(20 days)
The Straight-In - Orthopedic Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures. It is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as:
- Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromiociavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction.
- Repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation.
- Repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament.
- Repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis.
- Repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
The Orthopedic Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures. The design and materials of the Orthopedic Straight-In and Short shaft Straight-In systems are identical. The differences are that the Inserter of the Orthopedic Straight-In is designed for use in 10 procedures, while the predicate device is designed for single use.
The provided text describes a 510(k) submission for the "Straight-In - Orthopedic Bone Screw Fixation System," which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting a full clinical trial to establish new safety and effectiveness criteria.
As such, the document does not contain the detailed information typically found in a study designed to prove a device meets specific, quantitative acceptance criteria for performance, especially concerning an AI/ML model for which your questions are framed. Instead, it relies on demonstrating equivalence in design, materials, and performance testing to previous FDA-cleared devices.
Here's an analysis of the provided text in relation to your questions, highlighting what is not present:
Key Takeaway: This document describes a medical device clearance via substantial equivalence to predicate devices, not a study that proves the device meets new acceptance criteria for an AI/ML model.
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. The document states: "Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance."
- It does not list specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum displacement under load, etc.) for the new device or present a table comparing them to its measured performance. It implies that the test results supported equivalence to the predicate's performance.
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. This document does not describe a "test set" in the context of clinical data or AI/ML model validation. The "performance testing" mentioned would refer to benchtop mechanical tests, material analyses, and potentially cadaveric studies, not a data-driven test set for an algorithm. Therefore, information about data provenance is not relevant here.
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. "Ground truth" and expert reviews are concepts relevant to diagnostic AI/ML models or clinical studies where expert consensus is needed to classify outcomes. This is a submission for a mechanical fixation system, not a diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. See point 3.
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. An MRMC study is specific to evaluating diagnostic performance, often with AI assistance for human readers. This device is an orthopedic fixation system, not a diagnostic imaging aid or an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. As this is a mechanical device, its "performance" would be assessed through engineering specifications (e.g., mechanical strength, fatigue life, biocompatibility) rather than a "ground truth" derived from clinical outcomes or expert consensus on observations. The "ground truth" for demonstrating equivalence would be the established performance characteristics of the predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no AI/ML model involved, so no training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. See point 8.
Summary of what the document does provide:
- Device Name: Straight-In - Orthopedic Bone Screw Fixation System
- Intended Use: Soft tissue fixation to bones by means of bone screws threaded with sutures.
- Specific Clinical Indications: Repair of instability in shoulder, elbow, hand/wrist, knee, and foot/ankle due to various ligament/tendon tears or separations (a comprehensive list is provided).
- Predicate Devices:
- Short Shaft Straight-In Bone Screw System (K982155) - The new device is stated to be identical in design and materials, differing only in the inserter's intended use (multiple vs. single procedure).
- Anchorlok™ Soft tissue anchor system (K971282) - Substantially equivalent in intended use and performance of the bone screws.
- Equivalence Claim: Based on "information and performance testing," the device is substantially equivalent to the predicate devices regarding intended use, technological characteristics, and performance.
In conclusion, this document is a regulatory submission for a physical medical device (an orthopedic bone screw system) using the 510(k) pathway, which hinges on demonstrating substantial equivalence to existing devices. It does not address the specific questions about AI/ML model validation, ground truth, or expert review panels that your template is designed for.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.