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The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable bronchoscope under continuous and direct control by a physician operator. The Galaxy System™ includes full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan.

The provided document focuses on the substantial equivalence of the Noah Medical Galaxy System to a predicate device (Monarch Endoscopy Platform) and a reference device (superDimension Navigation System). It details various performance tests conducted to support this claim, but it does not explicitly define specific acceptance criteria with numerical thresholds for device performance, nor does it present a study that reports numerical device performance against such criteria.

Instead, the document broadly states that the device has been "successfully tested" and "meets the intended user needs". It also mentions a simulated use study where users were able to "navigate to within 30 mm of the lesion, complete tomosynthesis, and acquire tissue". However, this is described as a capability demonstrated rather than a performance metric achieved against a pre-defined acceptance criterion.

Therefore, I cannot fully complete the table for acceptance criteria and reported device performance as requested, as these specific numerical values and direct comparisons are not present in the provided text.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no explicit numerical acceptance criteria or corresponding reported device performance metrics are provided in the document. The performance data section describes general testing and findings without quantifiable acceptance thresholds.

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

The document mentions "human cadaver and animal models" for "Design Validation testing" and "Simulated Use" testing. It also refers to "representative users" for "Human Factor Usability Testing."

• Test Set Sample Size: Not explicitly stated as a number. The document refers to "human cadaver and animal models" and "representative users" without specifying the quantity.
• Data Provenance: The testing was performed by Noah Medical, implying it's internal study data. The document does not specify the country of origin of the cadavers or animals, nor does it explicitly state whether the study was retrospective or prospective, though design validation and usability testing are typically prospective.

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

The document does not describe a process for establishing ground truth for a test set through expert consensus in the context of clinical performance evaluation against a specific gold standard. The focus of the performance testing described is on functional verification, safety, and usability.

• For the simulated use, "The user group included physicians who have been trained and are actively using the predicate and reference devices." The number of these physicians is not specified, and their specific role in establishing "ground truth" (as opposed to being subjects performing tasks) is not detailed.
• Qualifications of these physicians are generally described as "trained and actively using the predicate and reference devices," suggesting experience with similar bronchoscopic navigation systems.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing focuses on functional and usability aspects rather than diagnostic or clinical accuracy requiring expert review and adjudication of findings.

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

The document does not mention a MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The performance data focuses on the device's functionality, safety, and usability, demonstrating substantial equivalence to predicate devices, not on the comparative effectiveness of AI-assisted vs. unassisted human performance.

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

The document does not explicitly describe a standalone algorithm performance study. The Galaxy System's navigation component is integrated and described as used by physicians: "The Galaxy System enables a physician to utilize electro-mechanical articulation for precise control... By utilizing electromagnetic field-based sensors on the tip of the endoscope tip location relative to the pre-operative scan anatomy is continuously displayed." The software verification and validation section confirms that "Galaxy System software conforms to the design specifications and meets the intended use and needs of the intended users," but this is about software correctness rather than a standalone performance metric against a clinical ground truth.

7. Type of Ground Truth Used

For the simulated use testing, the "ground truth" for navigation was implicitly the ability to "successfully navigate to a peripheral lung lesion" and reach "within 30 mm of the lesion." This appears to be based on an expected outcome in the cadaver/animal models, rather than a clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This suggests the described performance testing is for validation, not for the training of a machine learning model, or if there was training, its details are not included in this summary.

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

As no information about a training set is provided, how its ground truth was established is also not available in this document.

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The Galaxy R Digital Radiography Upgrade is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in all general purpose diagnostic procedures. Not for mammography.

This device is medical image acquisition device. X-rays generated by X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a personal computer (via Ethernet) where the companion software has been installed. This software was cleared in our previous submission, K132921, and it has not been modified. A monitor displays this image. Images can then be transferred via the DICOM protocol. There are four models available, two are 14″ x 17″ and two are 17″ x 17″ (Available in either CSI or GOS scintillator versions). The user must supply the x-ray generator and tubestand to form a full system. Exposure can be Generator Synchronous, or via - AED (Auto Exposure Detection). The technology is Amorphous Silicon (a-Si) Photodiode coupled with either the Gadox or Cesium Iodide scintillators, same as in the predicate.

This document is an FDA 510(k) summary for the Galaxy R Digital Radiography Upgrade, a device intended to replace radiographic film/screen systems in general-purpose diagnostic procedures (excluding mammography). The submission aims to demonstrate substantial equivalence to the predicate device, Atlaim ATAL 8C (K113812).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" is not explicitly defined in terms of specific performance thresholds that the device must meet in a formal, quantifiable sense within this 510(k) summary. Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This is primarily achieved through a comparison table highlighting technological characteristics. The "performance" is implicitly compared to the predicate, with minor differences deemed not to have a material effect on safety or effectiveness.

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

• Sample Size (Test Set): Not explicitly stated with a specific number of images. The document states "Clinical images of actual patients were submitted."
• Data Provenance: Not explicitly stated (e.g., country of origin). The images were from "actual patients," implying retrospective or prospective clinical acquisition, but the specific study design for the clinical images is not detailed.

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

• Number of Experts: Singular, "Board Certified Radiologist."
• Qualifications of Experts: "Board Certified Radiologist." No specific experience in years is mentioned.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that the clinical images "were evaluated by Board Certified Radiologist and found to be of excellent diagnostic quality." This implies a single expert review for quality, not a consensus-based adjudication for ground truth for diagnostic accuracy.

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

No MRMC comparative effectiveness study was mentioned. The device is an upgrade to a digital radiography system, not an AI-assisted diagnostic tool.

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

Yes, in a sense. The "non-clinical tests" section describes bench testing for imaging characteristics like MTF and DQE, which are measurements of the device's technical performance independent of human interpretation. The "clinical images" were used to show the complete system works as intended, evaluated by a radiologist. This suggests standalone performance of the image acquisition hardware, with a human validating the output quality.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests (MTF, DQE), the "ground truth" is derived from physical measurements and technical standards in accordance with the FDA Guidance Document on Solid State Imaging Devices.

For the clinical images, the ground truth is expert opinion/evaluation by a single Board Certified Radiologist, who deemed them to be "of excellent diagnostic quality." This is a qualitative assessment of image quality for diagnostic purposes, not a definitive ground truth for specific pathologies or outcomes.

8. The Sample Size for the Training Set

The document does not mention any training set. This device is a digital radiography upgrade, not an AI/machine learning algorithm requiring a separate training set.

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

Not applicable, as no training set is mentioned for this type of device submission.

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The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

Temporary stabilization of the femur, tibia and ankle in conditions and procedures, such as:

• comminuted open or closed fractures
• polytrauma patient
• damage control orthopedics for fractures with severe soft tissue injuries
• peri-prosthetic or peri-implant fractures
• joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
• intra-operative fracture reduction
• intermediate stabilization in staged surgery
• infected non-union pending second stage treatment bone-loss or other reconstructive procedures.

The Galaxy UNYCO System consists of a series of sterile kits that include clamps, rods, screws and specific application tools. An external fixation system, as the subject device, is modular and so different frame configurations are possible. The Orthofix components in the Galaxy UNYCO System are not intended to replace normal healthy bone or to withstand the stresses of weight bearing. The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws.

Here's an analysis of the provided text regarding acceptance criteria and studies, organized as requested.

The provided document describes the Galaxy UNYCO System, which is an external fixation device. This device is exempt from the typical AI/machine learning evaluation criteria, as it is a mechanical device, not a diagnostic algorithm. Therefore, many of the requested fields (such as effect size of human readers with AI, standalone performance, training set details, and expert ground truth establishment for AI) are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, mechanical performance, and biocompatibility, as is typical for traditional 510(k) submissions for mechanical devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Galaxy UNYCO System are based on its mechanical performance and biocompatibility, demonstrating that it meets established standards for external skeletal fixation devices and medical-grade materials. The reported performance indicates that the device met or exceeded these requirements.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Focusing on Mechanical Device Evaluation)

As this is a mechanical device, the "study" primarily refers to bench testing and material characterization, not clinical trials or AI performance evaluations.

• Sample size used for the test set and the data provenance: Not explicitly stated in terms of a "sample size" for a test set as would be for an AI model. The evaluation involved mechanical testing of device components and biocompatibility testing of materials. The data provenance would be laboratory testing conducted by or for Orthofix Srl. No specific country of origin for this testing data is provided, but Orthofix Srl is located in Italy.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is established through engineering specifications, material science, and established international standards (e.g., ASTM, ISO), not by expert consensus in diagnosing cases.
• Adjudication method for the test set: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, common in diagnostic imaging studies for AI.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
• The type of ground truth used:
  • Mechanical: Engineering specifications and performance defined by international standards (ASTM F1541-02e1, ASTM F899-12b, ASTM F543-13e1).
  • Biocompatibility: Standards for non-pyrogenicity and material safety (USP 38:2014, ANSI/AAMI ST72:2011).
• The sample size for the training set: Not applicable. This is not an AI device and does not have a "training set" in the machine learning sense. The design and material choices are based on established engineering principles and prior knowledge.
• How the ground truth for the training set was established: Not applicable.

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The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 Mini Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The EnPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable.

The provided document describes the development and testing of the GALAXY G3 Mini Microcoil Delivery System. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document reports several performance tests, and for each, the result is "PASS: Samples passed the established acceptance criterion." The specific numerical acceptance criteria are generally not explicitly stated, but the passing result indicates they were met.

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

The document does not explicitly state the exact sample sizes used for each individual performance test (test sets). It generally refers to "samples" being tested.

The data provenance is bench testing, which implies the data was collected within a laboratory setting, likely in the US, given the submission to the FDA. It is retrospective in the sense that it's testing a finished device against predetermined criteria.

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

No individual experts or their qualifications are mentioned for establishing ground truth for the bench tests. The "ground truth" for these tests is based on established engineering specifications, industry standards (e.g., USP788, ISO standards), and clinical relevance/simulated use scenarios. For the "Overall Coil Performance" test, "physician's satisfaction rating" was evaluated, implying input from medical professionals, but the number and qualifications are not specified.

4. Adjudication Method for the Test Set

Not applicable for the reported tests. The tests are primarily objective measurements against established criteria, or visual inspections by qualified personnel (not specified as "experts" in the context of adjudication).

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not required as appropriate verification and validation of the GALAXY G3 Mini Microcoil Delivery System was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing."

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

Not applicable. This device is a physical medical device (microcoil delivery system), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. The performance tests are for the physical device itself.

7. The Type of Ground Truth Used

The ground truth for the bench tests is based on:

• Engineering specifications and design requirements: For dimensional checks, material properties, and functional performance (e.g., spring constant, detachment force, tensile strength).
• Industry standards: Such as USP788 for particulate matter, ISO 11607 for packaging, ISO 10993-1 for biocompatibility, and ISO 11135-1 for sterilization.
• Simulated use in clinically relevant models: For tests like track force, coil durability, detachment durability, resheathing reliability, fluoro saver marker durability, and distal outer sheath durability.
• Physician satisfaction rating: For "Overall Coil Performance" compared to a predicate device, which implies a subjective expert assessment.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set." The listed studies are verification and validation tests for the device itself.

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

Not applicable, as there is no training set for this device.

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The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

Temporary stabilization of the tibia and foot in conditions and procedures, such as:

• · comminuted open or closed tibial fractures
• · polytrauma patient
• · damage control orthopedics for fractures with severe soft tissue injuries
• peri-prosthetic or peri-implant fractures
• · joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
• · intra-operative fracture reduction
• · intermediate stabilization in staged surgery
• · infected non-union pending second stage treatment bone-loss or other reconstructive procedures

The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws. Galaxy Fixation System and bicortical screws must be used when Galaxy UNYCO is not indicated or available. The product is indicated for non-weight-bearing use.

The Orthofix Galaxy UNYCO System consists of a series of sterile kits that include UNYCO Cancellous Screws, Large Multiscrew Clamps for UNYCO Screws, Rods Ø 12mm, a radiolucent Foot Unit and specific application tools. External fixation systems are modular, therefore different frame configurations are possible. The Orthofix components in the Galaxy UNYCO System are not intended to replace normal healthy bone or to withstand the stresses of weight bearing.

Acceptance Criteria and Device Performance for Galaxy UNYCO System (K153233)

The provided documentation describes the acceptance criteria and study findings for the Orthofix Galaxy UNYCO System, a device intended for temporary bone stabilization.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily relies on mechanical testing and material comparison for demonstrating substantial equivalence. It does not mention a "test set" in the context of clinical data or patient data.

• Test Set (for mechanical and MRI testing): The specific number of devices/components tested for mechanical performance (ASTM F 1541) and MRI compatibility (ASTM F2182) is not explicitly stated in the provided summary.
• Data Provenance: The studies are described as non-clinical technical assessments (mechanical and MRI compatibility testing) rather than clinical studies with patient data. Therefore, there is no mention of country of origin or retrospective/prospective nature regarding patient data.

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

This information is not applicable as the studies were non-clinical mechanical and MRI compatibility tests. Ground truth in this context would be defined by the technical specifications of the standards (ASTM F 1541, ASTM F2182).

4. Adjudication Method for the Test Set:

This information is not applicable as the studies were non-clinical mechanical and MRI compatibility tests. Adjudication methods are typically associated with human reviewer assessments in clinical or diagnostic studies.

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

No MRMC comparative effectiveness study was mentioned. The submission explicitly states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."

6. Standalone Performance (Algorithm Only):

No standalone performance study for an algorithm was mentioned. The device is a physical external fixation system, not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the evaluation of the Galaxy UNYCO System was based on:

• Engineering Standards: Specifically, the requirements and methodologies outlined in ASTM F 1541 for mechanical performance and ASTM F2182 for MRI compatibility.
• Predicate Device Characteristics: Comparison to the established design, materials, and mechanical performance of legally marketed predicate devices (Synthes Large External Fixation, MR Conditional (K082650) and Orthofix Galaxy Unyco Diaphyseal Tibia Kit (K142052)).

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

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The GALAXY MIS Screw System is intended to provide immobilization of the posterior, non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The GALAXY MIS Screw System consists of GALAXY MIS SCREW (cannulated polyscrews), GALAXY MIS ROD (straight type rods and pre-bent type rods) and GALAXY Set Screw (set screw components) that can be inserted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile.

This FDA submission is for a medical device, the GALAXY MIS Screw System, which is a pedicle screw spinal system used for spinal fixation. As such, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories regarding clinical study details (like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable in this context.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. For non-clinical (mechanical) testing, sample sizes typically refer to the number of devices or components tested, and provenance is not relevant.

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

This is not applicable. Ground truth, in the context of clinical studies and AI, refers to expert-validated diagnoses or outcomes. This submission involves non-clinical mechanical testing, where the "ground truth" is defined by the physical properties measured against engineering standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are used in clinical studies to resolve disagreements among experts or raters. Mechanical tests are typically performed according to standardized protocols without expert adjudication in this sense.

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 is not applicable. The device is a surgical implant, not an AI-powered diagnostic tool, and therefore no MRMC study would be conducted.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was defined by the acceptance criteria established in the ASTM F1717 standard for various mechanical properties (static compression, tension, torsion, dynamic compression bending). This is a technical standard rather than an expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

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

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The CO2-2B Galaxy CO2 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:

Laser skin resurfacing.

Treatment of furrows and wrinkles.

Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.

Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.

Blepharoplasty.

Site preparation for hair transplants.

The fractional scanner is for treatment of wrinkles and skin resurfacing.

Galaxy CO2 Laser System consists of Mainframe, Optical Delivery System, Protective Glasses and Footswitch. Mainframe consists of CO2 laser generator, laser power supply, control device, safety protection system and cooling system. Optical delivery system consists of articulated arm, aiming beam, normal handpiece and fractional scanner handpiece.

Galaxy CO2 Laser System produces a beam of coherent infrared light --- 10.6µm laser which is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. The heating causes instantaneous vaporization of the target issue. Equipped with the scanner, the system delivers a high-speed laser scan with micro spots for optional control of treatment area and depth.

The provided document is a 510(k) summary for the CO2-2B Galaxy CO2 Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with performance criteria. As such, the information you're requesting regarding acceptance criteria and a study proving those criteria are met, particularly in the context of AI performance, human-in-the-loop studies, and detailed ground truth establishment, is not present in this document.

Here's why and what information is available:

• Device Type: The CO2-2B Galaxy CO2 Laser System is a surgical laser, not an AI/ML diagnostic or prognostic device.
• 510(k) Process: The 510(k) pathway for medical device clearance primarily requires the manufacturer to demonstrate that their new device is "substantially equivalent" to an existing, legally marketed predicate device. This often involves non-clinical testing (bench testing, electrical safety, EMC, etc.) and comparison of technical characteristics, indications for use, and safety. Extensive clinical efficacy studies or performance comparisons against a human standard are typically not required, especially for devices with well-established technologies like CO2 lasers.
• "No Clinical Information is required.": The summary explicitly states this in the "Non-Clinical Conclusion" section, further indicating that the type of study you're asking about (with detailed performance metrics, test sets, ground truth, etc.) was not part of this submission.

Therefore, I cannot provide the requested table or detailed study information from the provided text for the following reasons:

1. No Acceptance Criteria for Performance Defined and Tested: The document does not specify performance acceptance criteria in terms of accuracy, sensitivity, specificity, AUC, or other metrics typically associated with AI/ML or diagnostic devices. The acceptance criteria relate to compliance with safety and performance standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, UL 60601-1:2003 R6.03).
2. No Performance Study in the Context of AI/ML: There is no mention of a performance study involving a test set, ground truth, or human readers, as this device is a surgical instrument, not a diagnostic AI.

However, I can still extract the information that is relevant to the "Testing" section and the overall submission:

1. Table of Acceptance Criteria and Reported Device Performance (as per document's scope):

Missing Information (Not applicable or not provided in the document for this type of device/submission):

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set as described for AI/ML performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No clinical ground truth establishment for a diagnostic AI.
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 is not an AI-assisted diagnostic device.
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: Not applicable. The "ground truth" for this device's clearance is its compliance with established engineering and safety standards, and its technical equivalence to predicate devices, verified through non-clinical laboratory testing.
8. The sample size for the training set: Not applicable. There is no AI training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI training set.

In summary, the provided document outlines an engineering and regulatory compliance review (510(k) clearance) for a surgical laser, not a clinical validation study for an AI-powered diagnostic tool. The "testing" referred to is primarily non-clinical, demonstrating adherence to technical standards and specifications, and substantial equivalence to existing devices.

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The Galaxy Plus Digital Radiography System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

The digital diagnostic x-ray system consists of a generator, a tube, an x-ray console, a beam limiting device, an image receptor, a u-arm stand and software. The digital panels supplied are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. Product features: This system is designed to maintain the alignment between a tube and the image receptor, regardless of the angle on the image receptor or image tilt positions. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on patients. Its flexibility makes the system ideal for all patient examinations including the standing, sitting and lying patient positions.

The provided 510(k) summary for K132921 describes the Galaxy Plus Digital Radiography System.

Here's an analysis based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, resolution targets) for the device. Instead, the primary acceptance criterion appears to be demonstrated substantial equivalence to the predicate device (DRGEM Corporation's DIAMOND-5A, 6A, 8A, K102408) through non-clinical and clinical testing, and the ability to produce images of "good diagnostic quality."

Given this, the table would look like this:

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

• Sample Size: The document does not specify a numerical sample size for the clinical test set (i.e., the number of patients or images). It vaguely states "Clinical images for all four panels were obtained."
• Data Provenance: Not explicitly stated (e.g., country of origin). It states the images were obtained "in accordance with the FDA Guidance Document on Solid State Imaging Devices," implying they met U.S. regulatory standards for data collection, but no further details on location or retrospective/prospective nature are provided. It is likely retrospective or a limited prospective case series given the summary nature.

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

• Number of Experts: Not specified. The document states "They were evaluated by board certified radiologist." This could imply one or more radiologists.
• Qualifications: "board certified radiologist." The experience level in years is not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1, none). It simply states the images "were evaluated by board certified radiologist." This suggests either independent evaluations or a consensus approach, but the specific process is not detailed.

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

No. The document does not mention an MRMC study. The comparison is primarily against the predicate device's technological characteristics and the general standard of "good diagnostic quality" for radiographic images, rather than a comparative effectiveness study with human readers.

6. Standalone Performance

Yes, a standalone evaluation was performed. The clinical images generated by the algorithm/system only (i.e., the Galaxy Plus Digital Radiography System itself) were evaluated by radiologists for their diagnostic quality. This evaluation was independent of human interpretation improvements; it assessed the quality of the raw output from the device.

7. Type of Ground Truth Used

The ground truth used for the clinical evaluation was expert consensus/evaluation by "board certified radiologist[s]" who determined the images were of "good diagnostic quality." There is no mention of pathology, outcomes data, or other objective measures of truth. For a diagnostic imaging device like an X-ray system, "good diagnostic quality" determined by an expert is a common form of ground truth for substantial equivalence.

8. Sample Size for the Training Set

The document does not mention a "training set" or provide any sample size for training. This device is a digital radiography system, not an AI/ML algorithm that typically requires a large training set in the way a diagnostic AI would. The software components are an update of previously cleared software (K093816), implying its core functionality was already established. The emphasis is on the image acquisition hardware and its ability to produce images.

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

As no training set is mentioned in the context of this 510(k) summary (because it's not a de novo AI/ML solution), the method for establishing ground truth for a non-existent training set is not applicable here. The software is an update of a previously cleared version, suggesting its underlying principles and performance were evaluated during its initial clearance (K093816).

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)

This is a complete stationary diagnostic x-ray system employing a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in four different power ratings. All components are either 510(k) exempt or previously cleared. The only difference between the two models is the configuration of the tube stand. Galaxy has a straight arm and the Galaxy+ Plus is in a U-Arm configuration. Generators are available in 40-50-65-or 80 kW (High Frequency) models.

The provided text describes a 510(k) summary for the Galaxy and Galaxy+ Plus Digital Diagnostic X-Ray System. It does not contain information about specific acceptance criteria or a detailed study proving the device meets them in the way typically found for AI/algorithm-driven devices.

The document focuses on demonstrating substantial equivalence to a predicate device (Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems, K090238) rather than meeting pre-defined performance acceptance criteria for an AI algorithm. The core of the submission is to show that the new device has "essentially the same technological characteristics" and similar clinical indications for use as the predicate.

Here's an analysis based on the information provided, highlighting what is present and what is not:

Acceptance Criteria and Device Performance:

The document doesn't explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, AUC) for an AI component, nor does it report such metrics for the device. Instead, the "acceptance criteria" for this 510(k) submission appear to be implicitly about demonstrating that the new device is as safe and effective as the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Study Information:

The document describes non-clinical and clinical tests, but these are general descriptions rather than a detailed study protocol for an AI/algorithm.

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

   • Test Set Sample Size: Not specified. The clinical tests mention "Clinical images were obtained," but no quantity is given.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

   • Number of Experts: Not specified, but referred to as "professional radiologist" (plural).
   • Qualifications of Experts: "professional radiologist." No years of experience or specific subspecialty mentioned.

3. Adjudication method for the test set:

   • Not specified. The text simply states images "were evaluated by professional radiologists and found to be of good diagnostic quality." No mention of consensus, voting, or specific adjudication rules.

4. 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:

   • No MRMC study was performed or described. This submission is for a conventional digital X-ray system, not an AI-driven diagnostic aid. The "clinical tests" assessed the diagnostic quality of the images produced by the system itself, not the performance of human readers with or without AI assistance.

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

   • No standalone algorithm performance study was done. This device is a diagnostic imaging system, not an algorithm. The "performance" being evaluated is the image quality produced by the system for human interpretation.

6. The type of ground truth used:

   • The "ground truth" for the clinical images appears to be the expert opinion/consensus of professional radiologists regarding the "good diagnostic quality" of the images generated by the device. It's not pathology, outcomes data, or a pre-defined objective reference standard for specific病灶 detection, but rather an assessment of general image utility.

7. The sample size for the training set:

   • Not applicable. This device is a digital X-ray system, and the submission does not mention any machine learning or AI components that would require a "training set."

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

   • Not applicable, as no training set for an AI algorithm is mentioned or implied.

Summary of the Device and Submission Context:

This 510(k) pertains to a new digital X-ray system. The "study" described is a testing and evaluation process for a medical device's physical and functional characteristics, not a clinical trial or performance study for an AI algorithm. The device produces images, and the "clinical tests" verified that these images are of "good diagnostic quality" as assessed by radiologists, aligning with the performance expected from similar legally marketed predicate devices. The core argument for clearance is substantial equivalence based on comparable indications for use, technological characteristics (with the new device having higher resolution panels), and meeting relevant safety and EMC standards.

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The Galaxy System (which includes the Jupiter amplifier and Galaxy software) is intended for use as a polysomnographic system to acquire record, display, print and store physiological parameters to assist clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers, clinics or other test environments where adults or infants require the documentation of sleep or other physiological disorders. The Galaxy system does not provide alarms and is not intended for use as an automated apnea monitor.

The Galaxy system (which includes the Jupiter and Galaxy software) is a Polysomnography System that is intended to acquire, record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders.

The system can record, monitor, store and transfer of up to 42 channels of biophysical parameters. Generally the device is capable of acquiring and displaying the following parameters:

• EEG .
• EOG (eye movement) ●
• Chin EMG .
• . Leg EMG (leg movement)
• ECG (single channel) ●
• . Chest respiratory effort
• . Abdomen respiratory effort
• . Nasal Flow Thermistor
• . Nasal Flow Pressure
• . Body position
• . Snoring
• Oximeter .
• . Patient "Event" button

The components of the Galaxy system include:

• Headbox/Amplifiers (i.e., "BrainBox EEG amplifier, "Touchproof connector box", "Jupiter 1. amplifier") – Galaxy can support two amplifier/headbox models, 1166 and 1142. Both models are electrically exactly the same, except for the differences between the number of channels.
• Ethernet Interface
• Isolator (ISO101)
• Connecting Wires
• Desktop Computer
• Electrodes Third party electrodes and sensors such as surface electrodes compatible with 32 AC inputs by means of touch-proof connectors, "Nonin oximeter (XPOD3012)," and "respiratory effort sensors" can be used with the system, but these sensors are not provided with the device. Only sensors specifically tested and verified for use with the device should be used and are listed in the user's manual.
• Galaxy Software The Galaxy software's main functionalities include the following:
  • a. Record and display signals Collect and display PSG parameters. Plot acquired data on screen (within a time window of 30 seconds) and store on hard-disk of computer.
  • b. Provide tools for Manual Review of Data Allow the user to review and manually analyze data, edit this analysis and delete the entered events if needed. Software also displays the user annotations along with the signal traces, as trend overview over the night and as a list, and allows the user to review the acquired data after the completion of the recording to examine and annotate afterwards (offline).
  • c. Generate Patient Reports The software calculates summaries of the manually scored data and print them as tabulated reports and shows simple computer calculations like average value, rates etc ...

Galaxy also has the following additional functions:

• changing the mode of the amplifier for calibration, impedance check or data acquisition .
• sending commands to set sample rate of the digitization, to specify the recording montage . and to receive data from the Jupiter amplifier via Ethernet interface.

The device does not provide any automatic scoring algorithms.

I am programmed to be an obedient and helpful AI assistant. I will do my best to fulfill your request.

The provided document describes a 510(k) premarket notification for the Galaxy System, a Polysomnography (PSG) System. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove specific performance metrics through a clinical study with acceptance criteria in the typical sense of algorithm performance. The device itself (Galaxy System) is a data acquisition and display system for physiological parameters, not an automated diagnostic algorithm. Thus, the "acceptance criteria" and "study" are focused on safety, effectiveness, and functional equivalence to existing legally marketed devices, rather than a clinical performance study with predefined statistical endpoints for an AI algorithm.

However, I will extract the information that aligns closest to your request, interpreting "acceptance criteria" as the comparable characteristics to predicate devices that demonstrate safety and effectiveness for its intended use, and "study" as the testing and verification performed to support these claims.

Here's a breakdown of the information based on your request, as much as can be gleaned from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) submission for substantial equivalence of a polysomnograph system (not an AI algorithm with specific performance metrics like sensitivity/specificity), the "acceptance criteria" are interpreted as the functional and technical characteristics deemed equivalent to the predicate devices. The "reported device performance" is essentially the detailed specification of the Galaxy System, demonstrating its equivalence to the predicate devices.

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

The document does not describe a clinical study with a "test set" of patient data for evaluating an algorithm's performance. The testing mentioned in the document is primarily hardware and software verification and validation, safety testing, and compliance with standards.

• Test Set Sample Size: Not applicable in the context of an algorithm's performance on patient data.
• Data Provenance: Not applicable. The device itself records physiological data; it does not process pre-existing data or make interpretations. The testing involved "work-bench by developers, in the factory by developers and in the field by sleep-technicians and researchers." This suggests functional testing, not a clinical trial on a specific dataset.

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

This is not applicable. The device does not involve an AI algorithm that requires expert-established ground truth on a test set. It's a data acquisition and display system. Clinicians/physicians use the displayed parameters for "diagnostic review," but the device itself does not provide automated diagnoses or interpretations that would require ground truth for validation.

4. Adjudication Method for the Test Set

This is not applicable, as there is no test set in the sense of a dataset requiring expert adjudication for algorithm 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

No such study was done or is mentioned. The Galaxy System "does not provide any automatic scoring algorithms" and "does not provide alarms and is not intended for use as an automated apnea monitor." Therefore, there is no AI component for human readers to interact with or improve upon.

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

No. The device "does not provide any automatic scoring algorithms." Its function is to "acquire, record, display, print and store physiological parameters to assist clinicians/physicians."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable. As highlighted, this device is a data acquisition and display system, not an AI diagnostic tool. Its validation focuses on accurate signal acquisition, display, and compliance with safety and electrical standards.

8. The Sample Size for the Training Set

Not applicable. The document describes a traditional medical device (polysomnograph system) that acquires and displays physiological data. It is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for an AI algorithm.

Summary of Device Nature and 510(k) Context:

This 510(k) submission is for a Polysomnography (PSG) System, which is a device designed to collect, display, and store physiological signals for manual review by clinicians. It explicitly states it does not contain automatic scoring algorithms, alarms, or automated apnea monitoring. The "testing" described is focused on:

• Hardware verification and validation: Ensuring the amplifier, interfaces, and other physical components function correctly and meet specifications.
• Software verification and validation: Ensuring the software accurately records, displays, stores, and allows for manual review and reporting of data.
• Safety and EMC compliance: Adhering to relevant IEC and EN standards for medical electrical equipment.
• Substantial Equivalence: Demonstrating that its technological characteristics and intended use are similar to legally marketed predicate devices (Natus Neurolink IP Model PK1117 and Alice 5 by Respironics), thereby establishing its safety and effectiveness without requiring a new clinical performance study for an AI component.

Therefore, the types of "acceptance criteria" and "studies" you are asking about, which are typical for AI/ML-based diagnostic devices, are not relevant or present in this specific 510(k) document because the device does not incorporate AI or automated diagnostic functions.

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