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Anspach micro saw attachments are indicated for use with eMax electrical and Black Max, MicroMax pneumatic drill systems for surgical cutting, shaping and removal of bone, including bones of the spine and cranium.

Keyless driver connects to surgical motor (or eMax Console - electric driver) and holds the micro saw head.. It reduces motor speed and drives the attached saw blade.
There designs: Black Max, MicroMaxleMax and "stand alone" electric driver certified to:

• UL 2901-1: Second Addition, Rev. 10/24/97 .
• CSA-C22.2 No. 601.1- M90, including General Instruction No. 1 .
• EN60601-1. Issue 2. (including A1. A2. A11-13) .
  Drivers are non-invasive and non-patient contact; contain no materials or substances which could be transferred to patient. Drivers cannot internally transfer materials or substances from motor. Drivers are reusable and can be cleaned with soap/water or isopropyl alcohol and can withstand temperatures of up to 278°(F) for up to 30 min. (static).
  Micro saw head attaches to keyless driver without tools. Head converts motor rotational drive to sagittal, oscillating or reciprocating motions. Heads may be surgically invasive. Unintentional contact may occur due to proximity of blade and tissues of surgical site. Heads are constructed of biocompatible materials and contain no substances which could be transferred to patient. Like drivers, heads cannot internally transfer substances from motor. Heads are reusable and can be cleaned with soap-water or isopropy! alcohol and can withstand temperatures up to 278°(F) for up to 30 min. (static).
  Saw blades are pre-sterilized, single-use, disposable bone cutting blades. Saw blades are sterilized to an appropriate SAL as specified by recognized standards for sterilization.

The provided document is a 510(k) summary for "Advanced Micro Saw Attachments." It describes the design, materials, operation, risk assessment, and indications for use of the device, and then establishes substantial equivalence to a predicate device.

However, the document does not contain any information regarding specific acceptance criteria for a device's performance that would require a study to prove it meets those criteria. Instead, it focuses on the device's design specifications and how they compare to an older model to establish substantial equivalence for regulatory purposes.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and establishment methods, training set size) are not applicable to this document as it doesn't describe a performance study with such metrics.

Below is a response attempting to answer the relevant questions based on the provided text, while clearly indicating where information is not available.

Acceptance Criteria and Device Performance Study for Advanced Micro Saw Attachments

The provided 510(k) summary for the "Advanced Micro Saw Attachments" primarily focuses on establishing substantial equivalence to a predicate device based on design, operational characteristics, and intended use. It does not present specific quantitative acceptance criteria related to a device's functional performance (e.g., precision, speed, cutting efficiency) that would be evaluated through a clinical or performance study with defined metrics like sensitivity, specificity, or reader agreement.

The "Substantial Equivalence" table outlines design and feature comparisons rather than performance metrics with thresholds for acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present quantitative performance acceptance criteria in the typical sense (e.g., accuracy, reliability metrics) that would be measured in an evaluation study. Instead, it compares specific design and functional features to a predicate device to demonstrate substantial equivalence.

* OLD: Speed reduction achieved only by power reduction. NEW: Speed reduction achieved with internal gear reduction mechanism.
* Excluding saw blades which are single use and disposable.

2. Sample size used for the test set and the data provenance

Not Applicable. The document does not describe a performance study with a test set of data or samples for evaluating typical device performance metrics. The comparison is based on design features.

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

Not Applicable. No test set or ground truth establishment by experts is described in this regulatory submission for a performance study.

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

Not Applicable. No test set or adjudication method is described.

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 document pertains to surgical micro saw attachments, not AI-based diagnostic or assistive devices that would typically undergo MRMC studies with human readers.

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

Not Applicable. This is a mechanical surgical device, not an algorithm, so "standalone" performance in the context of AI or software is irrelevant here.

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

Not Applicable. The submission focuses on substantial equivalence based on design characteristics and compliance with electrical safety standards (UL, CSA, EN). There is no "ground truth" as would be defined for a diagnostic or predictive device's performance study.

8. The sample size for the training set

Not Applicable. This is a mechanical device, and the submission does not describe any machine learning or AI components that would require a "training set."

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

Not Applicable. As there is no training set mentioned or implied, the method of establishing ground truth for it is also not applicable.

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