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The subject Diapason Combo, like the predicate OSS Combination Screw Ring/Blocker, are intended for use only with the components of the commercially available Osteonics "Spinal System/ Diapason System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System/Diapason System are as follows:

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• Vertebral fracture or dislocation .
• Spondylolisthesis .
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies).
• Previously failed fusion
• Spinal tumor .

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

The design change involves modifying the ring height, blocker height and assembly process of the predicate OSS Combination Screw Ring/Blocker. In addition, the submission covers use of predicate Xia 6 mm diameter Rods with the Osteonics Spinal System. The submission involves no change to the Xia rods themselves.

The subject component, a design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker, is a single-use device which is sold non-sterile and is intended for use only with the other components of the commercially available Osteonics® Spinal System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System.

This document describes a Special 510(k) submission for a device modification to the Osteonics® Spinal System, specifically for the Diapason Combo and the use of Xia 6mm diameter rods with the system. The submission does not contain information typically found in studies for AI/ML-based medical devices. Instead, it focuses on the mechanical performance of modified spinal implant components. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) are not applicable to this submission.

The "study" referenced in this document is a series of mechanical tests designed to demonstrate the comparable performance of the modified components to their predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" as this is a mechanical engineering study. The "sample size" would refer to the number of individual test specimens of the device components. This detail is not provided in the summary.
• Data Provenance: Not applicable. This is a laboratory study involving physical testing of materials/components, not patient data from a specific country or retrospective/prospective collection.

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

Not applicable. "Ground truth" in this context refers to established mechanical engineering standards and measurements, not expert clinical interpretation of medical data. The "experts" would be the engineers and technicians performing and analyzing the mechanical tests, operating under established protocols.

4. Adjudication method for the test set

Not applicable. This is a mechanical testing study, not a clinical study requiring adjudication of expert opinions. The determination of "comparable" or "acceptable" performance would be based on engineering analysis and adherence to pre-defined test protocols and measurable criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No.
• Effect Size of AI: Not applicable, as this is not an AI-based device.

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

Not applicable, as this is not an AI-based device.

7. The type of ground truth used

The "ground truth" for this engineering study is based on:

• Established Mechanical Engineering Principles and Standards: This includes accepted methods for static and fatigue testing of spinal implants.
• Performance of Predicate Devices: The key ground truth for comparison is the documented and accepted mechanical performance of the previously cleared Osteonics® Spinal System components (the OSS Screw Blocker and Cap) and the Xia 6mm diameter rods. The goal is to show "comparable" or "acceptable" properties relative to these established devices.

8. The sample size for the training set

Not applicable. This is a mechanical testing study, not a machine learning study that requires a training set.

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

Not applicable, as this is not a machine learning study.

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The subject components of the Osteonics® Spinal System Rod / Plate are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein, are available in either ASTM F-136 Ti6AV ELI Alloy. Ti6Al4V ELI alloy components are intended for use only with other Ti6Al4V ELI alloy components.

The specific indications of the Osteonics® Spinal System, including the subject additional components, are as follows:

As a non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• . Long and short curve scoliosis
• . Vertebral fracture or dislocation
• . Spondylolisthesis
• . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• . Previously failed fusion
• . Spinal tumor

For Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in . skeletally mature patients, the Osteonics® Spinal System is indicated for one or more of the degenerative spondylolisthesis with objective evidence of neurological following: impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in . skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.

The Osteonics® Spinal System Rod / Plate System (RPS) is designed for fixation of one or two levels of the lumbar and thoracic spine. The RPS offers options of both a low-profile plate and a stiff rod. The components which comprise the Osteonics® Spinal System Rod / Plate System are: The Rod / Plate, One-Level, Short, the Rod / Plate, One-Level, Long, the Rod / Plate, Two-Level, Long, the 5.0 mm Bone Screw (25mm to 60mm lengths) which are compatible with the rod / plate bone screw holes, the Threaded Cap (which tightens the 5.0mm bone screw to the Rod / Plate), and the Rod / Plate Ball Ring (pre-assembled to the Two-Level, Long Rod / Plate) in order to secure an Osteonics® Spinal System Bone Screw to the two-level rod / plate assembly.

The provided 510(k) Premarket Notification for the Osteonics® Spinal System - Rod / Plate System (K991055) primarily focuses on demonstrating substantial equivalence to predicate devices based on mechanical properties and intended use. It does not describe a study involving human or image-based performance for an AI/CAD/Software device, but rather a mechanical device.

Therefore, most of the requested information regarding acceptance criteria for device performance in a clinical/diagnostic context, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not applicable to this submission.

However, I can extract the relevant information regarding the performance claims and the study type conducted.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples of the device components (rods, plates, screws) that were subjected to mechanical testing. The specific number of physical components tested is not provided in this document.
• Data Provenance: Not applicable in the context of clinical data. The "data" refers to the results of the mechanical (fatigue and static) testing of the Osteonics® Spinal System Rod / Plate System components. This testing would have been conducted in a laboratory setting by Howmedica Osteonics Corp.

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

• Not applicable. The "ground truth" for this device is established through engineering and materials science principles, verified by mechanical testing, not by expert clinical consensus.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods are typically used for disagreements in human expert interpretations of data (e.g., medical images). For mechanical testing, the "adjudication" is based on established engineering standards and whether the physical samples meet those standards.

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 clinical performance of diagnostic or AI-assisted devices where human readers are involved. The K991055 submission is for a mechanical implantable device.

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

• Not applicable. This device is a physical spinal implant system, not an algorithm or software. Its performance is evaluated through mechanical testing, not standalone algorithmic performance.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on engineering standards for mechanical strength, durability (fatigue), and material properties. The performance of the device components (rods, plates, screws) under static and dynamic loads is compared against established benchmarks and the performance of predicate devices.

8. The Sample Size for the Training Set

• Not applicable. As this is a physical medical device, not an AI/ML algorithm, there is no "training set" in the computational sense. The design and manufacturing processes are informed by established engineering principles and prior device experience, but not through a "training set" of data.

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

• Not applicable. See point 8. The "ground truth" for the device's design and manufacturing is derived from validated engineering specifications, material science, and regulatory requirements, not from a dataset with established ground truth labels for training.

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The subject components. Osteonics® Spinal System Versatile Cross Connector, are single-use devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Osteonics® Spinal System.

The uses for the legally marketed Osteonics® Spinal System are as follows:

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• . Vertebral fracture or dislocation
• . Spondylolisthesis
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies).
• . Previously failed fusion
• . Spinal tumor

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.

The Osteonics® Spinal System is comprised of single use, non-sterile devices manufactured from ASTM F-136 Titanium alloy (Ti-6AI-4V ELI). The Osteonics® Spinal System Versatile Cross Connector may be used in spinal applications where additional stability for the device construct is desired by the surgeon. The Osteonics Spinal System Versatile Cross Connector allows a spinal construct on one side of the spine to be joined to another construct on the other side of the spine. The joining is intended to provide additional resistance to physiological forces such as unequal lateral loads, rotation, and isolated torsional movements.

The provided text is a 510(k) summary for the Osteonics® Spinal System Versatile Cross Connector. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

The document primarily states:

1. Acceptance Criteria (Implied): The mechanical and endurance properties of the subject components must be "within the range demonstrated by other existing spinal systems."
2. Study Type: "Fatigue and static testing" was performed.
3. Reported Device Performance: The testing "demonstrates the mechanical and endurance properties of the subject components are within the range demonstrated by other existing spinal systems."

Since this is a submission for substantial equivalence based

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The following are specific indications for the Osteonics® Spinal System:

As a non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• . Vertebral fracture or dislocation
• . Spondylolisthesis
• . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• . Previously failed fusion
• . Spinal tumor

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients. the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.

The Osteonics® Spinal System is comprised of single use, non-sterile devices manufactured from ASTM F-136-96 Titanium alloy (Ti6A1-4V ELI). The Osteonics® Spinal System Sacral Offset Connector Assembly may be used in any application where supplemental sacral screw placement is desired by the surgeon. This assembly allows a sacral connector with supplemental sacral screw to the joined to the spinal rod in the sacral offset blocker secures the sacral screw to the connector assembly. The Clamping Screw is used with the Sacral Offset Connector to provide a stable lock on the longitudinal spinal rod.

This document describes a 510(k) premarket notification for a medical device, specifically the Osteonics® Spinal System - Sacral Offset Connector Assembly. The submission focuses on demonstrating substantial equivalence to predicate devices through material, design, and intended use comparison.

However, the provided text does not contain information about acceptance criteria for device performance or a study proving that the device meets such criteria.

The document primarily covers:

• Submission Information: Sponsor, contact, date, device identification (proprietary name, common name, classification name).
• Predicate Device Identification: Listing similar commercially available spinal systems.
• Device Description: Materials, intended use (sacral screw placement, connecting to spinal rod, clamping screw for stable lock).
• Intended Use/Indications For Use: Detailed list of spinal conditions for which the system is indicated, both as a non-pedicle screw system and as a pedicle screw fixation system.
• Statement of Technological Comparison: Asserts substantial equivalence based on materials, intended uses, and basic design concepts, and mentions that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components."

Missing Information:

The document explicitly states that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components" under the "Statement of Technological Comparison." This indicates that some form of testing was performed. However, the details required to directly answer your request are not present in the provided text.

Specifically, the following information is not provided:

1. A table of acceptance criteria and the reported device performance: While testing is mentioned, no specific criteria (e.g., maximum load, cycles to failure) or numerical results are given.
2. Sample size used for the test set and the data provenance: No information on the number of devices tested or if the data was retrospective/prospective, or country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is a mechanical device, so expert review of "ground truth" in clinical image interpretation or diagnosis would not be applicable in this context.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a mechanical spinal fixation device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a mechanical device.
7. The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties or failure points under specified conditions, defined by engineering standards. The document only states "Fatigue and static testing," but no specific standards or detailed methodology.
8. The sample size for the training set: Not applicable, as this is a mechanical device, not an AI alogorithm that uses training data.
9. How the ground truth for the training set was established: Not applicable.

To answer your request thoroughly, additional documentation regarding the specific fatigue and static testing performed on the Osteonics® Spinal System Sacral Offset Connector Assembly would be required. This would typically be found in engineering reports or test summaries that are part of the full 510(k) submission, but are not included in this excerpt.

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As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• Vertebral fracture or dislocation
• . Spondylolisthesis
• . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Previously failed fusion
• . Spinal tumor

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolistlisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.

The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System consists of rods, hooks, containment rings, bone screws and their accessories (blockers and caps), and transverse links.

The provided document is a 510(k) Premarket Notification for the Osteonics® Spinal System. It seeks expanded indications for use, particularly concerning pedicle screw applications, due to a recent reclassification of such uses.

However, the document does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established, which are typically found in clinical trial reports or validation studies.

This document is primarily a regulatory submission for expanding the indications of an already cleared device, asserting substantial equivalence to the previously cleared version of the same device. It focuses on the scope of use rather than proving specific performance metrics through new studies.

Therefore, I cannot populate the requested table or provide details about the study because the provided text does not contain that information. The document explicitly states:

• "The Osteonics® Spinal System functions as the subject and predicate device. The components of the Osteonics® Spinal System were determined to be substantially equivalent via 510(k) #K951725."
• "The design and function of the Osteonics® Spinal System remains unchanged."
• "As a result of the recent downclassification of pedicle screw uses, the indications of the Osteonics® Spinal System will be expanded..."

These statements indicate that the submission is based on regulatory reclassification and previous substantial equivalence determinations, not on new performance studies for the expanded indications.

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The following are specific indications for the Osteonics® Spinal System:

For non-pedicular fixation of the T4-S2 spine:

• Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis) .
• . Vertebral fracture or dislocation
• . Spinal stenosis
• Spondylolisthesis ●
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by patient history and radiographic studies).
• . Previously failed fusion
• . Spinal tumor

For pedicular use:

• Additionally, when used as a pedicle screw system, the system is intended for patients: (a) . having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System bone screws are top loading screws that are threaded distally, have a forked proximal design, and are available in both standard and extended ("extra-long" or "long arm") proximal length configurations. The cylindrical bone screws will be available in standard and extra-long versions in lengths and diameters identical to the predicate top loading tapered screws.

This document is a 510(k) Premarket Notification for the Osteonics® Spinal System Cylindrical Bone Screws. It's a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving performance against acceptance criteria for a novel device. Therefore, a direct answer to your request in the format provided is not fully applicable as the document does not contain a study with acceptance criteria and device performance in the way you've outlined for a new device's validation.

However, I can extract the relevant information from the document to address aspects of your request within the context of a 510(k) submission for substantial equivalence.

Here's an analysis based on the provided text, outlining why some requested information is not present in this type of document and what can be inferred:

Key Takeaway: The provided document is a 510(k) submission, whose primary goal is to demonstrate "substantial equivalence" of a modified device (cylindrical bone screws) to an existing, legally marketed predicate device (tapered bone screws within the same Osteonics® Spinal System), not to establish novel performance against clinical acceptance criteria through a new study.

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable in this format: A 510(k) submission for substantial equivalence typically does not present new acceptance criteria and reported device performance in the way a clinical trial or performance study for a novel device would. The core "acceptance criteria" here are that the modified device demonstrates substantial equivalence to the predicate device in terms of intended use, materials, design, and safety/effectiveness.
• Inferred Performance: The document states: "The function of the modified spinal system bone screws remains unchanged and is identical to that of the predicate Danek TSRH bone screws." This is the core "performance" claim for a 510(k) – that the new device performs equivalently to the predicate. The "study" here would be the comparative analysis outlined in the submission.

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

• Not Applicable (Clinical Study): This document does not describe a clinical "test set" in the sense of a patient cohort for a performance study.
• Inferred "Test": The "test" in this context refers to the comparison of the cylindrical bone screws with the tapered predicate screws. This comparison is based on design parameters, material specifications, and intended uses. The "sample size" would effectively be "one" (the modified cylindrical bone screw design) compared against "one" (the predicate tapered bone screw design).
• Data Provenance: Not applicable for a clinical study. The data provenance would relate to the design specifications, material testing (if new), and intended use statements.

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

• Not Applicable: There is no mention of experts establishing a "ground truth" for a clinical test set because a clinical performance study (as you might see for a diagnostic AI device) was not conducted or reported here.
• Inferred Experts: The "experts" involved are likely the engineering and regulatory teams at Osteonics® who designed the device and prepared the submission, and later, the FDA reviewers who assessed the submission for substantial equivalence. Their qualifications are inherent in their roles, but not explicitly stated as "experts for ground truth."

4. Adjudication Method for the Test Set

• Not Applicable: No clinical test set or adjudication method is described. The "adjudication" in this regulatory context is the FDA's review and decision on substantial equivalence.

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

• Not Conducted/Applicable: This is not a study type relevant to the submission of a medical implant (bone screws) for substantial equivalence. MRMC studies are typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. There is no AI component here.

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

• Not Conducted/Applicable: This concept is not relevant to bone screws. There is no algorithm or AI component in this device.

7. Type of Ground Truth Used

• Not Applicable (Clinical): There isn't a "ground truth" derived from patient data, pathology, or outcomes in the traditional sense of a clinical performance study.
• Inferred "Ground Truth": The "ground truth" for this submission is the established safety and effectiveness of the predicate device (the tapered bone screws within the Osteonics® Spinal System) and the regulatory framework that dictates how substantial equivalence is demonstrated. The ground truth relies on the assertion that the design changes (cylindrical vs. tapered) do not alter the fundamental function, safety, or effectiveness when compared to the predicate, as evidenced by engineering principles, material science, and the lack of new risks.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/ML device or a device requiring a clinical training phase as part of its development.

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

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

Summary of Information from the Text Regarding Substantial Equivalence:

The "study" in this context is the comparison presented in the 510(k) to demonstrate substantial equivalence.

• Acceptance Criteria for Substantial Equivalence:
  • Intended Uses: Must be identical to the predicate device.
  • Material: Must be identical or equivalent (same medical-grade titanium alloy, ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI)).
  • Design: Changes (cylindrical vs. tapered) must not introduce new questions of safety or effectiveness and the fundamental function must remain unchanged.
• Reported Device "Performance" (Comparison to Predicate):
  • Intended Uses: "The intended uses of the subject bone screws are identical to those of the predicate bone screws."
  • Material: "The Osteonics® Spinal System is manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI)." (Implied identical to predicate).
  • Design: "The design of the modified cylindrical bone screw differs from the predicate bone screw in that the modified bone screw distal diameter is the same as the proximal diameter. The function of the modified spinal system bone screws remains unchanged and is identical to that of the predicate Danek TSRH bone screws."

This 510(k) submission successfully argued substantial equivalence based on these points, leading to FDA clearance (K984302).

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The uses for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, as part of the legally marketed Osteonics® Spinal System, are as follows:

Non-Pedicular Use; fixation of the T4-S2 spine:

• Long and short curve scoliosis
• Vetebral fracture or dislocation
• Spondylolisthesis
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Previously failed fusion
• Spinal tumor

Pedicular Use:

• When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System bone screws are top loading screws that are threaded distally, have a forked proximal design, and are available in both standard and extended ("extra-long" or "long arm") proximal length configurations. The 5.5mm bone screws will be available in standard and extra-long versions in lengths of 30mm, 35mm, 40mm, and 45mm. The 10.0mm bone screws will be available in one standard version only in lengths from 35mm to 60mm in increments of 5mm.

The provided text is a 510(k) Premarket Notification for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, dated September 25, 1998. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. A 510(k) submission for substantial equivalence primarily relies on comparison to a predicate device, as opposed to demonstrating specific performance against predefined acceptance criteria for novel devices. The "reported device performance" section would typically describe results from clinical trials or specific performance tests with quantitative outcomes, which are absent here.

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

This information is not applicable/not provided in the context of this 510(k) submission. There is no mention of a clinical "test set" in the traditional sense, nor any data provenance (country of origin, retrospective/prospective). The submission uses mechanical testing as supporting evidence for substantial equivalence, but details of the mechanical testing are summarized rather than presented as a full study with sample sizes.

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

This information is not applicable/not provided. There is no clinical "test set" requiring ground truth establishment by experts in this submission.

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

This information is not applicable/not provided. There is no clinical "test set" requiring adjudication in this submission.

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 information is not applicable. This document describes a medical device (spinal screws), not an AI-assisted diagnostic or treatment system, so MRMC studies are not relevant.

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

This information is not applicable. This document describes a medical device (spinal screws), not an algorithm.

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

This information is not applicable/not provided. Since there is no clinical "test set" or diagnostic algorithm being evaluated, the concept of ground truth in that context is not relevant. The basis for determining "substantial equivalence" is a comparison of design, materials, and intended use with previously cleared predicate devices, supported by mechanical testing.

8. The sample size for the training set:

This information is not applicable/not provided. There is no "training set" mentioned in this submission, as it relates to a physical device rather than a machine learning model.

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

This information is not applicable/not provided. As there is no training set, this question is not relevant.

Summary of the Study (as described in the 510(k) notification):

The "study" presented here is a demonstration of substantial equivalence to previously cleared predicate devices, rather than a clinical trial proving performance against specific acceptance criteria.

The key points of the "study" are:

• Objective: To demonstrate that the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws are substantially equivalent to:
  • Existing bone screws within the Osteonics® Spinal System (cleared via K951725).
  • The Danek TSRH Spinal System (for 5.5mm screws).
  • AcroMed Titanium Bone Screws (for 5.5mm screws).
• Methodology for Substantial Equivalence: Comparison of:
  • Intended Uses: Stated to be substantially equivalent.
  • Material: Osteonics® system and AcroMed screws are made from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Danek TSRH system is made from ASTM F-138-92 Stainless Steel alloy.
  • Design: Stated that the design and function remain unchanged and are substantially equivalent.
  • Supporting Testing Summary: The document mentions "supporting testing summary" but does not elaborate on the specific tests, methodologies, or quantitative results within the provided text. This typically refers to mechanical bench testing, but details are not included.
• Conclusion: Based on the similarities in intended uses, materials (with noted differences that are deemed acceptable), design, and supporting testing summary, the devices are considered substantially equivalent.

Important Note from the FDA Letter:

The FDA's response specifies a limitation on the pedicular use of the device. While the sponsor's intended use listed a broader set of conditions for non-pedicular fixation and then for pedicular fixation, the FDA explicitly restricts pedicular use to severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, with other specific conditions (autogenous bone graft, fixed to lumbar and sacral spine, removed after solid fusion). Any other pedicular use is considered Class III and requires a Premarket Approval (PMA) or an Investigational Device Exemption (IDE). This highlights that while the device was found substantially equivalent, its market clearance came with specific, narrowed indications for pedicular use.

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The subject components of the Osteonics® Spinal System Variable Offset Connector Assembly are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein, are available in either ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6A14V ELI Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6AV ELI alloy components are intended for use only with other Ti6Al4V ELI alloy components.

The Osteonics® Spinal System, including the subject additional components, is intended for fixation of the T4-S2 spine. All bone screws are indicated for sacral fixation, or for limited pedicular fixation. When used as a pedicle screw system is intended only for use with autogenous bone graft in order to facilitate fusions of the LS-S1 joint in patients with grade 3 or 4 spondylolisthesis. The screws are not intended for placement in the pedicles above L3, and are intended for removal after development of a solid fusion mass.

For non-pedicular use:

• Long and short curve scoliosis, ●
• Vertebral fracture or dislocation, ●
• Spondylolisthesis,
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

For pedicular use:

• When used as a pedicle screw system, the system is intended for patients: (a) having . severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

The Osteonics® Spinal System Variable Offset Connector Assembly may be used in any application where greater flexibility in bone screw placement is needed. This assembly allows a spinal rod to be joined to a bone screw when variations in the distance between these two components exists. The Variable Offset Connector is provided with a Ball Ring, which secures into the top of the bone screw. The bone screw is rotated to provide an access to the Variable Offset Connector in conjunction with the longitudinal construct. The Osteonics® Spinal System Clamping Screw is used with the Variable Offset Connector to provide a stable lock on the longitudinal rod.

The connector features a cylindrical arm at one end, a center round hole, and an open-ended split screw hole at the other end. The Ball Ring component is preassembled around the cylindrical arm. The round hole accommodates the spinal rod, and the split screw hole accepts the Clamping Screw, which secures the spinal rod into place.

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

The provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the context of device performance, as these are typically defined within the scope of clinical or simulated-use testing for assessing efficacy or safety.

Instead, the document is a 510(k) Premarket Notification Summary of Safety and Effectiveness for a new component (Variable Offset Connector Assembly) within an existing spinal system (Osteonics® Spinal System). The focus here is on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical trial design and performance evaluation against predefined criteria, which is a different regulatory pathway or stage of development.

However, I can extract information related to the device's technical comparison and its intended use, which indirectly relate to why it might be considered safe and effective by comparison.

Based on the provided text, here is what can be inferred or explicitly stated:

Analysis of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" for device performance (e.g., success rates, complication rates, specific functional outcomes in patients) or "reported device performance" against such criteria are present in this 510(k) summary.

The document states:

"Fatigue and static testing demonstrates the mechanical and endurance properties of these components."

This indicates that mechanical testing was performed, but the specific acceptance criteria for this testing (e.g., minimum load-bearing capacity, fatigue cycles) and the quantitative results are not provided in this summary. The purpose of this testing is to demonstrate that the new component is comparable in mechanical integrity to its predicate devices, rather than meeting novel performance criteria.

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

• Test Set Sample Size: Not applicable. This document describes a mechanical testing approach, not human clinical data or performance data from a specific "test set" of patients.
• Data Provenance: The mechanical testing would have been conducted in a laboratory setting. No country of origin for data is specified, as it's not patient data.
• Retrospective or Prospective: Not applicable, as it's mechanical testing, not clinical data.

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

• Number of Experts: Not applicable. Ground truth, in this context, would relate to clinical diagnosis or outcome assessment, which is not part of this 510(k) summary. Mechanical testing relies on engineering standards and measurements, not expert consensus on clinical cases.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This summary does not involve clinical data requiring adjudication.

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

• MRMC Study: No, an MRMC study was not done. This type of study is for evaluating diagnostic performance (e.g., imaging devices) where multiple human readers interpret cases, often with and without AI assistance. This 510(k) is for a spinal implant component.
• Effect Size of Human Readers Improvement with/without AI: Not applicable.

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

• Standalone Performance: Not applicable. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical testing mentioned, the "ground truth" would be established by engineering standards and measurements (e.g., force applied, displacement, cycles to failure) according to recognized test methodologies for spinal implants. This is distinct from clinical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve machine learning or AI that requires a "training set."

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Spinal implant component (Variable Offset Connector Assembly).
• Purpose of 510(k): To demonstrate substantial equivalence to legally marketed predicate devices (TSRH™ Spinal System; ISOLA Spinal System).
• Method of Equivalence Demonstration: Shared materials, intended uses, basic design concepts, and "Fatigue and static testing demonstrates the mechanical and endurance properties of these components." This implies that the mechanical properties of the new device are comparable to or better than predicate devices, fulfilling the requirements for substantial equivalence.
• Intended Use: Fixation of T4-S2 spine. Specific indications for non-pedicular and pedicular use (L5-S1 for severe spondylolisthesis grades 3 & 4 with autogenous bone graft, removed after fusion).
• Materials: ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6A14V ELI Alloy.

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The subject components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein. are available in either ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6Al4V Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6Al4V alloy components are intended for use only with other Ti6Al4V alloy components.

The specific indications of the Osteonics® Spinal System, including the subject additional components, are stated below:

For non-pedicular use:

• . Long and short curve scoliosis.
• Vertebral fracture or dislocation.
• . Spondylolisthesis,
• . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

For pedicular use:

• . When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

The Osteonics® Spinal System Top Loading Transverse Connector Assembly allows a spinal construct on one side of the spine to be joined to another construct on the other side of the spine. This joining provides additional resistance to physiological forces such as unequal lateral loads, rotation, and isolated torsional movements. Construction of this assembly requires two Osteonics® Spinal System Top Loading Transverse Connectors, each with a Top Loading Connector Set Screw, and a Transverse Connector Bar. Each top loading transverse connector joins one end of the transverse connector bar to one of the longjtudinal construct. The top loading connector set screw is used to secure the transverse assembly.

The provided text describes a 510(k) premarket notification for a medical device, the Osteonics® Spinal System -Top Loading Transverse Connector Assembly. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in clinical trials for novel devices.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test and training sets, expert qualifications, ground truth methodologies, and MRMC studies, is not present in the provided document.

Instead, the document details:

• Predicate Device Identification: It explicitly states that the new components are "substantially equivalent to other legally marketed spinal system crosslinking (transversing) assembly components."
• Predicate Devices Listed: Osteonics® Spinal System, TSRH™ Spinal System, GDLH™ Posterior Spinal System, and ISOLA Spinal System.
• Technological Comparison: "The components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly share the same materials, intended uses and basic design concepts as that of the predicate devices."
• Mechanical Testing: It mentions that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components." This is the primary "study" referenced, but no specific acceptance criteria or performance results from these tests are provided in the summary.

In summary, the provided text is a regulatory submission summary demonstrating substantial equivalence based on materials, intended use, basic design, and general mechanical testing, not a clinical study report with detailed performance metrics against specific acceptance criteria.

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