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

The Bi-Portal Bone Graft Delivery Device is comprised of a 21.0 cm length rectangular syringe barrel for surgical site access and bone graft material delivery; a compatible syringe plunger for pushing the allograft or autograft into the operative site; and, an attachable funnel reservoir for loading prepared material. The barrel has an 8.0 mm by 12.0 mm closed-end tapered distal shaft with a pair of longitudinal bilateral ejection holes near the distal end for material effusion into the surgical space. The barrel can be partially filled with up to 4.0 cc of material and refilled in-situ using the attachable funnel.

When used as an ancillary device to orthopedic surgical procedures that require the placement of autograft or allograft, the Bi-Portal Device can deliver a prepared amount of material. There are no luer lock components to the bi-portal design is intended to result in graft material effusion through the two laterally placed sideholes. This allows the material to be selectively placed within the surgical space adjacent to the Device barrel tip.

AI/ML Overview

The provided text does NOT describe a study that uses AI or machine learning, nor does it present acceptance criteria and reported device performance in the context of such a study.

Instead, the document is a 510(k) premarket notification summary for a medical device called the "Bi-Portal Bone Graft Delivery Device." It details the device's indications for use, description, and performance testing to demonstrate substantial equivalence to a predicate device, as required by the FDA.

Here's a breakdown of the information that can be extracted, and what cannot, based on your request:

Information NOT available in the document (as it pertains to AI/ML studies):

A table of acceptance criteria and the reported device performance (in the context of AI/ML): This document describes performance testing for a physical medical device (bone graft delivery device), focusing on mechanical properties, sterilization, and biocompatibility, not AI/ML performance metrics like sensitivity, specificity, or AUC.
Sample sized used for the test set and the data provenance: Not applicable to an AI/ML study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML study.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Information that CAN be extracted, though not in the context of AI/ML:

The document describes the device's performance testing to support its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML context):

The document states: "Testing has been performed to support safety and effectiveness to the predicate and to demonstrate performance as intended. The Bi-Portal Bone Graft Delivery Device was verified by bench evaluation for simulated use, pressure-force, leak test and shaft strength."

And: "All test acceptance criteria were met."

While specific numerical acceptance criteria and detailed performance results for each test (simulated use, pressure-force, leak test, shaft strength) are not provided in this summary, the general statement confirms that the device met internal acceptance criteria for these tests.

Regarding biocompatibility: "The Bi-Portal Bone Graft Delivery Device is composed of sterile medical grade plastic components, which has passed all of the recommended biocompatibility test requirements of ISO 10993-1." (Meaning, it meets the acceptance criteria of ISO 10993-1).

Regarding sterilization and packaging: "Studies were conducted in accordance with the applicable recommendations from the FDA Piston Syringe and 510(k) Guidance documents, and the applicable recognized standards. All test acceptance criteria were met." This implies meeting acceptance criteria for Sterility Assurance Level (SAL) of 10⁻⁶ per ANSVAAMI/ISO 11135-1 and supporting a labeled shelf life of 12 months based on accelerated aging.

2. Type of Ground Truth Used (Non-AI/ML context):

The "ground truth" in this context refers to the established standards and methods for testing physical medical devices. This includes:

Bench evaluation for simulated use, pressure-force, leak test, and shaft strength. The "truth" here is determined by engineering specifications and physical measurements.
Biocompatibility testing against ISO 10993-1 standards. The "truth" is whether the materials meet the criteria defined by this international standard for biological safety.
Sterilization validation and packaging studies according to FDA guidance and recognized standards like ANSVAAMI/ISO 11135-1. The "truth" is achieving the specified Sterility Assurance Level and maintaining packaging integrity and shelf life.

In summary, this document is a regulatory submission for a physical medical device and does not contain information relevant to an AI/ML study, its acceptance criteria, or performance in that domain.

Summary

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).