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510(k) Data Aggregation
(217 days)
SMALL BONE WEDGE
The Small Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- Opening wedge osteotomies of Hallux Valgus
- Evans lengthening osteotomies
- Metatarsal/cuneiform arthrodesis.
The Small Bone Wedge is not intended for use in the spine.
The Small Bone wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered in two distinct designs with varying widths and thicknesses to accommodate a variety of small bone applications.
Here's a breakdown of the acceptance criteria and study information for the Small Bone Wedge, based on the provided text:
It's important to note that the provided document is a 510(k) summary for a medical device (Small Bone Wedge), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a novel device. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for training/test sets, expert ground truth establishment, and comparative effectiveness studies, is not present in this type of regulatory submission. The document primarily confirms that the device is "substantially equivalent" to existing devices based on design, material, and intended use.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied by 510(k) process) | Reported Device Performance (Implied by 510(k) clearance) |
|---|---|---|
| Substantial Equivalence | Design features are similar to predicate. | Design features (titanium metal foam wedge, two designs, varying widths/thicknesses) are deemed substantially equivalent to predicate devices. |
| Material | Material is similar to predicate and suitable for implant. | Titanium metal foam is deemed substantially equivalent to predicate device materials. |
| Intended Use | Indications for use are similar to predicate. | Intended use for internal bone fixation for fractures, fusions, or osteotomies in the ankle and foot (e.g., Hallux Valgus osteotomies, Evans lengthening osteotomies, metatarsal/cuneiform arthrodesis) is deemed substantially equivalent to predicate devices. Exclusion of spine use is noted. |
| Safety & Effectiveness | Device is as safe and effective as predicate devices. | "The safety and effectiveness of the WMT Wedge is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." (Implies no new safety/effectiveness concerns beyond predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/Not provided. This 510(k) summary does not describe a performance study with a test set of data. The submission relies on a comparison to predicate devices.
- Data Provenance: Not applicable/Not provided. No specific data provenance for a test set is mentioned as no such study is detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not provided. The 510(k) process for this type of device does not typically involve expert consensus to establish ground truth for a performance study in the same way an AI device might. The "ground truth" for substantial equivalence is based on regulatory standards and comparison to legally marketed predicate devices.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided. No test set requiring expert adjudication is described in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This document does not describe a MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI tools, not for a bone fixation wedge.
- Effect Size of Human Readers with AI vs. Without AI: Not applicable, as no MRMC study was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Study: No. This device is a physical bone fixation wedge, not an algorithm. Therefore, a standalone algorithmic performance study is not relevant or described.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this 510(k) clearance is the established regulatory acceptance of predicate devices. The device is considered safe and effective because it is substantially equivalent to devices already on the market, which have a history of safe and effective use. This is primarily a regulatory and engineering assessment rather than a clinical ground truth derived from pathology or outcomes data for a new device performance evaluation.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. This device is a physical implant, not an AI algorithm, so there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable/Not provided. As above, this concept does not apply to a physical medical implant in the context of this 510(k) submission.
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