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The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant

The Bioplate® Titanium Fixation System includes a variety of plate configurations for different anatomical applications. Unalloyed commercially pure Grade 1, Grade 2 and Grade 4 titanium and titanium allov plates, and titanium allov screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial bony tissues. These materials have been implanted safely for many years. The predicate device had been approved under K022033.

The bone plates will be manufactured of unalloyed, commercially pure titanium and titanium 6A1-4V Eli alloy. The materials adhere to the American Society of Testing and Materials (A.S.T.M.) F67 Standards and the American Society of Testing and Materials ( A.S.T.M.) F136 Standard.. The screw will be manufactured of a titanium 6A1-4V Eli alloy that meets the American Society of Testing and Materials (A.S.T.M.) F136 Standard.

The plate and screw fit configurations are sterilized by gamma radiation sterilization, using VD Max dose setting method. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the device has been achieved and can be maintained.

The provided text is a 510(k) summary for a medical device (Modified Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System) and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria as would typically be seen for a new or novel device.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document states:

• Comparison of the device's technological characteristics with those of the predicate devices: "All the technical characteristics of the sterile plate and screw kit configurations for use Bioplate® Titanium Fixation System are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy."
• The materials used have been implanted safely for many years.
• Sterilization validation and packaging validation studies were successfully completed, providing a high level of assurance of sterility.

The "acceptance criteria" in this context are effectively demonstrating that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The study proving this involves comparing the new device's specifications (materials, sterilization method, intended use) against those of established predicate devices.

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The Sterile Bioplate ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

The Bioplate ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques. The device will be packaged and provided Sterile ( by gamma radiation)

This document describes a 510(k) premarket notification for a modified design of the Bioplate ZIP® Craniotomy Fixation System. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of device performance as one might expect for a diagnostic or AI-based device. Instead, this is a traditional medical device submission focused on substantial equivalence to predicate devices for regulatory clearance.

Therefore, many of the requested categories about acceptance criteria, study design, and ground truth are not applicable to this type of submission. The provided text does not contain any performance data from a clinical or analytical study in the way these questions are typically posed for AI/diagnostic devices.

Here's an assessment based on the provided text, indicating where information is present versus where it's absent or not applicable:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for performance metrics. The underlying acceptance criterion for this type of submission is "substantial equivalence" to predicate devices regarding safety and efficacy.
• Reported Device Performance: No performance metrics (e.g., accuracy, precision, sensitivity, specificity) are reported. The submission focuses on demonstrating that the modified design's technical characteristics are "substantially equivalent" to predicate devices and raise "no new issues of safety and efficacy."

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. There is no mention of a "test set" or data provenance in the context of device performance evaluation. The submission relies on a comparison of technical characteristics and intended use.

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. There is no "ground truth" establishment in the context of a performance study for this device type within this document. Regulatory review is done by FDA reviewers.

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

• Not applicable. No test set or expert adjudication process is described for performance evaluation.

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 physical implant (craniotomy fixation system), not an AI or diagnostic tool involving "human readers" or "AI assistance."

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. As there's no performance evaluation in the traditional sense, there's no "ground truth" specified for such an evaluation. The "truth" for this submission is that the device's technical characteristics and intended use are similar enough to previously cleared devices.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of physical device submission.

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

• Not applicable.

Summary based on the provided text:

This 510(k) submission (K082175) for the modified Bioplate ZIP® Craniotomy Fixation System describes a physical device intended to reattach a cranial bone flap. The "study" (or rather, the regulatory approach) detailed here is a demonstration of substantial equivalence to predicate devices (K070901, K013050, K020088).

The "acceptance criteria" and "study" are implicitly tied to the FDA's declaration of substantial equivalence. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that the provided information regarding the device's technological characteristics and intended use adequately demonstrated that it did not raise new questions of safety or efficacy compared to the predicate devices.

The document does not elaborate on specific engineering tests or biocompatibility assessments that would typically be part of such a submission, only that the "technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." These underlying tests would form the basis for proving that the device itself meets its design specifications and is safe, but the submission summary does not provide their details.

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The Bioplate® ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

The Bioplate® ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques.

This document describes the Bioplate® ZIP® Craniotomy Fixation System and its substantial equivalence to predicate devices, focusing on regulatory approval rather than a detailed performance study with acceptance criteria. As such, most of the requested information regarding acceptance criteria, study details, sample sizes, and expert adjudication for a device performance study is not available in the provided text.

The text primarily covers:

• Device identification and classification
• Intended use
• Comparison to predicate devices, stating "All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy."
• FDA's 510(k) clearance, indicating substantial equivalence to legally marketed predicate devices without requiring a full clinical performance study with specific acceptance criteria.

Therefore, many parts of your request cannot be fulfilled based on the provided input.

Here is the information that can be extracted or deduced:

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The modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surqical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone fixation. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery include a variety of plate configurations for different anatomical applications. Unalloyed commercial pure Grade 1, 2 and 4 titanium, titanium alloy plates as well as titanium alloy screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial tissues.

The provided document does not contain information about acceptance criteria or a study proving the device meets them. It's a 510(k) premarket notification for a medical device (bone fixation plates for craniomaxillofacial surgery), and the FDA letter indicates that the device has been found substantially equivalent to predicate devices.

Therefore, I cannot provide the requested table and study details.

Here's why the information isn't present in this document:

• 510(k) Substantial Equivalence: This regulatory pathway (510(k)) primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics and intended use, not necessarily providing new performance studies against specific acceptance criteria.
• Lack of Clinical Study Details: The document focuses on regulatory classification, intended use, and comparison to predicate devices, not on detailed clinical trial results or performance against quantitative acceptance criteria for a novel technology like an AI device would require.
• Device Type: The device described is a physical medical implant (bone fixation plates), not an AI/software as a medical device (SaMD). Performance for such physical devices is often evaluated through bench testing, material properties, and sometimes animal studies, rather than the types of clinical or reader studies described in your prompt for AI.

If you are looking for information regarding acceptance criteria and performance studies for an AI/SaMD, you would typically find that in a much more detailed clinical study report or a different section of a regulatory submission.

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The Bioplate Resorbable Bone Fixation Tack will be used to support non-load bearing tissues of the craniomaxillofacial anatomy, including but not limited to brow fixation.

The Bioplate Resorbable Bone Tack consists of a bone fixation device manufactured from a Poly (L-lactide-co-DL-lactide) co-polvmer that has been implanted safely for a number of years. The bone fixation devices will be provided sterile to the end-user, using gamma radiation as the method of sterilization and are not intended for re-sterilized by the enduser.

The provided text is a 510(k) premarket notification for a medical device (Bioplate Resorbable Tack for craniomaxillofacial surgery) and not a study report demonstrating the device meets acceptance criteria.

Therefore, none of the requested information (acceptance criteria, reported device performance, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, or training set details) can be extracted from this document, because such information is not typically part of a 510(k) summary for this type of device.

510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies with acceptance criteria in the manner described in the prompt. The text confirms substantial equivalence to predicate devices (K996040 and K012908) based on similar technological characteristics and restrictive indications for use.

In summary, there is no information in the provided text to fulfill the request.

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The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation. including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The modified screw designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and may be used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for a medical device (Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery) which asserts "substantial equivalence" to previously marketed predicate devices.

The document states: "All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." This indicates that the device's characteristics were compared to existing, approved devices, and no new studies demonstrating performance against specific acceptance criteria were necessary for this 510(k) clearance process.

Therefore, I cannot provide the requested information in the table or address points 2 through 9, as they pertain to a type of study that was not described or performed for this specific submission based on the provided text.

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The Bioplate® Riqid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The supplementary label/labeling material will be used for training and promotional purposes and does not affect the intended use of the devices.

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and are used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.

The provided text is a 510(k) premarket notification for a medical device – The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery. This document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a robust clinical trial with AI would.

Therefore, many of the requested sections (e.g., AI performance, MRMC study, ground truth for training data) are not applicable to this type of submission. The document relies on a comparison of characteristics and intended use to predicate devices that were already legally marketed.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or device performance measurements in the typical sense of a clinical study. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to existing legally marketed predicate devices. The "reported device performance" is implicitly that the device performs equivalently to the predicates.

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

Not applicable. This 510(k) submission does not describe a clinical "test set" in the context of evaluating a new performance claim or an AI algorithm’s accuracy. Substantial equivalence is typically demonstrated through bench testing (mechanical properties, material composition, etc.) and comparison to predicate devices, rather than a prospective clinical study with a patient test set for performance comparison. The document does not provide details on specific bench tests conducted or the data generated from them beyond general statements.

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

Not applicable. As there is no "test set" for performance evaluation against a ground truth in the context of an AI device, this information is not provided. The 'ground truth' here is essentially established by the historical performance and regulatory approval of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No "test set" and corresponding adjudication method are described for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical medical implant (bone plating system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in the context of this 510(k) submission is the established safety and efficacy of the predicate devices already on the market. The Bioplate® system is deemed safe and effective because it is substantially equivalent to these already accepted devices. This is a regulatory "ground truth" rather than a clinical ground truth like pathology or outcomes data for a novel performance claim.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As above, there is no AI algorithm or training set for this device.

In summary, this 510(k) submission for The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery demonstrates substantial equivalence to existing predicate devices by showing it has the same intended use and similar technological characteristics, raising no new safety or efficacy concerns. The requested information regarding acceptance criteria, study details, and AI performance metrics are primarily relevant for AI/ML-based medical devices or devices demonstrating novel clinical performance, which this implantable device is not.

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The modified plates designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The modified plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Commercially pure titanium plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxilloffacial bony tissue. The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards.

The provided text describes a 510(k) premarket notification for a medical device, the "Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." This submission focuses on modifications to existing predicate devices.

Crucially, this document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way one might expect for a new AI/software device or a device requiring clinical performance validation.

Instead, this 510(k) summary is centered on demonstrating substantial equivalence to previously cleared predicate devices. The "study" here is essentially a comparison to existing devices, asserting that the modified plate designs are functionally the same and raise no new safety or efficacy concerns.

Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown based on the provided text, indicating where information is present and where it is absent/not applicable:

Acceptance Criteria and Device Performance Study for Bioplate® Rigid Fixation Bone Plating System

As this is a 510(k) premarket notification affirming substantial equivalence for device design modifications, the "acceptance criteria" and "study" are framed around similarity to predicate devices rather than novel performance benchmarks.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This submission doesn't describe a clinical or performance "test set" in the traditional sense for evaluating a new device's performance against specific metrics. It's a comparison to existing predicate devices.
• Data Provenance: Not applicable. No new efficacy data from human subjects or retrospective/prospective studies are presented for the modified designs. The data "provenance" here relates to the established safety and efficacy of the predicate devices.

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

• Number of Experts & Qualifications: Not applicable. No "ground truth" for a test set was established by experts for this submission. The determination of "substantial equivalence" is made by the FDA based on the comparison provided by the manufacturer.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was conducted or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This type of study is not mentioned as it is irrelevant for a submission focused on demonstrating substantial equivalence of minor design modifications to existing hardware. There is no AI component or human-in-the-loop performance being evaluated.
• Effect Size of Human Readers with/without AI: Not applicable. No AI component is described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Not applicable. This device is a physical bone plating system, not an algorithm or software.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the established safety and efficacy profile of the legally marketed predicate devices. The submission argues that the modified device is equally safe and effective due to its substantial equivalence. There is no new "ground truth" derived from pathology, outcomes data, or expert consensus specifically for these modified plates beyond the assertion that they are functionally similar to the predicates.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.

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

• Ground Truth for Training Set: Not applicable. No training set for an algorithm was used.

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The modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Modified plate designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. The bone plates will be manufactured of commercially pure titanium.

This is a 510(k) premarket notification for a medical device (Modified plate designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, explicit "acceptance criteria" for device performance in the context of an AI study, and a "study that proves the device meets the acceptance criteria" as typically described for AI/algorithm performance, are not present in the provided text.

The document primarily relies on comparison with predicate devices to establish substantial equivalence regarding technological characteristics and intended use.

However, I can extract information related to the device and its intended purpose, which could hypothetically form the basis of acceptance criteria if this were an AI device.

Here's a breakdown of the requested information based on the provided document, noting that many items are not applicable (N/A) because this is not an AI device or an AI study:

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

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

• N/A. This is a 510(k) submission for a physical medical device, not an AI device or an AI study. There is no "test set" in the context of an algorithm's performance. The submission relies on a comparison of technical characteristics to predicate devices.

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)

• N/A. Since this is not an AI device or an AI study, there is no ground truth, test set, or experts establishing ground truth in this context. The FDA's review process itself involves experts within the agency, but this is for regulatory clearance based on substantial equivalence, not for evaluating an algorithm's performance against a ground truth.

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

• N/A. As there is no test set for an algorithm, there is no adjudication method 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

• N/A. No MRMC study was done, as this is not an AI device.

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

• N/A. This is a physical medical device, not an algorithm.

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

• N/A. There is no ground truth described as this is not an AI study. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices and the physical properties of the materials and design.

8. The sample size for the training set

• N/A. This is a physical medical device, not an AI algorithm, so there is no training set.

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

• N/A. As there is no training set, there is no ground truth for it.

In summary, the provided document is a 510(k) summary for a physical medical device (bone plates and screws). The regulatory pathway for such devices primarily involves demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than conducting new clinical trials or performance studies with specific statistical acceptance criteria as would be the case for a novel AI/software as a medical device (SaMD).

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The Bioplate® Battery Powered Drill is intended to be used to drill pilot holes to facilitate the insertion of self-tapping bone screws in surgical procedures on a patient's skull.

The Bioplate® Battery Powered Drill is not intended for bone cutting or bone shaping indications.

The Bioplate® Battery Powered Drill is comprised of a metal housing, containing the motor, designed to withstand steam sterilization. Two forward speeds are activated using control buttons on the body of the unit. There is no reverse. The operating portion of the instrument has a quick release mechanism that is designed to hold stainless steel drill bits for drilling pilot holes into bony tissue prior to insertion of self-tapping bone screws. Four (4) AAA batteries (sterile, unitized or non-sterile) are inserted into the back portion of the handle prior to use.

This document is a 510(k) premarket notification for a medical device submitted to the FDA in 2002. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as requested in the prompt.

The document primarily focuses on establishing "substantial equivalence" of the Bioplate® Battery Powered Drill to existing predicate devices. This type of regulatory submission in 2002 generally relies on comparing the new device's technical characteristics and intended use to already legally marketed devices, rather than presenting a standalone clinical study with detailed performance metrics and acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, number of experts for ground truth, or adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• A standalone algorithm performance study.
• The type of ground truth used.
• Sample size for a training set or how ground truth for a training set was established.

The "Summary of Safety and Effectiveness" section within the 510(k) summary for this type of device typically just states that the device is substantially equivalent to predicates and that any minor differences raise no new issues of safety and effectiveness, based on comparison of technical specifications rather than clinical trial data meeting predefined acceptance criteria.

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