(77 days)
The Normed® Pellegrin Calcaneus Stop Screw System is indicated for adult, children and adolescent patients. The screws are intended to block forward and medial displacement of the allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Adult - additive subtalar alignment for flat foot. Children - flexible flat foot treatment in children and adolescents
The Normed Pellegrin Calcaneus Stop Screws are threaded, cannulated, tapered screws. They designed to be inserted into the calcaneus bone of the foot for subtalar arthoroereisis. They are made from CrNiMO Stainless Steel for Surgical Implants (ASTM F138. ISO 58321). The implant is offered in 3 lengths - 25mm, 30mm and 35mm. The implants are provided non-sterile and singleuse only. The instruments are non-sterile and reusable.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Normed Pellegrin Calcaneus Stop Screw:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Standard) | Reported Device Performance (as tested) |
|---|---|
| Torsional properties of metallic bone screws (ASTM F543-07) | Device meets performance requirements as defined by Design Control activities and is substantially equivalent to predicate devices. |
| Driving torque properties of metallic bone screws (ASTM F543-07) | Device meets performance requirements as defined by Design Control activities and is substantially equivalent to predicate devices. |
| Press-in bending characteristics of medical bone screw (Custom Test) | Device meets performance requirements as defined by Design Control activities and is substantially equivalent to predicate devices. |
Explanation of the Acceptance Criteria and Performance:
The document states that the "Normed Pellegrin Calcaneus Stop Screw System meets performance requirements as defined by Design Control activities and are substantially equivalent to the predicate devices in terms of safety and efficacy."
While specific numerical acceptance values (e.g., minimum torque, maximum force) are not provided in this summary, the acceptance criteria are implicitly defined by compliance with the referenced ASTM standards (ASTM F543-07 for torsional and driving torque properties) and a "Custom Test" for press-in bending characteristics. The reported performance indicates that the device successfully met these criteria, establishing substantial equivalence to previously cleared devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "testing" and "non-clinical testing" but does not provide details on the number of screws or tests performed for each parameter.
- Data Provenance: Not explicitly stated, but given it's non-clinical (mechanical) testing, it would have been conducted in a laboratory setting (likely in Germany where the company is located or by a contract testing lab). This is not patient data, so "retrospective or prospective" is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the study described is non-clinical mechanical testing, not a clinical study involving human patients or expert interpretation of diagnostic data. Ground truth in this context would be the measurements obtained from the physical tests.
4. Adjudication Method for the Test Set
- This information is not applicable as the study described is non-clinical mechanical testing. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth or resolve discrepancies in interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This is a non-clinical mechanical performance study for a bone screw, not a study evaluating human readers' performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, this is not an AI/algorithm-based device. It is a physical medical implant (a bone screw). Thus, "standalone performance" in the context of an algorithm is not relevant.
7. The Type of Ground Truth Used
- The ground truth used here consists of the measured physical properties of the screws (torsional strength, driving torque, bending characteristics) obtained through laboratory testing as per ASTM standards and a custom test.
8. The Sample Size for the Training Set
- This information is not applicable as this is not a machine learning or AI-based device that would require a "training set."
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the reason stated above (not an AI/ML 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.