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BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are intended for the fixation of prothesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Description

BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are PMMA, radiopaque bone cements, containing gentamicin, designed for the fixation of prothesis to the living bone. BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are traditional bone cement products. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant and transfer stresses evenly to the bone. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, singleuse and sterile.

AI/ML Overview

This document is a 510(k) summary for the BonOs® HV Genta, BonOs® MV Genta, and BonOs® LV Genta bone cements. It does not describe a study involving an AI/ML powered device, but rather a traditional medical device (bone cement). Therefore, many of the requested fields are not applicable in this context.

Here's the information that can be extracted or noted as not applicable:

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

The document states that performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. It also notes compliance with several ASTM and ISO standards for mechanical and physical properties.

Specific acceptance criteria and reported numerical performance values are not provided in this summary. Instead, the summary generally states that "Results show comparable performances to the predicate device and are in compliance with ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17 and ASTM E399-20."

Acceptance Criteria Category	Specific Standard/Guidance	Reported Device Performance
Sterilization	ISO 11135, ISO 13408-1/2	Verified sterility, validated processes (ethylene oxide, membrane filter sterilization).
Biocompatibility	ISO 10993-1	Conformed to ISO 10993-1, identical materials to well-known bone cements, no additional risks.
Mixing & Application	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Chemical Composition	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Molecular Weight & Polymer Structure	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Physical Properties	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Stability of Components	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Thermal Properties	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Mechanical Properties	ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17, ASTM E399-20	Comparable to predicate device, in compliance with these standards (details not specified).
Bacterial Endotoxins	Ph. Eur. 5.01.10 (based on USP ), FDA Guidance "Submission and Review of Sterility Information..." (2016)	Test results meet endotoxin limits of 20 EU/device.
Pyrogen Limit	FDA Guidance "Submission and Review of Sterility Information..." (2016)	Device meets pyrogen limit specifications.

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

This information is not provided in the 510(k) summary. The document describes a traditional device and its performance testing against standards, not a clinical study with a "test set" in the context of an AI/ML 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)

This is not applicable as this is not an AI/ML device requiring human expert ground truth for its performance evaluation in that sense. The device's performance is established through laboratory testing against established physical, chemical, and mechanical standards.

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

This is not applicable as this is not an AI/ML device and does not involve human readers adjudicating findings.

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

This is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

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

For this traditional medical device, the "ground truth" for performance is based on:

Compliance with recognized international and national standards (ISO, ASTM).
Laboratory test results for physical, chemical, mechanical, and biological properties, compared against pre-defined specifications and/or predicate device performance.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device and therefore does not have a "training set."

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

This is not applicable as this is not an AI/ML device and therefore does not have a "training set" or corresponding ground truth.

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