Search Results

When used with the ANSPACH Systems, the OCM-G1 Attachment and Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cocleostomies.

The OCM-G1 (Otologic Curved Micro) Attachment is an accessory to the G1 electric drill system. It is a one-piece straight attachment that is manufactured from 17-4PH and 303 stainless steels (ASTM A564 and ASTM A582). The OCM-G1 Attachment can be connected and disconnected to the distal end of the handpiece via a locking mechanism by the user. After the OCM-G1 Attachment is secured to the handpiece, it will accept and hold an OCM curved burr support sleeve assembly (previously cleared). The OCM curved burr support sleeve assembly will rotate at a speed selected by the user for cutting and shaping bone, primarily in otology procedures such as cochleostomies. The OCM-G1 Attachment is provided non-sterile and is reusable.

This document describes the OCM-G1 Attachment, an accessory for surgical drills used in otology procedures. The submission is a 510(k) premarket notification, indicating a comparison to a predicate device demonstrating substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. A table of acceptance criteria and the reported device performance

• Locking feature compatibility: Tested and demonstrated.
• Temperature: Tested and demonstrated safe external temperatures.
• Disconnect without tools: Tested and demonstrated.
• System functionality: Tested and demonstrated proper functionality.
• Simulated use study: Demonstrated the OCM-G1 Attachment and curved cutting burrs perform as intended in cutting and shaping bone, similarly to the predicate. |
  | Cleaning and Reprocessing | Criterion: Ability to be cleaned and sterilized effectively to achieve a Sterility Assurance Level (SAL) of 10^-6 without adverse effects. |
  | | Performance: The OCM-G1 Attachment's characteristics are considered equal to or less challenging to sterilize than the currently validated "worst case" predicate device. This implies that existing validated cleaning and sterilization processes are capable of achieving the required SAL. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the test sets in the performance data section. The performance data seems to be based on bench testing and simulated use studies rather than clinical data from human subjects.

• Provenance: All testing appears to be internal verification and validation conducted by the manufacturer, The Anspach Effort, Inc., or its affiliates. No information is provided about the country of origin for the data or whether it was retrospective or prospective in a clinical context, as clinical testing was not performed or deemed necessary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Given that the testing included bench tests and a simulated use study, the "ground truth" would likely be defined by engineering specifications, performance standards, and the intended use of the device, rather than expert clinician consensus on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is typically used in clinical studies involving multiple readers evaluating medical images or diagnoses against a predefined ground truth. The studies described are engineering verification tests and a simulated use study, which would not involve such a method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices. The OCM-G1 Attachment is a mechanical surgical handpiece accessory, not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The OCM-G1 Attachment is a mechanical device, not an algorithm, so a standalone algorithm performance study is not relevant. Its performance is always in conjunction with a human operator and other surgical system components.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance data appears to be based on:

• Engineering Specifications and Standards: For tests like locking feature compatibility, temperature, disconnect without tools, and system functionality. These are likely evaluated against predefined design requirements and industry standards.
• Intended Use Performance: For the simulated use study, the ground truth is the successful cutting and shaping of bone as intended for otology procedures, evaluated by direct observation and measurement against expected outcomes.
• Predicate Device Equivalence: A significant part of the submission relies on demonstrating that the device performs "the same as the predicate (K131053)" in various aspects, implying the predicate's established safety and effectiveness serve as a practical ground truth.

8. The sample size for the training set

Not applicable. The OCM-G1 Attachment is a mechanical device, not an AI or machine learning algorithm, and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this mechanical device.

Ask a specific question about this device