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The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI).

The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use.

The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healtheare professional.

The LiteAire® BASIC Dual Valved, Collapsible MDI Holding Chamber (also referred to as the LiteAire® BASIC) and the modified LiteAire® Dual Valved, Collapsible MDI Holding Chamber (also referred to as the modified LiteAire®), are intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The subject devices feature a universal port designed for compatibility with most MDI medications. The subject devices are intended for use by a single patient and, when properly cared for, are reusable for up to one week. The devices consist of a collapsible paperboard housing and two one-way valves to control the direction of air flow when the patient inhales and exhales through the devices are popped-up by the user prior to use by pressing against the sides of the devices, can be collapsed flat between uses, and are anti-static. The intended environments of use include the home, hospitals and clinics. Note that the only differences between the modified LiteAire® and LiteAire® BASIC configurations is the removal of the window.

The provided text describes modifications to an existing medical device, the LiteAire Dual-Valved, Collapsible MDI Holding Chamber, and presents testing to demonstrate its substantial equivalence to the predicate device. It does not describe an AI/ML powered device, therefore the response below is based on the available information and identifies when specific AI/ML related questions are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the modified devices (LiteAire BASIC and Modified LiteAire) is to demonstrate substantial equivalence to the predicate device (LiteAire K160109) in terms of aerosol characterization (particle size distributions) and other performance aspects. The tables below summarize the key aerosol characterization data.

Table 1: Acceptance Criteria and Reported Device Performance (Aerosol Characterization at Adult Flow Rates - 28.3 L/min)

(Note: "Deemed substantially equivalent" is concluded from the 510(k) summary statement that "the modification in design of the subject devices does not negatively impact the device performance and the modified (subject) devices continues to perform with substantial equivalence to the cleared (predicate) device." Statistical methods for "statistically similar" are not explicitly detailed but are implied by the comparison of means and confidence intervals.)

Table 2: Other Acceptance Criteria and Reported Device Performance

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

• Sample Size for Aerosol Characterization: N=9 for each device (Predicate LiteAire, LiteAire BASIC, Modified LiteAire) for each MDI medication and flow rate tested (adult and pediatric). This means 9 units of each device type were tested for each specific drug and inhalation profile combination.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given that it's a bench performance test for a medical device's physical properties, the concept of "retrospective or prospective" as applied to clinical studies is not directly applicable. These are laboratory-based, controlled experiments.

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

This section is Not Applicable as the device is a medical device (MDI Holding Chamber), not an Artificial Intelligence/Machine Learning (AI/ML) powered device that relies on expert interpretation for ground truth establishment. The performance is measured through objective physical and chemical tests (e.g., aerosol particle size, emitted dose).

4. Adjudication Method for the Test Set

This section is Not Applicable as adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human readers. The tests performed here are objective bench tests.

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

This section is Not Applicable as the device is a medical device (MDI Holding Chamber), not an AI/ML powered device, and no human-in-the-loop performance or reader studies were conducted or described.

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

This section is Not Applicable as the device is a physical medical device, not an algorithm or AI/ML product.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through objective physical and chemical measurements obtained from standardized laboratory tests, specifically:

• Aerosol Characterization: Particle size distributions (MMAD, GSD), Total Emitted Dose, and Fine Particle Dose measured using an Andersen Cascade Impactor (ACI) as per FDA guidance.
• Biocompatibility: Conformance to ISO 10993-1, confirmed by material composition and manufacturing process identical to a previously cleared device.
• Bench Performance: Visual inspection, first article inspection, accelerated aging, and pop/collapse functionality.

The performance values obtained from the predicate device served as the reference for establishing substantial equivalence.

8. The Sample Size for the Training Set

This section is Not Applicable as the device is a traditional medical device, not an AI/ML powered device that requires a "training set."

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

This section is Not Applicable for the reasons stated above.

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The LiteSaber WTAD is used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. The LiteSaber WTAD is not intended for use in the neurovasculature.

The LiteSaber Wire Torque Assist Device (WTAD) is an electrically driven device that delivers a controlled, predictable number of rotations to guidewires.

The device consists of an ergonomically designed white case, onto which is attached a guidewire holder with a pin vise clamp. Once the pin vise is screwed open, the lumen is opened to permit the insertion of guidewires ranging in size from 0.009" – 0.018" in diameter into the holder. Screwing the pin vise clamp closed causes the inserted device to be firmly clamped into place.

The inside of the case contains a pack of three AAA batteries, a miniature brushed DC motor and a software driven electronic control unit (ECU). The outside of the case has a red button to turn the power on, a green light that illuminates when the unit is turned on, and a black adjustment knob at the bottom of the case to control the number of rotations. The number of rotations can be adjusted from 0 - 8 by rotating the knob in the direction shown by the indicator (increase or decrease rotations). If the user requires that the rotations be halted mid-procedure, then either the power may be turned off using the red button, or the white clamp can be held. Both actions will stop the rotations from occurring.

The device is provided sterile and is intended for single use.

The provided text is a 510(k) Summary for the LiteSaber Wire Torque Assist Device. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing, rather than presenting a study where a device's performance is compared against acceptance criteria in the way typically seen for diagnostic AI/ML devices or clinical effectiveness studies.

Therefore, much of the requested information regarding acceptance criteria for device performance, study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance), ground truth details (type, training set size, and how established) is not applicable or not present in this type of FDA submission.

However, I can extract information related to the device's technical specifications and the non-clinical performance data that was collected to support substantial equivalence.

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

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

The document does not provide specific numerical acceptance criteria and reported device performance for these tests in a table format. It only lists the types of tests performed and states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements."

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

• Sample Size for Test Set: Not specified. The document states "bench testing" was performed, which typically involves a defined number of units or test configurations, but specific sample sizes are not provided.
• Data Provenance: Not specified. The tests were performed pursuant to Vesatek's risk analysis, implying internal testing, likely in the US (where Vesatek is located). The data is from "bench testing," which is a form of prospective simulation/testing rather than data collected from patients.

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

Not applicable. This device is a mechanical torque assist device. "Ground truth" in the clinical or imaging sense (e.g., expert consensus on medical images) is not relevant to its performance evaluation for substantial equivalence in this context. The performance was evaluated against engineering specifications and standards.

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

Not applicable. This concept applies to human interpretation of data, typically in diagnostic studies. Bench testing of a mechanical device does not involve adjudication.

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

Not applicable. This device is not an AI/ML diagnostic tool, and no MRMC study was conducted or mentioned. The submission explicitly states: "No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence."

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

Not applicable. This device is a manual assist device for guidewires, not an algorithm, and does not have a "standalone" algorithmic performance in the context of AI/ML or diagnostic imaging. The bench tests evaluate the device's mechanical and electrical functions.

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

Not applicable. The "ground truth" for this type of device's performance evaluation would be its adherence to engineering specifications, design requirements, and relevant industry standards, as measured by various bench tests. It's an objective measurement against defined parameters, not a subjective clinical "ground truth."

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that undergoes machine learning training.

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

Not applicable. As above, this device does not involve a training set for machine learning.

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The LiteWalk is intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied.

The LiteWalk is a pneumatic sequential foot compression device, designed primarily for temporary improvement in blood flow circulation in the lower limb. The system is based on a pneumatic unit that includes a pump, valves, pressure sensor and tubing, and is fed by an external power supply of 12V DC. The unit is connected through 2 sets of 4-tubes to 2 inflatable sandals. Each sandal has 4 inflatable pressure chambers, located to match the foot anatomy: heel, arch, metatarsals, and toes. The sandals come in a pair, for right and left feet, and in 3 sizes: small, medium, large. The operation is based on sequential inflation of the 4 chambers, from heel to toes.

The provided document is a 510(k) premarket notification letter from the FDA for a device called "LiteWalk." It focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical testing. Crucially, the document explicitly states there was "No clinical study was conducted to support this application." Therefore, there is no information in this document regarding acceptance criteria for device performance based on clinical outcomes, nor any study proving the device meets such criteria.

The information provided primarily relates to comparisons with a predicate device and compliance with general safety standards.

Here's a breakdown of the specific points requested, based on the provided text:

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

No clinical performance acceptance criteria or reported device performance for clinical outcomes are mentioned, as no clinical study was conducted. The document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications. A summary table of technical comparison is provided in the document:

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

Not applicable, as no clinical study or test set data for clinical performance was used. The evaluation was based on non-clinical performance (bench tests, verification of specifications, software validation) and comparison to a predicate device.

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

Not applicable, as no clinical study that would require expert-established ground truth was conducted.

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

Not applicable, as no clinical study that would require adjudication was conducted.

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. The LiteWalk is a pneumatic sequential foot compression device, not an AI-assisted diagnostic or imaging device. No MRMC study was mentioned.

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

Not applicable. The LiteWalk is a physical medical device, not an algorithm.

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

Not applicable, as no clinical study was conducted. The "ground truth" for the substantial equivalence determination relied on demonstrating that the device's technical specifications and safety performance (through non-clinical testing and standard compliance) are comparable to the legally marketed predicate device.

8. The sample size for the training set

Not applicable, as no clinical study involving training data was conducted.

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

Not applicable, as no clinical study involving training data was conducted.

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The Lite is a mobility assistive device for indoor use and outdoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

The Lite scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Lite alone and to safely steer under all driving conditions. The Lite is intended for indoor use and restricted outdoor use on pavements or paved footpaths only. The Lite can be folded. This allows for easy storage and enables portability of the Lite. The control panel houses all the controls for operating the device. The control panel has a key switch for turning the device on and off, a lever for forward/reverse driving and a knob for speed adjustment. The control panel also contains the control indicator for the status of the device and a battery gauge. The LED control indicator shows the status of the scooter: steady light mean that all is well, blinking indicates an issue. The number of flashes indicate the type of issue. The User Manual contains a troubleshooting section where each type of error and its solution is specified. The steering column can be adjusted and put it in the position which is most comfortable for the operator. The armrests can be lifted to enable easy entry and exit from the scooter.

The provided document describes the FDA 510(k) clearance for the "Lite" mobility assistive device. This type of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with clinical endpoints and statistical power for performance metrics like sensitivity, specificity, etc., that would be expected for an AI/ML powered device.

Therefore, many of the requested fields are not applicable (N/A) in this context, as the "Lite" is a physical mobility device and not a diagnostic or AI-powered system that would require such studies.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for "Lite" Mobility Assistive Device

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

The acceptance criteria are generally met by demonstrating compliance with various ISO 7176 series safety standards. The reported device performance is presented as a comparison to a predicate device ("Elite").

Additional Performance Characteristics (Comparison to Predicate):

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

This device is not an AI/ML or diagnostic device that typically uses "test sets" of data in the common sense. The testing involved physical units of the device to confirm compliance with international standards.

• Sample size: Not explicitly stated, but typically, a limited number of physical prototypes or production units would be tested for compliance with engineering standards.
• Data provenance: Not applicable in the context of data for an AI/ML model. The tests were performed on the device itself. The manufacturer is Tzora Active Systems Ltd., located in Israel. The standards are international (ISO).

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

Not applicable. Ground truth, in the AI/ML sense, is not established for this type of device. Compliance is determined by objective measurements against established engineering and safety standards (ISO 7176 series). The "experts" would be the engineers and technicians performing the standard compliance tests, trained in their respective fields.

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

Not applicable. Adjudication methods are used to resolve disagreements in expert readings for diagnostic or AI/ML evaluations. This is a physical device tested against objective standards.

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 a physical mobility device that requires a human operator for its intended function. There is no standalone algorithm performance to evaluate.

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

The "ground truth" for this device's safety and effectiveness is established by compliance with internationally recognized engineering and safety standards (ISO 7176 series). This involves objective physical measurements and tests performed on the device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable. There is no training set for this type of device.

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The LITe® BIO Delivery System is intended to deliver autograft, allograft, or synthetic bone grafting materials to all orthopedic surgical sites.

The LITe® BIO Delivery System is a manually operated hand-held device used to facilitate delivery of bone graft material to all orthopedic surgical sites. The LITe® BIO Delivery System consists of a delivery cannula, a delivery plunger, a delivery plunger tip, a loading syringe, and a delivery handle. The cannula is filled with the physician's choice of bone graft material and is then delivered to the intended surgical site.

The provided text describes the 510(k) summary for the LITe® BIO Delivery System, a medical device. This document is a premarket notification for a Class II piston syringe intended to deliver bone grafting materials.

The document does not describe a study involving an AI/Machine Learning device. It refers to a physical medical device for delivering bone graft material. Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable to this document.

The "Summary of Performance Data" section lists several bench tests conducted to demonstrate the device's performance, but these are engineering performance criteria for a physical device, not an AI/ML algorithm.

Summary of Performance Data Provided:

The document states:
"Testing was conducted to demonstrate performance as intended and included the following bench testing:

• Functional testing (delivery of graft material through cannula)
• Life cycle testing
• Cantilever bending of cannula
• Radial compression of cannula
• Retention strength test of cannula
• Connection strength test of cannula to loading funnel"

This information aims to demonstrate that the LITe® BIO Delivery System is substantially equivalent to other currently marketed bone graft delivery systems and that its technological differences do not raise any new safety or effectiveness issues.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device based on this document.

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Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:

• · Dermatology
• · Cosmetic surgery
• · Plastic and general surgery
• · Oral surgery
• · Gynecology
• · Otorhinolaryngology
• · Podiatry

The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Gynecology; Otorhinolaryngology; and Podiatry.

The Lite Touch™ was previously cleared under K974460 in October 1997. This submission contains an expansion of the previously cleared indications for use. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.

This document is a 510(k) summary for the Lite Touch™ Er YAG Laser Treatment System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies to prove device performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., sample sizes, expert qualifications, MRMC studies) are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or detailed device performance metrics in the way one might expect for an AI/device performance study (e.g., sensitivity, specificity, or accuracy targets). Instead, it focuses on demonstrating compliance with recognized safety and performance standards, and substantial equivalence to a predicate device based on technological characteristics.

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

This document describes a medical device clearance process based on demonstrating substantial equivalence to a predicate device and compliance with standards, not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable and not provided.

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

Not applicable, as this is not a study requiring a ground truth established by experts on a test set of data.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This device is an Er:YAG laser system for surgical procedures, not an AI diagnostic tool that assists human readers.

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

Not applicable. The Lite Touch™ is a surgical tool, operated by a physician.

7. The type of ground truth used

Not applicable in the context of clinical performance evaluation studies for AI/diagnostic devices. The "ground truth" here is the device's adherence to engineering specifications and safety standards, and its perceived equivalence to an existing device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a 'training set.'

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

Not applicable.

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The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);Pseudoarthrosis;Spondylolysis;Spondylolisthesis;Spinal stenosis;Tumors;Trauma (i.e. Fractures or Dislocation)Deformities (i.e. Scoliosis, Kyphosis or Lordosis)Failed Previous FusionThe LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

The provided text describes a 510(k) premarket notification for the "LITe® Plate System," a spinal intervertebral body fixation orthosis. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of diagnostic or AI-driven performance.

Therefore, many of the requested categories related to AI device performance evaluation (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of medical device submission.

The "acceptance criteria" discussed in this document refer to the mechanical performance of the implant and its ability to meet established ASTM standards for orthopedic devices. The "study" demonstrating this is mechanical testing.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified in terms of clinical patient data. For mechanical testing, the number of samples tested per condition is not explicitly stated, but typically follows standard testing protocols for ASTM standards.
• Data provenance: Not applicable in the context of clinical or image data. The "data" pertains to mechanical test results.

3. 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 by engineering specifications and recognized consensus standards (like ASTM F1717-14), not by expert human readers.

4. Adjudication method for the test set:

• Not Applicable. Mechanical testing results are objective measurements against defined standards, not subjective assessments requiring adjudication.

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

• Not Applicable. This is a mechanical implant, not an AI diagnostic device.

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

• Not Applicable. This is a mechanical implant, not an AI diagnostic device.

7. The type of ground truth used:

• Mechanical Standards and Predicate Device Performance: The "ground truth" for this device's performance relies on meeting the specifications outlined in ASTM F1717-14 and demonstrating comparable mechanical properties and functional equivalence to its predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a mechanical implant, not an AI device that requires a training set.

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

• Not Applicable.

Summary of the Study:

The "study" referenced in the document is a risk analysis and mechanical testing comparison to predicate devices, not a clinical trial or AI performance study. The submission aimed to demonstrate substantial equivalence to already approved devices.

The key points of the study are:

• Mechanical Testing: The device underwent static and dynamic compression testing per ASTM F1717-14, static torsion testing per ASTM F1717-14, and buttress plate expulsion testing.
• Acceptance Criteria for Mechanical Testing: Predefined acceptance criteria associated with these tests were met. These criteria would be derived from the ASTM standards and comparisons to predicate device performance.
• Comparison to Predicates: The LITe® Plate System was compared to its primary predicate (Stryker Spine, LITe® Plate System, K142699) and additional predicates (Stryker Spine, CENTAUR™ Spinal System, K994347, K001844). The comparison covered intended use, material composition, principles of operation, and design.
• Conclusion: The risk analysis performed demonstrated that any minor differences between the LITe® Plate System and its predicates do not impact device performance, leading to the determination of substantial equivalence.

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The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (TI-LS) spine or via an anterior approach below the bifureation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Spinal stenosis; Tumors; Trauma (i.e. Fractures or Dislocation); Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion

The LITe® Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

The provided text is a 510(k) summary for a medical device called the LITe® Plate System. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance, rather than establishing acceptance criteria and proving performance through a clinical or algorithmic study with specific metrics like sensitivity, specificity, or reader improvement.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device 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 their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or human reader improvement with AI
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

The "Performance Data" section in the K142699 document refers to non-clinical mechanical testing, not a study of an AI/algorithm's diagnostic or predictive performance.

It states:
"Nonclinical testing was performed to demonstrate that the LITe® Plate System is substantially equivalent to its predicate devices. The following testing and analysis was performed:

• Static and dynamic compression testing per ASTM F1717-14
• Static torsion testing per ASTM F1717-14
• Buttress plate expulsion testing"

This type of testing is to ensure the physical integrity and mechanical properties of the orthopedic implant meet established standards for similar devices, not to assess the performance of a diagnostic algorithm or AI system.

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810 nm and 980nm wavelength:

LiteCure Therapy System, Model L TS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

980nm wavelength:

LiteCure Therapy System, Model L TS-1500 is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.).

Not Found

The provided text focuses on the FDA's 510(k) clearance for the LiteCure Therapy System, Model LTS-1500. This is a regulatory document and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

Specifically, the document performs the following functions:

• Confirms 510(k) clearance: States that the device is substantially equivalent to a legally marketed predicate device.
• Lists device names and regulatory information: Provides the Trade/Device Name, Regulation Number, Regulation Name, and Regulatory Class.
• Defines Indications for Use: Specifies the medical conditions and purposes for which the device is intended (e.g., pain relief, increased local blood circulation, temporary increase of clear nail in onychomycosis).
• Provides regulatory guidance: Reminds the manufacturer of ongoing responsibilities under the Act.

The document does NOT contain any information about:

• Acceptance criteria: No specific metrics (e.g., sensitivity, specificity, accuracy, or a defined therapeutic outcome threshold) are mentioned.
• Device performance metrics: No reported performance data (e.g., how much pain relief was achieved, or the percentage increase in clear nail).
• Details of a study: No information on study design, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, based solely on the provided text, I cannot complete the table or answer the specific questions about the study that proves the device meets acceptance criteria. The FDA 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, and while it requires evidence of safety and effectiveness, the detailed study results and acceptance criteria are typically found in the 510(k) submission itself (which is not provided here), rather than in the final clearance letter.

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The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.

The Stryker Spine LITe® Decompression System - Light Cable is a single use, sterile and disposable component. The Stryker Spine LITe® Decompression System - Light Cable consists of fiber optic cables contained within silicone tubing which can be connected to a light generator on one end and the tube of the Stryker Spine LITe® Decompression System on the other end.

This 510(k) summary is for the Stryker Spine LITe® Decompression System - Light Cable, which is a fiber optic light cable intended to provide surgical site illumination. The document focuses on establishing substantial equivalence to predicate devices and does not describe a study involving performance metrics for AI or machine learning algorithms. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable.

Here's an analysis based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain specific acceptance criteria and detailed performance metrics in the way one would expect for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "performance" described is in comparison to the predicate devices.

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

This information is not applicable. The device is a physical medical device (fiber optic light cable), not an AI/ML algorithm that processes data. Therefore, there is no "test set" of data in the context of AI/ML evaluation.

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

This information is not applicable, as there is no "ground truth" establishment in the context of an AI/ML test set. The evaluation is focused on the device's physical design, materials, and intended function compared to existing legally marketed devices.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "adjudication method" for a test set as would be used for AI/ML performance evaluation. The substantial equivalence determination is made by the FDA based on the provided comparisons to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers' improvement with AI vs without AI assistance

This information is not applicable. The device is a surgical light cable, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

This information is not applicable. The device is a physical light cable, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable. As stated, there is no "ground truth" in the context of AI/ML evaluation for this device. The evaluation relies on comparing the device's technical specifications and intended use against predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for it.

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