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This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis
Avascular necrosis of the femoral condyle
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
Moderate valgus, varus or flexion deformities
Rheumatoid arthritis
Treatment of fractures that are unmanageable using other techniques.

The 3DKnee™ porous coated femoral component is manufactured from CoCr alloy conforming to ASTM F75. The inner surface is porous coated with CoCrMo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in 7 sizes (2-12) and is provided in left and right configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is the same design as the 3DKnee™ cleared in K020114.

I am sorry, but the provided text only contains an FDA 510(k) submission summary for a knee implant device (3DKnee™ Porous Coated Femoral Component). This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as it pertains to AI/algorithm-based medical devices or comparative effectiveness studies.

The document is for a physical medical device (a knee implant) and focuses on describing the device, its indications for use, and its substantial equivalence to a previously cleared device (K020114) based on design, materials, and indications, rather than clinical performance data from a study with acceptance criteria.

Therefore, I cannot fulfill your request for an acceptance criteria table and information about a study proving the device meets those criteria, as that information is not present in the provided text.

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This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.

Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis
Avascular necrosis of the femoral condyle
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
Moderate valgus, varus or flexion deformities
Rheumatoid arthritis
Treatment of fractures that are unmanageable using other techniques.

The 3D Knee is comprised of a femoral and a tibial component. The femoral component is manufactured from CoCr alloy conforming to ASTM F75, is available in 6 sizes (2-12) and is provided in left and right configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is similar to the Foundation Knee cleared in K923277.

The 3D Knee tibial inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) that conforms to ASTM F648. The tibial inserts are available in 6 sizes (2-12) and 5 thicknesses (9-19) and are provided in right and left orientations. The tibial in design to the Foundation Lateral Pivot Insert cleared in K000590. This insert is intended to more closely complement the kinematics of the resurfaced knee, allowing rotation about the lateral condyle and increased congruency of the lateral condyle. The baseplate attachment mechanism is the previously cleared Foundation Knee System inserts; therefore, the attachment strength is the same.

The provided document describes a 510(k) premarket notification for a medical device called "3D Knee". It focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the way one might for an AI/ML device.

Here's an analysis based on the information provided:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics for a novel technology (e.g., sensitivity, specificity for an AI algorithm). Instead, the "acceptance criteria" for this device (3D Knee) are implicitly about demonstrating substantial equivalence to existing, legally marketed predicate devices.

The reported device performance is framed in terms of its similarity in design, materials, and indications for use to the predicates.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) summary. This document does not describe a clinical study with a "test set" in the sense of a dataset for evaluating an algorithm or a device's performance against ground truth. Instead, it relies on non-clinical mechanical testing and comparison to predicate devices.
• Data Provenance: Not applicable for the reasons above.

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

• Number of Experts: Not applicable. No "ground truth" was established by experts for a test set in the context of this submission. Substantial equivalence relies on regulatory review of design, materials, and non-clinical testing data compared to established predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There was no test set requiring multi-expert 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a mechanical orthopedic implant, not an AI-assisted diagnostic or therapeutic tool.
• Effect Size: Not applicable.

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

• Standalone Performance: No, this is not an algorithm. This question is not applicable to an orthopedic implant.

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

• Type of Ground Truth: No "ground truth" (in the sense of a definitive diagnostic or clinical outcome label) was explicitly used or established in this 510(k) submission. The basis for substantial equivalence is the safety and effectiveness of the predicate devices that have already been legally marketed and demonstrated performance through their own regulatory pathways (which often included clinical data or adherence to standards in their initial assessment). For the 3D Knee, the "evidence" is primarily the detailed comparison of its design, materials, and mechanical testing results against the established safety and performance of the predicates.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Summary of the Study Proving Device Meets "Acceptance Criteria":

The "study" proving the 3D Knee meets its (implicit) acceptance criteria for market clearance under 510(k) is a non-clinical mechanical analysis and a comparative assessment against legally marketed predicate devices.

• Non-Clinical Testing: "Mechanical analysis was completed to determine substantial equivalence." While the specific tests (e.g., fatigue strength, wear properties, fixation strength) are not detailed in this summary, the FDA's clearance indicates these tests were deemed sufficient to show the device performed comparably to its predicates.
• Basis for Substantial Equivalence: The primary "proof" is the detailed comparison presented to the FDA, demonstrating that the 3D Knee is "similar in design, materials and indications to the Foundation Knee System (K923277) and the Lateral Pivot Insert (K000590)." This comparative analysis essentially leverages the prior regulatory approval and established safety/effectiveness of the predicate devices. The FDA concurred with this assessment, leading to the device's clearance.

Essentially, for this type of device and regulatory pathway, the "acceptance criteria" are met by demonstrating that the new device is as safe and effective as a device already on the market, primarily through engineering principles and testing, rather than new human clinical trials.

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Intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.

The Uni Knee is comprised of a femoral and a tibial component. The femoral component is manufactured from CoCr alloy conforming to ASTM F75. The femoral component is available in 4 sizes (S, M, L, XL) and provided in two configurations (left medial/right lateral and right medial/left lateral).

The Uni Knee System tibial components are manufactured from ultra high molecular weight polyethylene (UHMWPE) that conforms to ASTM F648. The tibial inserts are available in 4 sizes (29-37 mm) and 3 thicknesses (7-9 mm).

This document is a 510(k) summary for the Uni Knee, a medical device for partial knee replacement. It states the device is substantially equivalent to legally marketed predicate devices based on design, materials, and indications for use. However, it does not contain any information about acceptance criteria, device performance testing, or clinical studies (such as MRMC, standalone performance, or training set details) that would be needed to answer your questions.

Therefore, I cannot provide the requested information from this document.

Summary of missing information:

• Acceptance Criteria Table: Not present.
• Sample Size and Data Provenance for Test Set: Not mentioned.
• Number and Qualifications of Experts for Ground Truth: Not mentioned.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: No mention of such a study or effect size.
• Standalone Performance Study: No mention of such a study.
• Type of Ground Truth Used: Not mentioned.
• Sample Size for Training Set: Not mentioned.
• Ground Truth Establishment for Training Set: Not mentioned.

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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 indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be pressfit.

The Keystone® Hip System is available in a variety of proximal bodies and distal stem diameter and length configurations. The proximal body and stem are attached via a Morse type taper junction with an axially loading screw providing secondary attachment. The bodies, stems, and fixation screws were cleared on 510(k) K000521. All components are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F136 with a porous coating that conforms to ASTM 1854-98 applied to the proximal body.

The additional components that are the subject of this Special 510(k) submission are the calcar replacement bodies and calcar build-ups.

The calcar replacement bodies are to be used either with or without a calcar build-up. During revision surgery or treatment of intertrochanteric fractures, the medial calcar bone is often deficient. This implant allows the surgeon to rest the calcar platform of the stem on the remaining medial bone. The modular build-up is available in a +15 and +30mm height for each size stem. The build-up is attached to the stem using an attachment screw. The modular buildups are fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

The attachment screw is used to attach the calcar build-up to the calcar replacement bodies. The attachment screw is fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

This document is a 510(k) premarket notification for the Keystone® Hip System Calcar Replacement Body and Build-up. It states that the device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating equivalence rather than conducting new clinical trials to prove efficacy and safety. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the way a de novo or PMA submission might.

Specifically, for the Keystone® Hip System Calcar Replacement Body and Build-up, the FDA determined substantial equivalence based on comparable features to predicate devices, including "same materials, design and indications." This implies that the acceptance criteria for this 510(k) were primarily satisfied by demonstrating that the new components perform similarly to previously cleared devices under similar conditions and for similar intended uses.

Given this context, I cannot provide the specific details for many of your requested points because they are not typically part of a 510(k) summary demonstrating substantial equivalence for an orthopedic implant of this nature.

Here's an attempt to answer based on the provided text, recognizing the limitations:

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

Based on the 510(k) summary, the acceptance criteria implicitly relate to demonstrating substantial equivalence to predicate devices. This means the new components must:

• Use the same materials (Titanium alloy (Ti-6A1-4V) conforming to ASTM F136 with a porous coating conforming to ASTM 1854-98).
• Have a similar design as the predicate and the existing Keystone® Hip System.
• Be intended for the same indications as the predicate (total hip arthroplasty for specific conditions like osteoarthritis, avascular necrosis, rheumatoid arthritis, etc., and revision arthroplasty).
• The mechanical properties of the attachment mechanism (Morse type taper junction with an axially loading screw) are implied to be robust and already cleared with the K000521 submission.

The "reported device performance" in this context is the FDA's determination that these new components do meet these implicit criteria for substantial equivalence. No numerical performance metrics are stated.

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

Not applicable. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study with a test set of data.

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 for a 510(k) substantial equivalence submission for this type of device. There was no "test set" requiring expert ground truth in the context of efficacy for the new components.

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

Not applicable. See point 3.

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

Not applicable. This device is a hip implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.

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

Not applicable. See point 5.

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

For a 510(k) substantial equivalence determination for an implant, the "ground truth" is typically established by:

• Regulatory Precedent: The FDA has previously cleared similar devices (predicates) based on their safety and effectiveness.
• Material Standards: Adherence to recognized national and international standards (e.g., ASTM F136, ASTM 1854-98) for materials.
• Bench Testing: Mechanical testing (which is not detailed in this summary but is typically part of a 510(k) submission for implants) to demonstrate that the new components meet performance specifications similar to the predicate.
• Clinical Experience: The established clinical history and performance of the predicate devices.

8. The sample size for the training set

Not applicable. This device is a hip implant, not an AI or machine learning system that requires a "training set."

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

Not applicable. See point 8.

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The indications for use of the Cemented Calcar Hip System in total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. The Cemented Calcar Hip Stem is intended for use with bone cement.

The Cemented Calcar Hip Stem is fabricated from wrought titaniumaluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136. The Cemented Calcar Hip Stem is available in sizes 12-16, which have diameters from 10-14mm and lengths of 18-20cm. The proximal body is polished and designed with filleted holes for cerclage cables. The distal and lateral portions of the stem are gritblasted. The Cemented Calcar Hip Stem is designed with a 1320 neck angle and a Morse taper to accept the femoral head. The distal portion of the stem tapers to accept a distal centralizer.

The Cemented Calcar Hip Stem is to be implanted either with or without a collar. The modular collar is available in a +15 and +30mm height for each size stem. The collar is attached to the stem using an attachment screw. The modular collars are fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

The attachment screw is used to attach the collar to the Cemented Calcar hip stem. The attachment screw is fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device (Cemented Calcar Hip System) and the FDA's substantial equivalence determination. It does not include information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy or meet specific performance acceptance criteria in the same way a Premarket Approval (PMA) would.

Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document clarifies the device's description, intended use, and comparison to predicate devices based on materials, design, and indications, but does not present a performance study with acceptance criteria.

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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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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.

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