(65 days)
The Phantom Metatarsal Shortening System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include:
Metatarsal and phalangeal osteotomies
Metatarsal deformity correction
Hammertoe
Revision hammertoe
Claw toe
Mallet toe
Proximal Interphalangeal Joint Arthrodesis
Distal Interphalangeal Joint Arthrodesis
The Phantom Metatarsal Shortening System includes a series of titanium (Ti-6Al-4V ELI per ASTM F136) intramedullary implants used for the correction of small bones in the foot. The implants are designed to provide stability and fixation of bone fragments to ultimately achieve fusion.
The provided document is a 510(k) summary for the Phantom Metatarsal Shortening System. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by performance testing. However, it explicitly states that clinical data are not needed to support the safety and effectiveness of the subject device. Therefore, the document does not contain information about a study involving human readers or ground truth determination as described in your request.
The "device" in this context is a medical implant (titanium intramedullary implants), not an AI algorithm or diagnostic tool. The performance testing refers to mechanical and material tests.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested AI/human study details are missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (Implied from testing types) | All performance testing conducted for the Phantom Metatarsal Shortening System met the predetermined acceptance criteria. |
| Torque to failure per ASTM F543 | Met acceptance criteria. |
| Insertion and removal torque per ASTM F543 | Met acceptance criteria. |
| Static pullout of threads per ASTM F543 | Met acceptance criteria. |
| Static pullout of the prongs | Met acceptance criteria. |
| Static cantilever bending | Met acceptance criteria. |
| Dynamic cantilever bending testing | Met acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document only mentions "All necessary testing has been performed on representative Phantom Metatarsal Shortening System components."
- Data provenance: Not applicable. This was mechanical/material testing of physical devices, not clinical data from patients.
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. Ground truth in the context of expert review for AI performance is not relevant to this type of device submission. The "ground truth" for this device would be the physical properties and performance characteristics measured against established ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in clinical studies with human readers, which were not part of this submission. The "adjudication" (if one could even call it that) of the mechanical tests would be the measurement against the ASTM standards.
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
- No. An MRMC comparative effectiveness study was not done. This is a submission for a physical medical implant, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. A standalone performance study of an algorithm was not done. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by validated mechanical testing standards (e.g., ASTM F543) and the inherent material properties of titanium (Ti-6Al-4V ELI per ASTM F136). The acceptance criteria are derived from these engineering and material standards.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or corresponding ground truth establishment process for a physical implant. The design and manufacturing process would be subject to quality control and engineering principles.
§ 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.