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Intended Use:
The ASTar System is intended to be used for the automated quantitative susceptibility testing for most clinically significant microorganisms. The ASTar System does not provide organism identification.

Indications for Use:
The ASTar System, comprised of the ASTar Instrument with the ASTar BC G- Kit (ASTar BC G- Consumable kit, ASTar BC G- Frozen insert, and ASTar BC G-Kit software), utilizes high-speed, time-lapse microscopy imaging of bacteria for the in vitro, quantitative determination of antimicrobial susceptibility of on-panel gram-negative bacteria. The test is performed directly on positive blood culture samples signaled as positive by a continuous monitoring blood culture system and confirmed to contain gram-negative bacilli by Gram stain. Organism identification is required for AST result interpretation and reporting.

Test results from the ASTar BC G- Kit should be interpreted in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing. Sub-culturing is necessary to support further testing for: bacteria and antimicrobials not on the ASTar BC G- panel, where inconclusive results are obtained, epidemiologic testing, recovery of organisms present in microbial samples, and susceptibility testing of bacteria in polymicrobial samples.

The ASTar BC G- Kit tests the following antimicrobial agents with the following bacterial species:

Amikacin: Citrobacter freundii, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens
Ampicillin: Escherichia coli, Proteus mirabilis
Ampicillin-sulbactam: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris
Aztreonam: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens
Cefazolin: Klebsiella pneumoniae
Cefepime: Citrobacter freundii, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens
Ceftazidime: Enterobacter cloacae complex, Escherichia oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens
Ceftazidime-avibactam: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella oxytoca, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens
Cefuroxime: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis
Ciprofloxacin: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens
Gentamicin: Citrobacter freundii, Citrobacter koseri, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens
Levofloxacin: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens
Meropenem: Acinetobacter baumannii, Citrobacter freundii, Citrobacter koseri, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens
Meropenem-vaborbactam: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens
Piperacillin-tazobactam: Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens
Tigecycline: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Serratia marcescens
Tobramycin: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens
Trimethoprim-sulfamethoxazole: Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus vulgaris

ASTar System is a fully automated system for antimicrobial susceptibility testing (AST). It consists of the ASTar Instrument which is used in combination with dedicated application kits. The ASTar BC G- Kit consists of the ASTar BC G- Consumable kit, ASTar BC G- Frozen insert, and ASTar BC G-Kit software which must be installed on the instrument to process the kit.

The system provides robust and consistent inoculum preparation for AST and utilizes high-speed, time-lapse microscopy imaging of pathogens in broth microdilution to determine minimum inhibitory concentration (MIC) and qualitative susceptibility results. Organism identification using an approved method is required to be entered into the ASTar Instrument for results to be reported.

The instrument is designed to carry out sample preparation of up to six samples in parallel, using a dedicated ASTar Cartridge consumable for each sample. In the subsequent AST culturing step, the instrument transfers the prepared sample into a second dedicated consumable, referred to as the ASTar Disc. Up to 12 Discs can be incubated simultaneously in the system. The processed samples can be in different stages of the processing protocol. New samples can be loaded in a random-access manner when there are available slots. Processing of loaded samples will, in most cases, start shortly after loading. If six samples are started at the same time limitations given by the sample scheduler will result in a queue. The operator interacts with the instrument via the touchscreen display by which the operator controls the instrument.

ASTar BC G- Kit is used for in vitro determination of antimicrobial susceptibility testing of commonly isolated bacteria derived from positive blood culture samples confirmed positive for Gram-negative bacteria by Gram stain. The antimicrobial and organism combinations are listed in Table 1. Reportable ranges for each antimicrobial are listed in Table 2.

To start an analysis approximately 1 mL of a positive blood culture, confirmed Gram-negative by Gram stain is pipetted into the ASTar Cartridge by the operator and loaded into the system, from which the system purifies and quantifies the bacterial concentration is adjusted to the appropriate inoculum concentration and produces an inoculum for analysis of non-fastidious organisms. The bacterial suspensions are transferred automatically to the ASTar Disc and antimicrobial susceptibility testing is performed based on a defined short-term protocol. Results are available within approximately six hours. Bacterial growth and response to relevant concentrations of different antimicrobial drugs are measured throughout the incubation period, using a high-performance optical detection system in combination with image analysis algorithms. The system generates an MIC and further qualitative susceptibility results (i.e., S, I, R) for the tested antimicrobials when applicable. The qualitative results are determined based on established breakpoints stipulated by applicable authorities, i.e., FDA, CLSI or EUCAST. FDA Susceptibility Testing Interpretive Criteria (STIC), aka "breakpoints" are found in Table 3.

The provided text describes the performance characteristics of the ASTar BC G- Kit and ASTar Instrument, primarily focusing on its antimicrobial susceptibility testing (AST) capabilities. While it details various studies, it does not describe an AI/ML device that utilizes a test set with ground truth experts. Instead, it describes a medical device for in vitro quantitative determination of antimicrobial susceptibility based on time-lapse microscopy imaging.

Therefore, many of the requested points, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone (algorithm only) performance," and "sample size for the training set" (for an AI model), are not applicable to this document as it does not describe an AI/ML-driven diagnostic device in the traditional sense.

However, I will extract relevant information about the device's acceptance criteria and studies to the best of my ability, interpreting "acceptance criteria" as performance metrics for this type of medical device.

Key Information from the Document:

The ASTar System is an automated system for antimicrobial susceptibility testing (AST) that uses high-speed, time-lapse microscopy imaging of bacteria to determine Minimum Inhibitory Concentration (MIC) and qualitative susceptibility results (S, I, R).

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

The document defines acceptance criteria primarily through performance metrics like Essential Agreement (EA) and Category Agreement (CA) compared to a reference method (frozen Broth Micro-Dilution, BMD), along with rates for Very Major (VMJ) discordant results, Major (MAJ) discordant results, and Minor (MIN) discordant results.

While a single explicit "acceptance criteria table" is not provided with specific pass/fail percentages before results, the overall performance table (Table 16) implicitly represents the success or failure against internal performance goals. The FDA's Special Controls guidance (referenced in 8.5.8) would typically outline such criteria. Based on the "Conclusions" section, the device was deemed "substantially equivalent," implying these metrics were acceptable.

Here's a summary of the reported device performance from Table 16, which reflects the met acceptance criteria for the clinical study:

Table: Reported Device Performance (Summary from Table 16)

*Note: Some "poor performance" combinations (EA 95% of MIC values within ±1 doubling dilution of the mode MIC of initial samples (loaded 95% pass rate as compared to control samples without interfering antibiotics.

Interfering Antibiotics Performance (Table 13):

• All six evaluated antibiotic/BCB-combinations had overall pass rates of 96.2% to 100%. Some individual combinations fell below 90% (e.g., Cefotaxime / BACTEC: Trimethoprim-sulfamethoxazole 77.8%), but the overall criterion (per combination type) was met.

Carry Over and Cross Contamination Acceptance Criteria: (Implicitly, close to 100% pass rate expected)

• MIC for the susceptible isolate for each antimicrobial must be within ±1 doubling dilution of the control mode MIC to pass.

Carry Over and Cross Contamination Performance:

• 99.7% pass rate (307/308) for susceptible isolate MIC value. No carry over or cross contamination observed.

Set Inoculum for AST Acceptance Criteria:

• For starting bacterial concentration >5 x 10^7 CFU/mL, assess and adjust successfully at high rate, producing an inoculum within acceptance ranges.
• For concentrations 5 x 10^7 CFU/mL: 95.8% (23/24) completed concentration adjustment, and 100% (23/23) of those produced an inoculum within acceptance ranges.
• For samples with starting bacterial concentration 5 x 10^6 to

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ASTRA and AVANT Navigated Reusable Instruments are indicated for preparation and placement of SpineCraft ASTRA Spine system pedicle screws during thoracolumbar sacroiliac spinal surgery to assist surgeon in precisely locating anatomical structures in either open, minimally invasive procedures, or percutaneous, procedures.

ASTRA and AVANT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the ASTRA and AVANT Navigated Reusable Instruments is limited to use only with ASTRA Spine System implants.

ASTRA-OCT Navigated Reusable instruments are indicated for preparation and placement of SpineCraft ASTRA-OCT Spine screws during cervico-thoracic spinal surgery to assist surgeon in precisely locating anatomical structures in open procedures.

ASTRA-OCT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the ASTRA-OCT Navigated Reusable Instruments is limited to use only with ASTRA-OCT Spine System implants.

The ASTRA, AVANT and ASTRA-OCT Navigation instruments are non-sterile, reusable surgical instruments designed for compatibility with the Medtronic NavLock Trackers and to ultimately provide seamless interaction with the Medtronic StealthStation® System. The ASTRA and AVANT Navigation instruments are for use with ASTRA Spine System pedicle screws and the ASTRA-OCT Navigation instruments are for use with ASTRA-OCT Spine System pedicle screws. The instruments are manufactured from medical grade stainless steel. The ASTRA-OCT navigation instruments are available in same or similar diameters and lengths as the corresponding predicate Medtronic navigated instruments. This includes awls, probes, drill bits, taps and screwdrivers.

This looks like a 510(k) summary for a medical device rather than a study evaluating the performance of an AI/ML powered device. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML system.

However, I can extract information related to the device's performance testing based on the provided document:

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

The document provides a list of performance tests conducted according to ASTM F2554-18, implying that the device performance demonstrated it "perform[s] as designed, are suitable for their intended use and are substantially equivalent to the cited corresponding predicate devices under the same test conditions." However, specific numerical acceptance criteria (e.g., "accuracy must be greater than X") and corresponding numerical performance results are not provided in this summary.

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

This document describes non-clinical performance testing of physical surgical instruments, not a study involving patient data or an AI/ML algorithm's test set. Therefore, information regarding "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary. The testing was laboratory-based.

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 is not applicable as the document describes non-clinical performance testing of physical instruments, not an AI/ML algorithm requiring expert ground truth for a test set.

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

This is not applicable for the reasons stated above.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a set of navigated surgical instruments, not an AI/ML assistance system for human readers. No clinical studies were performed.

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

This refers to an AI/ML algorithm. The device described, "ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System," is a set of non-sterile, reusable surgical instruments designed for compatibility with a navigation system (Medtronic StealthStation® System S8). It is not a standalone AI/ML algorithm. Non-clinical performance testing was done on the instruments themselves.

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

For the non-clinical performance testing, the "ground truth" would be established by the precise measurement systems and methodologies outlined in ASTM F2554-18 for determining positional accuracy. This is a technical standard measurement, not expert consensus, pathology, or outcomes data typically associated with AI/ML clinical studies.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm being trained by this device.

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

This is not applicable for the reasons stated above.

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The ASTRA Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar, and sacral spine.

The ASTRA Spine System is indicated for non-cervical (T)-S2/Ilium) pedicle fixation and non-pedicle fixation in skeletally mature patients as an adjunct to following indications: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture and/or dislocation); spinal stenosis; deformities (scoliosis, lordosis and/or kyphosis); spinal tumor; and failed previous fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ASTRA Spine System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ASTRA Spine System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The ASTRA fenestrated screw when used with other components of the ASTRA Spine System is indicated to provide the surgeon with an open or minimally invasive approach for posterior spinal surgery. The ASTRA fenestrated screw is intended to be used with saline or radiopaque dye.

The ASTRA Spine System consists of Ø 5.5mm, Ø 6.0mm and Ø 6.2mm longitudinal, lordosed, contoured and revision rods, pedicle screws (monoaxial, and uniplanar), cannulated pedicle screws (standard and reduction monoaxial, standard, reduction & extended tab polyaxial and standard & reduction uniplanar), fenestrated screws (standard, reduction & extended tab standard & reduction uniplanar), hooks (standard & reduction), lateral iliac connectors, rod-to-rod connectors and transverse (cross) connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.

The safety and effectiveness of the ASTRA fenestrated screw has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g.,osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

Materials: Titanium alloy per ASTM F136 and CoCr alloy per ASTM F1537

This document is a 510(k) summary for a medical device (ASTRA Spine System), not a study evaluating an AI/ML powered device. As such, it does not contain the information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML product.

Specifically, the document states: "No clinical studies were performed" (Page 6, Section 8), and the non-clinical tests described are mechanical tests for orthopedic implants (ASTM F1717 and ASTM F1798), not performance evaluations of an AI/ML algorithm.

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

1. A table of acceptance criteria and the reported device performance: This document reports mechanical test results against predicate devices, not AI performance metrics.
2. Sample sizes used for the test set and the data provenance: Not applicable to a mechanical device test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document describes a spinal implant system, which is a physical device, and its substantial equivalence is demonstrated through mechanical testing against predicate devices, not through a study involving AI/ML performance.

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ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. The face masks are single use, disposable device, provided non-sterile.

The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond non-woven polypropylene and the middle layer is constructed of melt blown non-woven polypropylene. The mask is held in place over the mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with Galvanized iron wire and allows the user to fit the facemask around their nose. The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is sold non-sterile and is intended to be a single use, disposable device.

The provided text is related to the FDA 510(k) clearance for a surgical mask. It details the device description, intended use, and a comparison of technological characteristics and performance between the subject device and a predicate device.

However, the questions you've asked about "acceptance criteria and the study that proves the device meets the acceptance criteria" are typically associated with artificial intelligence (AI) or machine learning (ML) medical devices, which involve performance evaluation against ground truth established by experts.

The document provided is for a physical medical device (a surgical mask) and its performance is evaluated against established physical and biological standards (e.g., fluid resistance, bacterial filtration efficiency, flammability, biocompatibility). It does not involve AI/ML performance metrics, expert adjudication, or MRMC studies.

Therefore, I cannot answer your specific questions based on the provided text, as they are not relevant to the type of device and study described in the FDA 510(k) submission for a surgical mask.

To give a complete answer, I would need a document related to an AI/ML medical device submission.

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The ASTRA Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).

The ASTRA Spine System is also a sacral/iliac screw fixation system of the indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ASTRA Spine System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ASTRA Spine System is intended to treat pediatric patients diagnosed with the following conditions:

spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The subject ASTRA Spine System is top loading, multiple components, posterior system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to match the patient's anatomy more closely.

The subject ASTRA Spine System includes the pediatric use in the indications and other labeling updates to provide more clarity to the device insert.

The provided text is a 510(k) premarket notification for the ASTRA Spine System, which is a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as typically done for new drug applications or certain high-risk medical devices.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Here's why and what the document does describe:

• Acceptance Criteria & Reported Device Performance: This section is explicitly missing because the submission is not focused on proving the device meets specific performance criteria through new studies. Instead, it argues that the device's design, materials, and function are similar enough to existing, legally marketed predicate devices to be considered substantially equivalent.
• Sample size used for the test set and the data provenance: Not applicable. No new test set in this context.
• Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. No new ground truth establishment study.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical studies were performed in support of this submission."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal implant system, not a software algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable. No training set for an algorithm.
• How the ground truth for the training set was established: Not applicable.

What the document does state regarding testing:

• Non-clinical Test Summary: "Non-clinical tests were not performed in support of this submission." This means no new bench testing or material testing data was submitted for this particular 510(k). The assumption is that the materials and design are already established as safe and effective by the predicate devices they are referencing.
• Clinical Test Summary: "No clinical studies were performed in support of this submission." This further reinforces that no human studies were conducted for this specific submission to prove performance or safety.

In summary, for a 510(k) premarket notification like this one, the "proof" the device meets acceptance criteria is primarily based on its substantial equivalence to already cleared predicate devices, meaning it shares similar technological characteristics and indications for use, and does not raise different questions of safety and effectiveness.

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The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.

The AST Model MA012 and MS019 Rehab Wheelchair are manual wheelchairs. They have adjustable armrests, and multiple axle position. The casters are 6"/7"/8" PU wheels with height adjustable forks and the rear wheels are 20"/22"/24″*1-3/8″ polyurethane(MA012 and MS019). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user, to minimize the sliding down of the user and also minimize the shear force and pressure against the back. The armrest height can be adjusted from 8" to 12" and it is detachable. The wheel for MA012 is quick release rear wheel. The AST MS019 Rehab Wheelchair has NO quick release rear wheel; The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices. The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

The provided document is a 510(k) summary for a medical device (AST Model MA012 and MS019 Rehab Wheelchair). It describes the process of demonstrating substantial equivalence to a predicate device, not the development and validation of an AI/ML powered device. As such, most of the requested information regarding acceptance criteria, study design for AI, expert involvement, and ground truth establishment is not applicable to this document.

However, I can provide information based on what is available in the document regarding the device's performance against non-clinical test standards, which serves as a form of acceptance criteria for this type of medical device submission.

Here's the breakdown of the information provided in the document:

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

For a traditional medical device like a manual wheelchair, "acceptance criteria" are tied to compliance with recognized consensus standards. The performance is reported as meeting these standards.

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

This information is not provided in the document. The document describes compliance with international standards for wheelchair testing, which implies internal testing by the manufacturer. The country of origin of the manufacturer is China (Sichuan AST Medical Equipment Co., Ltd., Luzhou City, Sichuan, China). The type of testing (e.g., retrospective or prospective) is not applicable in the context of these device performance tests; they are typically conducted on manufactured units.

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 is not applicable to a non-AI/ML device submission like this. The "ground truth" for a mechanical wheelchair's performance is determined by established engineering and medical device standards and test methods, not by expert consensus in a clinical diagnostic sense. The experts involved would be engineers and technical specialists responsible for conducting the ISO standard tests.

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

Not applicable. Adjudication methods are relevant for clinical studies or expert review processes, which are not described here. Device performance is determined by passing predefined test criteria in the ISO 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-powered device, and no MRMC comparative effectiveness study was performed or is relevant for this type of device.

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

Not applicable. This is not an AI-powered device.

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

For this medical device, the "ground truth" is defined by the objective performance criteria specified within the referenced ISO standards (e.g., static stability limits, brake effectiveness, dimensions within tolerance, strength requirements). Compliance with these standards confirms the device's fundamental safety and performance characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

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The ASTRA-OCT Spine System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or Traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudoarthrosis);
• · Tumors involving the cervical/thoracic spine: and
  · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The ASTRA-OCT Spine System implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.

The ASTRA-OCT Spine System consists of a series of polyaxial screws, occipital screws, occipital plates, hooks, rods, lateral connectors, rod-to-rod connectors, set screws, and cross connectors.

Materials:
Titanium alloy per ASTM F136 CoCr allov per ASTM F1537

This FDA 510(k) summary describes a new medical device, the ASTRA-OCT Spine System, and its substantial equivalence to a predicate device. The information provided is for a traditional medical device (spinal implant) and does not include acceptance criteria or a study proving device meets acceptance criteria in the context of an AI/ML powered device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device.

The document states:

• "No clinical studies were performed" for the ASTRA-OCT Spine System.
• The substantiation for equivalence is based on non-clinical mechanical testing and comparison to predicate systems.

The requested information is typically found in submissions for AI/ML powered devices, which are assessed differently from traditional hardware devices like the ASTRA-OCT Spine System.

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For the ASTRA TEE® -

The ASTRA TEE® automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

For the ASTRA VR™ -

The ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal/endorectal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

The ASTRA Product Family of automated reprocessors are floor standing electromechanical lab equipment that facilitate high-level liquid disinfection of ultrasound probes that have been enzymatically pre-cleaned.

The provided document is a 510(k) Pre-Market Notification for medical devices (ASTRA TEE® Transesophageal Probe Reprocessor and ASTRA VR™ Endovaginal/Endorectal Probe Reprocessor). It outlines the device description, intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document primarily discusses the device's technical specifications and the testing conducted to ensure its safety and effectiveness in controlling high-level disinfection processes.

Unfortunately, the provided document does not contain the specific details required to answer all parts of your request about acceptance criteria met by a "device" in the context of an AI/human-in-the-loop study. The device in question here is an automated reprocessor for ultrasound probes, not an AI-powered diagnostic tool, and the performance criteria are related to disinfection efficacy, not diagnostic accuracy.

Therefore, I cannot populate most of the requested table and details, as they pertain to performance metrics and study designs common for AI-based diagnostic devices (e.g., sensitivity, specificity, reader performance studies, expert adjudication for ground truth).

However, I can extract the information relevant to the device's operational performance and the studies conducted to support its substantial equivalence.

Here's what can be extracted and what cannot be from the provided text:

What can be extracted:

• Acceptance Criteria (Performance Attributes): The core performance attribute for this device is its ability to "control the HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terrae using Metricide OPA Plus, Cidex OPA, and Resert XL." This is the primary functional performance claim.
• Study That Proves the Device Meets Acceptance Criteria:
  • Performance Testing Summary:
    • "The ASTRA system maintains time and temperature required for disinfection as per HLD manufacturers' specifications."
    • "The ASTRA system passed Safety and EMC testing."
    • "The ASTRA system passed Simulated use and Residual testing."
    • "The ASTRA system passed In-use testing."
  • Efficacy (Disinfection and Residual testing): "Pass as per simulated use (6log reduction of M. terrae), In-use Testing (complete kill) and residual testing (ISO10993-5 cytotoxic effect of

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The ASTRA System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).

The ASTRA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials:
Titanium alloy
CoCr alloy

Here's an analysis of the provided text regarding the ASTRA Spine System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (Spine System), not an AI/ML device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by performance equivalence to predicate devices in standardized mechanical tests. The "reported device performance" is a statement of comparative equivalence.

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

This is a physical device, and the "test set" refers to the tested device components.

• Sample Size: Not explicitly stated in terms of number of components tested for each test, but standard engineering practices for medical device testing would involve a sufficient number (e.g., n=5 or n=10 per test) to ensure statistical significance, though the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) since no human data was used for these mechanical tests.

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

• Not Applicable. For mechanical testing of a physical device, ground truth is established by standardized testing protocols (e.g., ASTM standards) and measured physical properties, not by expert consensus on clinical data. Engineers and lab technicians perform and analyze the tests according to these standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no adjudication in the sense of reconciling human expert opinions for clinical images or data. The results of mechanical tests are objective measurements against defined criteria.

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 physical spinal implant, not an AI/ML diagnostic or assistive device. No MRMC studies were performed.

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

• Not Applicable. This is a physical spinal implant; there is no algorithm or standalone performance.

7. The Type of Ground Truth Used

• Mechanical Test Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is based on the established performance characteristics and safety profiles of legally marketed predicate devices, as defined by FDA regulations for substantial equivalence, and adherence to relevant ASTM standards (ASTM F1717 and ASTM F1798).

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no AI/ML model or "training set" in the context of machine learning. The device design and materials are based on engineering principles and knowledge of predicate devices.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for developing the physical device is based on established biomechanical and medical understanding of spinal fixation and the performance of existing, cleared devices.

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Astroglide® TTC is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina. Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide. This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.

The provided text discusses the premarket notification for Astroglide TTC Fertility Friendly Personal Lubricant, detailing its characteristics and comparison to a predicate device. It includes a summary of performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the test sets (e.g., number of mouse embryos, human sperm samples, or animals for biocompatibility). The studies performed are laboratory-based and animal studies (New Zealand White Rabbits for irritation, Guinea Pig for sensitization, mice for embryo assay). The data provenance is not explicitly stated as "country of origin" but implies controlled laboratory settings, which are typically retrospective in terms of analyzing the results from a pre-defined experiment.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic studies. The ground truth for these types of in vitro and in vivo studies is established by the experimental protocols themselves, with results interpreted against scientific and regulatory standards (e.g., ISO standards for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable. The studies described are laboratory, animal, and in vitro tests, not clinical trials requiring adjudication of observer 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

Not applicable. This is a medical device (personal lubricant) and the studies do not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study and effect size in human reader improvement are not relevant.

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

Not applicable. This device is not an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily:

• Experimental Results against predefined thresholds/standards: For pH, osmolarity, endotoxin, MEA, HSSA, and condom compatibility, the "ground truth" is whether the measured values or observed outcomes meet the established scientific and regulatory criteria (e.g., >80% expanded blastocysts, ≥80% sperm survival).
• Biocompatibility Standards: For cytotoxicity, sensitization, irritation, and systemic toxicity, the ground truth is whether the device passes the requirements of specific ISO 10993 standards.
• Functional Assays: For sperm function (penetration, motility, DNA integrity) and IVF, the ground truth is the scientific demonstration that the device does not impede or harm these biological processes.

8. The Sample Size for the Training Set

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

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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