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The Pallas M Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudarthrosis).

The Pallas M Spinal System consists of rods, screws, revision rod system, lilac rod system, MIS pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pallas M Spinal System:

The provided 510(k) submission does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance testing. Instead, this submission relies on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested sections (2-9) related to a performance study will be marked as "Not Applicable" or "Not Provided" because such a study was not performed for this specific submission as stated in the document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. No performance testing with a specific test set was conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable / Not Provided. No performance testing with expert-established ground truth was conducted for this 510(k) submission.

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

• Not Applicable / Not Provided. No performance testing requiring adjudication was conducted for this 510(k) submission.

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 / Not Provided. This device is a pedicle screw spinal system, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.

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

• Not Applicable / Not Provided. This device is a pedicle screw spinal system, not an algorithm. No standalone performance evaluation was done.

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

• Not Applicable / Not Provided. No performance testing requiring ground truth was conducted for this 510(k) submission.

8. The sample size for the training set

• Not Applicable / Not Provided. This submission is for a medical device (spinal implant), not an AI algorithm requiring a training set.

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

• Not Applicable / Not Provided. This submission is for a medical device (spinal implant), not an AI algorithm.

Summary of the Study (or lack thereof) to Prove Acceptance:

The Pallas M Spinal System obtained 510(k) clearance by demonstrating substantial equivalence to an existing legally marketed device, the "Pallas M Spinal System (Korea Bone Bank Co., Ltd.; K102574)".

The key points from the submission are:

• No additional testing was performed for this 510(k) submission. The device's safety and effectiveness were concluded by comparing its design, materials, indications for use, intended use, packaging, labeling, and performance to the predicate device.
• The difference between the subject device and the predicate device is limited to the addition of curved rods and new surgical instruments. The submission implies these minor differences do not alter the fundamental safety and effectiveness profile such that new performance testing would be required.
• The FDA's clearance is based on the determination that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective as the legally marketed device to which it is compared. This is a common pathway for medical device clearances where new performance data specific to the device being submitted is not always required if equivalence to an already cleared device can be sufficiently demonstrated.

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