FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs
Osteosynthesis requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.

Device Description

The modified I.B.STM osteosynthesis screws are a range extension of the existing screw line cleared in K131920 I.B.STM osteosynthesis screw.
The modification made on the I.B.S.TM osteosynthesis screw are:
I.B.S.TM Osteosynthesis Compression Screw, diameter 6.5mm:

Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references;
Modification of the distal thread to a long distal thread for screws, with total length comprised between 60mm and 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Neutralization Screw, diameter 6.5mm:
Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Compression and Neutralization screw, diameter 2.5mm:
Range extension of the total screw length, with addition of length 30mm, and creation of dedicated references.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically osteosynthesis screws. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving new efficacy or safety through clinical trials or comprehensive performance studies against acceptance criteria in the way AI/ML devices typically would.

Therefore, the requested information categories (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are largely not applicable in the context of this device type and the regulatory submission provided.

However, I can extract information related to the device's technical validation, which serves a similar purpose to "meeting acceptance criteria" in this context:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Equivalence: Device's mechanical behavior to be substantially equivalent to predicate devices.	Dimensional modifications were evaluated through comparison with predicate devices and analysis of impact on mechanical behavior based on standard ASTM F543.
Pyrogenicity: Device must meet pyrogen limit specifications.	Passed Limulus Amebocyte Lysate (LAL) test in accordance with ANSI/AAMI ST72:2011.
Material Equivalence: Material should be identical to predicate devices.	Manufactured from Titanium alloy Ti6Al4V, according to ISO 5832-3 and ASTM F136 standards, identical to predicate materials.
Design Equivalence: Similar design to predicate devices (cannulated, self-tapping, self-drilling, compression/neutralization).	Confirmed.
Size Range Equivalence: Comparable size range to predicate devices.	Confirmed, with length discrepancies of the I.B.S.™ osteosynthesis screw predicate (K131920) in comparison to the modified I.B.S.™ Osteosynthesis screws 6.5mm diameter specifically addressed and deemed not to impact safety/effectiveness.
Indications for Use Equivalence: Similar indications to predicate devices.	Confirmed (fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs, osteosynthesis requiring mono or bicortical compression).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This is not a study involving patient data or test sets in the typical sense of AI/ML device evaluation. The "test set" here refers to the physical devices undergoing mechanical testing and material analysis.
The document states, "No new bench testing was deemed required to assess the torsional properties, driving torque and axial pullout of the modified I.B.S.™ osteosynthesis screws." This implies that existing data or established properties from the predicate device (K131920) were leveraged, and the analysis focused on the impact of the modifications on these properties rather than re-testing a specific number of new screws for all properties.
The pyrogen test refers to "batch testing"; however, the specific sample size for LAL testing is not provided.
Data provenance regarding a specific country of origin or retrospective/prospective nature isn't applicable as it's primarily an engineering and material equivalence assessment against standards.

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. The "ground truth" for this type of device is established by engineering standards (e.g., ASTM F543, ISO 5832-3, ASTM F136, ANSI/AAMI ST72:2011) and material science principles, not by human experts interpreting clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring human adjudication for data interpretation. Adherence to standards is the primary method of verification.

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 (screw), not an AI/ML diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance and safety is rooted in engineering standards, material specifications, and regulatory requirements (e.g., ISO, ASTM, ANSI/AAMI) that define the expected mechanical properties, material composition, and biocompatibility (e.g., pyrogenicity) for bone fixation screws. The demonstration of substantial equivalence relies on conforming to these established objective benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires ground truth for a training set.

Summary

Regulation Number and Section

§ 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.