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The WASTON General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) spinal stenosis. It is not intended for pedicle screw fixation above T8.

The WASTON General Spinal System consists of Fixed-Angle Screws, Fixed-Angle Reduction Screws, Rods, Crosslink and Set Screws. The proposed general spinal system is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The document provided is a 510(k) premarket notification for the WASTON General Spinal System, identifying it as a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Trauson General Spinal System, K082617) through non-clinical testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact sample size for the mechanical tests conducted per ASTM F1717-14. It only states that "Non clinical tests were conducted." Typically, these tests involve multiple samples for each component or construct configuration, but the precise numbers are not disclosed in this summary.
• Data Provenance: The device manufacturer is Changzhou Waston Medical Appliance Company, Limited, located in China. Therefore, the non-clinical test data was likely generated in China, associated with the manufacturer or a contracted testing facility. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

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

• This information is not applicable to this submission. The "test set" in this context refers to non-clinical, mechanical performance testing of a spinal implant system. The "ground truth" is established by adherence to a recognized standard (ASTM F1717-14) and the physical properties of the materials and device design, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

• This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting human-read data or clinical endpoints. For mechanical testing against a standard, the results are objectively measured and compared to the standard's pass/fail criteria, often requiring a pass for all tested samples.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study is relevant for AI-powered diagnostic or interpretive devices, which is not the case for a spinal implant system.

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

• No, a standalone algorithm performance study was not done. This device is a physical spinal implant system, not an algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study would not be relevant.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" is typically defined by established engineering standards and material specifications. The device's performance is compared against the requirements and methodologies outlined in:
  • ASTM F1717-14 for mechanical performance (static compression bending, dynamic compression bending, static torsion).
  • ASTM F136-02a for material composition and properties.
  • ISO 17665-1: 2006 for sterilization validation.

8. The Sample Size for the Training Set

• This information is not applicable to this submission. "Training set" refers to data used to train machine learning models. As this device is a physical spinal implant system and does not involve AI or algorithms, there is no training set in this context.

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

• This information is not applicable as there is no training set for this type of device.

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WASTON Metallic Bone Plate and Screw Systems are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femuri

The proposed products, WASTON Metallic Bone Plate and Screw Systems, contain (1) Distal lateral femoral (condylar) LOC plate, (2) Bone screws and (3) various specific instruments.

The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

The provided document does not describe the acceptance criteria and study for a software-based AI/ML device. Instead, it details a 510(k) premarket notification for "WASTON Metallic Bone Plate and Screw Systems," which are physical orthopedic implants.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this document.

The document focuses on demonstrating the substantial equivalence of the metallic bone plates and screw systems to predicate devices through non-clinical mechanical testing and material standards conformance.

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The Disposable Circular Stapler is intended to be used throughout the alimentary tract for the creation of end-to-end and end-to-side anastomosis.

The Disposable Circular Stapler places a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. It is applicable to end-to-end and end-to-side anastomosis. The proposed device is provided EO sterilized.

The provided text is a 510(k) Summary for a medical device (Disposable Circular Stapler) and the FDA's response. It does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the way typically expected for an AI/CADe device. The "Testing Conclusion" section states: "Performance testing was conducted to validate and verify that the proposed device, Disposable Circular Stapler met all design specifications and was substantially equivalent to the predicate device." However, it does not provide details about what those design specifications (acceptance criteria) were, nor does it describe the study that was conducted.

Therefore, most of the requested information cannot be extracted from the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document states "Performance testing was conducted to validate and verify that the proposed device... met all design specifications," but it does not list these specific design specifications (acceptance criteria) or the quantitative results of the device's performance against them.

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

• Cannot be provided. The document states "Performance testing was conducted," but it does not specify any test set size, data provenance, or the nature of the data (e.g., in-vitro, ex-vivo, in-vivo animal, or human clinical data).

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):

• Cannot be provided. There is no mention of ground truth establishment by experts for a test set, as this is not a study of diagnostic accuracy or similar performance for which expert consensus would typically be required. The device is a surgical stapler, and its performance evaluation would likely involve mechanical and functional testing, not expert interpretation of outputs.

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

• Cannot be provided. As there's no mention of a test set or expert involvement, adjudication methods are not applicable and not discussed.

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:

• Cannot be provided. This is not an AI/CADe device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed or reported.

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

• Cannot be provided. This is a physical surgical device, not an algorithm. Standalone algorithm performance is not applicable.

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

• Cannot be provided. The concept of "ground truth" as typically applied in AI/CADe studies (e.g., for diagnostic accuracy) does not directly apply to the performance testing of a mechanical surgical stapler. Its "ground truth" would likely be defined by engineering specifications, material properties, and functional tests (e.g., staple formation, burst pressure, tissue compression, leak tests). The document does not detail these.

8. The sample size for the training set:

• Cannot be provided. The device is a physical stapler, not a machine learning model, so there is no training set in the context of AI.

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

• Cannot be provided. As above, there is no training set for this type of device.

In summary: The provided document is a 510(k) summary for a physical surgical device. It states that performance testing was conducted to verify that the device met design specifications and was substantially equivalent to a predicate device. However, it does not provide the specific details of these design specifications (acceptance criteria) or the methodology, sample sizes, or results of the performance testing in the manner typically expected for a detailed study report of an AI/CADe device. The questions posed are primarily relevant to AI/CADe device evaluation, which is not what this document addresses.

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