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The PASSmed is a pedicle screw 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 the 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 PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-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.

It also includes hooks and a sacral plate 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 PASSmed system includes pedicies include polyasial screws in a various lengths and diameters. Standard and offist height seres are available, with the offset used in cases of severe spondylolisticsis. Standard and realignment clamps are used to connect the screw and rods. Rods are Ø6mm in lengths ranging from 50mm. It also includes sacral plates and serens. The sacral plate takes the place of pedicle screw in connecting the rod to the sacrum. The place is attached to the sarum with two serews. The polyasial attachment mechanism to the same as the pedicle screws. The plates come in right and left configuration. The rod-plates are similar to the consist of a short rod segment that has enarged portions at the ends with holes to attach directly to screw with hemispherical nuts rather than connecting to the rod was a clamp. The rods attach to the hooks and can be used for single or multiple level lisations. They have the same rod attachment mechanism as the polyasial serews. The laminar hooks are inserted inferior around the lamina, pediele hooks are inserted inferior and superior around the pedicles.

This is a 510(k) summary for a spinal fixation device, not a diagnostic or AI-driven device. As such, the information typically found in acceptance criteria and efficacy studies for software-driven medical devices (such as sensitivity, specificity, reader studies, ground truth establishment) is not applicable here.

The provided document describes the PASSmed Spinal System, a hardware device used for spinal immobilization and stabilization. The "study" mentioned in the document is a non-clinical mechanical test to demonstrate the device's physical properties, not a clinical study involving human patients or a software algorithm evaluating medical images.

Here's an analysis based on the information provided, reinterpreting the "acceptance criteria" in the context of a mechanical spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for the ASTM F1717 testing. For mechanical tests of components, this would typically involve a statistically significant number of samples of each device configuration or critical component.
• Data Provenance: The testing was "performed according to ASTM F1717," indicating it was likely conducted in a controlled laboratory setting. No country of origin for data is specified, but the submitter (Medicrea) is from FRANCE, and the contact person is in the USA. Given it's a mechanical test, the origin of the data isn't tied to patient demographics or retrospective/prospective collection as it would be for a clinical diagnostic study.

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

• Not Applicable. For a mechanical device, "ground truth" typically refers to the physical properties of the materials and design, evaluated against established engineering standards (like ASTM F1717). There aren't "experts" in the same way as radiologists for image interpretation; rather, there are engineers and technicians who conduct and analyze the mechanical tests according to predefined protocols.

4. Adjudication Method for the Test Set

• Not Applicable. Mechanical testing against an ASTM standard doesn't involve "adjudication" in the sense of resolving disagreements among human reviewers. The results are quantitative and objective measurements of material properties and structural integrity.

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

• No. This type of study is relevant for evaluating the performance of diagnostic tools or AI algorithms where human readers interpret data. It is not applicable to a mechanical implant device.

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

• No. This refers to the standalone performance of a software algorithm. The PASSmed Spinal System is a physical implant, not a software algorithm. The "standalone performance" equivalent would be the mechanical performance of the device itself, which was evaluated via ASTM F1717.

7. The Type of Ground Truth Used

• Engineering Standards and Material Specifications. The "ground truth" for a mechanical device is its ability to withstand specified loads, fatigue, and other physical stresses as defined by relevant engineering standards (in this case, ASTM F1717) and the material properties of its components.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not a machine learning or AI device.

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

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

Summary of the "Study" Mentioned:

The "study" referenced in the 510(k) summary is identified as:

• "Testing performed according to ASTM F1717."

ASTM F1717 is a standard test method for "Spinal Implant Constructs in a Vertebrectomy Model (Mechanical Testing of Spinal Implants)." This standard specifies the methodology for mechanical characterization of spinal implant assemblies, including pedicle screw systems, under various loading conditions (e.g., static, fatigue).

The purpose of this testing is to demonstrate the mechanical equivalence and safety of the PASSmed system compared to legally marketed predicate devices. The acceptance criterion is that the device is "as mechanically sound as other devices commercially available," which is demonstrated by meeting or exceeding the mechanical performance benchmarks set by the ASTM F1717 standard and comparing favorably to predicate devices that have also undergone similar testing. This is a common approach for demonstrating substantial equivalence for hardware medical devices in 510(k) submissions.

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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.

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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, 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.

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