(164 days)
The Omnibone™ Bone Marrow Biopsy Kit is indicated for bone marrow aspiration and biopsy of the anterior or the posterior iliac crest of adult patients.
The Omnibone™ Bone Biopsy Kit is indicated for bone biopsy of the vertebral body and bone lesions.
The OmniBone™ Powered Biopsy System consists of a rechargeable Power Driver with Charger and compatible Biopsy Kits with Power Driver Pouch.
The OmniBone™ Bone Biopsy Kit with Power Driver Pouch and the OmniBone™ Bone Marrow Biopsy Kit with Power Driver Pouch are both provided sterile (EtO), are both single-use and are both designed exclusively for use with the OmniBone™ Power Driver. All OmniBone™ Biopsy Kits are available in different needle gauge sizes and lengths.
The OmniBone™ Power Driver with Charger is a handheld, Lith-on battery powered, and rechargeable Power Driver, reusable and supplied non-sterile.
The OmniBone™ Power Driver has a 3-position switch that controls the motion of the driver: reverse (counter clockwise) – off – forward (clockwise). The OmniBone™ Power Driver has a variable speed trigger that controls the speed of the driver. Applying light pressure on the trigger activates the driver at low speed and increasing the trigger pressure activates higher speeds. Full pressure on the trigger will activate full speed. No pressure on the trigger will stop the motor function. A charging LED indicates the level of charge of the battery of the OmniBone™ Power Driver. An integrated connector allows the OmniBone™ Power Driver to connect to the OmniBone™ Charger.
The provided text describes the regulatory clearance (K230015) for the OmniBone™ Bone Marrow Biopsy Kit with Power Driver and OmniBone™ Bone Biopsy Kit with Power Driver. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the level of detail requested for acceptance criteria and the comprehensive study design typically associated with proving a device meets those criteria for AI/ML-based medical devices.
The document is a 510(k) summary for a medical device (a biopsy kit with a power driver), not an AI/ML-driven diagnostic or assistive technology. Therefore, the "acceptance criteria" discussed are related to the mechanical, electrical, and biocompatibility performance of the physical device, not the performance metrics of an AI algorithm (like sensitivity, specificity, or reader improvement).
Therefore, I cannot fully answer your request based on the provided text, as it does not describe an AI/ML study.
However, I can extract the information related to the device's non-AI related performance testing and acceptance, interpreting "acceptance criteria" in the context of a physical medical device.
Based on the provided text, here's what can be inferred about the device's non-AI related performance and acceptance:
The document states that the OmniBone™ Powered Biopsy System "met all the predetermined acceptance of design verification and validation as specified by applicable standards, guidance, tests protocols and/or customer inputs." This is a general statement of acceptance, and the subsequent list outlines the types of tests performed to achieve this.
1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a physical device):
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical/Functional Performance | - Battery charging time: Met predetermined acceptance. |
| - Battery capacity: Met predetermined acceptance. | |
| - Rotation Speed: Met predetermined acceptance. | |
| - Needle Penetration Force: Met predetermined acceptance. | |
| - Power Driver Coupler Reliability: Met predetermined acceptance. | |
| - Tensile Strength – Needle hub: Met predetermined acceptance. | |
| - Creep Testing: Met predetermined acceptance. | |
| - Dead Space Measurements: Met predetermined acceptance. | |
| - Tissue sampling: Met predetermined acceptance. | |
| Biocompatibility | - Biocompatibility testing performed in accordance with ISO 10993-1. |
| Sterility | - Sterilization performed in accordance with ISO 11135:2014 to confirm SAL of 10-6. |
| Shelf Life | - Label shelf life: 5 years. |
| Electrical Safety & EMC | - Electromagnetic Compatibility and Electrical Safety Testing performed on Power Driver and Charger in accordance with IEC 60601-2. |
| - Met electrical safety and performance requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not explicitly stated. The document lists the types of tests performed (e.g., "Battery charging time," "Tissue sampling," "Needle Penetration Force") but does not provide specific sample sizes (e.g., number of batteries tested, number of needles, number of tissue samples).
- Data Provenance: Not specified. This typically refers to the source of data for clinical studies (e.g., patient demographics, geographical locations). For this type of device testing, it would refer to the conditions under which the engineering tests were conducted (e.g., in-house lab, third-party lab). The document does not provide this detail.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable for this type of device submission. The ground truth for these engineering performance tests is typically established by direct measurement against engineering specifications and industry standards, not by expert consensus (like radiologists reviewing images).
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for AI/ML validation where human readers establish ground truth from complex data like medical images. This document describes physical device performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a physical biopsy device without an AI component.
6. If a Standalone (Algorithm Only) Performance Was Done:
- No. This device is a physical instrument, not an standalone algorithm.
7. The Type of Ground Truth Used:
- For the physical performance tests (e.g., speed, force, battery metrics): Engineering specifications and industry standards.
- For biocompatibility: ISO 10993-1 standards and associated biological endpoints.
- For sterility: ISO 11135:2014 standard for Ethylene Oxide sterilization, confirming SAL (Sterility Assurance Level).
- For electrical safety/EMC: IEC 60601-2 standards and associated electrical performance/safety thresholds.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
In summary: The provided FDA 510(k) summary focuses on the substantial equivalence of a physical medical device. It successfully outlines the types of engineering and laboratory tests conducted to ensure the device's safety and performance against established standards, but these are distinct from the types of studies and acceptance criteria applicable to AI/ML software.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.