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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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The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 turnor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the PASS 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.

When used as a posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intended for hook fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondification disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

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

The additional components that are the subject of this Special 510(k) submission are 04.5mm polyaxial pedicle screws and crosslinks (Exhibit I). The pedicle screws are the same design as the polyaxial screws cleared in K001024. The crosslinks are nut, rod and clamp assemblies that hook onto the rods of the assembled PASS Spinal System (K001024) to provide torsional stability to the construct.

The provided text is a 510(k) summary for a spinal system, not a study report that details performance against acceptance criteria for a device. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given input.

The document indicates that:

• No performance standards are applicable. "The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems."
• Substantial equivalence is based on design, materials, and indications. "The PASS Spinal System 4.5 mm Screws and Crosslinks is similar in design, materials and indications to the PASS Spinal System (K001024)."

Based on this, the other requested information regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth type, and training set details are not applicable as this 510(k) relies on substantial equivalence to a predicate device rather than a performance study demonstrating new acceptance criteria for the subject device.

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The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 spines: spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the PASS 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the PASS Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis), tumor, pseudarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The subjects of this submission are the addition of polyaxial crosslink components for the PASS Spinal System. The subjects of this submission are the addition of polyaxial crosslink components for the PASS Spinal System. The polyaxial crosslink components are manufactured from titanium alloy per ASTM F136.

The hooks can be used for single or multiple level fixation. The polyaxial hooks have the same attachment mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175.

The laminar hooks are inserted inferior and superior around the pedicles. The hooks are available in standard and double lamination with a superior offset. The double lamination hooks can be inserted inferior and superior around the pedicles with a pedicle screw assembly without any problem of superimposition.

The laminar hooks are inserted under the lamina and the polyaxial hooks are inserted under the pedicle. The polyaxial hooks are available from 0 to 30 degrees and the double lamination hooks can be inserted under the lamina with a pedicle screw assembly without any problem of superimposition.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Encore Orthopedics PASS Spinal System, formatted to answer your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., minimum tensile strength, fatigue life cycles) or their corresponding reported device performance values. Instead, it indicates that the device's performance was evaluated against a standard.

Note: ASTM F1717-96 is a standard specification for spinal implant constructs in vitro static and fatigue testing. This implies that the device's performance was found to be within the acceptable parameters defined by this standard, though the specific numerical results are not provided in this summary.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "The performance claims of the PASS Spinal System was performed according to ASTM F1717-96." This standard outlines methods for in vitro testing of spinal implant constructs, which typically involves a specified number of samples for static and fatigue tests, but the exact number used in this specific study is not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data for human or retrospective/prospective studies. The testing was in vitro (laboratory-based) according to an ASTM standard, not derived from human patients or clinical trials.

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

This question is not applicable to an in vitro mechanical performance study. "Ground truth" in this context would refer to the physical and mechanical properties of the device, established through standardized testing procedures, not through expert consensus or clinical evaluation.

4. Adjudication Method for the Test Set

This question is not applicable, as the study described is an in vitro mechanical performance test, not a clinical study requiring human adjudication for ground truth.

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

No, an MRMC comparative effectiveness study was not done. The provided document describes the mechanical performance testing of an orthopedic implant (PASS Spinal System), not an AI-assisted diagnostic or therapeutic device that would involve human readers.

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

No, a standalone algorithm performance study was not done. The product is a physical spinal implant system, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for this mechanical study is the physical properties and mechanical integrity of the spinal system components, as determined by standardized in vitro testing methods outlined in ASTM F1717-96. The "truth" is whether the device meets the mechanical performance requirements specified by that standard (e.g., in terms of bending stiffness, torsional stiffness, fatigue life).

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of a "training set" as this is a mechanical performance study of a physical device, not a machine learning or AI model development.

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

This question is not applicable, as no training set was used.

Ask a specific question about this device

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological imparment, fracture, soliocations, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the PASS 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 auto genouville 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 subjects of this Special 510(k) submission are the addition of polyaxial crosslink components for the PASS Spinal System (K001024). All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The hooks can be used for single or multiple level fixation. The polyaxial hooks have attachment mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175.

The laminar hooks are inserted inferior and superior around the polyaxial pedicle hooks are inserted inferior and superior around the pedicles. The double laminar hooks are available in standard and polyaxial configurations. The low profile of the hooks allows it to be used in conjunction with a pedicle screw assembly without any problem of superimposition.

The laminar hooks are inserted under the lamina and the polyaxial pedicle hooks are inserted under the pedicle. The low profile of the hook allows it to be used in conjunction with a pedicle screw assembly without any poblem of superimposition.

The provided text describes a 510(k) submission for the "PASS Spinal System" and its additional components. It focuses on the device's description, intended use, and substantial equivalence to a predicate device. However, it does not contain the detailed performance study information required to fill out all aspects of your request.

Here's what can be extracted and what is missing based on the provided document:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states, "The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the PASS Spinal System was performed according to ASTM F1717-96." While the standard used is mentioned, the specific acceptance values (e.g., minimum compression strength, number of cycles survived at a given load) and the results achieved by the device against these values are not detailed.

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

• Sample Size: Not specified. The document only mentions "static and fatigue compression testing of the PASS Spinal System." It does not provide the number of units tested.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. This was a mechanical engineering test, not a clinical study involving patients or data origin.

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

• Not Applicable. This submission is for a mechanical spinal implant. "Ground truth" in the context of expert review (e.g., for image analysis or diagnostics) does not apply here. The "ground truth" for mechanical performance is defined by the ASTM F1717-96 standard.

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

• Not Applicable. As this is a mechanical test, there is no expert adjudication process. The results are objectively measured against the test standard.

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. This is a medical device (spinal implant), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

• Not Applicable. As above, this is not an algorithm or AI device.

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

• Mechanical Test Standard (ASTM F1717-96): The "ground truth" for evaluating the device's mechanical performance is defined by the specified parameters and methodologies within the ASTM F1717-96 standard for static and fatigue compression testing of spinal systems.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of a mechanical device like a spinal implant. This term typically refers to data used to train AI/ML models.

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a spinal implant through mechanical testing against a recognized standard (ASTM F1717-96). It lacks the detailed quantitative performance data and the clinical/AI study information requested in your prompt.

Ask a specific question about this device

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the PASS 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 subjects of this Special 510(k) submission are the addition of rod-plate components for the PASS Spinal System (K001024). All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.

The rod-plates are similar to the rods as they consist of a short rod segment that has enlarged portions at the ends with holes to attach directly to the screws with hemispherical nuts rather than connecting the rod to the screw via a clamp. The proximal end is circular is shape with a circular hole, while the distal end is oval in shape with an oval opening that allows vertical variability of the distal screw placement. These components are offered in two versions (two or three holes) for one or two level instrumentation, each being available in two sizes, small and large. Rod-plates are present to match the lumbar lordosis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

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

Explanation: The document explicitly states, "The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the PASS Spinal System was performed according to ASTM F1717-96." This indicates that the chosen acceptance criteria were specific engineering tests to demonstrate the mechanical integrity of the device, aligned with an established standard for spinal implant testing. The reported performance is simply that these tests were conducted as per the standard. There is no pass/fail metric or numerical result provided in this summary.

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 for Test Set: Not specified. The document only mentions "static and fatigue compression testing of the PASS Spinal System," but does not provide details on the number of devices tested.
• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. Given that this is a 510(k) submission for mechanical components, the "data" would refer to laboratory test results.

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)

This section is not applicable to this device. This 510(k) pertains to a mechanical medical device (spinal system components), not an AI or diagnostic imaging device that requires interpretation by human experts to establish ground truth from medical images or clinical data. The "ground truth" here is the physical performance of the device under specific mechanical loads.

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

This section is not applicable to this device. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints where there might be disagreement among experts. For mechanical testing, the results are typically quantitative measurements that do not 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

This section is not applicable to this device. MRMC studies are relevant for diagnostic or AI-assisted interpretation devices, not for a mechanical spinal implant.

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

This section is not applicable to this device. This is a mechanical implant, not an algorithm.

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

The "ground truth" in this context is the mechanical performance of the device as measured by standardized engineering tests. Specifically, the performance under static and fatigue compression loading conditions, as defined and evaluated by ASTM F1717-96.

8. The sample size for the training set

This section is not applicable to this device. This is a mechanical implant, not an AI or machine learning model that requires a training set.

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

This section is not applicable to this device. As it's not an AI/ML device, there is no training set or ground truth established for one.

Ask a specific question about this device

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 (pseudarthrosis).

As a pedicle screw system, the PASS 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 Spinal System consists of pedicle screws, rods, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The additional component that is the subject of this Special 510(k) submission is the PASS Spinal System Sacral Plate. It has the same polyaxial mechanism as the polyaxial screws cleared in K001024. The difference is that the plate is attached by two additional screws rather than directly to the vertebrae.

The provided text describes a Special 510(k) submission for the PASS Spinal System Sacral Plate, not a study evaluating device performance against acceptance criteria using AI. The document is a regulatory approval letter based on "substantial equivalence" to a predicate device, not on performance data from a clinical or technical study.

Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document as it does not contain such a study.

The relevant sections state:

• "(6) Performance data: The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems."
• "(7) Basis for substantial equivalence: The PASS Spinal System Sacral Plate is similar in design, materials and indications to the PASS Spinal System (K001024)."

This indicates that the approval was granted based on the device's similarity to an existing legally marketed device, not on meeting specific performance criteria through a new study.

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Ask a specific question about this device