(259 days)
The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium.
When used with the ANSPACH® Systems, the OCM Attachment and OCM Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are surgical drills that handle a complete range of surgical procedures ranging from power demanding applications to the most delicate dissection.
The ANSPACH® Otologic Curved Micro (OCM) Attachment consists of the attachment which connects directly to the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems handpieces with the standard twist lock mechanism, and the OCM Burr Support Sleeves. The OCM is provided non-sterile and is reusable. Cleaning and sterilization instructions are provided in the ANSPACH® OCM Attachment package insert.
The ANSPACH® OCM Burr Support Sleeves with integral cutting burrs mount to the OCM Attachment with a simple snap-in connection. The 20° curve and small diameter of the OCM Burr Support Sleeves provides excellent visibility. The non-rotating support sleeve protects soft tissue from the rotating cutting burr shaft. The OCM Burr Support Sleeves can be used at speeds from 10,000 to 80,000 rpm. They are available in two lengths (5.6 and 7.3 cm), each with a wide variety of different cutting burr styles and diameters to accommodate varying surgeon preferences. The OCM Burr Support Sleeves are provided sterile and for single use only.
The provided text describes a 510(k) premarket notification for a surgical device, not an AI or imaging diagnostic device. Therefore, the information typically required for describing the acceptance criteria and study proving device performance for AI/diagnostic devices (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, effect size, standalone performance, ground truth types) is not present in this document.
This submission focuses on demonstrating substantial equivalence to predicate devices for a mechanical surgical instrument based on its physical characteristics, materials, and functional testing.
Here's an analysis of what is available regarding acceptance criteria and performance:
1. Acceptance Criteria and Reported Device Performance (based on mechanical and biocompatibility testing)
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Safety of patient-contacting materials (e.g., non-toxic, non-irritating, non-sensitizing). Adherence to GLP. | "A series of biocompatibility tests demonstrated the safety of the OCM Burr Support Sleeves patient contacting materials. All tests were conducted in accordance with the GLP regulation (21 CFR Part 58)." |
| Functionality/Performance | Proper functionality after repeated use; safe external temperatures; effective cleaning and sterilization; proper cutting/shaping of bone. | "Several performance tests demonstrated the safety and effectiveness of the OCM Attachment and OCM Burr Support Sleeves. Specifically, OCM Attachment testing demonstrated proper functionality after repeated use, safe external temperatures, and the ability to clean and sterilize effectively without adverse effects on functionality or performance. OCM Burr Support Sleeves testing demonstrated proper functionality and safe external temperatures. In addition, a simulated use study demonstrated both the OCM Attachment and the OCM Burr Support Sleeves perform as intended in cutting and shaping bone properly." |
| Equivalence | Demonstrated substantial equivalence to identified predicate devices in terms of indications for use, technological characteristics, and safety/effectiveness. | The entire 510(k) submission serves as the proof for this. The conclusion states: "Scientifically valid data demonstrates that the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems with the ANSPACH® Otologic Curved Micro (OCM) Attachment and OCM Burr Support Sleeves is as safe and effective as the predicate devices when used in accordance with the labeled directions for use and for the requested indication." The FDA's letter confirms the determination of substantial equivalence. The technological characteristics are stated to be "no new technological characteristics" and the new indications are "consistent with numerous other currently marketed surgical drill systems and accessories." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as numerical sample sizes for "test sets" in the context of an AI/diagnostic device. For this surgical instrument, testing would involve a certain number of units for various mechanical, thermal, and biocompatibility tests. For example, "a series of biocompatibility tests" and "several performance tests" imply multiple tests on one or more samples, but specific quantities are not provided.
- Data Provenance: The tests were likely conducted internally by The Anspach Effort, Inc. or by contract labs on their behalf, in accordance with regulatory standards (e.g., GLP for biocompatibility). The country of origin and retrospective/prospective nature are not specified, but typically this would be a prospective testing program for a new medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to a mechanical surgical device as there's no "ground truth" to be established by clinical experts in the same way as an AI diagnostic algorithm for image interpretation. The performance is assessed through objective physical and biological tests. A "simulated use study" implies assessment by skilled personnel, possibly surgeons or engineers, but their qualifications and numbers are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept belongs to studies where human experts are making subjective judgments (e.g., reading medical images) that need to be reconciled. For mechanical device testing, outcomes are typically measured quantitatively against defined specifications.
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. This is specific to AI/diagnostic imaging devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is specific to AI/diagnostic algorithms. The device is a physical surgical instrument that always requires a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through objective test methods and specifications. For instance:
- Biocompatibility: Adherence to ISO standards for biocompatibility (e.g., cytotoxicity, irritation, sensitization), with results compared against pass/fail criteria.
- Functionality: Measurements of power, speed, temperature, durability (after repeated cycles), efficacy of cleaning/sterilization methods, and successful cutting/shaping of target material (e.g., bone surrogate) as intended.
- Simulated Use: Demonstration that the device "perform[s] as intended in cutting and shaping bone properly." This would likely involve visual inspection and perhaps quantitative assessment of the cutting performance on a model.
8. The sample size for the training set
Not applicable. This refers to AI model development.
9. How the ground truth for the training set was established
Not applicable. This refers to AI model development.
In summary: This 510(k) submission relies on demonstrating substantial equivalence through a combination of:
- Comparison of technological characteristics with predicate devices.
- Biocompatibility testing to assure material safety.
- Performance testing to demonstrate proper functionality, thermal safety, durability, and effectiveness in simulated use, aligning with the intended purpose and implicitly meeting industry standards for such devices.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.