(82 days)
The Osteo BOS™ System components are intended for long and small bone fracture fixation.
The Osteo BOS" System components are used for internal fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from Titanium alloy and include the following:
- Plate - Wide (06.5mm/04.5mm)
- Plate Narrow (06.5mm/04.5mm) .
- . T-Plate (06.5mm/04.5mm)
- T-Buttress Plate (06.5mm/04.5mm) .
- L-Plate (Ø6.5mm/Ø4.5mm) .
- Plate Wide (@4.0mm/03.5mm)
- Plate Narrow (e4.0mm/03.5mm) & Osteo Plate (04.0mm/03.5mm)
- Small T-Plate (04.0mm/03.5mm) ◆
- Plate (@2.7mm)
- Cortex Screw (02.7mm) .
- . Cortex Screw (03.5mm)
- t Cortex Screw (03.5mm with shaft)
- Cortex Screw (04.5mm) .
- Cortex Screw (04.5mm with shaft) .
- Nut for @4.5mm cortex screw .
- Ø8mm Washer for Ø4.0mm cancellous screws & . @3.5mm cortex screws
- 06.5mm Washer for 02.7mm cortex screws
- Cancellous Screw (ø4.0mm) ↓
- Cancellous Screw ($4.0mm with short thread) .
- Cancellous Screw (06.5mm) ♥
- Cancellous Screw (06.5mm, thread lengths 16mm & 32mm) .
- 013.0mm Washer for cancellous screws 26.5mm & . cortex screws 04.5mm
This document describes the Osteo BOS™ System, a bone plate and screw system for fracture fixation. However, the provided text is a 510(k) premarket notification summary and an FDA clearance letter from 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics typically found in more recent device submissions or clinical trial reports for AI/software as a medical device (SaMD).
Therefore, the information requested about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not present in the provided text. The document primarily confirms the device's substantial equivalence in design and intended use to existing bone plates and screws.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are reported in this 510(k) submission summary. The demonstration of "substantial equivalence" is the primary acceptance criterion for a 510(k). Performance is implied to be equivalent to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Confirmed by FDA letter, based on design, materials (Titanium alloy vs. CP Titanium for predicate), and intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) summary does not describe a test set or clinical study involving patient data with sample sizes. Substantial equivalence was primarily based on comparing the design, materials, and intended use to a predicate device.
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 by experts is described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or human interpretation requiring adjudication 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. The Osteo BOS™ System is a physical medical device (bone plates and screws), not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth, in the context of device performance, as typically understood for diagnostic or AI devices, is not a concept applied in this 510(k) submission for mechanical equivalence. The "ground truth" for demonstrating substantial equivalence for a bone plate system would be its material properties, mechanical testing (which is not detailed here but would have been part of the full submission), and clinical history of similar predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; hence, no training set is relevant.
9. How the ground truth for the training set was established
Not applicable. No training set is relevant.
§ 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.