(142 days)
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.
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Packaging Adequacy (Reusable System) | Average measurement before testing vs. after transport: $73 \pm 1.5$ BMSi | Average measurement before testing was $72.4$ BMSi, and after testing was $73.0$ BMSi. Met. |
| % change in strain gage calibration constant after testing: $$(b)(4) logs for microorganisms. | No visible soil seen, hemoglobin and protein testing passed (Hemoglobin $$ (b)(4) logs for (b)(4) and $>$ (b)(4) logs for (b)(4)). Met for all. | |
| Shelf Life | Two-year service life verified by accuracy testing after accelerated aging. | Service life of two years was verified. Met. |
| Electrical Safety & EMC | Compliance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, CAN/CSA-C22.2 No. 60601-1:14IEC 60601-1:2005, and IEC 60601-1-2:2014. | Test results support electrical safety and electromagnetic compatibility. Met. |
| Software Reliability | Software documentation reviewed per FDA Guidance (May 11, 2005) for Moderate Level of Concern (includes hazard analysis, requirements, design, traceability, V&V, etc.). | Software documentation was found to be acceptable. Met. |
| Strain Gage Sensor Linearity | Sensor linearity (b)(4), average accuracy (b)(4), precision (b)(4) (SD=(b)(4)) over physiological range of indentation depths. | Sensor linearity (b)(4), average accuracy (b)(4), and precision (b)(4) (SD=(b)(4)). Met. |
| Device Variability | Device accuracy (b)(4) BMSi units, SD=(b)(4). Point estimate of Device Variability (b)(4) BMSi units (b)(4). | Device accuracy (b)(4) BMSi units, SD=(b)(4). One-way random effects ANOVA point estimate of Device Variability (b)(4) BMSi units (b)(4). Met. |
| Operator Variability | Operator accuracy (bias) $ |
§ 888.1600 Bone indentation device.
(a)
Identification. A bone indentation device is a device that measures resistance to indentation in bone.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the risk of bone fracture, soft tissue damage, pain, discomfort, bruising, or bleeding.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of the accuracy and precision of the device with respect to resistance to bone indentation.
(3) Human factors testing must demonstrate that the intended user(s) can correctly use the device, based on the instructions for use.
(4) The patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Performance testing must demonstrate:
(i) The sterility of the patient-contacting components of the device; and
(ii) Validation of reprocessing instructions for any reusable components of the device.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(7) Software verification, validation, and hazard analysis must be performed.
(8) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.
(9) Labeling must include:
(i) Instructions for use;
(ii) Validated methods and instructions for reprocessing of any reusable components;
(iii) A shelf life for any sterile components;
(iv) Information regarding limitations of the clinical significance of the device output; and
(v) A detailed summary of the accuracy and precision of the device.