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The Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins are components of a mechanical support system which is used in head and neck surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative CT or MR Imaging is used.

The DORO® Radiolucent / MRI Compatible Horseshoe Headrest System are components of a mechanical support system which is used in head and neck surgery when non-invasive head support is required and when intra-operative CT or MR Imaging is used.

The DORO® Radiolucent / MRI Compatible Halo System is a system of radiolucent halo rings of varying size and styles that may be used in neurosurgical applications as an arm rest during head and neck surgery when intra-operative CT or MR Imaging is required.

The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems are for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary (Skull Clamp with Skull Pins) or when secured noninvasive cranial stabilization (Horseshoe Headrest System) is required and when Intra-Operative CT or MR Imaging is used.

Main components:

• DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins
• DORO® Radiolucent / MRI Compatible Horseshoe Headrest Systems
• DORO® Radiolucent / MRI Compatible Halo System

The DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System uses a three-point fixation of the head during surgery in the prone, supine, lateral, and sitting positions via the radiolucent Skull Clamp with Skull Pins. The DORO® Radiolucent / MRI Compatible Horseshoe Headrest System is an alternative noninvasive gel-pad cranial stabilization system for prone and supine positioning. The Skull Clamp or Horseshoe Headrests can be connected to Swivel Adaptor which in turn can be connected to the appropriate Transitional Members (of varying lengths). These are all MR-Safe.

The Radiolucent Halo System is a series of radiolucent rings (full, half and quarter rings) with fixation rods to attach to the radiolucent skull clamp described above. It provides a hand rest for the Surgeon and a mounting place for a variety of surgeon tools, such as brain Retractor and a holding tray. The Halo Rings and the Rod Fixation Assembly are all MR-Safe.

The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems are sold non-sterile. The Swivel Adaptor, Skull Clamp and Horseshoe Headrests are intended to be cleaned by the user between uses. For rigid skeletal fixation, the Skull Clamp uses the disposable single-use ceramic (Yttried Zirconium) or Titanium Skull Pins, which are both x-ray and MRI-compatible.

The components of the DORO® Headrest Systems are made of the following materials:

• The Skull Clamp is made of NOVOTEX laminated fabric with phenolic resin (GRP) colored with BASANTOL black X82 liquid and POM (Delrin), PEEK and Polyurethan. MR-Safe.
• The Swivel Adaptor and the Horseshoe Headrest in adult and pediatric versions, the Transitional Members and the Halo Systems are made of Novotex, PEEK and POM. MR-Safe.
• DORO® Radiolucent Disposable Single-Use Skull Pins of Yttried Zirconium or Titanium are X-ray and MRI compatible. MR-Safe.

The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems can be used with accessories from the predicate DORO® Headrest System (K001808) with Gel Pads for adults, Headrest supports with one or two Gel Pads, single Pin Holders, dual Pin Holders for adults, dual Pin Holders for children, a Multi-Purpose Skull Clamp with six Pin fixation or three Gel Pads.

The provided text is a 510(k) summary for a medical device (DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems). This document is a regulatory submission for premarket notification to the FDA, demonstrating that a new device is substantially equivalent to a legally marketed predicate device.

It does not contain the acceptance criteria and study information typically found in a clinical performance study report for a diagnostic or AI-driven device. The document focuses on showing substantial equivalence based on design, construction, intended use, and performance characteristics compared to existing devices, particularly concerning its MRI compatibility.

Therefore, many of the requested categories (such as reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set) are not applicable to this type of regulatory submission for this device.

The "performance" aspect here refers more to the functional performance and safety of a mechanical device, rather than the accuracy of a diagnostic algorithm.

Here's a breakdown of what can be extracted and what is not available from the provided text:

Acceptance Criteria and Study for DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems

This 510(k) summary (K063494) for the DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems focuses on establishing substantial equivalence to predicate devices, rather than presenting a clinical study with acceptance criteria for diagnostic performance. The "performance" discussed primarily relates to the device's mechanical integrity, radiolucency, and MRI compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This is a 510(k) for a mechanical device, not a diagnostic algorithm that requires a "test set" in the context of diagnostic accuracy. Data provenance would refer to where clinical data for performance assessment came from, which is not relevant here.

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

• Not Applicable. No ground truth for a diagnostic test set is established. This device's performance is assessed through material properties, mechanical testing, and comparison of design features, not expert interpretation of outputs.

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

• Not Applicable. No test set or adjudication process as defined for diagnostic performance is mentioned.

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 a mechanical surgical device, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

• Not Applicable. This device does not involve an algorithm.

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

• Not Applicable. The "ground truth" for this device's regulatory review would be adherence to material specifications, engineering standards, biocompatibility testing results (implied), and demonstration of functional equivalence (e.g., rigid fixation, MRI safety) to predicate devices rather than a medical "truth" like disease presence.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm exists for a mechanical device.

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

• Not Applicable. No training set for an algorithm exists for a mechanical device.

In summary: The provided document is a 510(k) summary for a mechanical neurosurgical device. It addresses regulatory requirements by demonstrating substantial equivalence to previously cleared devices, primarily focusing on materials, construction, intended use, and functional properties like MRI compatibility. The questions regarding acceptance criteria, sample sizes, expert ground truth, and AI/algorithm performance are not applicable to the information contained within this type of submission for this device.

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The DORO® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.

The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterliization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument.

The DORO® Non-Stick Bipolar Forceps are for use in general surgical procedures. These devices are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.

During the coagulation of tissue, the coagulated tissue may stick to the forceps. This undesirable effect can be eliminated by the non-stick properties of the unique solid silver alloy tip forceps of the DORO line. The solid silver allov tip provides excellent thermal properties and eliminates the difficult and time-consuming of the forceps during a procedure. The non-stick properties are permanent since it is not a coating and the non-stick properties are retained through repeated and frequent sterilizations.

Reusable Standard two-pin round connector cables are designed to work with all foot-switching bipolar electrosurgical generators.

The DORO® Bipolar Reusable Cables are non-sterile, reusable bipolar cables of 3 and 5 meters. They are designed to transport electrical power from a high-frequency electrosurgical generator by a foot-activated switch. The cable fittings are compatible for use with: Erbe, Martin, Valleylab, Aesculap and other ES Generator Units with twinpin connectors (2-banana plug). The cables are comprised of silicone (outer insulation), PTFE or FEP (core insulation), and Cu-wire poreless silver plated (wire).

The cable consists of a twin-pin connector (2-banana plug) that is comprised of silver plated bronze and insulated with silicone. The connector cable at the forceps end is comprised of bronze or brass - silver or nickel plated, Stainless Steel 1.4310, PP (Polypropylene or TPE).

Here's an analysis of the provided text regarding the DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables, focusing on acceptance criteria and study information:

Analysis:

The provided 510(k) Notification (K070997) does not contain a study that proves the device meets specific performance acceptance criteria in the manner typically seen for AI/ML or diagnostic devices.

Instead, this submission seeks substantial equivalence for the DORO® devices based on their similarity to legally marketed predicate devices and compliance with recognized performance standards for electrosurgical equipment. The "performance" discussed primarily relates to safety and functional standards, not to a measurement of diagnostic accuracy or clinical effectiveness against a set of predefined acceptance metrics for a novel technology.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device and submission.

Detailed Breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance/Statement
   General Safety and Effectiveness (Implicit)	Substantial equivalence to predicate devices (K51429, K992931 for forceps; K061835, K051429 for cables).
   "Non-Stick" Property (for Forceps)	"This undesirable effect [tissue sticking] can be eliminated by the non-stick properties of the unique solid silver alloy tip forceps of the DORO line. The solid silver alloy tip provides excellent thermal properties and eliminates the difficult and time-consuming of the forceps during a procedure. The non-stick properties are permanent since it is not a coating and the non-stick properties are retained through repeated and frequent sterilizations." (This is a descriptive claim, not a quantitative performance metric with a defined acceptance threshold within this document).
   Compatibility (for Cables)	"The cable fittings are compatible for use with: Erbe, Martin, Valleylab, Aesculap and other ES Generator Units with twin-pin connectors (2-banana plug)."
   Sterilization (by user)	"The user may sterilize these devices by using a validated and applicable sterilization process." "Only a validated steam-sterilization process according DIN EN 554 / ISO 11134 that uses a sterilization cycle of 137°C / 280°F, 3 bar, for min. 15 minutes should be used." (Implicit acceptance is that the device withstands this process and remains functional and sterile.)
   Compliance with Recognized Standards	DIN EN 60601-1: Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988 + A1:1991 + A2:1995); German version EN 60601-1:1990 + A2:1995; Version: 01-Mar-1996; DIN EN 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:1998); German version EN 60601-2-2:2000; Version: 01-Aug-2001; ANSI/AAMI HF18-2001: Electrosurgical Devices: Version: 01-May-2001. (The device's performance is implicit in meeting these standards, but specific criteria and test results are not detailed in this summary.)
   Functionality (Forceps)	"designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch."
   Functionality (Cables)	"designed to transport electrical power from a high-frequency electrosurgical generator by a foot-activated switch."
   Limitations (Forceps)	"The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures." (This is a contraindication/limitation, not a performance metric itself.)

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

   • Not applicable / Not provided. The submission focuses on substantial equivalence to existing devices and compliance with recognized standards rather than a clinical or performance study with a test set of data. The "tests" would have been conducted against the standards themselves (e.g., electrical safety, mechanical durability, sterilization validation), but the details of those internal test sets are not in this summary.

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

   • Not applicable / Not provided. Ground truth establishment by experts is not relevant for this type of device submission where safety and functional compliance to standards are primarily demonstrated.

4. Adjudication method for the test set:

   • Not applicable / Not provided.

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 not an AI/ML device, nor a diagnostic device that involves human readers interpreting results.

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

   • Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

   • Not applicable. For this type of device, the "ground truth" would be the successful demonstration of compliance with the specified engineering and safety standards (e.g., electrical resistance within limits, mechanical strength, material biocompatibility, successful sterilization cycles), rather than clinical outcomes or expert consensus.

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this traditional medical device submission.

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

   • Not applicable.

Summary of the Study (or lack thereof, in the context of typical "device performance studies"):

The 510(k) K070997 for the DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables relies on a Substantial Equivalence pathway. This means that no specific clinical or performance study (in the sense of a trial with a defined 'test set' against a 'ground truth' for an AI/ML or diagnostic device) is presented within this summary.

Instead, the "study" is an assertion of equivalence and adherence to established regulatory and engineering standards. The key elements for proving acceptance were:

• Predicate Device Comparison: The devices are compared to previously cleared, legally marketed bipolar forceps and reusable cables (e.g., Günter Bissinger Medizintechnik GmbH (K51429), e.g. Link Technology, Inc. (K992931) for forceps; Stryker Silverglide Bipolar Forceps Reusable Cables (K061835) and CLARIS bipolar forceps (K051429) for cables). The claim is that the DORO devices have the same intended use, similar technological characteristics (e.g., material for non-stick properties, cable construction, connectivity), and raise no new questions of safety or effectiveness.
• Compliance with Recognized Standards: The devices are stated to comply with several international and national standards for medical electrical equipment and electrosurgical devices (DIN EN 60601-1, DIN EN 60601-2-2, ANSI/AAMI HF18-2001). This compliance implicitly means they have undergone testing to meet the safety and performance requirements outlined in these standards.
• Sterilization Validation (by user): The document specifies a validated steam-sterilization process, implying that the device was tested to withstand and allow for effective sterilization by the end-user.

In essence, the "proof" is the argument for substantial equivalence and adherence to existing safety and performance standards for electrosurgical accessories, rather than a novel study demonstrating a new type of performance metric.

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The DORO Radiolucent Headrest System is used in open and percutaneous craniotomies and spinal surgeries for rigid cranial fixation and when intraoperative CT imaging is used.

The DORO® J-ARM Retractor Accessory is used to fix tissue retractor during neurosurgical procedures.

The DORO® Radiolucent Headrest System is a device system used as a support during head and neck surgery. It is composed of several components which are fabricated of materials that allow it to be radiolucent on x-ray. These components are:

• 1. the adjustable Base Unit,
• 2. the Skull Clamp, and
• 3. the Swivel Adaptor,
• 4. Horseshoe Headrest Adult and Children

It is suitable for use in adults and children when the appropriate components are selected.

The DORO System uses a three-point fixation of the head during surgery in the prone, supine, lateral, and sitting positions. The double clamping of the Adjustable Base unit provides simultaneous fixation of the lateral and vertical positions. The Crossbar is used for connection to the side rails of standard operating tables for fixation in a sitting position. The Swivel Adaptor is used in the base unit to provide 360 degree rotation.

The DORO Headrest System, except for the disposable Skull Pins, is sold non-sterile. The Base Unit, Swivel Adaptor and Skull Clamp are intended to be cleaned by the user between uses. It is intended to be used with Disposable, Skull Pins which were cleared with the DORO Headrest System (K001808).

The components of the DORO Headrest System are made of the following materials:

Skull Clamp is made of NOVOTEX laminated fabric with phenolic resin (GRP) colored with BASANTOL black X82 liqu1d and POM (Delrin), PEEK and Polyurethan.

The Swivel Adaptor and the Horseshoe Headrest in adult and pediatric versions, made of Novotex, PEEK and POM

The Base is made of Novotex, PEEK, POM and aluminum.

The J-Arm Retractor System is made of aluminum alloy and is not radiolucent.

The DORO Radiolucent Headrest System can also be used with accessories from the predicate DORO Headrest System (K001808) with Elastic Pads for adults, Headrest supports with one or two Elastic Pads, single Pin Holders, dual Pin Holders for adults, dual Pin Holders for children, a Multi-Purpose Skull Clamp with six Pin fixation or three Elastic Pads).

The DORO Radiolucent Headrest System can also be used with the J-Arm Retractor and Halo Retractor Assembly (K001808) which allows for use as a support and retraction device during neurosurgical procedures where retraction of the brain tissue and handrest are needed.

The provided 510(k) summary for the DORO® Radiolucent Headrest System does not contain information about specific acceptance criteria, device performance metrics, or any detailed studies demonstrating the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, construction, intended use, and performance characteristics, as required for a 510(k) submission. It briefly mentions materials and intended use but does not present quantitative performance data or a study design.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are listed. The submission asserts "similar performance characteristics" to predicate devices without providing explicit data.
2. Sample size used for the test set and the data provenance: No test set is described, and thus no sample size or data provenance is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set 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. The device is a physical medical instrument (surgical head holder), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no ground truth is discussed for a study.
8. The sample size for the training set: Not applicable as there is no training set for a study of this nature.
9. How the ground truth for the training set was established: Not applicable.

The document states that "Performance standards for sheath introducers have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." This implies that the submission relies on substantial equivalence rather than meeting specific pre-defined performance standards or conducting extensive performance studies beyond what's needed for safety and equivalence claims.

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