices. The device's performance is compared against these engineering standards and the known characteristics of equivalent devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

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

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The Peridot-EX Expandable Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems and anterior screw and anterior screw and rod systems). The Peridot-EX Expandable Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment with an intervertebral cage. Hyperlordotic interbody devices (> 20° lordosis) must be used with at least anterior supplemental fixation.

The Peridot-EX Expandable Intervertebral body fusion system is various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. It is manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and 3D Printing manufactured from titanium power (Ti-6AI-4V ELI) as described by ASTM F3001.

The Peridot-EX Expandable Intervertebral body fusion system expands for adjustable lordosis and height to match patient anatomy. The hollow geometry of the implants allows them to be packed with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.

All implants are intended for SINGLE USE ONLY and should not be reused under any circumstances.

The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and non-sterile.

The provided document is a 510(k) summary for a medical device called the Peridot-EX Expandable Intervertebral body fusion system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information about clinical study design, sample sizes, expert involvement, and ground truth establishment is not available in this regulatory submission.

Here's a breakdown of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria. Instead, it lists various "Performance Testing" conducted according to ASTM standards for mechanical integrity. The conclusion states that the device is "substantially equivalent to predicate device," implying that its mechanical performance met the expected standards for such devices, likely by demonstrating similar or superior results to the predicate devices in these tests.

• Static Compression-shear (ASTM F2077): Tested
• Static Torsion (ASTM F2077): Tested
• Fatigue Compression (ASTM F2077): Tested
• Fatigue Compression-shear (ASTM F2077): Tested
• Subsidence (ASTM F2267): Tested
• Expulsion (ASTM F-04.25.02.02): Tested |

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

The document only mentions "The worst-case devices were tested" for mechanical performance. It does not provide specific sample sizes (e.g., number of devices) for any of these tests.

The data provenance is from mechanical testing in a laboratory setting, not from human subjects or clinical data. There is no mention of country of origin of this specific test data, but the submitter is GBS Commonwealth Co., Ltd. from South Korea.

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 as the study described is mechanical performance testing, not a study involving human interpretation or clinical diagnosis.

4. Adjudication method for the test set

This information is not applicable for mechanical performance 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

No such study was conducted or mentioned. The device is a physical intervertebral body fusion system, not an AI-assisted diagnostic or therapeutic device.

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 implant, not an algorithm.

7. The type of ground truth used

For the mechanical performance tests, the "ground truth" would be the physical properties and failure limits defined by the ASTM standards applied and potentially the performance data of the predicate devices for comparison.

8. The sample size for the training set

This information is not applicable. This document describes mechanical testing of a medical device, not a machine learning model.

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

This information is not applicable.

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Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Anterior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)

The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cages holders are made of titanium alloy as per ASTM F136.

The Peridot-TD Cages intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).

Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) Systems.

Each system features a full breadth of sizes, footprints, heights and angles.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screw and rod system, anterior plate and screw system, or lateral plate and screw system).

The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.

The hyperlordotic lumbar cages (>20 degree) should be an anterior plate system as the form of supplement fixation.

The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.

The provided document is a 510(k) premarket notification for a medical device called the "Peridot-TD Spacer system" and "Anterior cervical interbody fusion - ACIF". This submission is for additional models with added sterilization methods to a previously cleared 510(k) (K230708).

The document does not contain information about software performance, AI assistance, or human reader studies. It focuses on the mechanical performance and substantial equivalence of an intervertebral body fusion device. Therefore, many of the requested criteria cannot be extracted from this document.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted according to ASTM standards for mechanical properties. The "acceptance criteria" are implied by the successful completion of these tests, demonstrating substantial equivalence to the predicate device. Specific numerical "reported device performance" values or explicit criteria are not provided in this summary, only that the "worst-case devices were tested".

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

This document discusses in vitro mechanical testing, not a clinical test set with patient data. Therefore, the concept of data provenance (country of origin, retrospective/prospective) is not applicable in the way it would be for a diagnostic AI device. The sample size for the mechanical tests is not explicitly stated, although it mentions "worst-case devices were tested," implying a representative selection.

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

Not applicable. This document describes mechanical testing of a physical medical device, not a diagnostic device requiring expert review for ground truth.

4. Adjudication method for the test set

Not applicable. This document describes mechanical testing of a physical medical device.

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

Not applicable. This document is for a physical intervertebral body fusion device and does not involve AI assistance or human readers.

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

Not applicable. This document is for a physical intervertebral body fusion device and does not involve an algorithm.

7. The type of ground truth used

For mechanical testing, the "ground truth" is typically defined by the specified ASTM standards and the expected mechanical properties of the materials and design. Failure criteria for these tests would serve as the ground truth.

For the clinical indications for use, the document states that cervical disc degeneration and/or spinal instability are "confirmed by imaging studies (radiographs, CT, MRI)" and degenerative disc disease by "patient history and radiographic studies." This implies a combination of imaging and clinical assessment as the basis for patient selection for the device.

8. The sample size for the training set

Not applicable. This document is for a physical medical device and does not involve a training set for an algorithm.

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

Not applicable. This document is for a physical medical device and does not involve a training set for an algorithm.

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Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment.

The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)

The Peridot-TD Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

The Peridot-TD Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67.

And some cages holders are made of titanium alloy as per ASTM F136.

The Peridot-TD Cages intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).

Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) Systems.

Each system features a full breadth of sizes, footprints, heights and angles.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screw and rod system, anterior plate and screw system, or lateral plate and screw system). The implant cages are supplied sterilized.

The hyperlordotic lumbar cages (>20 degree) should be an anterior plate system as the form of supplement fixation.

The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.

This is a 510(k) premarket notification for a medical device (Peridot-TD Spacer system), not a study demonstrating AI performance. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance metrics is not present in the provided text.

The document describes the device, its intended use, and indicates that performance testing has been conducted according to ASTM standards to demonstrate substantial equivalence to predicate devices. However, it does not provide specific acceptance criteria values or detailed performance data from these tests. It also does not mention any AI component or associated studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert qualifications, or AI-related study outcomes as these are not discussed in the provided regulatory document.

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Peridot-PT Anterior Cervical Intervertebral body fusion System

The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and or pain at one or multiple contiguous levels from C2-T1. The Peridot-PT Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-PT Intervertebral body fusion system

The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Peridot-PT Cages are a comprehensive portfolio of 3D-pri interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).

Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The implant cages are supplied sterilized.

The Peridot-PT Cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft.

The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.

The provided FDA 510(k) clearance letter and summary for the Peridot-PT Anterior Cervical Intervertebral body fusion System and Peridot-PT Intervertebral body fusion system do not contain information about the device's acceptance criteria or a study proving its performance in a clinical or AI-assisted setting.

The document outlines a typical medical device clearance process for a Class II device, specifically focusing on substantial equivalence to existing predicate devices. This typically relies on:

• Mechanical and Biocompatibility Testing: Ensuring the device's physical properties are safe and effective. The document explicitly mentions "Performance Testing" with ASTM standards (F2077 for static/fatigue and F2267 for subsidence), which are engineering tests for intervertebral body fusion devices, not clinical performance or AI performance.
• Material Equivalence: The document states the devices are made from Ti-6Al-4V ELI conforming to ASTM F3001, which is a standard for titanium alloy implants.
• Indications for Use Equivalence: The indications for use are compared to predicate devices.

Therefore, based solely on the provided text, I cannot answer questions 1 through 9 as they pertain to clinical performance, AI-assisted performance, or the establishment of ground truth for such studies.

The document describes a medical device, an intervertebral body fusion system, which is a physical implant. It does not describe a device that performs any diagnostic or AI-assisted function requiring performance criteria like sensitivity, specificity, or human reader improvement with AI assistance.

In summary, the provided text details the regulatory clearance of a physical medical implant (intervertebral body fusion system) based on substantial equivalence to predicate devices, primarily through engineering performance testing and material compliance, not clinical or AI performance studies.

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Peridot Spinal Interbody System - Cervical

The Peridot Cervical Spinal Interbody System are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment.

The Peridot Cervical Spinal Interbody system are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to faciliate fusion with supplemental fixation indicated for cervical fusion procedures.

Peridot Spinal Interbody System - Lumbar

The Peridot Lumbar Spinal Interbody system are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. The Peridot Lumbar Spinal Interbody system are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

This product is intervertebral body fixation devices intended for use as an aid in spinal fusion. This product is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560.

X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.

The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile.

The device is supplied with their specific instrument. The specific instrument is supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instrument supplied.

This product is intervertebral body fixation devices intended for use as an aid in spinal fixation. This product is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. And some cage holders are made of titanium alloy as per ASTM F136.

X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.

The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile.

The devices consist of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages.

The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.

The device must be used in combination with the dedicated instrument supplied.

This document is a 510(k) premarket notification for a medical device called the "Peridot Spinal Interbody System." It is a submission to the FDA seeking clearance to market this device based on its substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance (Not Applicable - This is a Spinal Interbody System, Not an AI/Software Device)

The provided document describes a Peridot Spinal Interbody System, which is a physical device used for spinal fusion. It is not an AI/software device.

Therefore, the concepts of acceptance criteria related to software performance (sensitivity, specificity, AUROC, etc.), test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this type of medical device as described in this document.

The "Performance Testing" section (Page 6, Section 7) explicitly states:
"The Peridot Spinal Interbody System is the same as the legally marketed devices 'K192026' and 'K202872'. So, the performance test was proved by the previous legally marketed devices performance test."

This indicates that the performance of the device is assessed through equivalence to predicate devices, likely based on mechanical, biocompatibility, and sterilization testing, as is typical for intervertebral body fusion devices, rather than a clinical study evaluating an AI algorithm's diagnostic or predictive performance.

Summary of Relevant Information from the Document:

• Device Name: Peridot Spinal Interbody System
• Device Type: Intervertebral Body Fusion Device (physical implant)
• Product Code: ODP, MAX
• Regulatory Class: Class II
• Basis for Clearance: Substantial Equivalence to previously cleared predicate devices (K192026 Peridot Intervertebral body fusion system and K202872 Prase PEEK Anterior Cervical Interbody Spacer).
• Materials: Made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560.
• Intended Use: For intervertebral body fusion in skeletally mature patients for cervical disc degeneration/instability (C2-T1) or degenerative disc disease (DDD) at L2-S1, to be used with bone graft and supplemental fixation.
• Performance Testing Strategy: Relies on the performance testing of the predicate devices due to the subject device being "the same" in design, material, scientific technologies, and indications for use. This typically involves bench testing (e.g., mechanical strength, fatigue, subsidence), biocompatibility testing, and sterilization validation, not clinical performance studies with human readers or AI algorithms.

In conclusion, the requested information regarding acceptance criteria for an AI/software device and its validation study cannot be provided from this document, as it pertains to a physical spinal implant device.

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The Prase-C Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with: · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), · spondylolisthesis, · trauma (i.e. fractures or dislocations), · tumors, · deformity (defined as kyphosis, lordosis, or scoliosis), · pseudoarthrosis, · failed previous fusion, · spinal stenosis.

The Prase-C Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI as per ASTM F136. The plates are offered in one-level, two-level, three-level, four-level, five-level fusion configurations. In addition, one level plate consists of a four hole for screw insertion and a two-hole and three-hole for screw insertion. The plate lockers are fixed into the main plate body by rivet technique. The screw type consists of single and double thread and fixed and variable type. This device is supplied non-sterile.

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested details.

The document is an FDA 510(k) clearance letter for a medical device called the "Prase-C Anterior Cervical Plate System." While it mentions "Performance Testing" according to ASTM F1717, it does not provide any specific acceptance criteria (numerical values or performance thresholds) nor does it report detailed device performance data (e.g., specific loads applied, displacements, or number of cycles achieved).

In essence, the document confirms that the device was tested per a standard and found to be "substantially equivalent" to predicate devices, but it does not disclose the actual test results or the pre-defined target values for those results.

Therefore, I cannot populate the table or provide the requested information regarding sample size, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details, as this information is not present in the provided text.

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Prase PEEK Anterior Cervical Interbody Spacer is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Prase PEEK Anterior Cervical Interbody Spacer is used to facilitate intervertebral body fusion in the cervical spine from the C3 to C7 disc levels using autograft bone. Prase PEEK Anterior Cervical Interbody Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Prase PEEK Anterior Cervical Interbody Spacer is intervertebral body fixation devices intended for use as an aid in spinal fusion. The Prase PEEK Anterior Cervical Interbody Spacer is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile. The device is supplied with their specific instruments. The specific instruments are supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instruments supplied.

The provided document, K202872, is a 510(k) premarket notification for a medical device called "Prase PEEK Anterior Cervical Interbody Spacer." This document describes the device, its indications for use, and its substantial equivalence to previously marketed predicate devices.

However, this document does NOT contain information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria related to its performance.

The "Performance Testing" section (Section 7) of the summary states that mechanical tests were performed according to ASTM standards for intervertebral body fusion devices (e.g., static compression, fatigue, subsidence). These are physical performance tests for the implant itself, not a study evaluating the performance of a digital health or AI-driven device.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an algorithm.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI-related study.

The document discusses the regulatory clearance of a physical medical implant (a PEEK interbody spacer), not an AI/software as a medical device.

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The Prase-AP Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with: · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - spondylolisthesis - · trauma (i.e. fractures or dislocations) - · tumors - · deformity (defined as kyphosis, lordosis, or scoliosis) - · pseudoarthrosis - · failed previous fusion - · spinal stenosis

The Prase-AP Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI as per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level, five-level fusion configurations. The plate lockers are fixed into the main plate body by rivet technique. The screw type consists of single and double thread and fixed and variable type. This device is supplied non-sterile.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called the "Prase-AP Anterior Cervical Plate System." This document focuses on demonstrating substantial equivalence to a predicate device based on design, material, scientific technologies, and indications for use, along with performance testing for mechanical properties (Static compression bending, Static torsion, and Fatigue compression bending).

There is no information in the provided text regarding any study involving AI/ML, human readers, or the establishment of ground truth for diagnostic purposes. Therefore, I cannot generate a response that fulfills the requirements of your prompt, as the information simply isn't present in the document.

The document is purely about the physical characteristics and mechanical performance of an orthopedic implant, not about a diagnostic or image-analysis device that would require the type of studies you are asking about.

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