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IVA-C (ACIF):
The IVA-C Cage System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

AEON-C (ACIF):
The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF):
The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon's discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA & AEON Cervical and Lumbar Cage System are cervical and lumbar intervertebral fusion cages that are implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The cages are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method). The cages are manufactured from titanium alloy powder per ASTM F3001 or titanium alloy per ASTM F136 or PEEK per ASTM F2026. The screws are manufactured from titanium alloy per ASTM F136. They are provided non-sterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

This FDA 510(k) Clearance Letter is for the IVA & AEON Cervical and Lumbar Cage System, which are intervertebral body fusion devices. It is a Class II device.

Crucially, this document focuses on the substantial equivalence of a physical medical device (intervertebral cages) based on engineering performance tests, materials, and design features, not on the performance of an AI/ML software.

Therefore, most of the requested information regarding AI/ML device performance (acceptance criteria table, study details, human reader improvement, ground truth, training set, etc.) is not applicable to this specific submission.

The document states:

• "Summary of Performance Data (Nonclinical and/or Clinical):" and then lists "Non-Clinical Tests" such as Static/Dynamic Compression Bending, Static/Dynamic Compression Shear Bending, Static/Dynamic Torsion, and Subsidence, all referencing ASTM standards.
• "Clinical Tests: - N/A"

This means that the device was cleared based on non-clinical (laboratory/mechanical) testing, not on clinical performance studies involving patient data or AI/ML algorithm evaluation.

To answer your specific questions in the context of this document:

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

   • Not Applicable (N/A) for AI/ML performance.
   • For the physical device, the acceptance criteria would be defined by the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267) for specific mechanical properties (e.g., strength, durability, resistance to subsidence). The document states that the "Results of the non-clinical tests indicate that the device will perform within the intended uses," implying these criteria were met, but specific numerical performance data is not provided in this public summary.

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

   • N/A for AI/ML performance.
   • For the mechanical tests, the "sample size" would refer to the number of physical devices tested to ASTM standards. This information is not provided in this summary. Data provenance is also N/A as it's not patient data.

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

   • N/A. Ground truth establishment by experts is relevant for diagnostic or AI/ML interpretation performance, not for the mechanical testing of a physical implant.

4. Adjudication method:

   • N/A. Adjudication is relevant for expert consensus in AI/ML or clinical studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • N/A. This is a physical implant, not an AI-assisted diagnostic tool.

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

   • N/A. This is not an algorithm.

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

   • N/A for AI/ML. For the device, the "ground truth" would be established mechanical properties as defined by the ASTM standards (e.g., material properties, structural integrity under load).

8. The sample size for the training set:

   • N/A. There is no training set as no AI/ML algorithm is involved.

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

   • N/A. There is no training set.

In summary, the provided FDA 510(k) clearance letter pertains to a surgical implant, not an AI/ML software. Therefore, the questions related to AI/ML device performance and associated studies are not applicable to this document. The clearance is based on the substantial equivalence to predicate devices and adherence to mechanical performance standards, as indicated by the non-clinical tests section.

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TRUDERMAL Pro (Model: ZLD-390) is an over-the-counter(OTC) device that delivering targeted phototherapy using three wavelengths(blue:415nm, red:630nm, Infrared(IR):850nm):

Red light: Reduces full-face wrinkles.
Blue light: Treats mild to moderate inflammatory acne.
IR light: Provides topical heating for the purpose of elevating tissue temperature, temporarily relieving minor muscle and joint pain, arthritis and muscle spasms; relieving stiffness; promoting relaxation of muscle tissues and temporarily increasing local blood circulation.

Mixed lights:
Red+IR light: Reduces full-face wrinkles.
Blue+Red light:Treats mild to moderate inflammatory acne.

The TRUDERMAL Pro is an over-the-counter LED light therapy medical device. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the TRUDERMAL Pro system are Blue 415nm, Red 630nm and Near Infrared 850nm.

The device consists of a TRUDERMAL Pro (with LED flexible silicone panel, Controller and AC/DC adapter), power cable, and 2 base seats, a pair of eye protectors. The TRUDERMAL Pro enables treatment of the face and the body via a LED flexible silicone panel.The system is operated by a controller and treatments can be performed by selecting different wavelengths. The light is generated by Light Emitting Diodes(LED's) that are contained within the LED flexible silicone panel. The LED panel can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body,the LED panel is removed from the Base unit and placed over the appropriate body part.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

I apologize, but I cannot fulfill your request to create a table of acceptance criteria and reported device performance, nor can I describe a study that proves the device meets specific acceptance criteria based solely on the provided FDA 510(k) Clearance Letter for TRUDERMAL Pro (ZLD-390).

Here's why:

• No Performance Data or Acceptance Criteria in the Document: The provided 510(k) clearance letter and its associated summary (510(k) Summary) do not contain any information about specific performance acceptance criteria or the results of clinical performance studies that demonstrate the device meets such criteria.
  • The document states, "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." This explicitly indicates that no clinical performance data (which would typically include performance against acceptance criteria) was provided or evaluated for this 510(k) submission.
  • The non-clinical tests mentioned (electrical safety, EMC, biocompatibility, software V&V) are regulatory compliance tests, not performance studies assessing the therapeutic efficacy against specific clinical endpoints or acceptance criteria.

Therefore, I cannot extract or infer the following information from the provided text:

1. Table of acceptance criteria and reported device performance: This data is not present. The document explicitly states clinical testing was not needed.
2. Sample size used for the test set and data provenance: Since no clinical performance study was conducted or reported, there is no test set, sample size, or data provenance information.
3. Number of experts used to establish ground truth & qualifications: Not applicable, as no clinical performance study data relying on expert ground truth is provided.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported. The device is a phototherapy device, not an AI-powered diagnostic tool, so an MRMC study is generally not relevant.
6. Standalone (algorithm only) performance study: Not applicable. This is a physical phototherapy device, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is a phototherapy device, not an AI model that would have a "training set" in the traditional sense.
9. How ground truth for the training set was established: Not applicable.

What the document does provide regarding "performance" is:

• Comparison to Predicate Devices: The submission argues for substantial equivalence by comparing the TRUDERMAL Pro's technical characteristics (wavelengths, irradiance, treatment time) to legally marketed predicate devices. The claim is that "The subject device's wavelengths, treatment time, irradiance and radiation dose are similar and close to those of the predicate devices," and this, combined with non-clinical tests, "supports that the subject device is safe and as effective as the predicate devices for its intended use."
• Non-Clinical Test Summary: This section lists the electrical safety, electromagnetic compatibility, biocompatibility, and software verification/validation tests performed, demonstrating compliance with relevant industry standards (IEC, ISO). These tests ensure the device is safe and functions as designed electrically and mechanically, but they do not prove clinical efficacy against specific performance metrics related to wrinkle reduction, acne treatment, or pain relief.

In summary, the provided FDA document is a clearance letter and 510(k) summary that emphasizes substantial equivalence to existing predicate devices based on design, intended use, and non-clinical safety testing, rather than presenting a performance study with defined acceptance criteria and clinical results.

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Telescopes for adults
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults.

Telescopes for adults and pediatrics
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use.

The provided text is an FDA 510(k) clearance letter and its accompanying summary for the KARL STORZ HOPKINS Telescopes for Urology. This document details the regulatory pathway for a medical device, specifically rigid endoscopes, not an AI software or system. Therefore, most of the questions regarding acceptance criteria and study design for AI performance are not applicable.

Here's an analysis of the provided information:

Analysis of Acceptance Criteria and Study for a Medical Device (Endoscope):

Given that this is a medical device (endoscope), the "acceptance criteria" are typically related to meeting established performance standards for such devices. The "study" refers to non-clinical bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical performance targets and reported values in the way you might see for an AI algorithm's accuracy or sensitivity/specificity. Instead, the acceptance criteria are implicit in the adherence to international and national standards for medical devices, particularly endoscopes. The reported device performance is that it complies with these standards.

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

• Sample Size: Not applicable in the context of an endoscope's non-clinical bench testing. The "test set" here refers to the actual device prototypes or representative samples tested in a laboratory setting to verify compliance with engineering and safety standards. The number of units tested isn't specified but typically involves a sufficient number to ensure reproducibility and meet statistical requirements for the specific test (e.g., several samples for biocompatibility, multiple cycles for reprocessing).
• Data Provenance: The testing is non-clinical bench testing, meaning it does not involve human subjects or real-world patient data. It is performed in a controlled laboratory environment by the manufacturer (KARL STORZ SE & Co. KG), likely in Germany given their address.

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

• Experts for Ground Truth: Not applicable. For a rigid endoscope, "ground truth" is defined by established engineering specifications and compliance with recognized national and international standards. The "truth" is whether the device performs according to these measurable standards, not a subjective interpretation by experts.
• Qualifications of Experts: Not applicable. The "experts" involved are likely engineers, quality assurance personnel, and regulatory specialists within Karl Storz and external testing laboratories who are qualified to conduct and interpret the specified tests according to the standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image diagnosis). For physical device testing, the results are typically quantitative measurements that either pass or fail against predefined criteria in the standards.

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

• MRMC Study: No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like an AI system) on human reader performance across multiple readers and cases. This is not relevant for a rigid endoscope, which is a physical visualization and access tool.

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

• Standalone Performance: Not applicable. This device is a physical endoscope, not an AI algorithm. Its function is to provide visualization, which inherently involves a human user (the clinician) in the loop.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" is adherence to established engineering specifications, safety standards (e.g., thermal safety), optical performance metrics (e.g., field of view, resolution), biocompatibility requirements, and validated reprocessing protocols as defined by the numerous ISO, IEC, AAMI, ASTM, and ANSI standards listed. It is a technical and regulatory compliance "ground truth."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.

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

• Training Set Ground Truth: Not applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set."

In summary, the provided document is a regulatory submission for a physical medical device (an endoscope) and not for an AI/software device. Therefore, the specific questions related to AI performance metrics, sample sizes for AI training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" are demonstrated through non-clinical bench testing proving compliance with relevant industry standards and substantial equivalence to a predicate device.

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Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are intended to fill a bony void or defect area in a patient's specific cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).

Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are individually sized and shaped implantable prosthetic plates intended to fill a bony void or defect area in a specific patient's cranial and craniofacial skeleton, ranging from 2 mm to 10 mm thick (typically 4mm thick based on the patient CT Scan imaging data) x 25mm to 250 mm wide x 25 mm to 250 mm long.

A Fusion Skull Implant (FSI) is intended to fill a bony void or defect area in a specific patient's skull, whereas a Fusion Craniofacial Implant (FCI) is intended to fill a bony void or defect area in a specific patient's facial region of the skull, excluding the Maxilla (upper jaw area surrounding the teeth only) and Mandible, both considered load bearing areas of the facial region of the skull.

The size, asymmetrical shape, thickness, contour, and edge profile are design elements of the non-load bearing patient-specific base implant. These design elements are used to support the base implant in the bony void or defect area to provide a "Precise Fit."

The single-use alterable base implant (1) is fabricated from a billet block of implant grade Polyether ether ketone (PEEK) Thermoplastic Polymer formulated with biphasic calcium phosphate (BCP PEEK), using a patient's CT scan imaging data, (2) is provided clean (non-sterile) for steam sterilization prior to implantation at a hospital or surgical site, and (3) are attached to the native bone using commercially available cranioplasty hardware and fasteners.

The provided FDA 510(k) clearance letter (K250334) addresses the marketing of the Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI). However, this document does not describe a study involving an AI model or a human-in-the-loop system.

The device described is a physical implant (Preformed Alterable Cranioplasty Plate) intended to fill bony voids or defects in the cranial and craniofacial skeleton. The review focuses on the substantial equivalence of this implant to previously cleared predicate devices, primarily based on material composition (a new PEEK formulation: BCP PEEK) and manufacturing processes.

Therefore, the requested information regarding acceptance criteria and studies proving an AI-driven device's performance (including sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment) cannot be extracted from the provided text.

The performance data section in the document describes:

• Biocompatibility testing: Performed on the new material (Evonik Vestakeep iC4800R® BCP PEEK) according to ISO 10993 standards.
• Performance Testing: Refers to raw material certification and acceptance.
• Cleaning Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Steam Sterilization Validation: Conducted according to ANSI/AAMI ST79.
• Mechanical Testing Validation: A protocol developed by Kelyniam was used as there's no industry-accepted standard for non-load-bearing plates. It states that "all samples passed the acceptance criteria" and "performed equivalent to the predicate devices during mechanical testing using a worst-case scenario."
• Ship Testing Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Summary on Clinical Testing: States "Clinical Testing was determined not applicable" for these devices.

In summary, the provided document does not contain any information about an AI/software-based device, nor does it detail acceptance criteria or studies related to AI performance.

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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) indicate that no clinical performance study was conducted to prove the device meets acceptance criteria. The summary explicitly states:

"7.2 Summary of Clinical Performance: Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, the following information cannot be extracted from the provided document as it pertains to clinical performance which was not performed or deemed necessary for this 510(k) clearance.

1. A table of acceptance criteria and the reported device performance (for clinical performance)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
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 typically for AI/imaging devices, not a light therapy wand)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable for this device type)
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

However, based on the non-clinical tests performed, we can infer the acceptance criteria for those tests and their reported performance:

Non-Clinical Acceptance Criteria and Reported Device Performance

Additional Information Not Applicable/Provided:

• Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed. For non-clinical tests, these metrics are not typically reported in this format.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
• Adjudication method: Not applicable as no clinical study was performed.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is typically for AI/imaging devices.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is typically for AI/software devices.
• The type of ground truth used: Not applicable as no clinical study was performed.
• The sample size for the training set: Not applicable as no clinical study was performed.
• How the ground truth for the training set was established: Not applicable as no clinical study was performed.

In summary, the KALA Therapy Wand (Model: KALA-03) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with relevant safety and performance standards, without the need for a separate clinical effectiveness study.

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The B-Scan module is used for imaging the internal structure of the eye, including the opaque media and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. The probe is intended to be used on both adult and pediatric patients that require imaging of the eye.

The B-Scan device is designed as an ultrasound B-Scan, which uses pulsed echo ultrasound to image the structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulse signals and provides a graphic display of returning pulse echoes to indicate the various structures.

All of the critical functions of the B-Scan are calculated in the same manner as in the predicate device, B-Scan Plus. The software algorithms for clinically critical functions remain the same as in the predicate device. However, the user interface and the workflow of B-Scan have enhancement to support cybersecurity implementation.

Both the subject device and predicate device are compatible with the Connect Software (K070943, K123349) and 4Sight (K152573). The software improvements in Connect were focused on enhancing features that optimize integration with the personal computer's processing, data storage, display, and printing capabilities.

The energy source for the B-Scan is USB power as in the predicate device, B-Scan Plus.

The software utilized on both the Connect and 4Sight platforms is fundamentally identical in core clinical functions, including image scanning, rendering, IOL calculations, data storage, and report formatting. Additionally, the key features within the B-Scan module do not differ significantly between the two systems, nor do they make an impact on the established clinical workflow.

Track 1 is being followed for this 510(k) submission.

Here's a breakdown of the acceptance criteria and the study details for the B-Scan Ultrasonic Imaging System, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" for a novel device performance. However, we can infer acceptance criteria from the comparison table (Table 2) and the performance data section, where the subject device's performance is either "Same" or "SE" (Substantially Equivalent) to the predicate, or explicitly lists performance metrics.

For quantitative metrics, the "acceptance criteria" for the subject device can be interpreted as performing comparably or within acceptable limits relative to the predicate device, or meeting specific new specifications.

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

The document does not explicitly state a sample size for patients or images used in any clinical or test set. The performance data mostly refers to bench testing and validation against standards.

• The only mention of a "sample" related to performance is "average time recorded across 5 probes" for the image preview time. This refers to hardware units, not patient data.
• Data Provenance: Not applicable, as no external data set or clinical study on patients is described beyond bench tests. The focus is on device specifications and in-house validation.

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

Not applicable. The submission does not describe a study involving expert readers establishing ground truth for a test set of images for diagnostic performance evaluation. The "Performance" section outlines bench tests and compliance with recognized standards.

4. Adjudication Method for the Test Set

Not applicable. Since there's no mention of a clinical test set requiring human expert review to establish ground truth, there is no adjudication method described.

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

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify improvement in human readers with AI assistance. The device is purely an imaging system, and there is no mention of AI assistance for image interpretation.

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

The device described is an "B-Scan Ultrasonic Imaging System," which is a diagnostic tool that produces images for human interpretation. It does not contain an AI algorithm for standalone diagnostic performance. Its performance is related to image acquisition parameters, accuracy of measurements, and adherence to safety/design standards.

7. Type of Ground Truth Used

For the quantitative performance claims (e.g., Clinical Accuracy Line/Area), the ground truth was established by physical measurements against known standards or calibrated references during bench testing ("Physical Accuracy and Range Test"). For other aspects, the ground truth is adherence to technical specifications, safety standards, and validated manufacturing/reprocessing procedures.

8. Sample Size for the Training Set

Not applicable. This device is an ultrasound imaging system, not an AI-driven diagnostic algorithm that requires a "training set" of data in the typical machine learning sense. The software aspects mentioned are primarily for device control, image rendering, data storage, and report formatting, enhanced for cybersecurity and usability – not for learning from data to perform a diagnostic task.

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

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

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PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. PathLoc Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The PathLoc Lumbar Interbody Fusion Cage System implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

• PathLoc – TM / BluEX-TM are to be implanted via transforaminal and posterior approach.

The provided FDA 510(k) clearance letter for the PathLoc Lumbar Interbody Fusion Cage System focuses on the mechanical testing and material composition of the device, rather than a clinical study evaluating its performance with human readers or AI assistance. Therefore, many of the requested criteria, particularly those related to AI algorithm performance, multi-reader multi-case (MRMC) studies, ground truth establishment for image datasets, and training/test set details for AI, are not applicable to this submission.

This document describes a medical device (an intervertebral body fusion cage) which is a hardware implant, not an AI/Software as a Medical Device (SaMD). The acceptance criteria and "study" described are focused on bench testing (mechanical performance) and material biocompatibility to prove substantial equivalence to existing predicate devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Mechanical Testing)

The "acceptance criteria" for this device are based on demonstrating mechanical performance that is either superior or equivalent to the predicate device and in compliance with specified ASTM standards. The "study" proving this involves a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a number of devices or units. For mechanical bench testing, sample sizes are typically defined by the ASTM standards (e.g., n=5, n=6, etc.) but are not detailed in this summary. It would be a sample of the manufactured devices.
• Data Provenance: The "data" here refers to the mechanical test results from manufactured devices. This is not "data" in the sense of patient images or clinical outcomes. The device is manufactured in South Korea. The testing would have been conducted in a lab environment. The provenance is internal bench testing, not patient-derived data, and is not retrospective or prospective in the clinical sense.

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

• Not applicable. This is a hardware device; its performance is measured by mechanical properties according to engineering standards, not by human interpretation of images or clinical outcomes requiring expert consensus. The "ground truth" is established by the specified ASTM test methods.

4. Adjudication Method for the Test Set:

• Not applicable. As the "test set" is physical devices undergoing mechanical tests, there is no human adjudication process involved as there would be for, e.g., image interpretation. The machines measure and report data directly.

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

• No. An MRMC study is relevant for evaluating the performance of AI (or human readers) in interpreting medical images. This device is a physical implant, not an imaging or diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done:

• Not applicable. This is a hardware device, not an algorithm or software. "Standalone performance" here is interpreted as the device's mechanical performance in isolation, which is precisely what the bench tests measure.

7. The Type of Ground Truth Used:

• Engineering/Material Standards and Predicate Device Performance: The "ground truth" for this device's performance is its ability to meet predefined mechanical specifications outlined in ASTM standards and to demonstrate substantial equivalence (i.e., not inferior performance) to the predicate device. It's about physical properties, not clinical "truth" from patients.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this traditional hardware device clearance. This term (training set) relates to machine learning models.

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

• Not applicable. As there is no training set for a machine learning model, this question is irrelevant to this device submission.

In summary: The FDA 510(k) clearance for the PathLoc Lumbar Interbody Fusion Cage System relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device in terms of design, materials, and mechanical performance. The framework of questions about AI algorithm performance, clinical ground truth establishment, and training/test datasets is not applicable to this type of medical device submission.

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The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for aesthetic indication for treating facial wrinkles. It emits light energy in the red and near infrared (NIR) region of the light spectrum.

The device consists of a flexible silicone mask that contains light emitting diodes (LEDs) and a controller, multi-straps, a USB-C charging cord, a pair of eye inserts and a storage bag. The LEDs generate the light. The mask is worn on the face and is held in place by the adjustable strap. The controller contains a rechargeable Lithium ion polymer battery and controls power to the mask. The controller has only one key to switch the LEDs ON/OFF and it will automatically shut down after a 10-minute treatment is completed.

The provided FDA 510(k) clearance letter for the CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966) does not contain the detailed study information typically associated with acceptance criteria and clinical performance for an AI/ML device in the context of diagnostic performance (e.g., detecting a disease).

This device is an LED light therapy mask intended for treatment of full-face wrinkles, falling under the regulation 21 CFR 878.4810 (Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology). The primary focus of the regulatory review for such a device is safety and effectiveness based on its physical properties and intended use for cosmetic purposes, rather than diagnostic accuracy or AI-driven image analysis.

Therefore, many of the requested elements are not applicable to the information provided in this document. The document explicitly states:

• "Clinical testing is not needed for this 510(k)."
• "The non-clinical performance testing described above is sufficient to demonstrate that the device can be used safely and effectively."

This indicates that the device's clearance was based on demonstrating substantial equivalence to a predicate device through non-clinical tests (electrical safety, EMC, photobiological safety, battery safety, biocompatibility, and software verification/validation) and not on clinical performance metrics like sensitivity, specificity, or reader studies for diagnostic accuracy.

Addressing the Request Based on the Provided Document:

Given the nature of the device and the clearance documentation, I will answer the applicable points and explain why others are not present.

Acceptance Criteria and Device Performance for CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966)

The CurrentBody Skin™ LED Light Therapy Mask Series 2 is an LED phototherapy device for the treatment of full-face wrinkles. The acceptance criteria and performance evaluation for this device, as detailed in the 510(k) summary, are primarily focused on safety, electrical performance, material compatibility, and functional equivalence to a predicate device, rather than diagnostic performance metrics (e.g., accuracy in identifying wrinkles).

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this device is primarily based on compliance with specific international safety and performance standards, and demonstrating substantial equivalence to a predicate device for its intended use. "Device performance" is therefore reported in terms of compliance with these standards and matching key operational parameters with the predicate.

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

Not applicable for performance evaluation in the context of typical AI/ML diagnostic devices. The clearance is based on non-clinical engineering and safety testing, component material equivalence, and functional equivalence to a predicate device. There is no "test set" of patient data or images in the conventional sense for evaluating diagnostic accuracy or clinical outcomes directly in this 510(k) submission.

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

Not applicable. No ground truth established by experts for a test set of clinical data, as no clinical performance study was conducted or required for this 510(k). Approval is based on safety, hardware specifications, and substantial equivalence.

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

Not applicable. No clinical test set requiring adjudication was used.

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 a diagnostic AI device. No MRMC study was conducted or is relevant for this product's intended use (treatment of wrinkles).

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

Not applicable. This device is a hardware LED light therapy mask. While it has software for control (e.g., timer), it is not a standalone diagnostic algorithm.

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

The "ground truth" for this device's clearance is not related to clinical data or diagnostic accuracy. Instead, the "truth" is established by:

• Compliance with recognized international standards for electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility.
• Demonstration of substantial equivalence (same intended use, similar technological characteristics, and no new questions of safety or effectiveness) to a legally marketed predicate device (K221946).

For the purpose of treatment effectiveness validation in general, the underlying scientific basis for LED light therapy's effect on wrinkles (which is outside the scope of this specific 510k submission's clearance process details) would typically stem from clinical trials and dermatological research. However, this 510(k) relies on the predicate's established performance without new clinical studies.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data for learning or inference.

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

Not applicable. As above, no training set for an AI/ML algorithm.

In summary, the provided 510(k) clearance letter details an approval based on substantial equivalence and compliance with safety and performance standards for a hardware medical device, not on the clinical performance or diagnostic accuracy of an AI/ML driven system. Therefore, many of the requested details regarding AI/ML study methodologies are not present in this document.

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The Globe PF System is indicated for catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.

The Globe Pulsed Field System (Globe PF System) comprises the following components and accessories to support anatomical and electrophysiological mapping, and pacing stimulation of cardiac tissue:

• Globe Controller: Used for the acquisition and processing of signals for cardiac anatomical and electrophysiological mapping, generation of mapping energy and stimulation pulses.

• Globe Workstation: A PC workstation configured with the Globe Software, which the clinician uses to assess contact between the mapping catheter electrodes and the atrial wall, map the atrial electrical activity, and apply stimulation pulses for diagnostic purposes.

• Globe Positioning System (GPS™) Electrodes and GPS Cable: Surface electrodes and cables for localization of the mapping catheter.

The provided FDA 510(k) clearance letter and summary for the Globe® Pulsed Field System do not contain the detailed information required to answer all parts of your request. This document primarily focuses on establishing substantial equivalence to a predicate device based on intended use, indications for use, and a high-level comparison of technological characteristics.

Specifically, the document does not include:

• Specific acceptance criteria values (e.g., minimum sensitivity, specificity, or accuracy targets).
• The reported device performance against such criteria.
• Detailed information about the study design for clinical or performance evaluation (e.g., test set sample size, provenance, expert qualifications, ground truth establishment methods, or whether MRMC studies were conducted).
• Training set details.

Therefore, I can only provide information directly extractable from the given text.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: NOT PROVIDED. The document mentions "performance testing" but does not specify the sample size for any clinical or test data used to evaluate the device.
• Data Provenance: NOT PROVIDED. No information is given regarding the country of origin of data or whether it was retrospective or prospective.

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

• NOT PROVIDED. The document does not detail any expert involvement for ground truth establishment in performance testing.

4. Adjudication method for the test set

• NOT PROVIDED. No information is available regarding any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results.

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 PROVIDED. The document does not mention any MRMC comparative effectiveness study or any evaluation of human reader improvement with AI assistance. The device description focuses on its mapping and stimulation capabilities, not AI-assisted interpretation.

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

• NOT PROVIDED. While software verification and validation were performed, the document does not specify whether "standalone" performance (without human-in-the-loop) was a distinct part of the performance evaluation, or what specific algorithms were evaluated in such a manner. The device is a "Programmable diagnostic computer" that aids clinicians.

7. The type of ground truth used

• NOT PROVIDED. The general "performance testing" and "software verification and validation" are mentioned, but the specific type of ground truth (e.g., expert consensus, pathology, outcomes data) used for evaluation is not described. For the CONTACT and FLOW maps, it mentions they are "based on the same principles of operation as the reference device (Swan-Ganz catheter, K160084)" and that "the scientific methods used to evaluate the safety and effectiveness... are adequate." This suggests a comparison to established methods or a reference standard, but not explicit "ground truth" as you might see for diagnostic classifications.

8. The sample size for the training set

• NOT PROVIDED. The document does not mention a "training set" or any details about it. This submission is for a medical device that includes software, but it doesn't specify if it employs machine learning or requires a distinct "training set" in the common understanding of AI/ML development.

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

• NOT PROVIDED. As no training set is mentioned, naturally, no information on its ground truth establishment is available.

Summary of Device and Study Information (based on available text):

• Device Name: Globe® Pulsed Field System
• Intended Use/Indications for Use: Catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.
• Study Type: Performance testing (bench, biocompatibility, usability, electrical safety, EMC, software V&V, cybersecurity, packaging validation) to demonstrate substantial equivalence to a predicate device.
• Predicate Device: Affera Integrated Mapping System; Impedance Localization Patch Kit (K241828)
• Reference Device: Swan-Ganz Catheter (K160084) (for CONTACT and FLOW maps)
• Key Finding for Equivalence: "The Globe PF System meets the performance criteria for its intended use and does not raise new questions on safety or effectiveness compared to the predicate device."

The FDA 510(k) clearance letter and summary are high-level documents focused on regulatory substantial equivalence. They typically do not delve into the granular details of performance study designs, such as specific sample sizes, expert qualifications, or ground truth methodologies, to the extent that you are asking. Such detailed information would typically be found in the full 510(k) submission itself, which is not publicly released in its entirety.

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