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LC ChromeFlow is a flowable light cure resin based dental restorative material which is indicated to be used for small restorations; extended fissure sealings; restorations of class III, IV and V and lining of cavities.

LC ChromeFlow is a light cure flowable radiopaque composite. LC ChromeFlow can be used for a lot of natural tooth shades due to its continuous color matching properties.

The provided FDA 510(k) summary for LC ChromeFlow does not contain any information about acceptance criteria or a study proving the device meets said criteria, in particular no information about AI algorithm performance.

The document is a standard 510(k) submission, focusing on establishing substantial equivalence to predicate devices based on intended use, chemical composition, and physical properties, as per ISO 4049. It does not refer to any AI/ML component or associated studies for performance evaluation against specific criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The AERO CHROME* Select Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcate professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter The AERO CHROME* Select Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.

The AERO CHROME* A-Line Breathable Performance Surgical Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of micro-organisms, body fluids, and particulate matter The AERO CHROME* A-Line Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70 2012 Liquid Ba111er classifications.

The AERO CHROME* Select Breathable Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 4 Liquid Barrier Performance Barrier in the critical zone. The back of the gown is comprised of the identical fabric as the front of the gown and meets AAMI Level 1 Liquid Barrier Performance Barrier. The AERO CHROME* Select Breathable Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in the following various sizes: Large, X-Large, XX-Large.

The AERO CHROME* A-Line Breathable Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 4 Liquid Barrier Performance Barrier in the critical zone. The back of the gown is lightweight, air-breathable, and provides AAMI Level 1 protection. The AERO CHROME* A-Line Breathable Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in an X-Long, X- Large size.

The provided document describes the acceptance criteria and performance data for surgical gowns, not a medical device that uses algorithms or AI. Therefore, most of the requested information (sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training) is not applicable.

Below is a table summarizing the acceptance criteria and reported performance based on the non-clinical testing for the AERO CHROME* Select Breathable Performance Surgical Gown and AERO CHROME* A-Line Breathable Performance Surgical Gown.

1. Table of Acceptance Criteria and Reported Device Performance

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Chrome is intended for use in aesthetic, cosmetic and surgical applications requiring incision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

Chrome is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos

Treatment of benign vascular lesions including, but not limited to:

• port wine birthmarks
• telangiectasias
• spider angioma
• Cherry angioma
• Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

• cafe-au-Iait birthmarks
• Ephalides, solar lentigines
• senile lentigines
• Becker's nevi
• freckles
• common nevi
• nevus spilus
• Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

• nevus of Ota
• Café au lait spot
• Ephalides, solar lentigo (lentigines)
• Becker Nevus
• Nevus spilus

Treatment of common nevi

Removal or lightening of unwanted hair

Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.

The laser is also intended for the treatment of benign pigmented lessons such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles.

Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The laser is also indicated for benign pigmented lesion size, for patients with benign lesions that would potentiallybenefit from aggressive treatment, and for patients with benign that have not responded to other laser treatments.

It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

Chrome is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at 532 nm and 1064 nm (Nd:YAG laser).

Chrome, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.

It can also be connected to Er:YAG handpieces cleared under K173002.

Chrome, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.

The optical delivery system is an articulated arm with fixed or variable handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.

Chrome is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Unfortunately, the provided text does not contain information about acceptance criteria for performance, device performance metrics, or any clinical study details (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, or training set details).

The document focuses on regulatory approval (510(k) premarket notification) for a laser device called "Chrome." It establishes "substantial equivalence" to predicate devices, primarily based on technological characteristics and safety standards.

The sections that might typically contain such information (like "Performance data" and "Technological Characteristics Comparison") focus on:

• Performance data: Lists recognized consensus safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and states that "Software Verification and Validation Testing" was conducted. It also mentions biocompatibility was established by comparison to a predicate. This refers to safety and electrical performance standards, not clinical efficacy or diagnostic accuracy.
• Technological Characteristics Comparison: Compares specific technical parameters (laser wavelengths, pulse width, max fluence, spot size, repetition rate, microbeam handpiece details, IPL wavelengths) of the Chrome device to two predicate devices. This demonstrates that the device operates within similar technical specifications as already approved devices, not that it has met specific clinical performance criteria.

Therefore, I cannot populate the requested table and answer the detailed questions about the study that proves the device meets acceptance criteria, as that information is not present in the provided document.

The document primarily demonstrates:

1. Indications for Use: What conditions the device is intended to treat (various dermatological conditions, tattoo removal, hair reduction, etc.).
2. Technological Equivalence: That its technical specifications (laser types, wavelengths, power, etc.) are comparable to previously cleared devices.
3. Safety & Standards Compliance: That it complies with general safety and electrical standards for medical devices and lasers.

This type of 510(k) submission often does not require new clinical studies if substantial equivalence can be established based on technological characteristics and intended use compared to legally marketed predicate devices.

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The AERO CHROME* Breathable Performance Surgical Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The AERO CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.

The AERO CHROME* Breathable Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown- Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 4 Liquid Barrier Performance Barrier in the critical zone. The back of the gown has a Spundbond-Meltblown- Spunbond (SMS) fabric which allows for air-breathability with an AAMI Level 1 Liquid Barrier Performance Barrier. The AERO CHROME* Breathable Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in the following various sizes: Small, Large, X-Large, XX-Large, XXX-Large, X-Long XL, X-Long XXL.

This document is a 510(k) Premarket Notification for the AERO CHROME* Breathable Performance Surgical Gowns, seeking substantial equivalence to a predicate device (K153255). It is not a study proving device meets acceptance criteria in the context of an AI/ML medical device. Therefore, it does not contain the information required to answer the requested questions regarding acceptance criteria, study design, sample sizes, expert involvement, or training data for an AI/ML device.

This document describes the physical and performance characteristics of a surgical gown and compares it to a previously cleared predicate device to demonstrate substantial equivalence for regulatory purposes. The "acceptance criteria" referred to in the document are the performance standards (e.g., AAMI PB70:2012 liquid barrier classifications, ISO standards for biocompatibility, flammability) that the surgical gown must meet. The "study" proving device meets acceptance criteria refers to the non-clinical testing performed on the gowns to ensure they comply with these standards.

Here's an attempt to answer the questions based on the provided document, understanding that the questions are framed for AI/ML devices and this document is for a physical medical device (surgical gown):

Acceptance Criteria and Device Performance (for a physical medical device - surgical gown)

The document primarily focuses on demonstrating that the subject device (AERO CHROME* Breathable Performance Surgical Gowns) is substantially equivalent to a predicate device (K153255) by meeting the same regulatory and performance standards. The "acceptance criteria" here are established industry standards and regulatory requirements for surgical gowns. The "reported device performance" is a statement of compliance with these standards based on non-clinical testing.

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

Based on the "Technological Characteristic Comparison Table" and "Summary of Non-Clinical Testing" sections:

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

The document does not specify the exact sample sizes used for each material or performance test. It states "non-clinical tests" were conducted. The data provenance is industrial testing of material and product performance, typically conducted in a laboratory setting by the manufacturer or a third-party testing facility. This is a prospective testing regimen to ensure product quality and regulatory compliance. Country of origin for data is not specified but would be the location of the testing laboratories.

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

This question is not applicable to this type of device. "Ground truth" in this context is established by standardized test methods (e.g., AATCC, ASTM, ISO standards) and the results obtained from calibrated scientific instruments. There are no human "experts" establishing ground truth in the sense of medical diagnosis or image annotation for this product testing. The "experts" involved would be qualified laboratory technicians and engineers proficient in performing the specified material and performance tests.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML or diagnostic study requiring adjudication of expert opinions. Results are binary (Pass/Fail) based on meeting pre-defined thresholds in the specified standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This is a physical medical device (surgical gown), not a diagnostic tool or AI/ML system, so MRMC studies are not relevant. This document is a comparison of the subject device to a predicate device based on material composition and physical performance, not a comparative effectiveness study involving human readers.

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

Not applicable. This is not an algorithm. The "standalone" performance here refers to the gown's intrinsic physical and barrier properties as measured in the laboratory tests.

7. The type of ground truth used

The "ground truth" for this device is based on standardized physical and chemical test results against established performance specifications (e.g., AAMI PB70, ISO 10993, ASTM standards). It is not expert consensus, pathology, or outcomes data in the medical context of AI/ML.

8. The sample size for the training set

Not applicable. Surgical gowns are not "trained" like AI models. The document describes the "construction overview" and materials used, which are the product's design specifications. There isn't a "training set" in the computational sense.

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

Not applicable. As there is no "training set," there is no "ground truth" to establish for it in this context. The manufacturing process and material specifications for the gown are derived from engineering design, material science data, and compliance with the relevant industry standards.

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The Aero Chrome* Select Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Select Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.

The Aero Chrome* Select Breathable Performance Surgical Gown has a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Select Breathable Performance Surgical Gown in the non-critical zone also has the same Spunbond/Film/Spunbond/Meltblown/Spunbond fabric (SFSMS) that provides ASTM 1671 liquid barrier protection. The Aero Chrome* Select Breathable Performance Surgical Gown is single use, disposable medical device that will be provided in a variety of sizes and sterile and non-sterile packaging configurations.

The provided text describes a medical device, the Aero Chrome* Select Breathable Performance Surgical Gown, and its equivalence to a predicate device. The information details various performance tests and their results, which serve as criteria for establishing substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

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

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gowns, or material samples tested per batch). It only lists the tests performed and that the product "met the predetermined specifications."

The data provenance is industrial testing data, generated by Halyard Health, Inc. or its designated testing facilities, to demonstrate compliance with relevant industrial standards and regulations (e.g., AAMI, ISO, ASTM, CFR). The testing appears to be prospective in nature as it is being conducted to demonstrate the performance of a new 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):

This information is not applicable. The device is a surgical gown, and its performance is evaluated against objective, standardized physical and biological parameters, not subjective expert assessment as would be the case for an AI diagnostic tool.

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

This information is not applicable for this type of device and testing. The tests involve quantifiable measurements according to established methods, not subjective interpretations 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:

This is not applicable. MRMC studies are typically for diagnostic imaging devices where human interpretation is involved. This device is a surgical gown.

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

This is not applicable, as this is a physical medical device (surgical gown), not a software algorithm.

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

The "ground truth" for this device is defined by the established industry standards and regulatory requirements for surgical apparel. These standards specify objective, measurable performance criteria (e.g., liquid barrier effectiveness, flammability, biocompatibility).

8. The sample size for the training set:

This is not applicable. This is not a machine learning or AI device that requires a training set. The device's performance is tested against predetermined physical and biological standards.

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

This is not applicable, as there is no training set for this type of device. The ground truth for evaluating the device is based on established scientific and regulatory standards.

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The Aero Chrome* Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Chrome* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.

The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization

The Aero Chrome* Breathable Performance Surgical Gowns have a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Breathable Performance Surgical Gown in the non-critical zone has a SMS Spunbond/meltblown/spunbond) fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection. The Aero Chrome* Breathable Performance Surgical Gowns are single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations described below.

The provided document is a 510(k) premarket notification for a medical device: the Aero Chrome Breathable Performance Surgical Gown*. This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving novel efficacy or safety through primary clinical trials for the device itself. Therefore, the "study" proving the device meets acceptance criteria primarily consists of non-clinical performance testing to show that the new device performs at least as well as, or equivalently to, the predicate device in relevant aspects.

Here's an analysis of the acceptance criteria and the provided information:

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

The document doesn't present a single consolidated "acceptance criteria" table as one might find for a diagnostic AI device with precision/recall metrics. Instead, it details various performance tests demonstrating compliance with recognized standards for surgical gowns. The acceptance criteria for each test are implicitly (or explicitly, as "Pass") stated as meeting the requirements of the specified standard.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical performance test. Standard test methods (e.g., ASTM, ISO, AAMI) typically define the minimum sample sizes required for statistically valid testing. For example, for textile testing (tensile strength, abrasion), there would be a specified number of specimens. For biocompatibility (cytotoxicity, irritation, sensitization), there would be a defined number of replicates and control groups.
• Data Provenance: The data comes from the manufacturer's (Halyard Health, Inc.) own non-clinical performance testing. It is not explicitly stated if these were internal labs or third-party labs, but generally, such tests are conducted in controlled lab environments. The document does not specify a country of origin for the data; it's implicit to be associated with Halyard Health's operations for regulatory submission in the US.
• Retrospective or Prospective: These are prospective tests performed specifically to demonstrate that the newly designed Aero Chrome* gown meets the required performance standards for its intended use and for comparison with the predicate device.

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

• This question is not applicable in the context of this device and submission. This is a surgical gown, not an AI/diagnostic device that relies on expert interpretation of images or patient data to establish ground truth. The "ground truth" for a surgical gown's performance is established by objective, measurable physical, chemical, and biological properties, as defined by recognized consensus standards (e.g., AAMI, ISO, ASTM). The expertise lies in conducting the tests according to the standard protocols and interpreting the quantitative results against the specified pass/fail criteria.

4. Adjudication method for the test set:

• This question is not applicable. Since the "ground truth" is established through objective laboratory testing against predefined standards (e.g., a specific resistance value, a pass/fail for bacterial penetration), there is no human "adjudication" in the sense of multiple readers or experts reviewing subjective data. The test results are quantitative/qualitative outcomes of physical/chemical processes.

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 question is not applicable. This is a physical medical device (surgical gown), not an AI diagnostic algorithm. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

• This question is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The ground truth for this device's performance is established by objective, quantitative measurements and qualitative assessments derived from standardized laboratory test methods (e.g., AAMI PB70:2012, ASTM D5034, ISO 10993 series). These standards define specific criteria (e.g., pressure resistance, microbial penetration, tensile strength limits, cytotoxicity levels) that the device must meet. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic tool would be.

8. The sample size for the training set:

• This question is not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The manufacturing process of surgical gowns involves material selection, design, and fabrication, which are validated through process controls and quality assurance, not through a "training set" of data.

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

• This question is not applicable for the reasons stated above.

In summary: The submission for the Aero Chrome* Breathable Performance Surgical Gown focuses on demonstrating substantial equivalence to a predicate device (Aero Blue* Performance Surgical Gown) by providing comprehensive non-clinical performance test results against established industry standards. The "acceptance criteria" are the "Pass" outcomes for each of these standardized tests, indicating that the gown meets the specified physical, chemical, and biological performance requirements relevant to its intended use as protective apparel. The evaluation does not involve clinical studies with human "readers" or AI algorithms.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Ascent POCT System is indicated for:
a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
b) spondylolisthesis;
c) fracture/dislocation;
d) spinal stenosis;
e) atlanto-axial fracture with instability:
f) occipito-cervical dislocation;
g) tumors;
h) revision of previous cervical spine surgery

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.

The Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Orthofix Spinal Fixation System using the Ascent Axial or Parallel Rod Connector.

The Ascent® POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium and Cobalt Chrome allov that allow the surgeon to build a spinal implant construct. The system design is intended to promote immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and for upper thoracic spine. Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables. Ascent POCT system can also be linked to Orthofix Spinal Fixation System (SFS) using the Ascent Axial or Parallel Rod Connector or Transition Rods.

The provided document is a 510(k) Premarket Notification for the Orthofix Ascent POCT System, a spinal fixation system. It describes the device, its intended use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. This type of regulatory submission typically focuses on mechanical and material testing for medical devices, rather than AI/ML algorithm performance studies. As such, the specific information requested about AI/ML acceptance criteria and studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.

However, I can extract information related to the performance data presented in the document, which pertains to the mechanical performance of the device components.

Acceptance Criteria and Device Performance (Mechanical)

The acceptance criteria for the Orthofix Ascent POCT System are based on demonstrating substantial equivalence to predicate devices through mechanical testing in accordance with ASTM F2706-08 standards.

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of non-clinical mechanical tests to evaluate the physical performance of the Orthofix Ascent POCT System components (specifically the new rods).

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

   • The document does not explicitly state the number of samples (e.g., number of rods tested) for each characteristic. It refers to "Test results," implying that multiple samples were likely tested as per ASTM F2706-08 standards.
   • Data Provenance: The tests were conducted internally by Orthofix Inc. or contracted to a testing facility. The document doesn't specify the country of origin data beyond the submitter's address in Lewisville, TX, USA. These are laboratory-based, prospective tests for this specific submission.

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

   • Not applicable. For mechanical tests of this nature, "ground truth" is established by the standardized testing protocols (ASTM F2706-08). Expertise would lie in the engineers or technicians performing and interpreting the mechanical tests according to the standard.

3. Adjudication method for the test set:

   • Not applicable. The "adjudication" in this context refers to whether the test results meet the predefined criteria of the ASTM standard and demonstrate substantial equivalence. This is typically a pass/fail determination based on quantitative measurements against thresholds defined by the standards or comparison with predicate device performance.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, this type of study is not applicable to the mechanical testing of a spinal fixation device. MRMC studies are typically used to evaluate the performance of diagnostic imaging or AI systems read by multiple human readers.

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

   • No, this is not applicable as the submission is not for an algorithm or AI system.

6. The type of ground truth used:

   • For mechanical testing, the "ground truth" is generally the physical properties and performance of the device components as measured by calibrated equipment and according to established engineering standards (ASTM F2706-08). The benchmark for acceptance is the performance of the predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML study; therefore, there is no "training set."

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

   • Not applicable.

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The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporine, tacrolimus, or sirolimus.

The Chromsystems MassCheck Immunosuppressant Controls are Ivophilized, multi-analyte human whole blood based products containing the analytes Ciclosporin A, Rapamycin (Sirolimus) and Tacrolimus. The Controls are available as four levels + blank. Prior to use the different lyophilized controls need to be reconstituted by adding the corresponding amount of water as indicated on the respective packing leaflet. Each donor was tested and found negative for Human immunodeficiency virus (HIV) 1 and 2, Hepatitis B virus (HBV), Hepatitis C virus (HCV) in European blood banks. The tests used were cleared for in vitro diagnostic use in the EU (in compliance with the European Directive 98/79/EC on in vitro Diagnostic Medical Devices as Annex II, List A products) and are also approved by the Paul-Ehrlich-Institute in Germany.

The document provided is a 510(k) summary for the Chromsystems MassCheck Immunosuppressants Whole Blood Controls. This type of device is a control material used to verify the performance of laboratory assay systems that measure concentrations of immunosuppressant drugs.

Based on the information provided in the document, here's a breakdown regarding acceptance criteria, study details, and related aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., ±X% accuracy, Y% precision).
It also does not report specific performance data for the Chromsystems MassCheck Immunosuppressants Whole Blood Controls.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices. The claim of substantial equivalence is based on the following similarities:

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

The document does not describe a specific "test set" in the context of a performance study with a defined sample size for the proposed device itself, nor does it specify data provenance (country of origin, retrospective/prospective).

The submission relies on a comparison to predicate devices, implying that the performance of the proposed device is expected to be similar to that of the already legally marketed predicates. The comparison focuses on the characteristics and intended use rather than new clinical performance data from a specific test set.

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

This information is not applicable or provided in the 510(k) summary. Given that the device is a control material and the submission aims for substantial equivalence based on product characteristics rather than a diagnostic performance claim, there is no mention of an expert panel establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

This information is not applicable or provided for the same reasons as above. No adjudication method is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. This type of study is typically performed for diagnostic imaging or screening devices to assess human reader performance with and without AI assistance. The MassCheck Immunosuppressants Whole Blood Controls are laboratory control materials, not diagnostic AI systems for human interpretation.

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

No, a standalone (algorithm only) performance study was not described. The device is a physical control material, not an algorithm. Its "performance" is in its stability, accuracy of stated concentrations, and ability to challenge an assay system appropriately. These characteristics are typically validated through analytical studies, not an algorithm-only performance study.

7. The Type of Ground Truth Used:

For the purpose of this 510(k) (seeking substantial equivalence for a control material):

• The "ground truth" for the analytes (Ciclosporin A, Rapamycin (Sirolimus), and Tacrolimus) in the control material would be their known, precisely manufactured concentrations.
• The "ground truth" for the safety of the human whole blood matrix is based on testing for specific pathogens (HIV 1 and 2, HBV, HCV) using cleared in vitro diagnostic tests in EU blood banks.

However, the document does not elaborate on how the precise concentrations of the analytes within the controls were verified or how the controls were analytically characterized. The focus is on the device's intended use as a control, not on its own diagnostic accuracy against a gold standard in patient samples.

8. The Sample Size for the Training Set:

This information is not applicable or provided. The device is a manufactured control product, not an AI algorithm that requires a training set.

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

This information is not applicable or provided for the same reason as above.

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1. Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
7. Revision of previously failed total joint arthroplasty.
8. Trauma
   These devices are to be used with bone cement unless a proximal femur is indicated (USA).
   Not applicable to Regenerex™ Ultra Porous Construct titanium knee augment usage, or any other knee component.

9cm resection tibial bodies
The OSS 9cm Tibial Bodies are being modified to be made from Co-Cr-Mo Cobalt Chrome alloy rather than Ti-6Al-4V titanium alloy.

This document, a 510(k) summary for the OSS 9cm Cobalt Chrome Tibial Bodies, states that no non-clinical or clinical testing was considered necessary to establish substantial equivalence to the predicate device. Therefore, it does not contain the information requested about acceptance criteria or a study proving the device meets them.

The submission is based on the modification of the material from Ti-6Al-4V titanium alloy to Co-Cr-Mo Cobalt Chrome alloy for the 9cm Tibial Bodies, part of the Oncology Salvage System (now Orthopedic Salvage System). The FDA determined that the device is substantially equivalent to the predicate device without requiring additional testing.

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The Portland Cobalt Chrome Femoral Head has the following indications for use:
• The patient should be skeletally mature.
• The patient's condition should be due to one or more of the following:

1. Osteoarthritis.
2. Rheumatoid arthritis.
3. Tumor conditions involving the upper third of the femur or of the Acetabular.
4. Ankylosing spondylitis.
5. Psoriatic arthritis.
6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and C-reactive protein.
7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
8. Post-traumatic fracture/dislocation of the hip.
9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The Portland Cobalt Chrome Femoral Head is provided as a single component. The device is manufactured from a cobalt chrome alloy and is available in various sizes. The internal bore of the femoral head is designed to taper lock (12/14) with the external male taper on a Portland Orthopaedics femoral hip stem providing articulation with a suitable acetabular module.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific acceptance criteria.

The document is a 510(k) summary for the Portland Cobalt Chrome Femoral Head, which is a regulatory submission to the FDA. It primarily focuses on demonstrating "substantial equivalence" to existing legally marketed devices.

Here's what the document does include:

• Description of the Device: Details on its material (cobalt chrome alloy), design (taper lock), and intended use (articulation with an acetabular module and femoral hip stem).
• Indications for Use: A list of conditions for which the device is intended to be used (e.g., osteoarthritis, rheumatoid arthritis, certain hip fractures or revisions).
• Substantial Equivalence Information: States that the device is substantially equivalent to cobalt chrome femoral heads from Biomet and Exacted due to similarities in design, intended use, material, and manufacturing.
• Summary of Testing: Mentions that "Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the Cobalt Chrome Femoral Head." However, it does not provide any details about the specific tests performed, the acceptance criteria for those tests, or the results.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert involvement as this information is not present in the provided text.

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