The device uses a four (4) point system to clamp a patient's head during surgical procedures. The material used was selected to reduce or eliminate interference normally associated with all metal skull clamps should x-rays or similar diagnostic activity be utilized during the procedure.

AI/ML Overview

The provided text describes a medical device, the Mizuho Radiolucent Head Frame, and its testing. However, it does not contain the specific information required to complete the detailed acceptance criteria and study description as outlined in your request. The document is a 510(k) summary for a medical device and focuses on establishing substantial equivalence to legally marketed devices.

Here's why the requested information cannot be fully provided from the given text:

No explicit "Acceptance Criteria" table: The document describes tests performed (Deflection Under Load, Durability of Reusable Skull Pins, Radiolucence) and their results, but it doesn't present them in a structured "acceptance criteria vs. reported performance" table format with numerical targets.
No detailed information on "Study" for device performance: The tests mentioned are more akin to engineering verification tests rather than a clinical study evaluating diagnostic accuracy or effectiveness in a human-in-the-loop scenario.
- Sample size and data provenance: Not applicable in the context of the described engineering tests.
- Experts for ground truth / adjudication: This is irrelevant for the material property and deflection tests conducted.
- MRMC study: No indication of any multi-reader multi-case study, as the device is a mechanical head frame, not an AI diagnostic tool.
- Standalone performance: The concept of "standalone performance" as it relates to AI algorithms is not relevant here.
- Type of ground truth: The "ground truth" for the tests mentioned would be established engineering standards or direct measurements, not clinical outcomes or expert consensus.
- Training set size/ground truth for training set: These concepts are applicable to machine learning models, not to a physical medical device like a skull clamp.

Based on the provided text, here is what can be inferred and what cannot be provided:

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

Acceptance Criteria (Implied)	Reported Device Performance
Deflection Under Load: Deflects similarly to a metal device.	"The results show that the devices deflect essentially the same amount."
Durability of Reusable Skull Pins: No significant change after multiple sterilization cycles; break load substantially higher than surgical use.	"There was essentially no change in the results compared with unprocessed pins." "The break load during all testing was substantially higher than that which is used in surgical procedures."
Radiolucence: Minimal interference during x-rays.	"Representative x-rays included in advertising show that the interference resulting from the use of this device is minimal."

2. Sample sized used for the test set and the data provenance:

Sample Size:
- Deflection Under Load: Not specified (refers to "The device" and "The metal device," implying one of each type for testing).
- Durability of Reusable Skull Pins: "sample skull pins" were tested, but the exact number is not specified. They were tested at 5, 10, 20, and 40 cycles.
- Radiolucence: Not specified (refers to "Representative x-rays").
Data Provenance: Not specified, but implied to be laboratory/engineering testing performed during the device development process. This is not clinical data.

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

This information is not applicable to the engineering verification tests described. Ground truth for these tests would be based on physical measurements and material science standards, not expert medical opinion.

4. Adjudication method for the test set:

This information is not applicable to the engineering verification tests described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. The document describes engineering tests, not a clinical study involving human readers or AI assistance.

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

No. This term is specific to AI algorithms and is not applicable to this mechanical device.

7. The type of ground truth used:

Deflection Under Load: Direct physical measurement against a control (metal device).
Durability of Reusable Skull Pins: Destructive testing and comparison to unprocessed pins; physical measurement of break load.
Radiolucence: Visual assessment of x-ray interference.

8. The sample size for the training set:

This information is not applicable as the device is a physical product, not an AI model requiring a "training set."

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

This information is not applicable as there is no training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a date stamp. The stamp reads "SEP 12 1988". The text is in a bold, sans-serif font and is black in color.

Image /page/0/Picture/1 description: The image shows the word "MIZUHO" in white letters against a black background. The letters are bold and sans-serif. The black background is a rounded rectangle.

Mizuho America Inc. 123 Brimbal Avenue, Beverly, MA 01915 800-699-CLIP(2547) TEL: 508-921-1718 FAX: 508-921-4003

K955012

510(k) SUMMARY

Mizuho Radiolucent Head Frame

Applicant:

Mizuho America Inc. 123 Brimbal Avenue Beverly, MA 01915

Contact: Brian Connelly

Telephone: 508-921-1718 FAX: 508-921-4003

Submitted by:

Curtin & Associates International 1200 East Street Dedham, MA 02026

Contact: Donald A. Lincoln

Telephone: 617-329-1955 FAX: 617-329-2529

Date this Summary was prepared: 26 October 1995

Trade Name: Mizuho Radiolucent Head Frame Common Name: Skull Clamp or Head Holder Classification Name: Neurosurgical Head Holder (Skull Clamp)

Legally Marketed Devices to Which Substantial Equivalence is claimed:

Malcolm-Rand Radiolucent Headrest Sugita Multi-Purpose Head Frame

{1}------------------------------------------------

510(k) SUMMARY-continued Mizuho Radiolucent Head Frame

Description of Device: The device uses a four (4) point system to clamp a patient's head during surgical procedures. The material used was selected to reduce or eliminate interference normally associated with all metal skull clamps should x-rays or similar diagnostic activity be utilized during the procedure.

Intended Use of the Device: Clamping of a patient's head and neck in a particular position during surgical procedures.

Summary of Technological Characteristics: The four (4) point systems is found in each of the legally marketed devices to which substantial equivalence is claimed. The devices components will function in conjunction with operating table attachments currently marketed by Mizuho America. The radiolucent characteristic is similar to that which is found in the Malcolm-Rand system. In each system, the main components are carbon fiber. The Malcom-Rand system uses disposable pins which are attached to the end of the four (4) screws while the proposed Mizuho device will have reusable pins which are a combination of metal and non-metal.

Summary of test data:

Deflection Under Load: The device was assembled onto an operating table and loads applied. The metal device was subjected to the same test procedure. The results show that the devices deflect essentially the same amount.

Durability of Reusable Skull Pins: Testing of sample skull pins was conducted in which they were processed in a hospital using a normal high temperature pre-vacuum cycle for that hospital, 274°F for four (4) minutes. Pins were removed after 5, 10, 20 and 40 cycles for destructive testing. There was essentially no change in the results compared with unprocessed pins. The break load during all testing was substantially higher than that which is used in surgical procedures.

Radiolucence. Representative x-rays included in advertising show that the interference resulting from the use of this device is minimal.

Regulation Number and Section

§ 882.4460 Neurosurgical head holder (skull clamp).

(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).