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The "Astrasono A3Pro Bladder Scanner" is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated device. The device projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. It is intended to be used only by qualified medical professionals.

Environments of intended use: Professional medical environments

The intended patient population: Adult patients who require bladder volume measurement (not applicable to pediatric patients).

The "Astrasono A3Pro Bladder Scanner" is a hand-held battery-operated device, it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging.

The "Astrasono A3Pro Bladder Scanner" measures the bladder volume in the range of 0 – 999 mL.

There are three scanning modes (all B-modes): Easy Mode, Expert Mode, and Empower Mode:

• Easy Mode: Under this mode, the screen displays a real-time image of bladder silhouette.
• Expert Mode: Under this mode, the screen displays a real-time image of bladder.
• Empower Mode: Under this mode, the screen displays a real-time image of bladder projection.

This device consists of a console (including a rechargeable Li-ion battery pack and built-in printer), a probe, and a medical switching power supply.

The obtained ultrasound images and calculated bladder volume results can be downloaded to USB drive as encrypted Data.

N/A

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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 <90% or higher VMJ/MAJ rates) are noted as having limitation statements in the device labeling, indicating that these specific combinations might have had acceptance criteria adjusted or were deemed acceptable if the overall performance portfolio met the standard for substantial equivalence.

Reproducibility Study Acceptance Criteria:

• Overall reproducibility of ≥ 95% based on the number of results that fall within ±1 doubling dilution between the test MIC result and test MIC mode.

Reproducibility Study Performance (Aggregated, Table 5):

• Best case scenario: All antimicrobials showed ≥95% reproducibility (range 95.1% to 100%).
• Worst case scenario: Most antimicrobials showed ≥95% (range 88% to 100%). Two were slightly below: Ceftazidime (88%) and Ceftazidime-avibactam (90.7%).

Blood Culture Bottle Compatibility Acceptance Criteria:

• Overall essential agreement (EA) as compared to reference MIC obtained by frozen broth microdilution according to CLSI M07 shall be ≥90% for each antimicrobial, stratified by bacteria.
• Percentage of MIC values within ±1 doubling dilution of the mode MIC for each antimicrobial/bottle were determined, with the expectation of high agreement.

Blood Culture Bottle Compatibility Performance (Table 7):

• EA with BMD: Ranged from 97.2% to 99.8%. Some individual antimicrobial/bottle/isolate combinations had EA <90% (e.g., Tobramycin / BACTEC Standard Anaerobic: K. pneumoniae QM2403 (0/3)), but overall, the performance met the criterion.
• MIC values ±1 from mode: Ranged from 98.9% to 100% across different bottle types, indicating similar performance.

Sample Stability Acceptance Criteria:

• 95% of MIC values within ±1 doubling dilution of the mode MIC of initial samples (loaded <1 hour).

Sample Stability Performance (Table 8):

• 16-24 hours at room temperature: 100% pass rate.
• 16-24 hours at 35°C: 99.6% pass rate.

Interfering Substances Acceptance Criteria: (Implicitly, high pass rate expected)

• The comparison was to control samples; a MIC value within ±1 doubling dilution from the control value was considered a "pass."

Interfering Substances Performance (Table 11):

• Pass rates were 100% for most substances, except RBCs (99.1%). All were deemed acceptable.

Interfering Antibiotics Acceptance Criteria:

• 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 10^6 CFU/mL, acceptable to be aborted.

Set Inoculum for AST Performance (Table 14):

• For samples with starting bacterial concentration >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 < 4.99 x 10^7 CFU/mL: 75% (9/12) completed concentration adjustment, 88.9% (8/9) within range.
• For samples with starting bacterial concentration < 5 x 10^6 CFU/mL: 0% completed concentration adjustment and 36/36 were aborted, as expected.

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

• Clinical Study Test Set Sample Size: A total of 1,068 samples were enrolled. After exclusions (off-panel organisms, contamination, non-viable isolates, protocol deviations), 880 samples were included in the performance analysis. This included:

  • 256 fresh, positive blood cultures (Fresh PBC)
  • 223 contrived with clinical stock isolates
  • 401 contrived blood cultures with challenge isolates.
  • 933 valid samples were analyzed (907 produced at least a partial AST result).

• Data Provenance: The study involved both prospective collection (fresh, left-over samples from patients with suspected bacteremia, implicitly "clinical samples") and retrospective/contrived samples (clinical stock isolates and challenge isolates).

• Country of Origin: The initial study was conducted at four sites: three external clinical sites in the United States (US) and one internal site in Sweden. The supplemental testing phase was conducted at three sites: two of the original external clinical sites in the United States (US) and one internal site in Sweden.

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 in the traditional sense of human experts annotating images for ground truth in an AI/ML context. The ground truth for this device's performance is established by a gold standard laboratory method: frozen Broth Micro-Dilution (BMD) performed according to CLSI M07 11th Edition. This is a well-established, standardized microbiological method, not reliant on human expert interpretation of a visual output.

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

Not applicable in the human-in-the-loop expert adjudication sense for an AI/ML device. For the reference BMD, if a Mode MIC could not be established with the first set of three replicates, a second set of three frozen replicates was tested. If a Mode MIC still could not be established, the Median from all six plates was used. This is a form of scientific replication/adjudication.

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

Not applicable. This device is an automated system for AST, not an AI assistance tool for human interpretation of medical images or other diagnostics. There are no "human readers" directly assisted by AI in its primary function as described.

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

This is an automated device that provides quantitative MIC and qualitative S/I/R results. Its "performance" (EA, CA, etc.) is inherently the standalone performance of the system against the gold standard BMD. The "imaging of bacteria" and "image analysis algorithms" mentioned in the device description imply automated processing, which is essentially "algorithm only" performance for generating the MIC. While "Organism identification is required for AST result interpretation and reporting" (and likely entered by a human user), the core AST algorithm itself acts in a standalone manner once the species ID is provided.

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

The ground truth used for performance evaluation was frozen Broth Micro-Dilution (BMD) results run in triplicate according to CLSI M07 11th Edition. This is a laboratory gold standard method for antimicrobial susceptibility testing.

8. The sample size for the training set

The document does not describe an AI/ML model in the sense of a deep learning model requiring a discrete "training set" of labeled data for model development. The "image analysis algorithms" mentioned are part of the core technology of the ASTar Instrument. If these algorithms involved machine learning, no details about a specific "training set" size are provided in this document. Given it's a 510(k) submission for a non-AI/ML device, such details are typically not required or relevant in the same way as for AI/ML device submissions.

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

As there's no explicitly defined AI "training set" described, this point is not applicable. The device's performance is inherently compared to the established laboratory gold standard (BMD).

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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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Astroglide Warming is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Astroglide Warming is non-sterile, clear and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms only. It is not compatible with polyurethane condoms. The device is composed of water, glycerin, propylene glycol, polyquaternium-7 and citric acid.

The provided document describes the K221036 submission for Astroglide Warming, a personal lubricant. It does not describe a study involving an AI/ML device and human readers. Therefore, I cannot fulfill all aspects of your request as it pertains to AI/ML device performance, ground truth, expert opinions, or MRMC studies.

However, I can extract the acceptance criteria and the summary of non-clinical performance testing for the Astroglide Warming device itself.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical performance testing for a personal lubricant, not an AI/ML device. Therefore, the concept of "test set" in the context of AI/ML is not applicable here. The testing involved samples of the product itself.

• Biocompatibility testing: Not specified number of samples, but refers to ISO and ASTM standards.
• Shelf Life Accelerated Aging Study: Not specified number of samples. The study duration was 3 months at 40°C.
• Condom Compatibility: Not specified number of samples, but refers to ASTM D7661-18.
• Data provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by or for BioFilm, Inc. It is retrospective in the sense that the tests were completed before submission.

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

Not applicable. This is a physical product, not an AI/ML device requiring expert ground truth for image or data interpretation.

4. Adjudication method for the test set:

Not applicable. This is a physical product, not an AI/ML device requiring adjudication for ambiguous cases.

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 product, not an AI/ML device.

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

Not applicable. This is a physical product, not an AI/ML algorithm. The "standalone" performance here refers to the device's inherent physical and chemical properties.

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

The "ground truth" for this product is based on established industry standards and validated test methods as defined by organizations like ISO, ASTM, and USP. For example:

• Physical and Chemical Properties: The specifications (e.g., viscosity, pH, osmolality, color, odor, clarity, absence of particulate matter) are based on direct measurements against defined ranges.
• Microbial Limits: Determined by specific USP <61> and <62> methods.
• Antimicrobial Effectiveness: Determined by USP <51> methods.
• Biocompatibility: Determined by ISO 10993-5, ISO 10993-11, and ASTM D6355 standards.
• Condom Compatibility: Determined by ASTM D7661-18.

8. The sample size for the training set:

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

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

Not applicable.

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Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Astroglide Ultra Gentle Gel is a non-sterile, clear, odorless, and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The device is composed of water, propylene glycol, hydroxyethylcellulose, polyquaternium 7, potassium sorbate, sodium benzoate and citric acid. The product primary packaging is a white LDPE 3-ounce tube with a screw on cap. The tube and cap constitute the device final packaging.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each test in the "Summary of Non-Clinical Performance Testing" section. For the Shelf Life study, it mentions an "accelerated aging study, conducted for 8 months at 40°C," but doesn't detail the number of samples or batches tested. The provenance of the data is internal to BioFilm, Inc., as these are non-clinical performance tests conducted for device clearance. There is no information regarding country of origin or whether it's retrospective or prospective beyond the description of the tests themselves.

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

This information is not applicable to this type of device and study. The testing described (biocompatibility, shelf life, condom compatibility) are laboratory-based, objective performance tests conducted against established international or national standards (e.g., ISO, ASTM, USP). Ground truth is established by the test method's specified criteria, not by expert consensus in the way a clinical diagnostic device would require.

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

This is not applicable as the tests are objective laboratory performance tests, not subjective interpretations requiring adjudication among experts.

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 done. This type of study is typically performed for AI-driven diagnostic or screening devices involving human interpretation, not for a personal lubricant.

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

This is not applicable. The device is a personal lubricant, not an AI algorithm. The performance tests are directly on the physical product.

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

The ground truth for the acceptance criteria for most of the parameters (Color, Clarity, Odor, Absence of particulate matter, Viscosity, pH, Osmolality, Microbial Limits, Antimicrobial effectiveness) is based on pre-defined quantifiable specifications and standard laboratory test methods (USP <61>, USP <62>, USP <51>).

For Biocompatibility, the ground truth is established by the pass/fail criteria defined in international standards like ISO 10993-1, ISO 10993-5, ISO 10993-11, and ASTM D6355.

For Condom Compatibility, the ground truth is established by the pass/fail criteria defined in ASTM D7661-18.

For Shelf Life, the ground truth is that the device must continue to meet all the physical, chemical, and microbiological specifications after accelerated aging, following ASTM F1980-16.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm. There is no "training set" for a physical personal lubricant.

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

This is not applicable as there is no training set for this device.

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Astroglide® Glycerin & Paraben Free is a personal lubricant for penile, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Astroglide® Glycerin & Paraben Free is a non-sterile, water-based liquid personal lubricant for penile, anal, and/or vaginal application. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The subject device is sold as an overthe-counter (OTC) product in a 2.5 oz. clear PETE bottle with a screw on polypropylene flip-top cap. The bottle is labeled front and back and then packaged in a cardboard carton which constitutes the final packaging. This device is composed of water, butylene glycol, propylene glycol, xylitol, methyl gluceth-20, polyquarternium-7, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, citric acid.

The provided document is a 510(k) Premarket Notification from the FDA for a personal lubricant called Astroglide® Glycerin & Paraben Free. It primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device, rather than providing details on a study of a device's performance against specific clinical acceptance criteria for diagnostic or AI-driven devices.

Therefore, much of the requested information (sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details) is not applicable to this type of regulatory submission for a personal lubricant.

However, I can extract information related to the acceptance criteria for the product's physical and chemical properties, as well as its biocompatibility and condom compatibility.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• For physical/chemical specifications: The document refers to standard test methods (e.g., USP <61>, USP <62>) but does not specify the sample size for these tests. The data provenance is implied to be from BioFilm, Inc.'s internal testing, likely from the U.S.
• For biocompatibility: No specific sample sizes for human subjects or animal models are provided for the HRIPT or systemic toxicity tests. For cytotoxicity, it's generally in vitro testing. Data provenance is implied to be from BioFilm, Inc.'s testing.
• For condom compatibility: No specific sample size (i.e., number of condoms tested) is explicitly mentioned, but the testing was conducted according to ASTM D7661-18. Data provenance is implied to be from BioFilm, Inc.'s testing.
• For shelf life: The study was an accelerated aging study conducted for 8 months at 40°C, per ASTM F1980-16. No sample sizes (number of devices) are given.

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

Not applicable. This is not a study requiring expert clinical review or ground truth establishment for diagnostic accuracy. The ground truth for the physical/chemical properties, biocompatibility, and condom compatibility are defined by the standardized test methods themselves.

4. Adjudication method for the test set

Not applicable. There is no subjective assessment requiring adjudication in this type of testing.

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 personal lubricant device, not an AI-driven diagnostic device.

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

Not applicable. This is a personal lubricant device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the various acceptance criteria were established by:

• Standardized laboratory methods/specifications: For color, clarity, odor, particulate matter, viscosity, pH, osmolality, microbial counts (TYMC, TAMC, pathogens), and antimicrobial effectiveness, the ground truth is defined by specified ranges, limits, or absence/presence criteria according to recognized pharmacopeial (USP) or internal standards.
• International Standards (ISO) and ASTM Standards:
  • Biocompatibility: ISO 10993-5 (cytotoxicity), ASTM D6355 (sensitization/irritation), ISO 10993-11 (systemic toxicity).
  • Shelf Life: ASTM F1980-16 (accelerated aging for medical devices).
  • Condom Compatibility: ASTM D7661-18.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device that requires a training set.

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

Not applicable.

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Astroglide® Sensual Strawberry Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene or polyurethane condoms.

Astroglide® Sensual Strawberry Personal Lubricant is a non-sterile, clear, strawberry-scented and flavored, water-based personal lubricant intended for penile, anal, or vaginal application. This product is not a spermicide or contraceptive. Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms. It is not compatible with polyisoprene and polyurethane condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is then packaged in a cardboard carton which constitutes the final packaging.

This document is a 510(k) Premarket Notification from BioFilm, Inc. to the FDA for their product, Astroglide® Sensual Strawberry Personal Lubricant. It aims to demonstrate substantial equivalence to a legally marketed predicate device (Glycerin & Paraben Free Astroglide, K072647).

Therefore, this document does not describe:

• Acceptance criteria and device performance for an AI/ML medical device.
• A study proving the performance of an AI/ML medical device.
• Data provenance, sample sizes for test/training sets, expert qualifications, or adjudication methods related to AI/ML model development or validation.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
• Details about ground truth establishment for AI/ML models.

Instead, the document focuses on:

• Device Description: A water-based personal lubricant, its physical characteristics, and specifications.
• Predicate Device Comparison: Highlighting similarities (indications for use, over-the-counter status, base type, pH) and differences (ingredients, osmolality, viscosity, packaging, shelf-life). The document asserts that these differences do not raise new questions of safety and effectiveness.
• Non-Clinical Performance Testing: This is the equivalent of "proof" in this context, demonstrating the device's safety and effectiveness through:
  • Biocompatibility Testing: Cytotoxicity, sensitization, irritation, and acute systemic toxicity.
  • Condom Compatibility Testing: Specifically with natural rubber latex condoms using ASTM D7661-10.
  • Shelf-Life Testing: Using accelerated aging (ASTM F1980-16) to determine an 8.5-month shelf-life.

To answer your specific questions based on the provided document, which is NOT about an AI/ML device:

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

   Physical Specification Tests	Acceptance Criteria / Ranges/Specifications	Reported Device Performance (from text, implicitly met for approval)
   Particulate matter	No particles	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
   Color	Clear to slight golden	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
   Clarity	Clear	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
   Odor	Strawberry scent	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
   pH (per USP <791>)	3.5-5.5	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
   Viscosity (per USP <912>)	200 - 450 cps	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." The value 200-450 cps is the reported device performance for this specific product, which is different from the predicate, but deemed acceptable by the FDA.)
   Osmolality (per USP <785>)	200 - 450 mOsm/kg, dilution factor of 5	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." The value 200-450 mOsm/kg is the reported device performance for this specific product, which is different from the predicate, but deemed acceptable by the FDA.)
   Antimicrobial effectiveness (per USP <51>)	Category 2: bacteria show ≥2.0 log reduction at 14 days, no increase from 14-day count at 28-day count; yeast/molds show no increase from initial calculated count at 14 and 28 days.	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
   Total yeast/mold count (per USP <61> & USP <62>)	< 10 cfu/mL	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
   Total aerobic microbial count (per USP <61> & USP <62>)	< 100 cfu/mL	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
   Absence of pathogenic organisms (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans - per USP <61> & USP <62>)	Absent	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
   Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic	Demonstrated to be non-cytotoxic, non-sensitizing, non-irritating, and not systemically toxic.
   Condom Compatibility (Natural Rubber Latex) (per ASTM D7661-10)	Compatible	Results show that Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms.
   Shelf-Life (per ASTM F1980-16)	All specifications from Section IV met throughout the study.	8.5 months shelf-life achieved; all specifications in Section IV were met throughout the shelf-life study.

2. Sample size used for the test set and the data provenance: This document describes non-clinical performance testing for a personal lubricant, not an AI/ML device using a "test set" in the machine learning sense. The tests are laboratory-based.

   • Sample Size: Not explicitly stated for each test (e.g., number of lubricant samples tested for pH, viscosity, microbial counts). For biocompatibility, it's not specified how many samples/subjects were used for the in-vitro and in-vivo tests. For condom compatibility, ASTM D7661-10 would specify the number of condoms and lubricant samples, but this detail is not provided in the summary. For shelf-life, a sufficient number of product units would have been put on accelerated aging.
   • Data Provenance: Not applicable in the geopolitical sense. The data comes from the results of laboratory testing conducted for the purpose of this 510(k) submission. These are not "retrospective or prospective" patient data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a lubricant is established by laboratory measurements (e.g., pH meter for pH, viscometer for viscosity, microbial culture for counts, established protocols for biocompatibility and condom compatibility). There are no human "experts" establishing a "ground truth" for classification or detection tasks as would be the case for an AI/ML device.

4. Adjudication method: Not applicable. This is not a human-reader study where adjudication is needed.

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 document is not about an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/ML device.

7. The type of ground truth used:

   • Physical Specifications: Instrumental measurements (pH meters, viscometers, osmolality readers) and laboratory assays (microbial cultures, particulate inspection).
   • Biocompatibility: In-vitro (cytotoxicity) and in-vivo (sensitization, irritation, acute systemic toxicity) testing according to ISO standards.
   • Condom Compatibility: Standardized mechanical and material property testing (ASTM D7661-10).
   • Shelf-Life: Stability testing over time under accelerated conditions according to ASTM F1980-16, measuring the physical specifications listed in the table.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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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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