(336 days)
The Phantom™ Interference Screw, M. Kurosaka Interference Screw and the BioScrew® are intended to provide bone-tendon-bone patellar graft fixation, employing the same principles of graft fixation. These fixation screws provide an interference fit engaging both the drill tunnel and the bone plug of the graft.
The Phantom PLLA Interference Screw is an absorbable interference fixation screw. The DePuy DuPont Phantom™ Interference Screw is a fully threaded cancellous bone screw available in 7.0mm, 8.0mm and 9.0mm diameter sizes. Each diameter is available in either 15, 20, 25, and 30mm lengths and is offered in cannulated and non-cannulated versions.
The tip of the 9mm sized screw is tapered to a point which produces the self tapping feature of the screw. The screw is inserted by a square drive which is broached into the minor diameter of the screw body. The headless, low profile design minimizes subcutaneous surface protrusions. The threads are a symmetrical thread form designed to equally match stiffness between bone and thread. The Phantom screw is radiolucent on x-rays, but can be visualized with MRI and CAT scans.
This submission K955733 describes an absorbable interference fixation screw, the "Phantom PLLA Interference Screw." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria.
Therefore, many of the requested details regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not present in this type of submission.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report device performance in the context of a study demonstrating such. The focus is on demonstrating substantial equivalence to predicate devices. The "Basis of Substantial Equivalence" section highlights similarities in:
| Feature | Phantom™ PLLA Interference Screw (This Device) | Predicate Devices (M. Kurosaka, BioScrew®) |
|---|---|---|
| Principle of Graft Fixation | Bone-tendon-bone patellar graft fixation, interference fit engaging drill tunnel and bone plug | Bone-tendon-bone patellar graft fixation, interference fit engaging drill tunnel and bone plug |
| Material | PLLA (Poly L-Lactic Acid) absorbable polymer | PLLA (Poly L-Lactic Acid, for BioScrew®); Ti-6A1-4V alloy (for M. Kurosaka) |
| Design | Headless, fully threaded, cannulated and non-cannulated versions, tapered tip, square drive, radiolucent | Headless, fully threaded, cannulated (BioScrew®); cannulated and non-cannulated (M. Kurosaka) |
| Intended Use | Bone-tendon-bone patellar graft fixation | Bone-tendon-bone patellar graft fixation |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" in the sense of a clinical or ex-vivo performance study is described. The submission focuses on device characteristics and comparison to predicates.
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. No ground truth establishment for a performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a performance study 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. This is a medical device (implant) submission, not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (implant) submission, not an AI/software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The submission refers to manufacturing specifications, material properties, and design similarities for establishing substantial equivalence.
8. The sample size for the training set
Not applicable. No "training set" in an AI/machine learning context is described.
9. How the ground truth for the training set was established
Not applicable.
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NOV 1 8 1996
X. SUMMARY OF SAFETY AND EFFECTIVENESS
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| NAME OF FIRM: | DePuy IncP.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988 |
|---|---|
| FIRM CONTACT: | Steve WentworthRegulatory Affairs ManagerTel. No. (219) 372-7171 |
| TRADE NAME: | Phantom™ PLLA Interference Screw |
| COMMON NAME: | Bone/Tendon/Bone Screw |
| CLASSIFICATION: | Smooth or threaded bone fixation fastener: 888.304- |
DEVICE PRODUCT CODE: 87 HWC
SUBSTANTIALLY EQUIVALENT DEVICES:
- BioScrew® Fixation System (Linvatec) - K933719
- M. Kurosaka Interference Screw (DePuy) - K933798
- Biologically Quiet Interference Screw (Instrument Makar) - K943249
DEVICE DESCRIPTION AND INTENDED USE:
The Phantom PLLA Interference Screw is an absorbable interference fixation screw. The DePuy DuPont Phantom™ Interference Screw is a fully threaded cancellous bone screw available in 7.0mm, 8.0mm and 9.0mm diameter sizes. Each diameter is available in either 15, 20, 25, and 30mm lengths and is offered in cannulated and non-cannulated versions.
The tip of the 9mm sized screw is tapered to a point which produces the self tapping feature of the screw. The screw is inserted by a square drive which is broached into the minor diameter of the screw body. The headless, low profile design minimizes subcutaneous surface protrusions. The threads are a symmetrical thread form designed to equally match stiffness between bone and thread. The Phantom screw is radiolucent on x-rays, but can be visualized with MRI and CAT scans.
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BASIS OF SUBSTANTIAL EQUIVALENCE:
The Phantom™ Interference Screw, M. Kurosaka Interference Screw and the BioScrew® are intended to provide bone-tendon-bone patellar graft fixation, employing the same principles of graft fixation. These fixation screws provide an interference fit engaging both the drill tunnel and the bone plug of the graft. The Phantom™ Interference Screw is substantially equivalent to the M. Kurosaka Screw with respect to design and intended use and is substantially equivalent in material, design and intended use to the Bioscrew.
Both the Phantom™ Interference Screw and the Bioscrew® are manufactured from PLLA (Poly L-Lactic Acid) absorbable polymers and the M. Kurosaka/Advantage Screw is manufactured from Ti-6A1-4V alloy. All three screws are headless and fully threaded. The BioScrew® is offered in a cannulated version only. The M. Kurosaka Interference Screw and the Phantom™ Interference Screw are offered in both cannulated and non-cannulated versions.
Reg\510\1996\phantom.new
§ 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.