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The Phantom™ Plus Cages- Lumbar are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six (6) months of nonoperative therapy. The Phantom™ Plus Cage System- Lumbar is to be filled with autogenous bone graft material. The Phantom™ Plus Cages- Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.

Phantom™ Plus Cages-Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Phantom™ Plus Cages-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Phantom™ Plus Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Phantom™ Plus Cage System consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is made of various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 22mm in height and 11mm to 45mm in length. Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum rods to be Grade UNS R05200 according to ASTM F560.

This 510(k) summary for the Phantom™ Plus Cage System describes a medical device, an intervertebral body fusion cage. For such devices, acceptance criteria and performance studies generally focus on mechanical properties, biocompatibility, and substantial equivalence to predicate devices, rather than AI/software performance metrics like sensitivity or specificity.

Based on the provided text, there is no information regarding:

• Acceptance Criteria and Reported Device Performance (as a table): The document doesn't provide specific quantitative acceptance criteria (e.g., minimum compression strength, fatigue life) or corresponding reported performance values for these metrics.
• Sample size and data provenance for a test set: This is not relevant for this type of device submission, as there's no "test set" in the context of AI or diagnostic performance.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable, as this is not an AI/software device.
• Type of ground truth used: Not applicable in the AI/diagnostic sense.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does describe is a regulatory submission demonstrating substantial equivalence to predicate devices, which is the primary "proof" for this type of medical device.

The relevant sections of the document indicate:

• Description of the device: The Phantom™ Plus Cage System consists of hollow vertebral body spacers made of PEEK featuring a convex, bullet nose design and angular teeth for expulsion resistance. They range from 6mm to 22mm in height and 11mm to 45mm in length. Materials are Medical Grade PEEK (OPTIMA® LT1) and Tantalum rods.
• Intended Use:
  • Lumbar: For use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, with or without up to Grade I spondylolisthesis, who are skeletally mature and have undergone six months of non-operative therapy. To be used with supplemental spinal fixation systems.
  • Cervical: For use in skeletally mature patients with DDD of the cervical spine with accompanying radicular symptoms at one disc level (C3 to C7), using autograft bone and supplemental fixation, after at least six months of non-operative treatment.
• Comparison to predicate devices: "There are no significant differences between the Phantom™ Plus Cage System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."

In summary, for K082801, the "study that proves the device meets the acceptance criteria" is the demonstration of substantial equivalence to legally marketed predicate devices. This involves showing that the design, materials, function, and intended use of the Phantom™ Plus Cage System are equivalent to previously approved devices, therefore implying it meets the safety and effectiveness standards established for those predicates. The 510(k) clearance letter (pages 2-3) confirms the FDA's agreement with this assessment.

If this were an AI or diagnostic device, the requested information would be crucial. However, for a physical implant like an intervertebral cage, the regulatory pathway and "proof" focus on mechanical integrity, biocompatibility, and comparison to existing, safe, and effective devices.

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The Preference Pedicle Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Preference Pedicle Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis) and/or spinal deformities such as scoliosis, kyphosis or excessive lordosis.

In addition, when used as a pedicle screw fixation system, the Preference Pedicle Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the Preference Pedicle Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The Preference Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, hooks, connectors and rods. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-Eli) or Cobalt Chrome.

The provided text does not contain any information about acceptance criteria or a study that demonstrates the device meets these criteria.

The document is a 510(k) summary for the "Preference Pedicle Screw System," indicating it's a submission to the FDA for market clearance. It details:

• Contact Information: Trace Cawley, US Spinal Technologies.
• Trade Name: Preference Pedicle Screw System.
• Classification: Pedicle screw spinal system (21 CFR §888.3070), Spinal intervertebral body fixation orthosis (§888.3060), Spinal interlaminal fixation orthosis (§888.3050).
• Class: II.
• Product Codes: KWO, KWP, MNH, MNI.
• Indications for Use: Detailed descriptions for both pedicle screw fixation and posterior, non-cervical, non-pedicle screw fixation systems in the lumbar and/or sacral spine.
• Device Description: Comprised of monoaxial and polyaxial pedicle screws, hooks, connectors, and rods, manufactured from medical grade titanium alloy or Cobalt Chrome.
• Predicate Device(s): US Spinal Technologies Preference Pedicle Screw System (K081296), DePuy Expedium Spine System (K073364, K041119 and K033901), and Stryker Xia Spinal System (K080928 and K060361).
• Substantial Equivalence: The FDA's letter confirms substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.

Missing Information:

The document focuses on establishing substantial equivalence to previously cleared devices based on similar indications for use, design, function, and materials. It does not describe a study involving specific acceptance criteria and performance metrics in the way requested for medical device software or AI systems.

Therefore, I cannot provide the requested table or answer any of the questions (1-9) regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text. This device is a physical implant, and its clearance relies on established equivalence to existing devices, not typically on performance metrics derived from clinical studies with ground truth in the same way an AI diagnostic tool would.

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The Preference Pedicle Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Preference Pedicle Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Preference Pedicle Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the Preference Pedicle Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The Preference Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, hooks, connectors and rods. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli) or Cobalt Chrome.

The provided text describes a 510(k) premarket notification for the Preference Pedicle Screw System. It focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance criteria against predefined acceptance thresholds. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not available in the provided document.

Here's a breakdown of the available and unavailable information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: Not specified. The document mentions "pre-clinical testing" but does not detail the number of units tested (e.g., for mechanical strength, fatigue).
• Data Provenance: The testing was "pre-clinical," meaning it was likely laboratory-based (in-vitro) or potentially animal studies, but the exact location (e.g., country of origin of the data) is not specified. It is not explicitly stated if it was retrospective or prospective, but pre-clinical testing is typically prospective in its design.

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

• Not Applicable. This device is a pedicle screw system, a mechanical implant. Performance is evaluated through engineering and materials testing, not typically through ground truth established by medical experts in the way an AI diagnostic device would be.

4. Adjudication method for the test set:

• Not Applicable. As above, this is a mechanical device, not a diagnostic one requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI-assisted diagnostic device.

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

• Not Applicable. This is a physical medical device (pedicle screw system), not an algorithm or AI.

7. The type of ground truth used:

• Not Applicable in the traditional sense. For mechanical devices, "ground truth" would relate to engineering standards, material properties, and biomechanical performance data. For instance, the "truth" is that the device can withstand certain loads or stresses without failure according to established physical criteria. The document only broadly states "pre-clinical testing."

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

• Not Applicable. See point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device (pedicle screw system). The regulatory pathway for such devices largely relies on demonstrating substantial equivalence to already approved predicate devices through non-clinical performance testing (e.g., mechanical, material, and biocompatibility testing). It does not involve the kind of clinical study and performance metrics common for AI/ML-based diagnostic devices, which would require detailed information on acceptance criteria, ground truth, expert adjudication, and reader studies. The "performance testing" mentioned in the document refers to these pre-clinical tests, the details of which are not included in this summary but would have been part of the full 510(k) submission.

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The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The LTD Polyaxial Fixation System consists of a variety of shapes and sizes of rods, screws and connecting components, sold with or without the surgical instrument tray. These components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The LTD Polyaxial Fixation System implant components are fabricated from medical grade titanium or titanium allow described by such standards at ASTM F67 or ASTM F136 for ISO 5832-2/3.

This Pre-market Notification adds 5.5mm rods and associated polyaxial screws to the LTD Polyaxial System.

The provided text describes the 510(k) summary for the LTD Polyaxial Fixation System, a spinal fixation device. The study described focuses on biomechanical testing to demonstrate the device's mechanical integrity and performance, rather than clinical efficacy or diagnostic accuracy. Therefore, many of the typical acceptance criteria and study design elements for AI/diagnostic devices (e.g., sample size for test sets, ground truth establishment, MRMC studies) are not applicable here.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list numerical "acceptance criteria" for each performance metric in a table format, nor does it provide specific "reported device performance" values beyond a general statement of meeting acceptance criteria. This is common for predicate device submissions where the focus is on demonstrating equivalence to already marketed devices through similar testing.

However, the "Performance Data" section indicates the types of tests conducted and a general statement of their success:

Note: The specific numerical acceptance limits for these biomechanical tests are not provided in the summary. For spinal fixation devices, these limits are typically derived from standards (e.g., ASTM, ISO) or established by comparison to predicate devices, ensuring the device can withstand physiological loads without failure.

Study Details

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 applicable in the context of this biomechanical testing. The "test set" would refer to the number of device components or constructs tested. The specific number of samples tested for each biomechanical test (e.g., number of rods, screws, or constructs) is not specified in this summary.
• Data Provenance: Not applicable. Biomechanical tests are laboratory-based and do not involve human data.

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

• Not Applicable. This is a biomechanical study, not a study requiring expert interpretation or ground truth establishment based on human or biological data. The "ground truth" in this context would be the physical properties and performance characteristics of the materials and device constructs as measured by specialized testing equipment.

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

• Not Applicable. As this is biomechanical testing, no expert adjudication is involved.

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

• Not Applicable. This is not a study involving human readers or AI assistance. It is a biomechanical performance study of a physical medical device.

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

• Not Applicable. There is no algorithm or AI involved in this device or its testing as described.

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

• Mechanical Performance Standards/Specifications: The "ground truth" or reference for passing these tests would be the established industry standards (e.g., ASTM F1717-96 for Spinal Implant Constructs, which often specifies testing methods and acceptance criteria) or the measured performance of legally marketed predicate devices. The device is expected to meet or exceed these established benchmarks for strength and durability.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning study.

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

• Not Applicable. There is no "training set" or corresponding ground truth establishment process for this type of device submission.

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The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.

The US Spine Facet Fixation System consists of two implantable components, the screw in various lengths and an optional washer. Both components are made from implant grade wrought Titanium 6-Aluminum 4-Vanadium (Ti6Al4V) alloy.

The provided text describes a medical device, the "US Spine Facet Fixation System," and its 510(k) submission. However, it does not include information about a study based on AI/ML.

Here's a breakdown of the requested information based on the provided text, with "N/A" indicating information not present:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific quantitative acceptance criteria (e.g., "withstanding X N of force for Y cycles") and the actual quantitative results achieved by the device are not provided in this summary. It only states that testing was performed.

Study Details (Focusing on AI/ML, which is not present)

2. Sample size used for the test set and the data provenance
N/A - The document describes biomechanical testing, not a study involving a test set of data for an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This is not an AI/ML study.

4. Adjudication method for the test set
N/A - This is not an AI/ML study.

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
N/A - This is not an AI/ML study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI/ML study.

7. The type of ground truth used
N/A - The performance data is based on biomechanical testing of the physical device. For a physical device, the "ground truth" would be objective measurements from these tests and observation of the device's physical integrity and stability under load.

8. The sample size for the training set
N/A - This is not an AI/ML study.

9. How the ground truth for the training set was established
N/A - This is not an AI/ML study.

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