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The PASS Anterior Spinal System is an anterolateral screw fixation system intended to provide immobilization and stabilization of spinal segments from T4 to L5 in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic and lumbar spine:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• · Traumatism (ex: fracture, dislocation)
• · Tumor
• · Spinal deformation such as scoliosis or kyphosis
• · Failed previous fusion (Pseudoarthrosis)

The Medicrea PASS Anterior Spinal System consists of screws, rods, plates, staples, connection and locking devices. It can be used for single or multiple level fixations, with one or two rods. This system has been developed to accommodate a left or right anterior approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ISO 5832-3 specifications and ASTM F136 specifications.

This is a 510(k) premarket notification for a medical device called the "PASS Anterior Spinal System." It is a spinal intervertebral body fixation orthosis. The document focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than providing detailed acceptance criteria and a study to prove performance in the context of an AI/machine learning device.

Therefore, most of the requested information for an AI/ML device's acceptance criteria and study proving performance is not applicable to this document.

However, I can extract what is provided regarding non-clinical testing and the overall conclusion.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical spinal implant, the "acceptance criteria" are based on mechanical performance tests, and "reported device performance" refers to the device passing these tests.

Note: The document states "The following tests were conducted according to ASTM F1717," implying successful completion and meeting relevant standards for spinal implants. However, specific numerical acceptance thresholds or results (e.g., "device withstood X N-m," or "deformation less than Y mm") are not provided in this summary.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML test set. For mechanical testing, the "sample size" would refer to the number of devices tested. This information is not explicitly stated in the summary, but typically multiple units are tested per configuration to ensure reproducibility and statistical significance.
• Data Provenance: Not applicable for AI/ML specific data provenance. The testing is non-clinical, done in a laboratory environment according to ASTM F1717.

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

Not applicable. This is a mechanical device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. Adjudication methods are relevant for clinical studies or AI/ML evaluations, not mechanical 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. This is a mechanical spinal implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is a mechanical spinal implant.

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

For the mechanical tests, the "ground truth" would be the engineering specifications and performance standards defined by ASTM F1717 for spinal implant constructs. The device's ability to withstand certain loads and cycles without failure or exceeding deformation limits constitutes meeting the "ground truth" for mechanical integrity.

8. The sample size for the training set

Not applicable. There is no AI/ML training set for this mechanical device.

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

Not applicable. There is no AI/ML training set for this mechanical device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the provided document):

The provided document describes a Non-Clinical Test Summary which details mechanical testing performed according to ASTM F1717. These tests included:

• Static testing in a load to failure mode in axial compression bending.
• Static testing in a load to failure mode in torsion.
• Cyclical axial compression bending testing.

The conclusion drawn from these tests is that "The PASS Anterior Spinal System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function." This implies that the device successfully met the mechanical performance requirements defined by the ASTM standard, thereby demonstrating its safety and effectiveness comparable to existing, legally marketed devices.

No clinical studies were performed as the substantial equivalence was established through design, material comparison, and non-clinical mechanical testing, which is common for spinal fixation systems.

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IMPIX DLIF Lumbar Interbody Device 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 I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IMPIX DLIF Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The purpose of this submission is to submit the new Lumbar Interbody device: IMPIX-DLIF, or Dual Lateral Interbody Fusion, has a rectangular shape with a front beveled and has three areas inside for use with autogenous bone graft. This new device and IMPIX-L Interbody devices previously cleared in K072226 are manufactured in the same material, PEEK OPTIMA® LT1, and have the same Indications for use. The devices differ in geometry and approach.

The provided text describes a 510(k) premarket notification for a medical device called the IMPIX DLIF Lumbar Interbody Device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical studies or specific acceptance criteria with defined performance metrics.

Based on the provided document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics in a way that would typically be seen in a clinical study report. Instead, it describes mechanical tests performed and implies that the device's performance in these tests was comparable to or within acceptable limits for similar predicate devices. The "reported device performance" is essentially the execution of these tests, with the conclusion that the device is "substantially equivalent."

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

The document states:

• Sample Size for Test Set: Not explicitly stated for specific numerical outcomes. For non-clinical tests, it's typically a small number of devices per test (e.g., n=5 or n=10 per test condition). The summary only mentions "The following tests were conducted," implying a standard set of tests for interbody fusion devices.
• Data Provenance: The data is based on non-clinical laboratory testing performed in support of regulatory submission (510(k)). This is not human data (retrospective or prospective), but rather mechanical test data from the device itself. The country of origin for the testing is not specified, but the applicant is from France.

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

• Experts: Not applicable for non-clinical mechanical testing. Ground truth for mechanical tests is established by objective measurements against engineering standards (ASTM F2077, ASTM F2267).
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical tests have objective, quantifiable outcomes which don't require expert adjudication.

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

• MRMC Study: No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: No. This device is an interbody fusion device (an implant), not a software algorithm or an AI-powered diagnostic tool. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

• Ground Truth: For this device, the "ground truth" for demonstrating substantial equivalence relies on:
  • Engineering Standards: Conformance to recognized ASTM standards (F2077, F2267) for mechanical properties.
  • Material Specifications: Conformance to specified material standards (e.g., PEEK OPTIMA® LT1 (ASTM F2026), Tantalum (ISO 13782)).
  • Comparison to Predicate Devices: Demonstrating similar design, materials, and intended use as legally marketed predicate devices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, the provided document is a 510(k) summary for a physical medical implant. The "acceptance criteria" and "study" described are primarily related to non-clinical mechanical testing and material compatibility, demonstrating substantial equivalence to existing predicate devices rather than clinical performance against specific metrics with human data. Most of the requested information regarding AI performance, expert adjudication, or clinical study design is therefore not relevant or available in this context.

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IMPIX Lumbar Interbody Device 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 I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

IMPIX Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The IMPIX Lumbar Cage is bi-convex in the sagittal plane. It possesses teeth on both superior and inferior surfaces that assist in the anchorage and stability of the device to the bone of the vertebrae. The upper and lower aspects of the IMPIX-L are open, to allow the surgeon to pack the device with bone graft prior to insertion. Lateral holes exist to allow bone growth through the device. In order to the varying morphology of patients, the IMPIX Lumbar Cages are available in various sizes. The IMPIX Lumbar Cage is machined from PEEK OPTIMA LT1.

The provided text describes a 510(k) premarket notification for IMPIX Lumbar Interbody Devices. This submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, the information typically found in acceptance criteria and detailed study descriptions for a device that demonstrates performance against specific metrics with human involvement (like AI-assisted diagnostics) is not present.

Here's an analysis based on the available text:

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

   • Acceptance Criteria: The primary acceptance criterion for this type of device (intervertebral body fusion device) is demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and material equivalence. The text mentions "required mechanical strengths" as the benchmark.
   • Reported Device Performance:

     Performance Aspect	Reported Performance
     Mechanical Strength	"IMPIX Lumbar Interbody Fusion devices meet required mechanical strengths."
     Material	Manufactured from PEEK OPTIMA LT1 (same as predicate).
     Indications for Use	Same as predicate device.
     Design (IMPIX-LA, IMPIX-LAD, IMPIX-TLIF)	Different from the predicate in design, but still deemed substantially equivalent based on testing.

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

   • Test Set Sample Size: Not explicitly stated for mechanical tests. The "cadaver trial" would have involved a small number of cadavers, but the exact count is not provided.
   • Data Provenance: Not specified for the mechanical tests. The cadaver trial likely took place where the manufacturer (MEDICREA Technologies, France) or its contact (Donald W. GUTHNER, PA, USA) conducted R&D.

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 as this is a mechanical device submission, not a diagnostic device requiring expert interpretation of images. The "ground truth" here is mechanical integrity and adherence to ASTM standards.

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

   • Not applicable. The "test set" primarily refers to mechanical testing according to ASTM standards, which are objective measurements, not subjective evaluations by experts needing 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 a medical implant, not an AI-powered diagnostic device. No MRMC study was conducted.

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

   • Not applicable. This is a medical implant, not an AI or algorithm-based device.

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

   • The "ground truth" for this device's performance is based on engineering standards and mechanical testing results (e.g., meeting requirements for axial compression, compressive shear, resistance to subsidence, and expulsion as defined by ASTM F2077 & ASTM F2267). For substantial equivalence, the "ground truth" is also the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable. There is no training set for this type of device.

In summary, the 510(k) submission for IMPIX Lumbar Interbody Devices relies on demonstrating that the new devices are substantially equivalent to a previously cleared predicate device (IMPIX Lumbar Interbody Device, K072226) through mechanical testing and material similarity, as opposed to extensive clinical testing with patient outcomes or expert reviews.

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The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also includes hooks, rods and sacralliliac screws indicated for degenerative disc disease (ddd) defined as 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), tumor, pseudoarthrosis and failed previous fusion.

The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The provided document, K100297, describes a Special 510(k) submission for the Medicrea PASS LP Spinal System. This submission is for a product range extension and additional components to an already legally marketed predicate device (K080099).

The acceptance criteria and supporting study described in this document are mechanical performance tests rather than clinical or AI/software performance studies. The core of this submission focuses on demonstrating substantial equivalence to existing predicate devices by ensuring the mechanical integrity of the new components.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criterion is a comparative one: the modified components must exhibit mechanical properties equivalent to or better than those of already marketed, similar devices. The reported performance confirms that this criterion was met through standardized testing or finite element analysis.

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

• Sample Size: The document does not specify the exact number of components or samples used for the mechanical tests. It refers to "tests performed on the additional components," implying that the specifically added components were tested.
• Data Provenance: The tests are conducted according to recognized ASTM standards (F1717 or F1798), which are standard industry practices for mechanical testing of spinal implant devices. The document does not specify the country of origin of the data beyond the submitter being in France. The data would be prospective in the sense that the tests were performed on the new components to demonstrate their properties.

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

This question is not applicable in the context of this device submission. The "ground truth" for mechanical performance of spinal implants is established by adherence to recognized industry standards (ASTM testing) and engineering principles, not by expert clinical consensus on a test set as would be the case for an AI/software device. The regulatory body (FDA) reviews the test results against these standards.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements (e.g., load to failure, fatigue life) against predetermined specifications within ASTM standards, not subjective assessments requiring adjudication by multiple readers.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a device (often an AI-powered one) on human reader performance in diagnostic tasks, which is not the nature of this spinal implant submission.

6. If a Standalone Performance Study Was Done

Yes, in a sense. The mechanical performance tests on the "additional components" can be considered a standalone performance study. These tests were conducted on the device components themselves to evaluate their intrinsic mechanical properties, independent of human interaction. The results demonstrated their mechanical soundness.

7. The Type of Ground Truth Used

The "ground truth" for this submission is mechanical performance standards (ASTM F1717 or ASTM F1798). These standards define the expected mechanical behavior (e.g., strength, fatigue resistance) that spinal implant components must meet to be considered safe and effective. The test results are compared directly against these established engineering benchmarks.

8. The Sample Size for the Training Set

Not applicable. The device is a mechanical spinal implant, not an AI/software device that requires a training set.

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

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

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The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also includes hooks, rods and sacral/iliac screws indicated for degenerative disc disease (ddd) defined as 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

This document is a 510(k) summary for a medical device (PASS LP Spinal System) and does not contain information about the acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML algorithm.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the document focuses on regulatory approval for a spinal implant system and discusses:

• Its trade name, common name, classification, and product codes.
• The predicate devices it claims substantial equivalence to.
• Description of device modifications.
• Intended use.
• A brief mention of "performance data" stating that "When applicable, the tests performed on the additional components (according to ASTM F1717 or ASTM F1798) or the finite element analysis, indicate that the products are as mechanically sound as other devices commercially available."

This statement about performance data is very general and refers to mechanical testing of physical components (spinal system) against established ASTM standards, not the performance of an AI/ML algorithm against specific acceptance criteria using a test set, ground truth, or expert review.

Consequently, there is no information in the provided text to populate the table or answer any of the questions (2-9) related to AI/ML algorithm validation.

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The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The provided text describes a Special 510(k) submission for the PASS LP Spinal System, focusing on modifications to connectors. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a mechanical device, not an AI/algorithm-based one.

Specifically, the document states:

• Performance Data: "When applicable, the tests performed on the additional components according to ASTM F1798, indicate that the products are as mechanically sound as other devices commercially available."

This statement confirms that some mechanical testing was done according to ASTM F1798, but it does not provide acceptance criteria or detailed study results. AI/algorithm-related criteria or studies are not relevant to this device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as the provided text pertains to a mechanical spinal system and not an AI-based device. The original request's parameters (e.g., sample size for test set, number of experts, adjudication method, AI assistance, ground truth) are designed for AI/algorithm-based devices and are not applicable here.

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The PASS 2 Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

When used as a pedicle screw system, the PASS 2 Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS 2 also includes hooks and rods indicated for degenerative disc disease (ddd) defined as 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The Medicrea PASS 2 Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MEDICREA PASS 2 Spinal System:

The provided document, K082069, is a 510(k) summary for a Special 510(k) submission, primarily for a product range extension and additional components of the PASS 2 Spinal System. As such, the performance data provided is focused on mechanical testing rather than clinical or AI-driven performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the mechanical tests. It mentions "tests performed on the additional components," implying a discreet number of physical units were tested.

• Data Provenance: The tests refer to ASTM standards, which are recognized industry-wide standards for mechanical testing of medical devices. The country of origin for the data is not specified beyond being generated for a French company submitting to the FDA. The testing conducted is inherently prospective in nature, as it involves newly manufactured components undergoing specific mechanical tests.

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

This information is not applicable to this type of submission. The "ground truth" for mechanical testing of spinal implants is defined by the physical properties and performance characteristics measured against established ASTM standards, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing results are typically quantitative and objective measurements against predetermined pass/fail criteria from the ASTM standards, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation is involved. The PASS 2 Spinal System is a mechanical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study was not done. This submission is for a mechanical spinal implant, not an algorithm or AI device.

7. The Type of Ground Truth Used

For the mechanical performance, the "ground truth" is based on the specified mechanical properties and performance requirements outlined in the ASTM F1717 and ASTM F1798 standards. The device's components must withstand certain loads, fatigue cycles, and exhibit specific mechanical behaviors to be deemed acceptable.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of mechanical performance testing of a spinal implant. Training sets are typically associated with machine learning or AI algorithms.

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

This information is not applicable for the same reasons as #8.

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The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal deformations such as scoliosis or kyphosis, loss of stability due to tumors, and failed previous fusion (pseudoarthrosis).

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AJ-4V ELI) that conforms to ASTM F136.

The following information is extracted from the provided text to describe the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on a Special 510(k) submission for modifications to the PASS LP Spinal System, rather than presenting a performance study with specific acceptance criteria in the traditional sense of a clinical trial or algorithm evaluation. Instead, the acceptance is based on demonstrating mechanical equivalence to predicate devices.

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

• Sample Size for Test Set: Not applicable. The "test set" in this context refers to the additional components of the device, not a data set for an algorithm.
• Data Provenance: Not applicable. The tests performed are mechanical in nature, not based on patient data. The submitter is MEDICREA® Technologies, based in La Rochelle, France.

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

Not applicable. Ground truth for a device's mechanical soundness is established through standardized engineering tests (e.g., ASTM F1798), not through expert consensus on a test set of data.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, not for mechanical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance:

Not applicable. This document describes a medical device (spinal system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on engineering standards and specifications, specifically ASTM F1798 for mechanical testing, and the demonstration of substantial equivalence to predicate devices cleared by the FDA.

8. The Sample Size for the Training Set:

Not applicable. There is no training set mentioned, as this is not an AI/algorithm study.

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

Not applicable. There is no training set. The "ground truth" for the device's design and intended use is established through its adherence to manufacturing standards and its similarity to previously approved devices.

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The PASS 2 Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

When used as a pedicle screw system, the PASS 2 Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS 2 components consist of pedicle screws, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

This 510(k) premarket notification for the PASS 2 Spinal System is for a Class II medical device, specifically a posterior pedicle screw system and sacral plate. The submission describes modifications and an extension of the product range. The "acceptance criteria" here refers to the performance standards the device must meet to be considered substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This is a submission for a spinal implant system (hardware), not a diagnostic or AI-driven device that would involve a "test set" of patient data in the typical sense. The testing is mechanical engineering testing of the components. Therefore, the concept of sample size for a test set of data and its provenance is not applicable here. The "sample" would refer to the physical components tested for mechanical strength. The document does not specify the number of components tested.

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

This information is not applicable. The "ground truth" for a mechanical device is established by standardized material and mechanical testing procedures, not by human expert assessment of clinical data.

4. Adjudication Method for the Test Set

This is not applicable as the testing is mechanical and follows defined ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) with and without AI assistance. This submission concerns mechanical performance of a surgical implant.

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

This is not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this device is based on mechanical testing standards, specifically ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Guide for Evaluating the Static and Fatigue Performance of Posterior Spinal Systems). The "ground truth" is that the device components perform within acceptable mechanical limits defined by these standards.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical mechanical implant, not an AI model that requires a training set of data.

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

This is not applicable. The ground truth for mechanical testing is established by the specified ASTM standards and laboratory protocols, not by a "training set."

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IMPIX-C Cervical Interbody Device is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft.

IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

IMPIX-L Lumbar Interbody Device 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 I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

IMPIX-L Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The IMPIX Cervical Interbody devices consist of implants with a convexity on the upper surface with anti-migration upper ridging and lower pins. The IMPIX Cervical Interbody device has a D-forro with two openings that allow the surgeon to fill it with bone graft. In order to adapt to the warying morphology of patients, both IMPIX Cervical Interbody devices are available in various sizes. The IMPIX Cervical Interbody device is machined from PEEK OPTIMA LT1.

The IMPIX Lumbar Interbody device is bi-convex in the sagittal plane. It possesses teeth on both superior and inferior surfaces that assist in the anchorage and stability of the device to the bone of the vertebrae. The upper and lower aspects of the MPIX-L are open, to allow the surgently pack the device with bone graft prior to insertion. Lateral holes exist to allow bone growth through the device. In order to adapt to the varying morphology of patients, the IMPIX Lumbar Interbody devices are available in various sizes. The IMPIX Lumbar Interbody device is machined from PEEK OPTIMA LT1.

The IMPIX Interbody Device is a medical device and not an AI or software device. Therefore, the traditional metrics of acceptance criteria, sample size for test/training sets, ground truth establishment, expert qualifications, and MRMC studies that apply to AI/ML devices are not relevant here.

Instead, its "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices and meeting established mechanical strength standards for intervertebral body fusion devices.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
| Substantial Equivalence | Device must be similar in:

• Design
• Material
• Intended Use
  to legally marketed predicate devices cleared by FDA for intervertebral body fusion. | The IMPIX Interbody Fusion devices are stated to be "similar in design, material, and intended use to its predicate devices that have been cleared by FDA for intervertebral body fusion." This statement directly addresses the criteria for substantial equivalence. |
  | Mechanical Strength | Device must meet "required mechanical strengths" for intervertebral body fusion devices. | "Tests performed according to ASTM F2077 indicate that the IMPIX Interbody Fusion devices meet required mechanical strengths." |
  | Indications for Use | The device's indications for use (Cervical and Lumbar) must align with safe and effective applications for intervertebral body fusion as defined by current medical standards and established for predicate devices. | IMPIX-C Cervical Interbody Device: Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7, used with autogenous bone graft and supplemental fixation after at least six weeks of non-operative treatment.

IMPIX-L Lumbar Interbody Device: Indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, possibly with up to Grade I spondylolisthesis or retrolisthesis, used with autogenous bone graft and supplemental fixation after at least six months of non-operative treatment. |
| Material Composition | Material should be biocompatible and suitable for long-term implantation in the spine. | Both the IMPIX Cervical and Lumbar Interbody devices are machined from PEEK OPTIMA LT1. This material is widely accepted in spinal implants. An explicit performance metric is not stated beyond its use. |

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of an AI/ML test set. The performance data refers to mechanical tests. The number of devices tested for mechanical strength is not specified.
• Data Provenance: The mechanical tests were performed internally or by a testing laboratory according to the ASTM F2077 standard, which is an international standard for spinal implant testing. The country of origin of this specific test data is not mentioned, but the submitter is from France. The nature of these tests is prospective (performed for this submission) rather than retrospective clinical data.

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

• This is not applicable as there is no "ground truth" to be established by clinical experts in the context of a mechanical performance study or substantial equivalence review. The "truth" for mechanical testing is adherence to the ASTM F2077 standard. The FDA reviewers are experts in regulatory compliance and medical device safety.

4. Adjudication Method for the Test Set

• Not applicable. There's no clinical "test set" requiring adjudication. Mechanical test results are objective measurements against a standard.

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

• No. This device is not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant. The effectiveness is determined by its mechanical properties and long-term clinical outcomes (which are typically post-market surveillance for 510(k) devices, not pre-market studies).

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

• Not applicable. This is a physical intervertebral body fusion device, not an algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this submission relies on:
  • Mechanical Engineering Standards: Specifically, ASTM F2077 for intervertebral body fusion devices.
  • Regulatory Precedent: The FDA's existing clearances for predicate devices, establishing what is considered safe and effective in terms of design, materials, and intended use.
  • Material Science: The properties of PEEK OPTIMA LT1 as a biocompatible and structurally sound material for implantation.

8. Sample Size for the Training Set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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