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The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spinal stenosis. fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the indications specified above.

NexLink OCT is the re-design and modernization of the existing OctaFix svstem. The scope of the NextLink OCT Cervical Plating System will include 1) a modular occipital plate, 2) a selection of precontoured rods, 3) hooks and 4) a refined set of instrumentation. The scope of the project is for Next ink OCT to integrate as an option to the current Nex-Link System. The NexLink OCT Occipital Cervical Plating System components are temporary implants that are used to stabilize the spine (occiput-T3) during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.

The provided text describes the NexLink OCT Cervical Plating System. However, it does not contain information about the acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth details. The document explicitly states that "Clinical data and conclusions were not needed for this device." and relies on "Laboratory and bench testing results" to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be extracted and the reasons why other information is unavailable:

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

Reasoning: The document states, "Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device." However, it does not specify what specific acceptance criteria these tests were designed to meet (e.g., specific thresholds for strength, fatigue life, etc.), nor does it provide quantitative results of these tests.

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: Not applicable. No clinical test set was used.
• Data Provenance: Not applicable. The "testing" was non-clinical (laboratory and bench testing).

Reasoning: The document explicitly states, "Clinical data and conclusions were not needed for this device." The evaluation was based on non-clinical laboratory and bench testing.

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. No "ground truth" for a clinical test set was established as no clinical data was required or used.

Reasoning: As no clinical data was used, there was no need for experts to establish ground truth for a clinical test set.

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

• Not applicable. No clinical test set requiring adjudication was used.

Reasoning: No clinical data, no clinical test set, therefore no adjudication method applies.

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.

Reasoning: This is a medical device (cervical plating system), not an AI/software device involving human readers or interpretation of medical images. The concept of "human readers improve with AI" is not relevant to this type of device.

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

• Not applicable. This is a medical device (cervical plating system), not an algorithm or AI.

Reasoning: See above.

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

• Not applicable. The "ground truth" for this device's evaluation was based on engineering and material standards for mechanical testing to demonstrate substantial equivalence to a predicate device, rather than clinical outcomes or diagnostic accuracy.

Reasoning: The device's performance was evaluated through "Laboratory and bench testing results." This implies a comparison to established engineering specifications and benchmarks relevant to spinal implants, not clinical ground truth in the diagnostic sense.

8. The sample size for the training set

• Not applicable. This device is a physical medical implant, not a machine learning model that requires a training set.

Reasoning: The concept of a "training set" belongs to machine learning and AI, which are not relevant to this physical device.

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

• Not applicable. No training set was used.

Reasoning: See above.

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The Universal Clamp Stainless Steel System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications:

• Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis,
• Spinal degenerative surgery, as an adjunct to spinal fusions;

The Universal Clamp Stainless Steel System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

The Universal Clamp Stainless Steel System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

This document describes the Abbott Spine Universal Clamp® Stainless Steel System. However, it does not include information about acceptance criteria or a study proving that the device meets specific performance criteria.

Instead, the document focuses on:

• Device Description: A temporary orthopedic implant for stabilization during bone fusion and fracture repair, used with other stainless steel implants for "wiring."
• Indications for Use: Spinal trauma, reconstructive, and degenerative surgery, and in conjunction with other stainless steel implants where wiring helps secure attachment.
• Substantial Equivalence: The primary basis for clearance is demonstrated through "Engineering evaluations and bench testing" which showed the Stainless Steel system is substantially equivalent to a previously cleared titanium alloy version (K060009).

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. The device's approval is based on substantial equivalence to a predicate device, supported by engineering evaluations and bench testing, rather than a clinical study with specific performance outcomes against acceptance criteria.

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The Ardis™ Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The Ardis™ Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

Ardis™ Spacer is a hollow device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine.

The provided text is a 510(k) summary for a medical device called the Ardis™ Spacer. It describes the device, its indications for use, and states that substantial equivalence was demonstrated through engineering evaluations and bench testing.

However, the document does not contain any information regarding acceptance criteria, reported device performance metrics (like sensitivity, specificity, or accuracy), or details about a study that would demonstrate the device meets such criteria in terms of clinical performance.

Here's why the requested information cannot be fully provided from the given text:

• Type of Device: The Ardis™ Spacer is a physical implant (intervertebral body fusion device), not an AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically have performance metrics like sensitivity or specificity.
• Study Type: The submission focuses on demonstrating "substantial equivalence" to a predicate device primarily through "engineering evaluations and bench testing" to assess "physical and mechanical properties." It's not a clinical effectiveness study in the way one would assess a diagnostic algorithm.
• Clinical Performance Data Absence: There's no mention of a study involving human subjects, data sets for training or testing algorithms, expert opinions for ground truth, or statistical measures of diagnostic performance.

Therefore, most of the requested fields are not applicable or cannot be extracted from this document.

Based only on the provided text, here's what can be answered:

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

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

• Not Applicable. The submission refers to "engineering evaluations and bench testing," not a clinical test set with human data. Therefore, there's no sample size in this context, nor data provenance.

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 clinical performance for diagnostic or AI devices, is not discussed in this submission. The "ground truth" here would relate to the successful physical and mechanical performance defined by engineering standards.

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

• Not Applicable. There is no clinical test set described that would require adjudication.

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-assisted device. No MRMC study was mentioned.

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

• Not Applicable. This is a physical implant, not an algorithm.

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

• The implicit "ground truth" for the substantial equivalence claim is based on engineering standards and established performance characteristics of predicate intervertebral body fusion devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no training set.

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

• Not Applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.

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When intended for pedicle screw fixation from T1 -S1, the Sequoia Thoracolumbar Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion.

As pedicle screw system places between 1.3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative dise disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

When intended for anterolateral screw, rod and/or cable fixation of the T6-L5 spine, the indications are degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, and/or lordosis), turnor and failed previous fusion.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

The use of posterior spinal instrumentation in children has been reported in the literature. The Sequoia Spinal System may be used for non-pedicle posterior use in this patient group.

The Sequoia Spinal System consists of various open style screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the spine. This system includes titanium spinal pods in varying lengths. Additionally included are screws with a polyaxial design, allowing the surgeon to use a top loading technique for dropping the spinal rod down to the fixation components into a u-shaped opening.

The provided text describes the Abbott Spine Sequoia Spinal System, a spinal fixation device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical or AI-based evaluations.

Instead, the document focuses on:

• Substantial Equivalence: The primary method of demonstrating safety and effectiveness for this device is through substantial equivalence to a predicate device (InCompass® Spinal Fixation System). This means the new device is compared to an already legally marketed device with similar indications and technological characteristics.
• Non-Clinical Performance Data: The submission states that "Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device." This typically refers to mechanical and material testing to ensure the device meets engineering specifications and performs similarly to the predicate in a simulated environment.
• Absence of Clinical Performance Data: Crucially, the document explicitly states: "Clinical data and conclusions were not needed for this device." This confirms that no clinical study was conducted to demonstrate the device's performance in humans.
• Indications for Use: Detailed indications for when and how the device can be used in spinal fusion procedures are provided.

Therefore, since no clinical or AI performance study was conducted or reported in this document, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts for ground truth, adjudication methods, or MRMC/standalone studies for either a test set or training set.
• The type of ground truth used.

In summary, the provided document indicates that the Abbott Spine Sequoia Spinal System's acceptance was based on non-clinical (laboratory and bench) testing demonstrating substantial equivalence to a predicate device, and no clinical performance data was required or submitted.

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PathFinder - Mini-Open Posterior Approach

When intended for pedicle screw fixation from L1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.

As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking info consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

The Abbott Spine, Inc. PathFinder® system is a pedicle screw fixation system designed to allow for use of an open or mini open surgical technique. The approved Pathfinder® system consists of various screws and rods and is intended to provide temporary stabilization following surgery to fuse the spine.

The subject device is the result of modifications to the existing PathFinder® 6.5mm polyaxial pedicle screws resulted in the inclusion of a 4.5mm polyaxial pedicle screw to the Pathfinder System. The subject device shares the same intended use and fundamental scientific technology as the predicate device.

The Abbott Spine PathFinder® System is a spinal fixation system. The submission K071174 specifically concerns modifications to the existing PathFinder® 6.5mm polyaxial pedicle screws to include a 4.5mm polyaxial pedicle screw.

Acceptance Criteria and Device Performance

Study Details

1. Acceptance Criteria and Reported Device Performance: See table above.

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

   • Sample Size: Not applicable. The submission states "NONCLINICAL PERFORMANCE AND CONCLUSION: Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device. CLINICAL PERFORMANCE AND CONCLUSIONS: Clinical data and conclusions were not needed for this device." The evaluation relied on nonclinical (laboratory and bench) testing.
   • Data Provenance: Not applicable, as no clinical data was required or provided. The nonclinical testing would have been conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical ground truth was established. The device's performance was evaluated through nonclinical laboratory and bench testing against the predicate device.

4. Adjudication method for the test set: Not applicable, as no clinical ground truth requiring adjudication was established.

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 a mechanical spinal fixation 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: Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used: Not applicable for clinical ground truth. For the nonclinical evaluation, the "ground truth" was the
   performance characteristics and regulatory standards applied to the predicate device (PathFinder® System K030625). The new device's
   performance in laboratory and bench tests was compared to these established characteristics to demonstrate substantial equivalence.

8. The sample size for the training set: Not applicable, as no clinical trials or machine learning models were involved.

9. How the ground truth for the training set was established: Not applicable, as no clinical trials or machine learning models were involved.

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When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.

The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior cervico-thoracic spine. The subject devices share the same intended use and fundamental scientific technology as the predicate.

The provided document describes a medical device submission (K062505) for the Nex-Link Spinal Fixation System by Abbott Spine, Inc. This submission focuses on design modifications, specifically the addition of Poly-axial Offset Connectors, to an already cleared predicate device.

The document states that the Nex-Link Spinal Fixation System is intended for fixation to and stabilization of the cervicothoracic spine (C1-T3) to promote fusion.

Based on the information provided, here's a breakdown of the requested details:

1. Table of Acceptance Criteria and Reported Device Performance

Clinical Performance: "Clinical data and conclusions were not needed for this submission." |
| Substantial Equivalence to Predicate Device | "The subject device is the result of design modifications to the predicate device; they have the same intended use and are substantially equivalent to the predicate devices." (Predicate devices: Nex-Link Spinal Fixation System, K031985; OctaFix Occipital Cervical Plating System, K021009) |

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

• Sample Size for Test Set: Not applicable. The submission explicitly states, "Clinical data and conclusions were not needed for this submission." The evaluation for this 510(k) was based on non-clinical (laboratory and bench) testing and substantial equivalence to predicate devices, not on a clinical test set.
• Data Provenance: Not applicable for clinical data. For non-clinical testing, the provenance is internal laboratory and bench testing by Abbott Spine, Inc.

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

• Number of Experts: Not applicable. No clinical test set with human ground truth establishment was conducted for this submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set was conducted.

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

• MRMC Study: No. This submission is for a medical implant (spinal fixation system), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

• Standalone Performance: Not applicable. This document is for a physical medical implant, not a software algorithm.

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

• Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" for the device's performance was established through non-clinical laboratory and bench testing demonstrating mechanical safety and effectiveness, and through comparison to legally marketed predicate devices for substantial equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design and validation of the device are based on engineering principles, materials science, and testing against performance standards, not a data-driven training set in the context of an algorithm.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for this medical device submission.

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When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the NexLink Spinal Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.

The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior spine. The subject devices share the same intended use and fundamental scientific technology as the predicates.

Here's an analysis of the provided text regarding the Koro634 device, focusing on acceptance criteria and supporting studies:

Based on the provided document (KORO634, Nex-Link Spinal Fixation System), it appears this submission is for a 510(k) premarket notification of intent to market, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical effectiveness data.

Therefore, the typical structure for reporting acceptance criteria and a study proving device performance (especially for AI/standalone device cases) is not fully applicable here. However, I can extract the relevant information regarding performance and the type of evidence provided.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format one might expect for a new performance study. Instead, the "acceptance" for this 510(k) relies on demonstrating substantial equivalence to a predicate device. The performance data presented is focused on non-clinical (bench) testing to support this substantial equivalence.

Study Details (Based on the provided text)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable. The document refers to "Laboratory and bench testing results" but does not specify sample sizes for these tests (e.g., number of implants tested for fatigue, static bending, etc.).
   • Data Provenance: Not specified. It's safe to assume these were conducted in a laboratory setting, likely in the US where the submitter is located. This would be retrospective in the sense that the tests are performed on manufactured parts, not in vivo clinical data.

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

   • Not applicable. For mechanical bench testing, "ground truth" is typically established by engineering standards (e.g., ASTM, ISO) or internal specifications, not by expert consensus on diagnostic images or clinical outcomes.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods (like 2+1 or 3+1) are relevant for clinical endpoint determination or expert consensus on image interpretation, which are not part of the non-clinical performance data described here.

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

   • No. This document is for a spinal fixation system (physical implant), not an AI device or imaging software. Therefore, an MRMC study is not relevant.

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

   • No. This is a physical medical device. "Standalone" performance as an algorithm is not applicable.

6. The type of ground truth used:

   • The "ground truth" for the non-clinical performance data would be engineering specifications and established mechanical testing standards (e.g., strength, stiffness, fatigue life). The results of these bench tests are compared against the predicate device's known performance or established industry standards to demonstrate equivalence.

7. The sample size for the training set:

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

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

   • Not applicable. As above, no training set for an algorithm is involved.

Summary of Clinical Data (or lack thereof):

The document explicitly states: "Clinical data and conclusions were not needed for this submission." This further emphasizes that the basis for approval (substantial equivalence) rests solely on the non-clinical, laboratory, and bench testing, rather than human clinical trials or performance data.

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The Universal Clamp System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications:

1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions;
   The Universal Clamp System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

The Universal Clamp System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

This looks like a 510K submission document used to obtain FDA clearance for a medical device. These documents generally focus on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical study with acceptance criteria and detailed performance metrics as would be found in a PMA (Pre-Market Approval) application.

Therefore, the provided text does not contain the acceptance criteria or a detailed studyproving the device meets acceptance criteria in the way a clinical trial report would. The document focuses on demonstrating that the Abbott Spine Universal Clamp System is substantially equivalent to the CFix Cable System (K974020) through engineering evaluations and bench testing.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a clinical or performance study. The "acceptance criteria" here is implicitly "demonstrate substantial equivalence to the predicate device."
• Reported Device Performance: The document states: "Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Universal Clamp System is substantially equivalent to the CFix Cable system."
  • Comment: The specific results of these "engineering evaluations and bench testing" (e.g., tensile strength, fatigue life, material compatibility) are not provided in this summary. Therefore, a table of acceptance criteria and specific performance values cannot be constructed from this text.

Remaining Information Categories (2-9):

The following information points are typically found in detailed clinical study reports or significant clinical trials. This 510(k) summary focuses on substantial equivalence based on bench testing, not on human clinical outcomes or the kind of performance metrics implied by these questions. Consequently, most of these details are not available in the provided text.

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

• Not available. The document refers to "engineering evaluations and bench testing," which implies tests on device units, not human subjects. The sample size for these bench tests (e.g., how many clamps were tested for their physical properties) is not specified. Data provenance is not applicable in the context of bench testing described here.

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/Not available. This type of information is relevant for studies involving human interpretation (e.g., image analysis by radiologists). For engineering evaluations and bench testing of physical properties, ground truth is established by standardized testing methods and measurements, not expert consensus in this context.

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

• Not applicable/Not available. Adjudication methods are used in clinical studies where expert opinions (e.g., diagnosis, outcome assessment) need to be resolved. This is not relevant for physical property bench 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

• Not applicable/Not available. This is a medical device, specifically a surgical implant, not an AI diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this device.

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

• Not applicable/Not available. As mentioned, 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)

• For bench testing: The "ground truth" would be established by the physical and mechanical properties measured according to recognized standards (e.g., ASTM, ISO). For example, the breaking strength of a clamp measured on a testing machine. Specific details are not provided.
• Not available for clinical outcomes: There is no mention of clinical outcomes data in this summary.

8. The sample size for the training set

• Not applicable/Not available. This concept relates to machine learning models. For a physical device, there isn't a "training set" in this sense. If referring to product development, it would be R&D testing, but "training set" is not the correct terminology.

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

• Not applicable/Not available. See point 8.

In summary:

This document is a 510(k) summary, which aims to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device. The primary evidence presented for this equivalence comes from "engineering evaluations and bench testing" of the physical and mechanical properties of the device. It explicitly states that these results "demonstrate that the performance... is substantially equivalent to the CFix Cable system." However, the specific details, raw data, acceptance criteria, and methodologies of these tests are not included in this summary document. It does not describe a clinical study with human subjects, nor does it provide the detailed performance metrics or "acceptance criteria" that would be associated with such a study.

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When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only . The multiaxial screws are not intended to be placed in the cervical spine.

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants. The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior spine. The subject devices share the same intended use and fundamental scientific technology as the predicates.

The provided text is related to a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, the information requested in the prompt, such as acceptance criteria, performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is not applicable to this document.

The document discusses the substantial equivalence of the "Nex-Link Spinal Fixation System" to a predicate device based on design modifications and non-clinical performance (laboratory and bench testing). It explicitly states: "Clinical data and conclusions were not needed for this submission."

Therefore, I cannot provide the requested information as it pertains to AI/ML device studies.

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