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The Spinal Sphere System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. Properly used, this internal fixation device is intended and designed solely for holding bone parts in alignment while they heal. The Spinal Sphere System is intended to be used with bone graft. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. It is not intended for use in motion-sparing, non-fusion procedures.

The Spinal Sphere System consists of spheres manufactured from either CoCrMo or PEEK-OPTIMA. The device may be implanted from L3 to S1 to provide temporary stabilization in order to help promote fusion. The spheres are available in a variety of sizes.

I apologize, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

The provided documents are a 510(k) summary and an FDA clearance letter for the "Spinal Sphere System" by Life Spine. These documents relate to the regulatory clearance of a medical device, specifically demonstrating substantial equivalence to a predicate device.

They do not contain information about:

1. Acceptance criteria in terms of specific performance metrics for a software or AI device.
2. A study proving device meets acceptance criteria with details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
3. Performance metrics (e.g., sensitivity, specificity, accuracy) that would populate a table of acceptance criteria and reported performance for an AI/software device.

The context of the provided text is for a physical orthopedic implant (spinal spheres), not a diagnostic AI/software device. The FDA clearance is based on demonstrating the new device is "substantially equivalent" to an existing, legally marketed device, primarily in terms of intended use, design, function, and materials, rather than a performance study against specific AI-related acceptance criteria.

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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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The Spinal Stabilizing Sphere System is intended to be inserted between the 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 Stabilizing Sphere System is intended to be used with bone graft.

The Spinal Stabilizing Sphere System consists of two types of CoCrMo spheres (full and trimmed), which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.

The provided documents (K063139) for the Biomet Spinal Stabilizing Sphere System do not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

Instead, the documents describe:

• The device (Spinal Stabilizing Sphere System) and its intended use.
• The fact that it is a preamendment, unclassified device.
• A summary of the substantial equivalence claim, citing predicate devices.
• The determination by the FDA that it is substantially equivalent to legally marketed predicate devices, with a specific labeling limitation: "The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established."
• Non-clinical testing was performed to determine substantial equivalence, but "The results indicated that the device was functional within its intended use." No specific details or acceptance criteria for this non-clinical testing are provided.
• Crucially, it explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested table and study information because it is not present in the given text. The device's approval was based on substantial equivalence to predicate devices, not on meeting specific performance criteria demonstrated through a clinical study presented in this 510(k) submission.

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The SATELLITE™ Spinal System is intended to be inserted between the 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 SATELLITE™ Spinal System is intended to be used with bone graft.

The SATELLITE™ Spinal System consists of spheres manufactured from either cobalt chrome or medical grade PEEK-OPTIMA LT1, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.

The provided text describes the regulatory classification and marketing authorization for the SATELLITE™ Spinal System. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary and the FDA's clearance letter for the device, focusing on its substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, reported device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.

The information provided only discusses:

• Device Name: SATELLITE™ Spinal System
• Manufacturer: Medtronic Sofamor Danek
• Product Description: Spheres manufactured from cobalt chrome or PEEK-OPTIMA LT1, implanted from L3-S1 for temporary stabilization and to promote fusion.
• Indications for Use: Inserted between vertebral bodies L3-S1 to provide stabilization and promote intervertebral body fusion, used with bone graft. Designed solely for holding bone parts in alignment while they heal.
• Regulatory Classification: Unclassified (at the time of clearance), later reclassified as Class III (Premarket Approval) on March 30, 2023.
• Substantial Equivalence: Demonstrated the PEEK-OPTIMA LT1 spheres with Tantalum markers were substantially equivalent to previously cleared cobalt chrome SATELLITE™ Spinal System devices (K051320).
• FDA Clearance: K060415/S1 on January 5, 2007, with a specific labeling limitation: "The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established."

To answer your questions about acceptance criteria and study data, information beyond what is supplied in these specific documents would be required. This type of information would typically be found in detailed clinical study reports or premarket approval (PMA) applications, which are generally more comprehensive than a 510(k) summary.

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The SATELLITE™ Spinal System is intended to be inserted between the 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 SATELLITE™ Spinal System is intended to be used with bone graft.

The SATELLITE™ Spinal System consists of cobalt chrome spheres, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.

This device, the SATELLITE™ Spinal System (K051320), received 510(k) clearance in 2005. It's important to note that the provided documentation states this device is a "preamendment device" and was found substantially equivalent to a legally recognized preamendment device (the Harmon Spinal Sphere). This means that its acceptance criteria and the "study" that proves it meets them are fundamentally different from what would be expected for a novel device undergoing a PMA (Premarket Approval) process under current regulations.

The core of its "acceptance" is substantial equivalence to a predicate device that was on the market before the 1976 Medical Device Amendments. Therefore, the information requested about specific performance metrics, sample sizes, expert ground truth, etc., in the context of a prospective study for a novel device does not apply in the same way to this 510(k) clearance.

Here's an attempt to answer the questions based on the provided document, highlighting where the typical interpretation of these questions doesn't fit a preamendment predicate equivalence pathway:

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

For a 510(k) clearance based on substantial equivalence to a preamendment device, the "acceptance criteria" are primarily established by the characteristics and intended use of the predicate device. The "reported device performance" is demonstrating that the new device shares similar characteristics and performs as safely and effectively as the predicate for its intended use, based on documentation and engineering principles rather than a detailed clinical performance study against specific quantitative criteria.

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

This information is not applicable in the context of a 510(k) clearance based on substantial equivalence to a preamendment device like the SATELLITE™ Spinal System. There was no "test set" in the sense of a clinical study with a specified sample size. The clearance was based on comparison to an already marketed predicate, not new clinical data demonstrating specific performance metrics against a defined acceptance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. There was no "test set" requiring ground truth establishment by experts for performance evaluation in a clinical study. The FDA's review for substantial equivalence focuses on comparing the new device's design, materials, and intended use to the predicate.

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

This information is not applicable for the reasons stated above.

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. The SATELLITE™ Spinal System is a physical implant, not an AI or imaging device. Therefore, no MRMC study, AI assistance, or human reader improvement analysis would be relevant or performed.

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

This information is not applicable as the device is a physical implant, not an algorithm.

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

This information is not applicable in the context of establishing performance for this 510(k) clearance. The "ground truth" for the clearance was essentially the FDA's acceptance that the predicate device (Harmon Spinal Sphere) was legally marketed and considered safe and effective for its intended use, and that the SATELLITE™ Spinal System was sufficiently similar.

8. The sample size for the training set

This information is not applicable. There was no "training set" as this device is a physical implant and not an algorithm requiring machine learning.

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

This information is not applicable as there was no training set.

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