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The OsteoProbe is indicated for use as a measure bone tissue resistance to microindentation on the tibia in adults. The clinical significance of resistance to microindentation is unknown. The device is not intended to diagnose or treat any clinical condition.

OsteoProbe® is a bone microindentation measurement tool. It is a prescription device per 21 CFR Part 801.109. The device includes a single-use disposable component and reusable components. The single-use disposable component has a Spaulding classification of critical and is provided sterile. The reusable components have a Spaulding classification of non-critical and must be reprocessed (cleaning and intermediate-level disinfection) between each use. The device has one accessory: a single-use, disposable sterile cover.

This document is a 510(k) premarket notification for the OsteoProbe device. This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, based on the provided document, the device did not undergo a study to prove it meets specific acceptance criteria related to its clinical performance or diagnostic capability.

The document explicitly states: "Clinical testing was not necessary to support equivalence."

The "acceptance criteria" and "device performance" described in the document relate to the physical and material characteristics of the device, primarily to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of acceptance criteria and the reported device performance

Based on the provided document, the "acceptance criteria" and "reported device performance" are primarily related to general device characteristics and safety/manufacturing standards, rather than direct measurements of the device's intended clinical function (measuring bone tissue resistance to microindentation). The document does not provide quantitative performance metrics for the microindentation measurement itself, as clinical testing was not deemed necessary for this 510(k) submission.

• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous Reactivity
• Acute Systemic Toxicity
• Rabbit Pyrogen-Material Mediated
  These tests were conducted to ensure the device materials are safe for patient contact. No specific pass/fail criteria or quantitative results are provided, but completion indicates meeting standard requirements. |

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

No clinical test set was used for clinical performance evaluation as part of this submission. The tests performed (sterilization, distribution, shelf life, biocompatibility) are typically laboratory-based validations. Therefore, this information is not applicable to the provided document.

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 clinical test set or ground truth established by experts for clinical performance was used in this 510(k) submission.

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

Not applicable. No clinical test set requiring adjudication was used in this 510(k) submission.

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 OsteoProbe is described as a "bone microindentation measurement tool" and is not an AI-assisted diagnostic or imaging interpretation device that would typically involve human readers. No MRMC study was conducted.

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

Not applicable. The OsteoProbe is a physical device measuring bone tissue resistance, not an algorithm. Clinical performance studies were not performed for this submission.

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

Not applicable. No ground truth for clinical performance was established, as clinical testing was not performed for this 510(k) submission. The "ground truth" for the non-clinical tests (e.g., sterility, biocompatibility) would be defined by the specific standards and their acceptance criteria (e.g., acceptable levels of extractables for biocompatibility, absence of microbial growth for sterility).

8. The sample size for the training set

Not applicable. The OsteoProbe is a physical measurement device, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, no training set was used.

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The OsteoProbe is indicated for use as a measurement tool to measure bone tissue resistance to microindentation on the tibia in adults. The clinical significance of resistance to microindentation is unknown. This device is not intended to diagnose or treat any clinical condition.

The OsteoProbe is a cortical bone microindentation measurement tool based on reference point indenter technology. System hardware consists of a Stylus (1), an Electronics Adapter (2), a Reference Block Holder and single-use Reference Block (3), a single-use disposable Tip Assembly (4), and an Operator Interface (5).

OsteoProbe Acceptance Criteria and Study Summary

The OsteoProbe is a bone indentation device designed to measure bone tissue resistance to microindentation on the tibia in adults. The clinical significance of this measurement is explicitly stated as unknown, and the device is not intended for diagnosis or treatment. The device's acceptance criteria and performance were evaluated through a combination of non-clinical (bench) testing and clinical studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OsteoProbe were established through various tests including packaging adequacy, device performance checks, and detailed performance testing for accuracy and precision.

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