(112 days)
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.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Intended Use: Temporary stabilization to promote intervertebral body fusion (L3-S1). | Indication for Use: "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." (Identical to predicate's intended use in function). |
| Design/Materials: Spinal spheres made of suitable biocompatible material for intervertebral fusion. | "The SATELLITE™ Spinal System consists of cobalt chrome spheres..." (Implies material similarity or equivalence in performance to predicate). |
| Mechanism of Action: Provides internal fixation for bone alignment during healing. | "...designed solely for holding bone parts in alignment while they heal." (Consistent with predicate's mechanism). |
| Safety & Effectiveness: Comparable to the predicate device. | "Documentation was provided which demonstrated the SATELLITE™ Spinal System to be substantially equivalent to a legally recognized preamendment device, namely the Harmon Spinal Sphere manufactured by the Austenal Company of New York, NY." (The "performance" is demonstrated through this equivalence statement). |
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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