Search Results

The ESPINAX CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The DISTRACTANIA CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.

The ARTFX CORPECTOMY CAGE includes product range for cervical and lomber applications.

ESPINAX SPINAL CERVICAL CORPECTOMY CAGE is used in cervical spine (C2- T1)
ESPINAX SPINAL CERVICAL CORPECTOMY CAGE-ANGLED
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE-ANGLED is used in lumber spine (T1-L5)

ESPINAX SPINAL CERVICAL CORPECTOMY CAGE is used in cervical spine (C2- T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE is used , in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

ARTFX CORPECTOMY CAGE consisting of two parts, can easily be placed between the vertebra are the features to be distraction. Product is available in the cervical and lumbar spine, the upper and lower vertebrae, providing one to one contact with the angled surface. With gear structure with full contact surfaces of vertebrae forming the product surface, providing a tighter grip, eliminating the risk of slipping. Distraction prior to graft area at that provide a locking device which has a single-stage system after distraction.

The ARTFX CORPECTOMY CAGE, vertebral structure is used in cases where a portion or all of the damage. This damages the vertebral structure, tumors, fractures, and infections may occur due to.

The ARTFX CORPECTOMY CAGE is supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ISO 5832-2 and ASTM F136 .Various sizes of these components are available.

The provided document is a 510(k) summary for the ArtFx Corpectomy Cages, a medical device. This document does not describe a study involving AI or software performance. Instead, it focuses on the substantial equivalence of the ArtFx Corpectomy Cages to a predicate device based on non-clinical mechanical testing.

Therefore, many of the requested categories related to AI performance, such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information, are not applicable to the content of this document.

However, I can provide information about the acceptance criteria and the study that proves the device meets those criteria based on the non-clinical testing described.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical terms within this 510(k) summary (e.g., "The device must withstand X N of compression"). However, the summary indicates that non-clinical testing was performed "according to the Guidance for Industry and FDA Staff Spinal System 510(k)s." This implies that the acceptance criteria are adherence to the performance requirements outlined in the specified ASTM standards and FDA guidance for spinal systems.

The reported device performance is that these tests were "performed" and presumably met the requirements of these standards to demonstrate substantial equivalence to the predicate device.

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

The document only mentions "Non-clinical testing including below tests are performed". For mechanical testing of medical devices, the "sample size" typically refers to the number of devices or representative constructs tested for each specific test. This specific number is not explicitly stated in the provided 510(k) summary.

Data Provenance: Not applicable as this is non-clinical mechanical testing, not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth establishment with experts is relevant for clinical studies or AI/diagnostic device performance evaluation, not for mechanical device testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for clinical studies or AI/diagnostic device performance evaluation, not for mechanical device testing.

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

No. An MRMC study involves human readers interpreting cases, often with and without AI assistance. This document describes non-clinical mechanical testing of a physical medical device (corpectomy cages) and does not involve AI, human readers, or cases in this context.

6. Standalone Performance Study

Yes, in a sense, the non-clinical tests described (Dynamic Compression, Static Compression, Subsidence, Expulsion tests) represent a "standalone" evaluation of the device's mechanical performance without human interaction during the test itself. The performance is assessed against established engineering standards rather than against human performance.

7. Type of Ground Truth Used

The "ground truth" for this type of testing is established through industry standards and regulatory guidance. The device's performance is compared against the requirements and specifications outlined in the ASTM standards (F2077, F2267) and FDA guidance for spinal systems, which define acceptable mechanical properties and behaviors for such devices.

8. Sample Size for the Training Set

Not applicable. There is no AI or machine learning component mentioned that would require a training set. This is a physical medical device.

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

Not applicable, as there is no training set.

Ask a specific question about this device

The eSPIN System is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments 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 the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

The eSPIN System consists of access and positioning instruments to access the disc space and to position the hand-piece for discectomy, a handpiece, disposable cutting tips, a suction tube & alignments guide and electrical motor unit.

The provided text describes the 510(k) summary for NLT SPINE's eSPIN System, a device intended for cutting and grinding intervertebral disc material during discectomy.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document only states "Performance testing in bench (e.g. system mechanism durability & functionality)". There is no information provided about the specific sample size, country of origin, or whether the data was retrospective or prospective.

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

This information is not provided in the document. The testing described is "bench testing" focusing on mechanical performance rather than clinical data requiring expert review for ground truth.

4. Adjudication method for the test set

This information is not provided in the document. As the testing was bench-based, no human adjudication of diagnostic or clinical outcomes is mentioned.

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

There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. The device is a surgical instrument, not an AI diagnostic tool.

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

This is not applicable as the eSPIN System is a surgical instrument, not a diagnostic algorithm.

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

For the performance data reported, the "ground truth" seems to be based on engineering benchmarks and predicate device performance standards as assessed through "bench testing" for "system mechanism durability & functionality." It's about how well the device mechanically performs its intended function, not a diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

This information is not provided. The device is a physical instrument, and while it might have undergone extensive internal development and testing (which could be considered analogous to a "training set" for an algorithm development, though not typically referred to as such for hardware), the document doesn't detail this.

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

This information is not provided and is largely not applicable in the context of a physical surgical device's 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices through engineering and functional testing rather than algorithmic training against a defined ground truth.

Ask a specific question about this device

The eSPIN is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments 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 the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems.

The eSPIN powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and direct connection to a motor via motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator unit for discectomy. The eSPIN needs to be connected to an electrical motor or drill. The required motor/drill specifications are provided in the eSPIN User Manual. The primary changes from the cleared eSPIN are: Addition of Suction tube and irrigation system. Minor modifications to the device design.

Here's a breakdown of the acceptance criteria and study information for the NLT SPINE's eSPIN device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a numerical sample size for the test set of the specific performance tests (e.g., how many manipulator units were tested, how many tips were tested, how many cadavers were used).

• Test Set Description: The "Performance Data" section lists several types of tests:
  • Bending mechanism durability of manipulator unit
  • Verification of tip bending angle
  • Verification of discectomy cleaning work limits
  • Verification of motor parameters
  • Tip attachment strength under tensile force
  • Durability of tip bristle and tip under rotational and tensile loading
  • Biocompatibility evaluation
  • Cadaver studies
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) for a medical device modification, these would typically be internal, prospective verification and validation tests conducted by the manufacturer.

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

There is no mention of experts being used to establish "ground truth" in the traditional sense for these performance tests. The tests described are engineering and biocompatibility evaluations, as well as cadaver studies, which rely on established measurement techniques, protocols, and scientific standards.

• Regarding the cadaver studies: While general medical expertise would be involved, the document does not specify the number or qualifications of experts for judging annulus breach or radiopacity. These are objective observations.

4. Adjudication Method for the Test Set

Not applicable. The described tests are primarily objective performance verification and validation tests, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices and involves human readers interpreting cases with and without AI assistance to measure reader improvement. The eSPIN is a surgical instrument.

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

Yes, the performance tests described are essentially "standalone" in that they evaluate the device's physical and mechanical capabilities independently. The device itself (the eSPIN) is the "algorithm" in this context, and its performance characteristics were assessed. There is no AI algorithm being evaluated in this submission.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests is based on:

• Engineering specifications and standards: For mechanical durability, bending angles, work limits, motor parameters, strength, and durability.
• International standards (ISO 10993): For biocompatibility.
• Direct observation and measurement: For annulus breach (in cadaver studies) and radiopacity (in cadaver studies).
• Predicate device's established performance: The overall goal of the submission is to demonstrate substantial equivalence to the predicate, implying that the predicate's performance serves as the benchmark or "truth" for safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical surgical instrument, not an AI/machine learning algorithm requiring a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments 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 the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

The eSpin powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and a motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator for discectomy. The eSpin needs to be connected to an Electrical Motor. The required motor specifications are provided in the eSpin User Manual.

The NLT SPINE eSpin device is a medical device intended for discectomy procedures. The provided text, K120553, is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing novel acceptance criteria and proving performance against them through a detailed study like one would for a new technology or higher-risk device.

Therefore, the supplied text does not contain specific acceptance criteria, detailed performance metrics (like sensitivity, specificity, accuracy), or a study design for proving these metrics. It describes the device, its intended use, and states that performance testing in bench and cadaver models demonstrated substantial equivalence to the predicate device.

However, based on the information provided, here's an attempt to structure an answer, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence, explicit "acceptance criteria" and quantitative performance metrics (e.g., sensitivity, specificity, or specific success rates) are not provided in the document for the eSpin device itself. The primary acceptance criterion for a 510(k) is demonstrating that the new device is "as safe and effective" and "substantially equivalent" to a predicate device.

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

The document states "Performance testing in bench and cadaver models".

• Sample Size: Not specified. The number of bench tests or cadaver models used is not reported.
• Data Provenance: The location of the testing (e.g., country of origin) is not specified. It is likely conducted by the manufacturer, NLT SPINE Ltd. in Kfar-Saba, Israel, or a contract lab. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission.

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

Not applicable. The performance testing described (bench and cadaver models) would not typically involve expert radiologists or similar for "ground truth" establishment in the context of diagnostic or interpretive accuracy. Instead, it would involve direct measurement of physical properties, material analysis, mechanical testing, and functional assessment.

4. Adjudication method for the test set

Not applicable. The type of performance testing (bench and cadaver models) does not involve adjudication methods like 2+1 or 3+1, which are typically used for assessing agreement among human reviewers in diagnostic studies.

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. The eSpin device is a surgical instrument (arthroscope and accessories for discectomy), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

Not applicable. The eSpin is a physical surgical device, not a standalone algorithm.

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

For "bench and cadaver models," the ground truth would be based on:

• Bench Testing: Engineering specifications, material properties, mechanical test standards, and direct measurements of cutting/grinding efficacy and safety parameters (e.g., material removal rate, damage to surrounding tissue, tip integrity).
• Cadaver Models: Direct observation and assessment of the device's ability to cut and grind intervertebral disc material as intended, without damaging adjacent structures, and evaluating its handling characteristics in a simulated surgical environment. This is typically assessed by surgeons or technical experts.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.

The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.

The provided text is a 510(k) summary for the Espiner Tissue Retrieval System. This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and performance metrics typically associated with AI/ML medical devices.

Therefore, many of the requested categories based on AI/ML device studies are not applicable to this document.

Here's a breakdown based on the information available:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics, but the overarching criterion is "substantial equivalence" to the predicate device.
• Reported Device Performance:
  • Technological Characteristics: "A comparative review...found that the technological characteristics, performance and principle of operation were substantially equivalent (identical)."
  • Performance/Physical Data: "Bench testing demonstrated that the safety and effectiveness of the TFT Espiner Tissue Retrieval System is equivalent (identical) to the predicate devices."
  • Safety and Effectiveness: "indicated no adverse indications or results. It is our determination that the Espiner Tissue Retrieval System is safe, effective and performs within its design specifications and is substantially equivalent (identical) to the predicate device."

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. This submission relies on substantial equivalence and bench testing, not a clinical test set with human or patient data in the context of an AI/ML study.

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 established by experts for a test set in the context of an AI/ML study.

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

• Not applicable. No test set adjudication in the context of an AI/ML study.

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

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

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

• Not applicable in the context of AI/ML ground truth. The "ground truth" here is the established safety and effectiveness of the predicate device, which was deemed identical through comparative review and bench testing.

8. The sample size for the training set

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

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

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

Summary of the Study:

The "study" presented in this 510(k) is a substantial equivalence assessment. It's not a clinical trial or an AI/ML performance study. The core of the evidence is:

• Predicate Device: The Espiner Tissue Retrieval System identifies its own prior version (K982073) as the predicate device. Espiner Medical Ltd. states they are the "original manufacturer of the product family that is currently approved."
• Comparison: A side-by-side comparison table (Page 3) highlights that the new device has identical properties (manufacturer, trade name, 510(k) number - for predicate, product code, common name, classification, intended use) to the predicate device, with the exception of the 510(k) number itself.
• Bench Testing: The submission states that "Bench testing demonstrated that the safety and effectiveness of the TFT Espiner Tissue Retrieval System is equivalent (identical) to the predicate devices." The specifics of this bench testing (e.g., types of tests, number of units tested, precise parameters measured) are not detailed in this summary document but would have been part of the full 510(k) submission.
• Conclusion: The manufacturer concludes that the new device is "substantially equivalent (identical)" to the predicate device in its technological characteristics, performance, principle of operation, safety, and effectiveness.

Ask a specific question about this device