(54 days)
The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow, or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric and small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
The PediFlex™ Flexible Nail System includes stainless steel and titanium flexible nails, interlocking clamps, clamp screws and end caps for the application of aiding bone fracture repair and healing. All the implants are MR conditional. The system is implanted using Class II and Class I exempt surgical instruments.
The PediFlex™ flexible nails are provided in 316L stainless steel and titanium alloy (Ti-6Al-4V). The 316L stainless steel flexible nails are available in diameters ranging from 1.5 mm to 4.0 mm in increments of 0.5 mm. The titanium alloy (Ti-6Al-4V) flexible nails are available in diameters ranging from 1.5 mm to 4.5 mm in increments of 0.5 mm.
The PediFlex™ interlocking clamps are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. The use of the interlocking clamps is optional. The interlocking clamps are manufactured from both 316L stainless steel and titanium alloy (Ti-6Al-4V) materials. The 316L stainless steel interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm and 4.0 mm which are to be used with 316L stainless steel flexible nails in diameters of 3.0 mm, 3.5 mm and 4.0 mm. The 316L stainless steel clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The titanium alloy (Ti-6Al-4V) interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm. The titanium alloy (Ti-6Al- 4V) clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The material of the clamp must match the material of the nail and screw in the surgery.
The PediFlex™ end caps are designed to affix to the exposed nail tip to help prevent soft tissue irritation. The use of the end cap is optional. They are not a structural element and impart no additional strength to the construct. The subject end caps are manufactured in titanium alloy (Ti-6Al-4V) and are available in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments. The material of the end cap must match the material of the nail used in the surgery.
The flexible nails, interlocking clamps, clamp screws and end caps in PediFlex™ Flexible Nail System are offered both sterile and non-sterile. All other Class II implants and instruments of the PediFlex™ Flexible Nail System are offered non-sterile to be sterilized by the end-user.
The provided FDA 510(k) clearance letter for the PediFlex™ Flexible Nail System primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a study proving that the device meets specific acceptance criteria in a clinical performance sense (like an AI/ML device would).
The information in the document highlights design verification and validation activities related to safety and functionality for a medical implant, but it does not outline acceptance criteria for a diagnostic or AI-driven system that would involve performance metrics like sensitivity, specificity, or human-in-the-loop improvements.
Therefore, for aspects related to "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample sizes for test and training sets," "expert ground truth establishment," "adjudication," "MRMC studies," "standalone performance," and "ground truth types," the provided document does not contain the necessary information to answer those questions in the context of an AI/ML device or a comparative clinical study.
The document states:
- "The subject PediFlex™ Flexible Nail System and predicate device share identical intended use, patient population, principles of operation, and all fundamental technological characteristics."
- "There are some differences... However, those differences are supported by successful testing provided in this submission. Therefore, such differences do not raise new questions of safety and effectiveness."
- "Results of the performance testing demonstrate substantially equivalent performance of the subject device as compared to the predicate."
This indicates that the "acceptance criteria" were likely related to demonstrating that the changes (sterilization, packaging, shelf life, MR conditional labeling) did not negatively impact the established safety and effectiveness of the device, rather than establishing new performance benchmarks.
However, I can extract the information relevant to the types of studies and testing performed:
1. Table of Acceptance Criteria and Reported Device Performance:
As this is a 510(k) for a physical medical device (Flexible Nail System) demonstrating substantial equivalence to a predicate, the "acceptance criteria" are not reported as specific clinical performance metrics (e.g., sensitivity, specificity, or diagnostic accuracy) like they would be for an AI/ML diagnostic. Instead, the performance data focuses on demonstrating that the manufacturing/design changes (sterilization, packaging, shelf life, MR compatibility) do not raise new questions of safety or effectiveness and that the device maintains its intended physical properties and functionality.
| Acceptance Criteria Category (Implied) | Reported Device Performance / Assessment |
|---|---|
| Sterilization Efficacy | Validated following AAMI ST72, AAMI ST98, ASTM F3127, ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2, ISO 11737-3 and ISO 19227. |
| Packaging Integrity & Protection | Verified following ASTM D4332, ASTM D4169, ASTM F2096, ASTM F2203, ASTM F88, ASTM F1886, ISO 11607-1, ISO 11607-2 and ISO 15415/15416. |
| Device Shelf Life Stability | Validated following ASTM F1980, ASTM F1886, ASTM F2096, ASTM F2203, ASTM F88, ISO 11607-1, ISO 11607-2 and ISO 15415/15416. |
| Usability (Human Factors) | Validated following ISO 11607-1 and IEC-62366-1. |
| Biocompatibility | Assessed; no further testing deemed necessary based on review of device/packaging materials and updated manufacturing flow. |
| MR Compatibility | Evaluated following ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119, and FDA guidance. Determined to be MR Conditional and will be labeled as such. |
| Overall Performance & Functionality | Engineering analysis supports no impact of sterilization or aging on performance. Performance testing demonstrates substantially equivalent performance to predicate. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical performance data for an AI/ML algorithm. The studies mentioned are primarily bench testing and engineering analyses for device characteristics. Specific sample sizes for each standard (e.g., number of packages tested for sterility, number of nails tested for MR compatibility) are not detailed in this summary.
- Data Provenance: Not applicable for clinical data. The testing is laboratory and engineering-based (e.g., material testing, packaging integrity testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to defined engineering and material properties, not expert clinical interpretations via a consensus process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study involving human readers or interpretations needing adjudication.
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. This is a submission for a physical medical implant, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is for a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical device, the "ground truth" for the performance data is based on established engineering standards, material specifications, and regulatory guidelines. For example:
- Sterility: Absence of microbial growth (based on AAMI/ISO standards).
- Packaging integrity: No breaches or failures (based on ASTM/ISO standards).
- Material properties: Adherence to specified mechanical properties for the material (implied by type of material, though specific data is not shown).
- MR Conditional status: Demonstrating acceptable heating, artifact, and force under specific MR conditions defined by ASTM standards.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
In summary, the provided document details the verification and validation activities for a physical medical implant (PediFlex™ Flexible Nail System) to demonstrate its safety and effectiveness under a 510(k) pathway, primarily for design and manufacturing changes. It does not provide the kind of performance data (e.g., clinical accuracy, reader studies) that would be presented for an AI/ML-driven device.
§ 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.