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The intended use of VHT 200 wound treatment system is to provide humidified oxygen to open, acute or chronic wounds as an adjunct therapy in wound management and treatment.

The VHT-200 wound treatment system is intended for the following kinds of wounds:

• · skin ulcerations due to diabetes, venous stasis, and post-surgical infections, and gangrenous lesions
• decubitus ulcers
• · amputations/infected stumps
• · skin grafts
• burns
• · frostbite

The VHT-200 Wound Treatment System is a prescription medical device. This system is designed for most topical skin injuries that can benefit from the properties of oxygen and moisture therapy treatments. All the benefits of oxygen and moisture modalities are self-contained into one system and applied without the need of switching applications. The VHT-200 is made for clinical office use. The VHT-200 wound treatment system is designed for the medical provider to add oxygen flow rate and frequency of the treatments based on experience and professional assessment of the individual patient's medical need.

This document is a 510(k) summary for the VHT-200 Wound Treatment System. It does not describe a study involving acceptance criteria and device performance in the way a clinical performance study for an AI-powered diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various types of engineering and safety testing.

Therefore, many of the requested categories are not applicable to the information provided. The document outlines regulatory and engineering tests, not a clinical study involving human readers or AI algorithms.

Here's a breakdown based on the provided text, indicating where information is missing or not applicable:

No clinical performance study with acceptance criteria in the requested format was performed or described in this 510(k) summary. The provided text describes engineering, safety, and performance testing to demonstrate substantial equivalence to a predicate device, not a human-in-the-loop or standalone AI performance study against specific clinical acceptance criteria.

Here's how the information maps to your request:

1. A table of acceptance criteria and the reported device performance:
   This information is not provided in the context of a clinical performance study with specific metrics like sensitivity, specificity, or accuracy. The document states "The VHT-200 has been evaluated in various conditions and determined to be safe and effective" and lists types of engineering and safety tests, but does not provide a table of acceptance criteria and reported performance for clinical outcomes or diagnostic accuracy.

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. This document describes testing for a medical device (topical oxygen chamber), not an AI diagnostic algorithm evaluated on a test set of patient data. The "test set" here refers to conditions for engineering and safety tests.

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 document describes testing for a medical device, not a clinical study requiring expert ground truth for diagnostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. This document describes testing for a medical device, not a clinical study requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No. This document does not mention any MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The VHT-200 is a physical medical device (topical oxygen chamber) and does not involve an AI algorithm with standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable in the context of diagnostic "ground truth." The "ground truth" for the VHT-200 system would relate to its physical performance against engineering standards (e.g., oxygen concentration maintained, biocompatibility, electrical safety).

8. The sample size for the training set:
   Not applicable. This device does not use a training set in the context of AI or machine learning.

9. How the ground truth for the training set was established:
   Not applicable. This device does not use a training set.

Summary of "Performance Testing" from the document:

The 510(k) summary indicates that the VHT-200 Wound Treatment System underwent various tests to demonstrate its safety and effectiveness, and its substantial equivalence to the predicate device. These tests fall under engineering and regulatory compliance, not clinical diagnostic performance.

• Tests Performed:

  • Software validation
  • IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests)
  • IEC 80601-1-2 (Likely a typo and refers to IEC 60601-1-2 or another specific part of the IEC 60601 series)
  • IEC 80601-2-69 (Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrators) - This is highly relevant as the device includes an oxygen concentrator.
  • Biocompatibility evaluation
  • Performance testing (general statement, specific metrics not detailed)
  • Cleaning validation
  • Distribution testing

• Conclusion: Based on these tests, the VHT-200 was concluded to be as safe, as effective, and to perform at least as safely and effectively as the predicate device.

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The Smith & Nephew Conquest FN is indicated for displaced intracapsular femoral neck fractures.

The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional lengths of the proximal locking compression screws to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

The provided document is a 510(k) premarket notification for a medical device called CONQUEST FN, which is an internal fracture fixation device. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing (axial pullout strength).

It does not contain information related to a study proving the device meets acceptance criteria based on its performance in interpreting medical images or diagnosing conditions. The acceptance criteria described are for mechanical properties of the device (e.g., pullout strength), not for AI/ML performance metrics like sensitivity, specificity, or AUC which would be relevant to an imaging-based AI device.

Therefore, I cannot provide a response that includes the requested information regarding:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy.
• Sample size used for the test set and data provenance (as no such test set is described for diagnostic performance).
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study.
• Standalone performance.
• Type of ground truth used (clinical outcomes, pathology, expert consensus).
• Sample size for the training set.
• How ground truth for the training set was established.

The document is primarily a regulatory submission for a physical orthopedic implant, not an AI/ML-driven diagnostic imaging device. The "acceptance criteria" mentioned in the document refer to engineering/biomechanical performance standards for the implant itself, such as axial pullout strength, and bacterial endotoxin limits for sterility.

Summary of relevant information from the document (limited to what is present):

Acceptance Criteria and Performance (related to the physical device):

• Acceptance Criteria for Axial Pullout Strength: Not explicitly quantified in the provided text, but stated as "met the acceptance criteria" for two different tests. These criteria likely refer to specific biomechanical standards or comparisons to predicate devices.
• Reported Device Performance for Axial Pullout Strength:
  • OR-17-111: "Result concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior axial pullout strength compared to the predicate device [Targon FN Titanium System]."
  • OR-17-164: "Results of the test concluded that the CONQUEST FN proximal locking screws met the acceptance criteria and exhibited similar or superior axial pullout strength as compared to the predicate device [cannulated screws]."
• Acceptance Criteria for Sterility: "Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance, 'Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile,' 'Pyrogen and Endotoxin Testing: Questions and Answers,' and ANSI/AAMI ST72."
• Reported Device Performance for Sterility: "met the acceptable endotoxin limits."

Other information:

• Sample size for testing pullout strength: Not specified.
• Nature of data: Pre-clinical (mechanical testing in a lab setting), not human patient data.
• Ground truth: For mechanical tests, the "ground truth" is the measured physical property (axial pullout strength) compared against a defined standard or predicate performance. For sterility, it is the endotoxin level measurement compared to the standard. This is not "ground truth" in the diagnostic sense.
• No information on AI/ML components or studies for diagnostic performance is present in this document.

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The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The subject internal fixation plating system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. All described implant devices are manufactured from implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

The provided text describes mechanical testing conducted for the CONQUEST FN device to demonstrate its substantial equivalence to predicate devices. However, it does not contain information about a study involving human readers or AI assistance. Therefore, questions related to MRMC studies, human reader improvement with AI, and standalone AI performance cannot be answered from the provided text.

Here's the information extracted from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes pre-clinical mechanical testing. Typically, for such tests, "sample size" refers to the number of devices or constructs tested. The specific number of samples for each test (e.g., how many screws for pullout strength, how many constructs for fatigue) is not provided in the given text.

The data provenance is from pre-clinical mechanical testing conducted by Smith & Nephew, Inc. The country of origin is not explicitly stated for the testing, but Smith & Nephew is based in Memphis, Tennessee, USA. The data is prospective as it was generated specifically for the 510(k) submission to compare the new device against predicates.

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

This question is not applicable to this type of mechanical testing. Ground truth in this context is established by the physical testing methods and the measured mechanical properties, not by expert consensus on images or pathology.

4. Adjudication Method for the Test Set:

This question is not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for expert reviews, typically in image interpretation or clinical trials, not for direct physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

No, an MRMC comparative effectiveness study was not done. The provided text focuses exclusively on pre-clinical mechanical testing of a bone fixation device, not on AI-assisted diagnostic or interpretative tasks. Therefore, there is no information on human reader improvement with or without AI.

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

No, a standalone algorithm performance study was not done. The device being described is a physical medical implant (bone fixation system), not a software algorithm or AI device.

7. The Type of Ground Truth Used:

The ground truth used for these tests is mechanical performance metrics derived from standardized or accepted pre-clinical testing methods (e.g., axial pullout strength, insertion torque, torsional strength, fatigue life). The comparison is against established predicate device performance as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. The CONQUEST FN is a physical implant, not an AI model requiring a "training set."

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

This question is not applicable as there is no training set for a physical implant device.

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The Free-Gliding SCFE Screw System is indicated as a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.

The Free Glidinq SCFE Screw is a self-extending cannulated screw for use in fixation of slipped capital femoral epiphysis and femoral neck fractures. The design of the screw includes a male component (which is attached to the lateral cortex) and a female component (which is attached at the proximal epiphysis). Anchorage of the components is achieved through screw-type fixation. The screw has a built-in feature that allows for free extension of its length as the slipped capital physeal plate heals and normal patient growth continues. Stable fixation and rotational stability is created at the fracture (slip) site while avoiding compression forces thus avoiding premature closure of the physeal plate.

Here's an analysis of the provided text regarding the acceptance criteria and study for "The Free-Gliding SCFE Screw System":

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document explicitly states "No clinical testing is provided as a basis for substantial equivalence." This means that acceptance criteria for clinical outcomes (e.g., success rates, complication rates in patients) were not established or met through a clinical study for this device's 510(k) clearance. The substantial equivalence was based solely on non-clinical (biomechanical) testing and comparison to predicate devices.

Here's the breakdown of the other requested information, based on the provided document:

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

• Sample Size (Test Set): Not specified for the biomechanical tests. The document refers to "tests" but does not detail the number of samples tested for each biomechanical assessment (e.g., number of screws for four-point bending, torsional strength, or pullout strength).
• Data Provenance: The biomechanical testing was performed in Canada by Pega Medical Inc. (the applicant). This is an in-vitro (laboratory) study, not a human retrospective or prospective study.

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

• Not Applicable. Since this was a biomechanical (engineering) study, the "ground truth" was established by objective physical measurements according to specified ASTM standards and engineering analyses, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. No human-based adjudication was involved, as it was a biomechanical study.

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

• No. No MRMC study was conducted. The device is a physical implant, not a diagnostic imaging or AI-assisted system that would involve human readers.

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

• Not Applicable. This is a physical medical device (screw system), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Objective Mechanical Measurements: The ground truth for the biomechanical tests was based on objective measurements of physical properties (e.g., force, displacement, torque) as prescribed by ASTM F1264 and standard engineering principles. The comparison was made against the measurements obtained from predicate devices.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device. There is no concept of a "training set" as understood in machine learning or AI.

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

• Not Applicable. As there is no training set, this question is not applicable.

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The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.

Dovice Bels.ipness are comprised of various size cannulated screws for the fixation of bone fractures. POGO screws are made of 316LVM Stainless Steel conforming to ASTM F138. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.

The provided text describes a 510(k) premarket notification for a medical device called the "POGO Screw." This submission aims to demonstrate substantial equivalence to an already legally marketed predicate device (K080649), rather than proving the device meets specific acceptance criteria through clinical or even extensive bench performance studies with stated numerical targets.

Therefore, the requested information regarding acceptance criteria, study details like sample sizes, expert involvement, ground truth establishment, and comparative effectiveness with AI assistance is largely not applicable or not present in the provided document.

Here's an explanation of why and what information is available:

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

• Not applicable/Not provided. The document states "Bench testing was conducted to support equivalency" but does not detail specific acceptance criteria (e.g., minimum tensile strength, fatigue life thresholds) or the numerical results of this testing. The focus is on demonstrating "substantial equivalence" to a predicate device, meaning it performs similarly, not necessarily meeting a predefined set of numerical performance targets.

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/Not provided. This type of information is typically associated with clinical studies or extensive performance testing with defined test sets. For a 510(k) demonstrating substantial equivalence based on bench testing (as implied), these details are not usually required or disclosed in the summary.

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/Not provided. There is no mention of human expert involvement in establishing a "ground truth" for the testing in this submission, as it focuses on material and design equivalency, not diagnostic or clinical interpretation.

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

• Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here.

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

• Not applicable. This device is a bone fixation screw, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

• Not applicable. As a physical medical device (bone screw), there is no "algorithm only" performance to evaluate.

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

• Not applicable/Not provided. Since no specific "test set" and outcome evaluation in the clinical sense is detailed, there's no ground truth type mentioned. The "truth" in this context is the performance of the predicate device, to which the new device is compared.

8. The sample size for the training set

• Not applicable. The concept of a "training set" applies to machine learning models. This device is a mechanical implant, not an AI system.

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

• Not applicable. See point 8.

Summary of available information from the document that is tangentially related to "performance":

• Study type: Bench testing was conducted to support equivalency with a predicate device.
• Predicate Device: POGO Screw cleared under K080649.
• Equivalency Statement: "The POGO Screw is substantially equivalent in design, materials, construction and intended use as those of the predicate."
• Safety and Efficacy: The risk analysis and test results demonstrate that the POGO Screw is substantially equivalent to the predicate device and is capable of safely and effectively performing the stated intended use.
• Device Description (relevant to equivalency): The device consists of various size cannulated screws for bone fracture fixation, made of 316LVM Stainless Steel conforming to ASTM F138. Available in 55mm to 130mm lengths, provided sterile or non-sterile.
• Intended Use: General management of fractures and reconstructive surgery.

In essence, the entire document serves as evidence of substantial equivalence to a device already on the market, not as a detailed report of a study proving a device meets specific, pre-defined quantitative acceptance criteria with associated ground truth from experts or large datasets.

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