The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.

The evonos evoDrill cranial perforator are single-use for trephining the cranial bone. The perforators have an automatic stop mechanism that stops the trephination process as soon as the skull bone has been pierced. The two variants evoDrill cranial perforator 3-flutes and evoDrill cranial perforator 4-flutes are available in two versions that are suitable for different bone thicknesses.

The first version is used from bone thicknesses of 3mm, the second version is used for trepanation with bone thicknesses between 1mm and 3mm. Both variants are available in four different diameters.

The evonos evoDrill cranial perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr holes through the skull of a patient. The evonos evoDrill cranial perforator are devices similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra Cut Automatic Cranial Drill DGR-1 #200-241; DGR-II #200-251 and Codman Disposable Perforators 26-1222, 26-1223). The evonos evoDrill cranial perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 RPM to 1500 RPM.

The provided text describes a 510(k) premarket notification for the "evoDrill Cranial Perforator," a single-use surgical device used for cranium perforation. The document focuses on demonstrating substantial equivalence to predicate devices through various tests, including biocompatibility, sterilization, and cutting performance.

However, the provided document does not contain information related to an AI-based or software-driven medical device study. The device described is a mechanical surgical tool. Therefore, several of the requested information points, such as AI-specific acceptance criteria, multi-reader multi-case studies, ground truth establishment for training sets, etc., are not applicable and cannot be extracted from this document.

The available information pertains to the performance testing of a physical medical device.

Information Extracted from the Provided Document:

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

Based on the "PERFORMANCE TESTING" section:

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

• The document states "All tested specimen confirm..." for sterilization and cutting performance, and "All biocompatibility testing confirmed..." for biocompatibility. However, specific numerical sample sizes are not provided for any of these tests.
• Data Provenance: Not explicitly stated, but given the manufacturer (evonos GmbH & CO. KG) is based in Germany, the testing was likely conducted in Germany or a location compliant with international standards referenced (ISO). The terms "retrospective or prospective" are not applicable to the type of device and testing described.

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

• This concept is not applicable to the acceptance criteria and testing described for this mechanical device. Ground truth, in this context, would refer to objective measurements of device performance (e.g., sterilization levels, mechanical integrity, functional features) rather than expert interpretation of medical images or data.

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

• This concept is not applicable to the acceptance criteria and testing described for this mechanical device. Adjudication methods are typically used in studies involving subjective interpretation, often by multiple readers, which is not the case here.

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 cranial perforator, not an AI-based diagnostic or assistive software. No human reader study, AI assistance, or MRMC study was performed or mentioned.

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

• Not applicable. This is a mechanical device, not an algorithm or software. Its performance is inherent to its physical properties and design.

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

• For this mechanical device, the "ground truth" for the performance tests would be based on objective measurements and adherence to engineering and medical device standards (e.g., ISO standards).
  • For biocompatibility: Lab results adhering to ISO 10993.
  • For sterilization: Lab results showing a validated Sterility Assurance Level ($10^{-6}$) per ISO 11137.
  • For cutting performance: Mechanical measurements of auto-stop functionality, drilling time, and resulting burr hole characteristics against defined specifications and implied comparison to predicate device performance. It doesn't involve medical "outcomes data" in the sense of patient follow-up or disease progression, but rather the immediate success of the mechanical function.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not applicable. As above, it's a mechanical device, not an AI model.

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NeuroLine perforators are designed to make holes in the skull bone. The perforators have an integrated safety mechanism that releases automatically after passing through the bone and stops drilling.

The NeuroLine Disposable Cranial perforators (NLO-x/y-z) are single-use cutting devices that are packaged sterile and are used to perforate the skull bone. The perforator functions automatically, which means that it employs a clutch mechanism to automatically disenqage once perforation is accomplished and as the drill ceases to find resistance to bone.

The perforator has Hudson type connection and can connect to all the driver units with Hudson connection.

Perforators are offered in three different sizes: 6/9 mm, 7/13 mm and 11/14 mm. Sizes indicate hole diameters to be made by perforators in millimeters.

Perforators are also differentiated based on the thickness of skull bone. The NLO-x/y-3.0 perforators are used on skulls at least 3 mm thick, whereas NLO-x/y-1.5 ones are used on skulls at least 1.5 mm thick.

The provided text describes the regulatory clearance for a medical device, the NeuroLine Disposable Cranial Perforator with Hudson End, and details the performance testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document is a 510(k) summary for a mechanical device (a surgical drill), not an AI/ML-driven device or diagnostic tool.

Therefore, the information required to answer your questions about acceptance criteria and studies proving the device meets them, specifically in the context of AI/ML performance, ground truth establishment, expert adjudication, and MRMC studies, is not present in the provided text.

The document discusses:

• Acceptance Criteria (for a mechanical device): These are implicitly met by "Pass" results in the performance testing section. The specific criteria are related to Biocompatibility (ISO 10993), Sterilization and Packaging validation (ISO 11137-1/2, ISO 11607-1/2), and Bench Testing for automatic stop function, maximum number of uses, drilling time, and device geometry.

• Study Proving Device Meets Criteria: This refers to the "Performance Testing" section:

  • Biocompatibility: Tests conducted in accordance with ISO 10993.
  • Sterilization and Packaging Validation: Tests conducted in accordance with ISO 11137-1, ISO 11137-2, ISO 11607-1, and ISO 11607-2.
  • Bench Testing: Evaluated automatic stop function mechanism, maximum number of uses, drilling time, and device geometry.

None of the following questions can be answered from the provided text as they pertain to AI/ML device evaluations, which is not the subject of this document:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): The device is not an AI/ML device. The "Pass" results are reported for mechanical and biological performance.
2. Sample sizes used for the test set and the data provenance: Not relevant for this mechanical device.
3. Number of experts used to establish the ground truth... and qualifications: Not relevant. No "ground truth" in the AI/ML sense is established. Performance is measured against mechanical specifications.
4. Adjudication method for the test set: Not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant.
7. The type of ground truth used: Not relevant in the AI/ML context. Performance against mechanical specifications is the "truth."
8. The sample size for the training set: Not relevant. There is no AI/ML training set.
9. How the ground truth for the training set was established: Not relevant.

In summary, the provided document is about a hardware medical device (a cranial perforator) and its regulatory clearance based on mechanical, sterility, and biocompatibility testing, not an AI/ML or diagnostic software device.

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The Codman Disposable Perforator is for use in perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. When properly used, the Disposable Perforators are designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point. They are designed with a Hudson end and are available in three color-coded sizes:

• 14mm (blue ABS sleeve) – product number: 26-1221
• 11mm (green ABS sleeve) product number: 26-1222 ●
• 9mm (yellow ABS sleeve) product number: 26-1223 ●

This document describes a 510(k) premarket notification for "Codman Disposable Perforators," which are medical devices used to perforate the cranium. The submission aims to demonstrate substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

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

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The EasyDrill Autostop Cranial Perforator is a sterile, single use cutting device intended for performing cranial bone trephination.

The EasyDrill Autostop Cranial Perforator comprises of an Inner and Outer Drill, and a Hudson Shank that is designed to lock onto a Pneumatic or an Electric Drill Motors.

The EasyDrill Autostop Cranial Perforator device is a bone cutting and drilling instrument used in conjunction with a surgical motor and a Hudson Chuck - speed reducer attachment, to drill access holes through a patient's skull. When properly used, the EasyDrill Autostop Cranial Perforator employs a clutch mechanism to automatically disengage once perforation is accomplished and as the drill ceases to find resistance to bone.

The EasyDrill Autostop Cranial Perforator is a mechanically powered tool, designed to create an access hole through the skull. The subject Perforator device derives its mechanical torque and rotational speed from various legally marketed Electric and/or Pneumatic Drill Motors. The EasyDrill Autostop Cranial Perforator device is latched onto a Hudson Chuck device, which is in turn attached to the Drill Motors.

The EasyDrill Autostop Cranial Perforator is provided Gamma Sterilized, in a sealed packaging and is designed for single patient use only.

This document is a 510(k) summary for the EasyDrill Autostop Cranial Perforator. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a structured study validating those criteria. Therefore, several requested points, particularly those related to AI algorithm performance (such as MRMC studies, standalone AI performance, sample sizes for training/test sets as relevant to AI, and ground truth establishment methods typical for AI studies), cannot be fully addressed from the provided text.

However, I can extract the information relevant to the device's performance validation as described in the document.

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of quantitative acceptance criteria. Instead, it describes performance testing aimed at demonstrating safety, effectiveness, and equivalence to predicate devices. The "reported device performance" is qualitative and focused on meeting intended use and safety standards.

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

• Cadaver Study: The document mentions "human cadaveric specimen - skull" (singular, implying one or more but not a large number specified). The exact sample size (number of cadavers or number of drilling sites) is not provided.
• Bench Top Testing: The study was performed "in a Bovine Scapula" (singular, implying one or more but not a large number specified). The exact number of bovine scapulae or test instances is not provided.
• Endotoxin Testing: The sample size for endotoxin testing is not specified, but it refers to "subject EasyDrill Autostop Cranial Perforator devices."
• Data Provenance: Not explicitly stated, but the cadaver and bovine scapula tests would be prospective experimental data generated specifically for this submission. The country of origin for the data is not mentioned.

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

This information is not provided in the document. The studies described are performance tests of a mechanical device, not diagnostic studies requiring expert interpretation for ground truth.

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

This information is not applicable and therefore not provided. The studies described are performance tests of a mechanical device, not diagnostic studies requiring adjudication of output.

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:

This information is not provided and is not applicable. The device is a mechanical cranial perforator, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

This information is not provided and is not applicable. The device is a mechanical cranial perforator, not an algorithm.

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

For the Cadaver and Bench Top studies, the "ground truth" implicitly was the functional performance observed (e.g., successful perforation, automatic disengagement, lack of adverse events such as plunging, comparison to predicate performance). For Endotoxin testing, the ground truth was the analytical result against the specified limit. These are direct measurements of physical or biological properties, not ground truth established from expert consensus or pathology in the context of diagnostic performance.

8. The sample size for the training set:

This information is not provided and is not applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

This information is not provided and is not applicable. This is a mechanical device, not an AI algorithm.

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The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery.

The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm.

The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm.

The Meridian™ Cranial Perforator is a sterile packed, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery, driven by powered sources having a standardized and commonly used Hudson fitting clutch. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. Both versions are available for burr-hole diameters of Ø6. Ø7 and Ø11 mm.

The Meridian™ Cranial Perforator per CFR. Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr-holes through the skull of a patient. An integrated clutch mechanism prevents plunging of the perforator tip into the underlying dura and parenchyma tissue. The device is a Class II (USA) device and classified IIa in Europe (EEC).

The Meridian™ Cranial Perforator is a device similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra-Cut models DGR-II and Codman Disposable Perforators etc ... )

The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM.

The Adeor Meridian™ Cranial Perforator is a sterile, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery. Its primary function is to automatically release and stop perforating once a specific cranial bone thickness is reached, preventing plunging into underlying tissue.

Here's an analysis of its acceptance criteria and the study proving it meets these criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Meridian™ Cranial Perforator are primarily centered around its ability to automatically release and stop perforation at specified bone thicknesses, and its general mechanical functionality.

• No friction observed between rotating cutting parts.
• No skidding of the device on animal cadaver bone.
• A firm axial rotation and no wobbling observed.
• A plain and even surface of the perforated bone and on the bone flap was observed. |
  | Sterility Assurance Level (SAL) of

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The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick.

The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.

The Zyphr TM Disposable Cranial Perforator is a mechanically powered tool specifically designed to rapidly create an access hole through the skull in a safe and reliable manner.

The provided text is a 510(k) summary for the Stryker Zyphr™ Disposable Cranial Perforator. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for providing a table of acceptance criteria and reported device performance based on the input text, nor can I answer the specific questions about the study design. The document focuses on regulatory submission for substantial equivalence rather than detailing performance validation studies.

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The Cranial Perforator is a sterile, single use cutting device intended for performing cranial trephination in bone at least 3 mm thick (i.e., adult skulls).

The Cranial Perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument used in conjunction with a surgical motor and speed reducer attachment to drill holes through a patient's skull. The Cranial Perforator employs a clutch mechanism to disengage drilling action upon initial penetration of the skull to prevent plunging of the perforator tip into the underlying dura and brain tissues. The device is a Class II (USA) device. The Cranial Perforator is a device similar in design and construction to other devices currently on the market; (e.g.: Acra-Cut model DGR-1; 14/11mm). The Cranial Perforator is a compound drill which requires a motor to provide speed (70 - 80K RPM) and torque. But a speed reducer attachment is necessary to limit motor speed while delivering necessary torque. For this application the recommended motors are the Anspach Black Max. MicroMax and eMax motor systems. For speed reduction, it is recommended only the Anspach Speed Reducer attachments be used. The speed range when used with the listed Anspach equipment is 800 to 1200 RPM.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cranial Perforator:

The provided text describes a 510(k) submission for a Cranial Perforator. The primary goal of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, specifically the Acra-Cut DGR-1 and Codman 26-1221. The performance testing focuses on demonstrating that the Anspach Cranial Perforator's declutch features are equivalent to the predicate, and that it meets user requirements for cutting rate and hole quality, without gross mechanical failures.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text states testing was performed on "human cadaver test samples." No specific number of cadaver samples or perforations is provided.
• Data Provenance: Human cadaver test samples. The country of origin is not explicitly stated, but given the US regulatory context and submitter, it's likely US-sourced cadavers. The study was prospective in the sense that the Anspach Cranial Perforator was directly tested, but the comparison to predicate devices uses their established performance as a benchmark.

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

The text does not mention the use of experts to establish ground truth for the test set in the traditional sense (e.g., radiologists interpreting images). The assessment of "Plunge and Early Declutch failures," "cutting rate," "clean holes," and "gross mechanical failures" appears to be based on direct physical measurement and observation during cadaver testing, likely by engineers or technicians overseeing the mechanical performance test.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the performance metrics seem to be objective measurements or direct observations of mechanical function rather than subjective assessments requiring expert consensus.

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

No. An MRMC comparative effectiveness study was not conducted. This device is a mechanical surgical tool, not an imaging or diagnostic AI device that would typically involve human readers.

6. Standalone Performance Study

Yes. A standalone performance study of the Anspach Cranial Perforator was performed. The "Performance Testing" section states: "The Anspach Cranial Perforator (75-0002-1) was tested for performance and safety: refer to Verification Report 06-0708, using a comparative method to predicate cranial perforators Acracut and Codman." This testing evaluated the device's ability to:

• Perform without Plunge or Early Declutch failures (compared to predicates).
• Achieve a cutting rate equal to or greater than 0.24 mm/sec.
• Create clean holes.
• Operate without gross mechanical failures.

While a "comparative method" was used for some aspects (Plunge/Early Declutch), the other metrics (cutting rate, clean holes, no gross failures) indicate standalone performance evaluation against defined criteria.

7. Type of Ground Truth Used

The ground truth used is primarily physical performance metrics and direct observation on human cadaver bone, compared against established performance characteristics of predicate devices and user requirements. This isn't "expert consensus" or "pathology" in the medical imaging sense, but rather engineering-based verification.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical surgical tool, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As above, there is no training set for a mechanical device.

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The CODMAN® Disposable Perforators are indicated for perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. The perforators consist of a stainless steel inner and outer drill and a stainless steel Hudson End that locks onto a pneumatic or electric driving tool.

The provided 510(k) summary for the Codman® Disposable Perforator (K071931) is lacking the specific details required to fully address your request regarding acceptance criteria and the comprehensive study information.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

Paucity of Information: The document states "Substantial equivalence for this device is based upon comparison to predicate device characteristics and performance testing. Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device." However, it does not provide any specific acceptance criteria values or detailed performance results from the device testing. It also does not describe a specific "study" in the sense of a clinical trial or a detailed lab study with statistical analysis, but rather refers to "performance testing."

Despite these limitations, I will attempt to answer your questions as best as possible with the available text.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria or reported performance metrics are not available. The document broadly states:

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

• Sample Size: Not specified. The document mentions "performance testing" but does not indicate the number of devices or subjects tested.
• Data Provenance: Not specified. It's highly likely to be lab-based testing rather than clinical data, given the nature of the device and the general tone of the 510(k) summary, but this is not explicitly stated. It would be retrospective in the sense that the testing was conducted on manufactured devices.

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

• Not Applicable / Not Specified. This device is a mechanical surgical tool. "Ground truth" in the context of expert consensus, pathology, or outcomes data, typically refers to diagnostic or imaging devices. For a mechanical device like a perforator, "ground truth" for performance would be established through engineering specifications and objective measurements (e.g., disengagement force, drilling speed, material integrity), not expert consensus on interpretations. No experts are mentioned in relation to establishing ground truth for the performance testing.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's disagreement among human readers/experts, common in diagnostic studies. For objective performance testing of a mechanical device, such methods are not relevant or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is not applicable to a mechanical surgical perforator. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, for diagnostic tasks (e.g., radiologists reading images). This device is a tool, not an AI diagnostic system.

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

• Not Applicable. This device is a mechanical perforator, not an algorithm or AI system. Its performance inherently involves a human operator.

7. The Type of Ground Truth Used

• Objective Engineering/Performance Specifications. For a device like a surgical perforator, the "ground truth" for determining performance would be against pre-defined engineering specifications and measurable physical properties. For example, the automatic disengagement mechanism would be tested to ensure it activates within a specified force or depth range, and materials would be tested for strength and sterility. The document implies this by stating "Device qualification criteria meet or exceed the minimum qualification criteria."

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not a machine learning model, so there is no "training set" in the context of AI.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

Conclusion:

The provided 510(k) summary for the Codman® Disposable Perforator (K071931) is primarily focused on demonstrating substantial equivalence to a predicate device through similarity in design, materials, and intended use, along with general "performance testing" that ensures it "meets or exceeds minimum qualification criteria." It does not contain the detailed quantitative data, specific study designs (like MRMC), or AI-related information that your questions are structured to elicit. This is typical for submissions concerning mechanical surgical instruments where the focus is on safety, performance against established engineering benchmarks, and equivalence to existing devices.

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This device is for use on the skull area only. This device is disposable and for single patient use only. The device is used to aid the surgeon in perforating the skull for various types of purposes. The device does not assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure rest firmly with the surgeon.

The ACRA-CUT XPRESS 120 is a battery operated drill that has a skull perforator permanently attached to it. It is for one time use and is delivered charged and sterile.

This device, the ACRA-CUT XPRESS 120, is a surgical drill and perforator. Based on the provided 510(k) summary, it is being submitted for substantial equivalence to existing predicate devices.

Here's an analysis regarding acceptance criteria and supporting studies:

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

   Acceptance Criteria	Reported Device Performance
   Substantial Equivalence: The XPRESS 120 should be substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.	The device is claimed to be substantially equivalent to the Osteomed B Power System and the Stryker System II Orthopower 90 Battery Powered Instruments. It is also substantially equivalent to previously approved ACRA-CUT perforators. The key difference is the specified use area (skull only for XPRESS 120) and the permanent attachment of the perforator to the drill.
   Intended Use: For use on the skull area only, disposable, single-patient use, to aid the surgeon in perforating the skull for various purposes.	The device's stated indications for use are "for use on the skull area only. This device is disposable and for single patient use only. The device is used to aid the surgeon in perforating the skull for various types of purposes." This directly matches the acceptance criteria for its intended use. The 510(k) decision confirms that the FDA reviewed these indications for use and found substantial equivalence.
   Technological Characteristics: Similar in how the battery-operated drill operates, is used, and in technological characteristics to predicate devices. (Specifically, battery-operated drill with permanently attached skull perforator, delivered charged and sterile, single-use.)	The XPRESS 120 is described as a "battery operated drill that has a skull perforator permanently attached to it. It is for one time use and is delivered charged and sterile." It is explicitly stated that it is "very similar in how the battery-operated drill operates, is used and in technological characteristics" to the predicate devices. The primary difference noted is the area of the body treated. The perforators themselves are identical to already approved ACRA-CUT perforators, just now permanently attached.
   Safety & Effectiveness: The device must be deemed safe and effective for its intended use and equivalent to predicate devices.	The FDA's substantial equivalence determination implies that the device is considered safe and effective for its intended use, given its similarity to legally marketed predicate devices that are also considered safe and effective. No specific performance metrics (e.g., drilling speed, torque, battery life) are provided, as the basis for acceptance is substantial equivalence to existing devices.

2. Sample size used for the test set and the data provenance
   No clinical studies or test sets with human or animal subjects were conducted for this device. The submission explicitly states: "No clinicals were performed with this device." The acceptance is based on demonstrating substantial equivalence to predicate devices already on the market.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   Not applicable, as no test set or clinical studies were performed. The "ground truth" for acceptance is based on the regulatory review of substantial equivalence to predicate devices, which involves regulatory experts at the FDA.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable, as no test set or clinical studies were performed that would require adjudication.

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 surgical instrument, not an AI-assisted diagnostic or imaging device. No MRMC studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This is a standalone physical surgical instrument used by a surgeon. Its performance is inherent to its design and manufacturing, and its safety/effectiveness is established through comparison to similar existing devices, not through algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   The "ground truth" for the device's acceptance is its substantial equivalence to legally marketed predicate devices. This doesn't involve clinical outcomes, pathology, or expert consensus on a study dataset for this specific device. Instead, it relies on the established safety and effectiveness of the existing predicate devices (Osteomed B Power System, Stryker System II Orthopower 90 Battery Powered Instruments, and existing ACRA-CUT perforators).

8. The sample size for the training set
   Not applicable, as no training set was used. This is a physical medical device, not an AI/ML model.

9. How the ground truth for the training set was established
   Not applicable, as no training set was used.

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