(64 days)
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.
| Acceptance Criteria Category/Test | Reported Device Performance Summary |
|---|---|
Sterilization Validation (AAMI TIR28, ISO 10993-7, & ISO 11135) | Validated to ensure the single-use disposable component is sterile. No specific performance metrics (e.g., SAL) are provided, but validation implies meeting relevant standard requirements. |
Distribution Testing (ASTM D4169, ASTM D4332-1) | Validated to ensure the device maintains integrity and performance during shipping and handling. No specific performance metrics (e.g., damage rate) are provided. |
Shelf Life (ASTM F1980, ASTM F2096, ASTM F88) | Validated to ensure the device remains safe and effective for its intended shelf life. No specific duration or performance metrics (e.g., degradation rate) are provided. |
Biocompatibility (ISO 10993-5, -10, -11) | Includes validation for: |
- 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.
§ 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.