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Zeus Small Cervical Cages 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. Zeus Cervical Cages 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. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Zeus Lumbar Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from 12-51. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior/transforaminal/posterior approach. The Zeus Lumbar Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Zeus Small Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The top view is trapezoidal with a trapezoidal window for bone graft. The Zeus Cervical Cage has a flat top and bottom.

The Zeus Large/Extra Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using an Anterior Lumbar Interbody Fusion (ALIF) technique. To eliminate migration, ridges are incorporated on both the superior and inferior surfaces. Two large windows allow bony growth to form.

The Zeus Curved Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The Zeus Curved implant has ridges on both its inferior and superior surfaces to prevent migration, and two large graft windows which help facilitate bony integration. It is a curved shape to facilitate insertion using a T-LF approach.

The Zeus Straight Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The Zeus Straight implant incorporates ridges on both its superior and inferior surfaces to help eliminate migration. A large rectangular graft space help facilitate bony integration once implanted.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

This document is a 510(k) summary for the Interbody Innovation Zeus Intervertebral Fusion Devices. It focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel acceptance criteria and studies. Therefore, much of the requested information regarding AI device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies is not applicable or available in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for an AI device, as it is describing a physical medical device (intervertebral fusion devices). Instead, the "acceptance criteria" are implied by compliance with established standards and comparison to predicate devices.

Study Details:

The study referenced is a non-clinical test conducted to demonstrate the mechanical strength of the device.

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

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

   • The document does not specify a "test set" in the context of an AI device or a clinical study with human subjects.
   • For the mechanical tests, the sample size (number of devices tested) is not explicitly stated.
   • Data provenance: The tests were conducted according to ASTM standards (F2077/F2267). This implies a laboratory setting, not a country of origin in the typical sense of clinical data. The tests are non-clinical.

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

   • N/A. This is a physical device, and the "ground truth" for mechanical performance is defined by the ASTM standards and the physical properties of the device, not by expert consensus on data like images or patient outcomes.

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

   • N/A. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical or image-based studies, which are not described here.

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 document describes a physical medical implant, not an AI device or a diagnostic tool utilizing human readers.

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

   • N/A. This is not an AI algorithm.

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

   • For the mechanical strength, the "ground truth" is defined by established engineering standards (ASTM F2077/F2267) and the physical properties and performance observed during the non-clinical testing.

8. The sample size for the training set:

   • N/A. This is not an AI device, so there is no training set.

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

   • N/A. As there is no AI training set, this is not applicable.

In summary, this 510(k) pertains to a physical intervertebral fusion device and demonstrates its safety and effectiveness through mechanical testing against recognized standards and substantial equivalence to predicate devices. It does not involve AI, clinical studies with human "test sets," or the establishment of ground truth by clinical experts in the way an AI diagnostic device would.

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The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.

These spheres may be inserted between the vertebral bodies into the disc space from L3 to S1. The Spinal Sphere implants are single use implants and should never be reused under any circumstances. These spheres are available in Ø10-Ø16mm.

Materials: PEEK Optima per ASTM F2026

Function: The Spinal Sphere is a spherical implant designed to hold bone parts in alignment while they heal in order to promote interbody fusion.

The provided text describes a 510(k) summary for PEEK Spinal Spheres but does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a regulatory submission for a medical device seeking clearance to market based on substantial equivalence to existing devices. It focuses on:

• Device Identification: Trade name, common name, classification, and product code.
• Predicate Devices: Identification of devices to which the PEEK Spinal Spheres are deemed substantially equivalent.
• Device Description: Materials (PEEK Optima per ASTM F2026), dimensions (Ø10-Ø16mm), function (to hold bone parts in alignment to promote interbody fusion), and single-use nature.
• Intended Use/Indications for Use: To be inserted between vertebral bodies (L3-S1) to provide stabilization and promote intervertebral body fusion, used with bone graft.
• Comparison to Predicate Devices: Stating equivalence in material, design, and indications.
• FDA Response (Clearance Letter): Affirming substantial equivalence but imposing a labeling limitation regarding motion-sparing, non-fusion procedures.

To answer your request, an actual performance study with defined acceptance criteria would be necessary, which is absent from this 510(k) summary. For devices cleared through the 510(k) pathway, especially those deemed substantially equivalent to a predicate, extensive clinical performance studies demonstrating new acceptance criteria are often not required if the new device is sufficiently similar to an already cleared device. The focus is more on demonstrating that the new device performs as intended and is as safe and effective as the predicate.

Therefore, for each of your points, the answer based solely on the provided text is as follows:

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

   • Not provided. The document does not specify any performance acceptance criteria or report on device performance against such metrics. It states the device's function and intended use.

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 / Not provided. No test set or performance data from a study is mentioned.

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 / Not provided. No ground truth establishment is described.

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

   • Not applicable / Not provided. No test set or related adjudication is described.

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 / Not provided. This device is a physical spinal implant, not an AI-assisted diagnostic tool.

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

   • Not applicable / Not provided. This is not an algorithm-based device.

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

   • Not applicable / Not provided. No ground truth is discussed in relation to device performance. The "ground truth" for a 510(k) device is primarily its substantial equivalence to a legally marketed predicate and its ability to perform its intended function safely.

8. The sample size for the training set:

   • Not applicable / Not provided. The document does not describe any training sets for an algorithm.

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

   • Not applicable / Not provided. This information is not relevant to the described device.

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The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.

The Spinal Spheres consist of CoCtMo spheres which may be implanted from L3 to S1 to 16 morary stabilization in order to promote fusion. These spheres are available in Ø10-Ø16mm diameters.

This document is a 510(k) summary for the Spinal Spheres device, which is an orthopedic implant for intervertebral fusion. As such, it does not describe acceptance criteria, a study proving device performance, or information related to AI/algorithm performance. The provided text is a regulatory submission for a medical device and does not contain the requested information regarding AI device evaluation.

Therefore, I cannot fulfill your request as the provided input does not describe an AI medical device or its evaluation.

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This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictors are designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement.

This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.

The Interbody Innovations Cement Restrictors is a hollow curved rectangular frame that is machined from extruded Polyetheretherketone (PEEK). It contains tantalum inserts that serve as location and orientation markers for radiographs. The device is intended to be used in conjunction with standard PMMA

Let's break down the information provided in the 510(k) summary (K051371) to extract details regarding acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a Surgical Mesh, specifically a Cement Restrictor. These devices are typically cleared based on substantial equivalence to existing predicate devices, rather than extensive clinical efficacy studies with predefined acceptance criteria for performance metrics like accuracy, sensitivity, or specificity, as one might find for diagnostic AI algorithms. The "performance data" section for these types of devices usually focuses on material properties, biocompatibility, and mechanical characteristics.

Therefore, the interpretation of "acceptance criteria" and "study" will be tailored to what is relevant for this specific type of medical device submission.

Acceptance Criteria and Device Performance

For this device, the acceptance criteria are primarily related to material compliance and biocompatibility, as the function and design are substantially equivalent to existing cleared devices.

Study and Data Details

Given the nature of this device (a cement restrictor cleared via substantial equivalence), the "study" referred to in the document is primarily the demonstration of material equivalence and biocompatibility, rather than a clinical effectiveness study.

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

   • Test Set Sample Size: Not applicable in the context of clinical performance data for this type of 510(k). The "test" here refers to material and biocompatibility testing, which typically uses standardized samples of the material itself. The document does not specify the number of material samples tested.
   • Data Provenance: The biocompatibility certification (ISO 10993-1) is from the manufacturer of the PEEK-Optima material. ASTM F2026 compliance is a material standard. This data is likely retrospective, based on prior testing of the raw material. The country of origin for the material manufacturer is not specified.

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

   • Not applicable. "Ground truth" in the sense of expert consensus on diagnostic imaging is not relevant for this material and mechanical device submission. Material properties and biocompatibility are established through laboratory testing and standardized protocols, not expert clinical consensus review.

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

   • Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials. Material testing results are objective.

4. 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/diagnostic imaging device.

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

   • Not applicable. This is not an AI/algorithm device.

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

   • The "ground truth" for this submission are material specifications (ASTM F2026) and biocompatibility standards (ISO 10993-1).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. No training set is used.

Summary of the "Study" for K051371:

The "study" or performance data for the Interbody Innovations Cement Restrictor primarily consists of:

• Material Equivalence: Demonstration that the device is constructed of the same material (PEEK-Optima) as the predicate device(s) and that this material complies with ASTM F2026.
• Biocompatibility: Reliance on the manufacturer of the PEEK-Optima material having an FDA Device Master File and certifying biocompatibility to ISO 10993-1 requirements for implantable contact greater than 30 days.

This approach is typical for Class II devices that achieve market clearance through a 510(k) pathway by demonstrating substantial equivalence, often relying on material properties and existing predicate devices rather than new clinical effectiveness trials.

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