(14 days)
The Phantom SofThread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
The modified Phantom SofThread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The SofThread Screw is available in four diameters (7, 8, 9 and 10mm) in one 25mm length.
The provided text describes a Special 510(k) Device Modification Premarket Notification for the Phantom™ SofThread Soft Tissue Interference Screw. This type of submission is for minor changes to an already cleared device, and thus, typically relies on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies with detailed acceptance criteria and performance data as might be found in an original PMA or De Novo submission.
Therefore, many of the requested elements for a study proving device acceptance criteria are not applicable to this specific submission.
Here's a breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Not applicable in the traditional sense for a Special 510(k). This submission focuses on demonstrating that minor design modifications to the Phantom SofThread Soft Tissue Interference Screw do not raise new questions of safety and effectiveness compared to the predicate device (K980440).
- The "acceptance criteria" here are implicitly tied to maintaining substantial equivalence in terms of:
- Intended Use: Unchanged (interference fixation of soft tissue grafts in ACL reconstruction).
- Materials: Identical.
- Fundamental Scientific Technology: Unchanged.
- Performance (implied): The minor design changes (rounded head, increased broach depth, nose diameter, minor diameter, slightly reduced thread pitch) are presented as not altering the fundamental performance characteristics of the screw in its intended application. The Special 510(k) process assumes that these minor modifications do not necessitate new performance benchmarks or testing beyond what was established for the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. No specific test set data is provided or referenced, as the basis for substantial equivalence is the similarity to the predicate device and conformance with design control procedures, not new clinical performance data from a specific test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. No clinical study involving expert-established ground truth is described.
4. Adjudication Method for the Test Set
- Not applicable. No test set or related adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not mentioned or implied. The submission is not comparing the modified device's performance against human readers or other devices in a clinical or diagnostic context.
6. Standalone Performance Study (Algorithm Only)
- No. The device is a physical medical implant (interference screw), not an algorithm or AI-driven system.
7. Type of Ground Truth Used
- Not applicable. No ground truth, in the context of clinical studies or diagnostic accuracy, is relevant to this Special 510(k). The "ground truth" for this submission is the established safety and effectiveness of the predicate device.
8. Sample Size for the Training Set
- Not applicable. This pertains to algorithm development. The device is a physical implant.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
Summary of the Basis for Substantial Equivalence (as provided in the document):
- Predicate Device: Phantom SofThread Soft Tissue Interference Screw (K980440)
- Key Arguments for Equivalence:
- Unchanged Fundamental Scientific Technology: The basic principle of the screw remains the same.
- Identical Intended Use: Provides interference fixation of soft tissue grafts in ACL reconstruction.
- Identical Materials: No change in the material composition.
- Minor Design Modifications: Rounded head, increased broach depth, nose diameter and minor diameter, and slightly reduced thread pitch. These are considered minor and not impacting the safety or effectiveness to a degree that would necessitate new extensive testing.
- Conformance with Design Control Procedures: Compliance with 21 CFR 820.30 (Quality System Regulation).
Conclusion:
The provided document describes a Special 510(k) submission for a device modification. This pathway is designed for minor changes to an already cleared device. The "acceptance criteria" here are effectively met by demonstrating that the modified device remains substantially equivalent to its predicate device and that the minor changes do not introduce new safety or effectiveness concerns. Therefore, the detailed study information regarding test sets, expert ground truth, and statistical performance metrics typically found in original device approvals is absent and not required for this type of submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.