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Oral Surgery Contra is for oral surgery. This device is driven by an electronic micromotor for oral surgery and dental implant. This device aims to transfer the rotation of the power source with various gear ratios, and moves instruments such as a surgical bur to cut the maxillary/mandibular bone during oral surgery treatment.

The Ti-Max Series Oral Surgery Contra handpieces, X-SG93L, X-SG93 and X-SG25L, are contra-angle handpieces that are intended for use by a clinician in a healthcare facility/hospital setting for oral surgery and preparation for dental implant operation. The subject handpieces are available in two options: 1) fiber optic glass (X-SG93L and X-SG25L) or 2) non-optic (X-SG93). The Oral Surgery Contra handpieces are driven by a micromotor, thereby rotating surgical burs at different transmission gear ratios, to cut the maxillary/mandibular bone during oral surgery and preparation for dental implant surgery. The maximum rotational speeds of the handpieces are as follows: 120,000 min-1 for the X-SG93L and X-SG93 models; 40,000 min-1 for the X-SG25L model. The maximum rotation speed depends on the transmission gear ratios as follows:

• X-SG93L and X-SG93: ISO 1797 Type 3 FG burs (φ1.59 - 1.6 mm)
• X-SG25L: ISO 1797 Type 1 CA burs (φ2.334 - 2.35 mm).
  The Oral Surgery Contra handpieces are a prescription-only device.

This document describes a 510(k) premarket notification for the "Oral Surgery Contra" device. It is a submission for substantial equivalence based on comparisons to predicate and reference devices, and no clinical studies were conducted that prove device meets acceptance criteria.

Here's an analysis based on the provided text:

No clinical studies were performed. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the Oral Surgery Contra." Therefore, there is no information in the provided text regarding acceptance criteria for device performance based on clinical outcomes, nor any study proving the device meets such criteria through clinical data.

The "Summary of Performance Testing" section mentions "verification/validation testing to internal functional specifications" and conformance to various ISO standards (AAMI/ANSI/ISO 17665-1:2006 for sterilization, ISO 14457:2012 for handpieces and motors, and AAMI/ANSI/ISO 10993-1: 2018 for biocompatibility). These are bench tests and evaluations, not clinical studies involving patients or expert review of clinical images/data.

Therefore, since no clinical study was performed, the following requested information cannot be provided from the text:

1. A table of acceptance criteria and the reported device performance: Not applicable for clinical performance.
2. Sample sized used for the test set and the data provenance: Not applicable as there was no test set from a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 device is a mechanical handpiece, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a mechanical handpiece, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document describes a regulatory submission relying on substantial equivalence to predicate devices and bench testing, rather than novel clinical performance studies.

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The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, oral surgery (such as root tip resection. bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).

The Surgical Straight/Angle Handpiece features an allowable maximum motor speed at 40,000min-1. The handpieces are provided non-optic. The handpieces are designed with an angle appearance and a straight appearance. Models are available to be connected directly onto motors compliant to ISO 3964. All the devices are manufactured using stainless steel with some aluminum, and use a Bur Lock Ring Chuck Design. Available models include: Straight (1:1)- SGS-E, SGS-ES; Straight (1:2) - SGS-E2G, SGS-E2S; Angled (1:1) - SGA-E, SGA-ES; Angled (1:2) - SGA-E2G, SGA-E2S.

The provided text is a 510(k) summary for the "Nakanishi Inc. Surgical Straight/Angle Handpiece." This document describes a medical device seeking substantial equivalence to existing devices, not an AI/ML powered device. As such, it does not contain information related to acceptance criteria or studies involving AI/ML algorithms, human readers, ground truth, or training sets.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them from the given text.

The document discusses:

• Device Name: Surgical Straight/Angle Handpiece
• Intended Use: Oral surgical and dental use (e.g., sectioning and removal of wisdom teeth, oral surgery, implant treatment).
• Technological Characteristics: Maximum motor speed, non-optic, Bur Lock Ring Chuck Design, materials (stainless steel, aluminum), external water supply.
• Performance Testing: Bench testing against technical standards and internal specifications, sterilization validation (AAMI/ANSI/ISO 17665-1:2006, FDA Guidance for Reprocessing Medical Devices), biocompatibility evaluation (AAMI/ANSI/ISO 10993-1, FDA Guidance), and electrical safety (ISO 14457).
• Conclusion: The device is considered substantially equivalent to predicate devices based on similarities in intended use, principles of operation, functional design, and established medical use.

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The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with dental, orthognathic, and mandibular surgical procedures.

The PINNACLE Driver is a handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes. The device operates in both the forward and reverse directions. A sterile, single use battery powers the device and is intended for use solely with the PINNACLE Driver. Accessories for the PINNACLE Driver include hex shank drills and driver stems. The optional driver stems are reusable while the drills are single use. The PINNACLE Driver may be sterilized individually wrapped in two layers of 1-ply polypropylene wrap or unwrapped in a sterilization organizational tray inside a rigid sterilization container, which is available from OsteoMed.

The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device.

The PINNACLE Driver and lithium battery is made of medical grade stainless steel, aluminum, silicone, PEEK, gold plated brass, and medical plastic. The driver stems and drills are made of medical grade stainless steel. The sterilization organizational trays and rigid sterilization containers are made of aluminum.

The PINNACLE Driver is a battery operated driver/drill that operates in the both in the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.

The provided document is a 510(k) premarket notification for a medical device called the "PINNACLE Driver." It describes the device, its intended use, comparison to predicate devices, and performance data to support substantial equivalence.

Based on the information provided, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device for diagnostic or prognostic purposes, nor does it refer to a multi-reader multi-case (MRMC) comparative effectiveness study.

The "PINNACLE Driver" is a surgical tool (battery-operated driver/drill for bone, primarily for dental, orthognathic, and mandibular procedures). The "software" mentioned in the document is for torque limiting ("senses torque to prevent over-torquing and stripping of screws") and "bit recognition," not for diagnostic interpretation or image analysis.

Therefore, many of the requested elements (e.g., ground truth, sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm) are not applicable to this type of device and its regulatory submission.

However, I can extract the closest applicable information regarding "acceptance criteria" and "performance study" for this mechanical/software-controlled surgical device:

Acceptance Criteria and Device Performance (for a Mechanical/Software-Controlled Surgical Device)

Since this is a mechanical surgical device with integrated software for operational control (torque limiting), the "acceptance criteria" and "performance" are primarily addressed through engineering and safety standards, and bench testing, rather than diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of diagnostic data. Performance was evaluated through bench testing of the device itself (e.g., simulated use, electrical safety tests, sterilization validation). The number of test units or iterations for these engineering tests is not specified in this summary.
• Data Provenance: Not applicable as it's not a clinical data study for algorithm development. The "data" refers to the results of engineering tests conducted by the manufacturer, OsteoMed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This pertains to establishing ground truth for diagnostic data. For this device, "ground truth" would be established by engineering specifications, validated test methods, and compliance with recognized standards (e.g., IEC 60601). The "experts" would be the engineers, quality control personnel, and regulatory affairs specialists involved in the device design, manufacturing, and testing process.

4. Adjudication Method for the Test Set

• Not applicable. This applies to human review of diagnostic cases. For this device, compliance is determined by successful completion of specified engineering tests and validation protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is specifically for evaluating the impact of AI assistance on human readers in diagnostic tasks. The PINNACLE Driver is a surgical tool, not a diagnostic imaging device.

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

• Not applicable in the context of an AI algorithm for diagnostic purposes. The "software" in this device controls mechanical function (torque limiting, bit recognition). Its "standalone performance" is validated through the engineering bench tests (e.g., demonstrating it can limit torque as designed).

7. The Type of Ground Truth Used

• Engineering Specifications and Recognized Standards: The "ground truth" for this device's performance is adherence to its design specifications, established engineering tolerances, and compliance with relevant international and national safety and performance standards (e.g., IEC 60601-1 for electrical safety, ISO standards for biocompatibility). For the software component, the ground truth is its ability to correctly execute its programmed functions (e.g., accurately sense torque, correctly identify bits) as per its design requirements and software validation protocols.

8. The Sample Size for the Training Set

• Not applicable. This device's software is not based on machine learning that requires a "training set" of data in the typical sense (e.g., medical images). It's software for operational control.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As above, there's no "training set" in the context of AI/ML. The "ground truth" for its simple, rule-based software is defined by its functional specifications and verified through testing.

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Surgical treatment of dental hard tissue in oral and maxillo-facial surgery

Surgical handpieces and Mikro saw handpieces have been designed to transmit the rotational movement of the motor axle to the shank of a bur or a saw blade which will be inserted into the output end of the handpiece. They fit all surgical drive units and surgical motors with a coupling system according to ISO 3964. The user manual points out the recommendations for the different handpiece types covered by this application.

Here's an analysis of the provided text regarding the acceptance criteria and study for the W&H Dentalwerk Buermoos GmbH surgical handpieces:

It's important to note that the provided document is a 510(k) summary for a dental surgical handpiece, which is a mechanical device. The information requested in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set, etc.) is primarily relevant for AI/ML-based medical devices or diagnostic tools that involve interpreting data or images.

For a mechanical device like a surgical handpiece, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally focused on bench testing to ensure mechanical, electrical, and material performance, as well as safety and effectiveness compared to a predicate device. There is no AI/ML component to this device.

Therefore, many of the requested fields cannot be directly answered from the provided text, as they are not applicable to the type of device being described.

Here's a breakdown of what can be extracted and what cannot:

Device: Surgical straight handpiece SI-11 LED G, Surgical contra-angle handpiece WI-75 LED, Mikro saw handpieces S-8 R, S-8 O, S-8 S

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

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

• Not Applicable / Not Provided. For a mechanical device, "sample size" and "data provenance" in the context of a "test set" (as typically understood for AI/ML) are not relevant. Performance was assessed via bench testing, which involves physical testing of the device prototypes/samples. The specific number of physical units tested is not provided, nor is the "country of origin of data" in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This device does not involve a "ground truth" established by experts in the diagnostic sense. The performance evaluation is based on engineering principles and physical measurements from bench testing.

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

• Not Applicable. No expert adjudication method was employed as there is no diagnostic output requiring such a process.

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 tool, not an AI-assisted diagnostic device. No MRMC study was performed.

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

• Not Applicable. There is no algorithm or AI component in this device.

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

• Not Applicable / Engineering Standards & Predicate Comparison. The "ground truth" for this type of device is adherence to engineering specifications, performance parameters validated through bench testing, and demonstrating substantial equivalence to the legally marketed predicate device(s).

8. The sample size for the training set

• Not Applicable. This device does not have a "training set" as it does not involve machine learning.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided document details the 510(k) clearance for a mechanical dental surgical handpiece. The "acceptance criteria" and "study" described are typical for such devices, primarily relying on bench testing to demonstrate performance and substantial equivalence to existing predicate devices, particularly regarding mechanical function, material compatibility, and safety. The questions posed in the prompt are almost entirely tailored to AI/ML-based diagnostic devices and, therefore, do not align with the nature of this product.

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The FRIOS MicroSaw is indicated for use in preparing bone in conjunction with dental and craniofacial surgical procedures.

The FRIOS MicroSaw is a series of instruments used in preparing bone in dental and craniofacial surgical procedures. The MicroSaw components are used in conjunction with the FRIOS Contra-Angle and Straight Handpieces. The MicroSaw consists of the disc for cutting bone, the drill for predrilling techniques and the chisel for elevating and luxating bone. The FRIOS MicroSaw also includes a protector which is attached to the handpiece which is designed to protect the soft tissue and limit the cutting depth.

The provided text is a 510(k) summary for the FRIOS MicroSaw, a device used in dental and craniofacial surgical procedures. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a novel AI or diagnostic device.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Study for FRIOS MicroSaw

This 510(k) submission for the FRIOS MicroSaw focuses on demonstrating substantial equivalence to a previously cleared predicate device (OsteoMed Corporation OsteoPower System and Accessories, K971692). This type of submission does not typically involve a clinical study with specific performance acceptance criteria as would be seen for a new diagnostic or AI-driven device. Instead, the acceptance criterion is generally that the device is as safe and effective as the predicate device, based on similar technological characteristics and intended use.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. This submission is based on a comparison of technological characteristics and intended use to a predicate device, not on a test set or clinical data with a sample size.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. Ground truth, in the context of clinical studies with expert consensus, is not relevant for this substantial equivalence submission for a surgical instrument.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or associated adjudication was performed for this submission.

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 device is a surgical instrument, not an AI or diagnostic tool where MRMC studies are typically performed.

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

• Not Applicable. This device is a manual surgical instrument and does not involve any algorithm or AI component.

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

• Not Applicable. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device, as determined by the FDA. The comparison relies on documented design, materials, and functional specifications.

8. The Sample Size for the Training Set:

• Not Applicable. There is no training set as this is not an AI or data-driven device.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. No training set was used.

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Osteomed Corporation intends to market the OsteoPower System and Accessories for drilling or cutting bone or teeth, and for driving screws and/or pins and wires into bone, in conjunction with dental, craniofacial, craniotomies, orthognathic, spinal, mandibular, hand, foot, wrist, and extremity reconstruction surgical procedures.

OsteoPower System and Accessories

I am sorry, but the provided text from the FDA 510(k) notification for the "OsteoPower System and Accessories" does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document is a letter from the FDA to Osteomed Corporation, dated June 27, 1997, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classification, general controls, and provides contact information for further guidance. The "Indications for Use" are also described.

Therefore, I cannot provide the requested information based on the provided input.

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