(192 days)
The Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.
The Medline ReNewal Reprocessed Carter-Thomason Suture Passer Set (models CTI-512N, CTI-1015N, PG-15S, and PG-5/10) is a sterile, single-case use, hand-held suture grasping device that is designed to pass suture through soft tissue.
The provided text describes a 510(k) submission for a reprocessed medical device, the "Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer Instrument Set." This submission aims to prove substantial equivalence to an existing predicate device, not necessarily to meet specific performance criteria as one might find for novel AI/software as a medical device (SaMD) products.
Therefore, the structure of the acceptance criteria and the study that proves the device meets them will differ significantly from what would be expected for an AI-based diagnostic tool. The "acceptance criteria" here are based on demonstrating that the reprocessed device performs functionally identically and safely to the original, legally marketed device.
Here's an analysis based on the provided text, using the requested categories where applicable:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a quantitative table of acceptance criteria with specific numerical thresholds for performance metrics. Instead, it describes a series of tests conducted to demonstrate equivalence. The "acceptance criteria" are implicitly that the reprocessed device performs equivalently to the original device in key functional and safety attributes.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Summary from text) |
|---|---|
| Functional Equivalence | Demonstrated through "simulated use" and "device integrity" testing. The reprocessed device is stated to have "identical" technological characteristics and "functional performance specifications" to the predicate device. |
| Cleaning Effectiveness | Demonstrated by testing for residues: protein, carbohydrates, and hemoglobin. No specific numerical thresholds or residual levels are provided, but the successful completion of these tests indicates the device meets the reprocessor's cleaning standards. |
| Biocompatibility | Demonstrated by testing for: cytotoxicity, sensitization, irritation, pyrogenicity, and acute systemic toxicity. The implication is that the reprocessed device is as biocompatible as the original. |
| Performance Qualification | Not explicitly detailed, but stated as a conducted test, implying the device performs as expected under defined conditions. |
| Sterilization Validation | Stated as a conducted test, implying the device can be consistently sterilized to appropriate levels for single-use, sterile devices. |
| Product Stability | Stated as a conducted test, implying the device maintains its characteristics over its defined shelf-life. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the number of individual reprocessed devices tested for each category (e.g., how many devices were subjected to simulated use, or cleaning tests). It simply lists the types of tests performed.
- Data Provenance: Not explicitly stated regarding the origin of the reprocessed devices used for testing (e.g., country of origin of the used devices before reprocessing). The tests are described as being performed by the reprocessor, Medline ReNewal. The nature of the study is retrospective in the sense that existing used devices are collected for reprocessing and subsequent testing, although the testing itself is prospective on those reprocessed units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable in the context of this device type and submission. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is primarily relevant for diagnostic devices (especially AI/SaMD). For a reprocessed surgical instrument, the "ground truth" is its functional performance and safety profile, which is established through objective, standardized engineering and biological testing, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers or algorithms interpret data and discrepancies need to be resolved. For evaluating the physical and biological properties of a reprocessed surgical instrument, such methods are irrelevant. Test results are based on objective measurements against predefined specifications.
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. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical data (e.g., radiologists reading X-rays). This device is a surgical instrument used to pass suture, not a diagnostic tool, and involves no "human readers" in the context of interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this reprocessed device is established through:
- Engineering Performance Specifications: The device must meet the original manufacturer's specifications for mechanical function, integrity, and dimensions.
- Cleaning Efficacy Standards: Demonstrated by the absence of significant biological residues.
- Sterility Assurance Levels: Proven through sterilization validation.
- Biocompatibility Standards: Proven through direct testing on the reprocessed materials.
These are objective, measurable criteria, not subjective interpretations requiring expert consensus or pathology, nor are they based on patient outcomes data for the pre-market submission (though post-market surveillance would track adverse events).
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI model, this question is irrelevant to the reprocessing of a surgical instrument.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.