Search Results

The OsteoProbe is a measurement tool intended to assess bone tissue resistance to microindentation on the tibia of adults, reported as the Bone Material Strength Index (BMSi). In laboratory studies, BMSi measurements have been shown to correlate with biomechanical properties of bone, including whole-bone strength and fracture toughness. The clinical significance of laboratory-based biomechanical studies is unknown. The device is not intended to diagnose disease, predict fracture risk, or treat any clinical condition. Prescription use only, by or on the order of a physician.

OsteoProbe is a bone microindentation device. 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.

N/A

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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.

2. Sample Sizes and Data Provenance

Test Set for Performance Testing (Accuracy & Precision):

• Device Variability Testing: 5 devices, Noryl reference blocks. Total of (b)(4) data points (5 measurements per device for (b)(4) situations). Data provenance is likely internal lab testing.
• Operator Variability Testing: (b)(4) different laboratories with different operators/devices. (b)(4) reference polymer materials. Each lab measured (b)(4) materials (b)(4) times. Data provenance is multi-center, likely internal/contract lab testing.
• Cortical Bone Variability Testing: 5 bare-bone specimens from each of (b)(4) animal models (porcine tibia, ovine tibia, bovine femur). (b)(4) BMSi measurements per animal, with (b)(4) individual sets of measurements depending on specimen size. Simulated soft tissue: variations of (b)(4) in (b)(4) increments, with (b)(4) measurements each. Simulated skin and adipose tissue: 1019 measurements (through tissue and without tissue). Data provenance is likely internal lab testing and animal studies.
• Clinical Use Environment Variability (Swedish Study): (b)(4) Swedish female subjects aged 75-80 years. (b)(4) subjects were measured (b)(4) times in the same leg by the same operator (intra-operator variability). (b)(4) subjects were measured (b)(4) times by different operators (inter-operator variability). Data provenance: Prospective, Sweden.
• US Clinical Safety Study (IDE G200139): 40 subjects enrolled. Data provenance: Prospective, single-center, US.

Training Set:

• Training Set for Clinical Performance Context (Background data):
  • Complete clinical experience to December 2020: n=905 patients. BMSi range 45-102, age range 18-99, 368 male/537 female. Data provenance: Retrospective, from studies outside the US as well as previous US clinical studies.
  • US clinical study (G200139): n=(b)(4) (this seems to refer to the same IDE study but potentially specific performance data from it). BMSi range 62-89, age range 32-79, 10 male/30 female. Data provenance: Prospective, single-center, US.
    The narrative implies these datasets were used to demonstrate generalizability of the Swedish study results, rather than to "train" an algorithm in the traditional sense, as this is a physical device measurement.

3. Number of Experts and Qualifications for Ground Truth

• Clinical Safety Study (US IDE G200139): The study involved "trained operators" to perform the procedure. While not explicitly stated as "experts for ground truth," the medical professionals administering the device in the clinical study (physicians, physician assistants, nurses in usability testing) contribute to the practical application and safety assessment of the device, which forms part of the "ground truth" for its safe use.
• No explicit mention of "experts" to establish ground truth for the measurement output (BMSi) itself. The device measures a physical property (resistance to microindentation) directly, and "ground truth" for BMSi values is established by the materials themselves (e.g., Reference Block, Noryl Performance Check Block) with known reference values. The accuracy and precision studies evaluate how well the device measures these known values or consistently measures biological samples.

4. Adjudication Method

• No formal adjudication method (like 2+1 or 3+1) is mentioned for the test sets.
• For variability studies involving multiple operators or labs, the approach was to directly measure the variability (bias, repeatability, reproducibility) rather than adjudicating individual measurements against each other.
• For the clinical safety study, adverse events were likely reviewed and categorized by the study investigators.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The device measures a physical property directly, and its "effectiveness" is in the accuracy and precision of that measurement. The study focuses on the device's intrinsic measurement capabilities and its safety, not on human interpretation or diagnosis improved by AI assistance. Therefore, there is no effect size reported for human readers improving with/without AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done for the algorithm/device. The core of the performance testing (Device Variability, Operator Variability, Cortical Bone Variability, Environmental Conditions, and parts of Clinical Use Environment Variability) assesses the OsteoProbe's ability to accurately and precisely measure BMSi directly. The "software" component's function is to guide the operator, collect data, apply the BMSi formula, and ensure quality (e.g., by indicating when enough consistent indentations have been made). The reported accuracy and precision metrics directly reflect the device's standalone performance.

7. Type of Ground Truth Used

• Bench Testing:
  • Reference materials: For device variability, operator variability, and certain bone variability studies, known reference materials (Noryl reference blocks, reference polymer materials, polymethylmethacrylate (PMMA) Reference Block, Norvl Performance Check Block) with established "true" BMSi values were used.
  • Physical measurements: For strain gage sensor testing, comparison was made to a calibrated micrometer, indicating a physical measurement as ground truth.
  • Animal bone specimens: For cortical bone variability, these served as the biological "ground truth" for assessing variability in different bone types.
• Clinical Studies (Safety and Clinical Use Environment Variability):
  • Observed outcomes: For safety, the ground truth was the occurrence (or absence) of device-related Serious Adverse Events (SAEs), Adverse Events (AEs), and Unanticipated Adverse Device Effects (UADEs), as well as patient-reported pain scores (NRS).
  • Repeated measurements: For clinical use environment variability, the consistency of repeated measurements on the same patient by the same or different operators was the ground truth for assessing repeatability and reproducibility.

8. Sample Size for the Training Set

As mentioned in section 2, the OsteoProbe is a physical measurement device, not an AI/ML algorithm that undergoes traditional "training" with a dataset to learn patterns. However, extensive prior clinical experience data (n=905 patients) was used to contextualize and demonstrate the generalizability of the results from the specific variability studies (e.g., the Swedish study). This broader dataset (905 patients from studies outside the US and previous US clinical studies) provided a large sample size of observed BMSi values, age ranges, and sex distributions that characterize the device's real-world application range.

9. How the Ground Truth for the Training Set Was Established

For the "training set" in the context of device performance range (the n=905 clinical experience data), the ground truth for each data point was the BMSi value measured by the OsteoProbe on patients in those prior clinical studies. These measurements were generated by the device itself, under real-world clinical conditions. This established the expected range and distribution of BMSi values encountered in patient populations, which then served as a reference to validate that newer, focused studies (like the Swedish study) were representative of the intended use population.

Ask a specific question about this device